Dermatitis Atópica: Avances en su comprensión y abordaje clínico

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Dermatitis atópica: avances en su comprensión y abordaje clínico

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Explorando la psoriasis: aspectos generales de la enfermedad cutánea

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La nutrición y la enfermedad inflamatoria del intestino

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Dolor de espalda baja: aprendiendo a combatir al enemigo

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Soledad y aislamiento social: sus efectos en la salud física y mental del adulto mayor

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El capitolio de puerto rico se enciende de verde por los pacientes de dermatitis atópica

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Transcurrió el panel “cirugía 2.0: Una nueva era en la cirugía robótica”

Por: Reina M. González, MD, Lorna Torres, MD, Chavely Calderón, MS IV, Fitzgeraldo Sánchez, MD FAAD. Departamento de Dermatología Escuela de Medicina Ponce Health Sciences University Agosto 2023 Ponte al día con la agenda médica y las convenciones más relevantes para médicos, pacientes y profesionales de la salud. Pag. 38

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CONTENIDO 28 LA NUTRICIÓN Y LA ENFERMEDAD INFLAMATORIA DEL INTESTINO

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DERMATITIS ATÓPICA: AVANCES EN SU COMPRENSIÓN Y ABORDAJE CLÍNICO

EXPLORANDO LA PSORIASIS: ASPECTOS GENERALES DE LA ENFERMEDAD CUTÁNEA

DOLOR DE ESPALDA BAJA: APRENDIENDO A COMBATIR AL ENEMIGO

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EL CAPITOLIO DE PUERTO RICO SE ENCIENDE DE VERDE POR LOS PACIENTES DE DERMATITIS ATÓPICA

TRANSCURRIÓ EL PANEL “CIRUGÍA 2.0: UNA NUEVA ERA EN LA CIRUGÍA ROBÓTICA”

48 SOLEDAD Y AISLAMIENTO SOCIAL: SUS EFECTOS EN LA SALUD FÍSICA Y MENTAL DEL ADULTO MAYOR

EDITOR FUNDADOR Juan Carlos Orengo Valverde, MD, MPH, PhD EDITOR Alberto Santiago Cornier, MD, PhD CONSEJO ASESOR Oscar Soto Raíces, MD, Ahmed Morales, MD, FACP, FACG, FASGE, AGAF, Lcda. Wanda González fisióloga del ejercicio PRINCIPAL OFICIAL EJECUTIVO Pedro Carlos Lugo Hernández III, P.A.C. PRESIDENTA Y FUNDADORA Glorybelle Hernández Figueroa, MBA VICEPRESIDENTA Y FUNDADORA Laila Paloma Lugo, MBA CONTABILIDAD Julio Soto ADMINISTRACIÓN Marta Ivelisse Vélez Ramos, MBA, MARKETING Y SERVICIOS 360 Darlene Rodríguez, Yasmin Morell, Belinda Burgos PERIODISTAS Mayra Acevedo, Luis Penchi, Limarys Suárez DIRECCIÓN GRÁFICA Natalia Zoé Rivera Torres ARTISTA GRÁFICO Jhorman González DIRECTOR AUDIOVISUAL Christopher Soto REALIZADORA AUDIOVISIAL Salomé Mateus, Duban Valencia FOTOS Revista Medicina y Salud Pública DIRECCIÓN GENERAL / FUNDADOR Carlos Alexis Lugo Marrero DISTRIBUCIÓN OFICINAS Y TORRES MÉDICAS Editorial Mundo ENVÍO DE REVISTAS Y DISTRIBUCIÓN A GRUPOS MÉDICOS Servicio de correo postal/Comunicación Inteligente Para ventas y otros servicios pueden comunicarse al 787.848.3333, msp@editorialmundo.com o www.medicinaysaludpublica.com Revista Puertorriqueña de Medicina y Salud Pública ISSN 1937-8521 COMITÉ EDITORIAL CIENTÍFICO COMITÉ EDITORIAL Olga Rodríguez, MD - Decana Escuela de Medicina de Ponce (Puerto Rico), Vivian Green, LND, MS, PhD, Sub editora y fundadora (Puerto Rico), José Cordero, MD, MPH - Exdecano Escuela Graduada Salud Pública Recinto de Ciencias Médicas UPR (Puerto Rico), Ángeles Rodríguez, MD, MPH (Puerto Rico), Simón Carlo, MD (Puerto Rico), Bárbara Rosado, MD (Puerto Rico), Idhaliz Flores PhD (Puerto Rico), Jesús Cruz-Correa, MD, FACOG (Puerto Rico), Rafael Bredy, MD, LicMTo, MBE, MS (Puerto Rico), David Caseida, MD, FACOG, (Puerto Rico), José Capriles, MD, MHSA (Puerto Rico) Joaquín Laboy, MD, FACOG (Puerto Rico), Luis Adrian Rivera Pomales, MD, PEMBA, MPH, CMQ (Puerto Rico), Juan Fernández, MS, PhD (Puerto Rico), Nuria Sebate, MD (Puerto Rico), Pedro Amador, MD, MPH (Puerto Rico), Nydia Cappas, PsyD (Puerto Rico), Luis Franco, MD (Puerto Rico), Federico Montealegre, DVM, PhD, Msc (Puerto Rico), Nydia Ortiz, PsyD (Puerto Rico), José Pons, PhD, FPPR (Puerto Rico), Esdrás Vélez, JD, MPH (Puerto Rico), Diego Zavala, MSc, PhD, (Puerto Rico), Ana Torres-Martín, MD (Puerto Rico), Julio Cádiz, MD, MPH (Puerto Rico), Rafael Gómez-Cuevas (Colombia), José Javier Orengo, PhD(c) (España), Cesar A. Del Rey, MD (Panamá), Pedro Serrano, MD, PhD (España), Luis Serra-Majem, MD, PhD (España), José Ramón Calvo, MD, PhD (España).

Síguenos en www.medicinaysaludpublica.com, www.facebook.com/revistamsp, en Twitter @revistamsp, en LinkedIn como Revista Puertorriqueña de Medicina y Salud Pública. Las normas editoriales de la Revista Puertorriqueña de Medicina y Salud Pública para la publicación de artículos originales y cartas al editor pueden ser accesadas en la página web: www.medicinaysaludpublica.com, y solicitadas a través de msp@editorialmundo.com.

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EDITORIAL Preocupante la Escasez de Cirujanos Vasculares en Puerto Rico Durante la última década, un significativo número de residentes de Puerto Rico ha experimentado dificultades en el acceso a la atención médica. Este problema se presenta como un desafío complejo y multifacético, siendo la escasez de profesionales médicos uno de los factores predominantes en esta problemática. A pesar de que esta situación fue anticipada hace años, las iniciativas y legislaciones que han tenido un impacto positivo en el aumento del número de médicos en la isla han sido escasas e inefectivas.

Varios estudios han estimado un déficit de más de 30,000 cirujanos y sus subespecialidades en los Estados Unidos, incluyendo la cirugía vascular. En respuesta a esta demanda, el sistema de formación médica en los Estados Unidos ha incrementado el número de plazas académicas para la capacitación de cirujanos vasculares.

Sin embargo, se proyecta que no será sino hasta el año 2050 que la cantidad de cirujanos vasculares esté en consonancia con la demanda de sus servicios. En contraste con la situación en los Estados Unidos, Puerto Rico carece de un programa de formación acreditado en Cirugía Vascular, lo que agrava aún más este problema.

En la actualidad, la isla cuenta con solamente 14 cirujanos vasculares, con un promedio de edad de 55 años, muchos de los cuales tienen previsto retirarse en los próximos años. Según las recomendaciones de la Sociedad de Cirujanos Vasculares Americana, para atender adecuadamente a la población se requeriría alrededor de 1 cirujano vascular por cada 100,000 habitantes. Esto nos ubica en un déficit de aproximadamente 20 cirujanos vasculares. ¿Cómo hemos llegado a esta situación? En la isla, solo se ofrecen dos programas de cirugía general, graduando un total de 9 cirujanos al año entre ambos programas.

De estos graduados, solo un pequeño porcentaje manifiesta el deseo de continuar dos años adicionales de entrenamiento en cirugía vascular. Además, de los que aspiran a especializarse en esta subespecialidad, no todos logran obtener una plaza en un campo altamente competitivo.

Aquellos que consiguen una plaza de entrenamiento en cirugía vascular se ven obligados a emigrar a los Estados Unidos, ya que en Puerto Rico no existe un programa de formación en esta área. Los profesionales médicos que reciben entrenamiento en los Estados Unidos suelen encontrar oportunidades laborales abundantes y atractivas. Por cada graduado en cirugía vascular, existen cuatro puestos de trabajo disponibles, y los hospitales estadounidenses implementan

estrategias de reclutamiento efectivas. Por lo tanto, no es sorprendente que, de la generación de cirujanos vasculares puertorriqueños con edades comprendidas entre los 35 y 45 años, haya más del triple ejerciendo en los Estados Unidos que en Puerto Rico, a pesar de que muchos obtuvieron sus títulos en medicina y entrenamiento en cirugía general en la isla.

Es imperativo que el gobierno y los hospitales en la isla tomen medidas concretas para abordar esta situación.

Esto incluye la creación de nuevos programas de formación en cirugía general y vascular y un incremento en los esfuerzos de reclutamiento de cirujanos vasculares puertorriqueños. Asimismo, es crucial desarrollar herramientas de capacitación para médicos primarios en el manejo de enfermedades vasculares y establecer sistemas de transferencia de pacientes accesibles para las zonas desatendidas de la isla. Por igual es de suma importancia para los cirujanos vasculares dedicar esfuerzos significativos a la mentoría y la promoción acerca de esta especialidad entre los estudiantes de medicina y los residentes de cirugía.

La falta de cirujanos vasculares es solo un ejemplo de los numerosos problemas que afectan a diversas subespecialidades médicas en Puerto Rico, cada uno con sus desafíos particulares. Si no se inicia un proceso de cambio, el futuro para la población puertorriqueña en términos de atención médica se vislumbra desalentador y preocupante.

Dr. Rafael Santini Domínguez FACS Presidente de la Sociedad de Cirujanos Vasculares y Endovasculares de Puerto Rico Caribbean Vascular Center Ponce PR

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DERMATITIS ATÓPICA: AVANCES EN SU COMPRENSIÓN Y ABORDAJE CLÍNICO

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Reina M. González, MD Departamento de Dermatología Escuela de Medicina Ponce Health Sciences University Agosto 2023

Chavely Calderón, MS IV Departamento de Dermatología Escuela de Medicina Ponce Health Sciences University Agosto 2023

Lorna Torres, MD Departamento de Dermatología Escuela de Medicina Ponce Health Sciences University Agosto 2023

Fitzgeraldo Sánchez, MD FAAD Departamento de Dermatología Escuela de Medicina Ponce Health Sciences University Agosto 2023

RESUMEN

INTRODUCCIÓN

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a dermatitis atópica es una enfermedad crónica de la piel que se caracteriza por disfunción de la barrera de la piel, picor e inflamación.

Es una enfermedad compleja que resulta de la interacción entre factores genéticos, inmunológicos y ambientales.

Está asociada a otros trastornos atópicos, como lo son la rinitis alérgica y el asma. Puede afectar a personas de todas las edades, pero es más común en niños y es más prevalente en países desarrollados. El tratamiento de la dermatitis atópica implica el control de la inflamación, la hidratación adecuada de la piel y el manejo de los factores desencadenantes, en adición del uso de medicamentos tópicos o sistémicos para aliviar los síntomas y prevenir exacerbaciones. Es importante trabajar en colaboración con un profesional de la salud, como un dermatólogo, para desarrollar un plan de tratamiento personalizado para controlar esta condición crónica.

a dermatitis atópica, también conocida como eccema atópico, es una enfermedad de la piel crónica y recurrente que se caracteriza por picazón intensa e inflamación en la piel. Esta puede verse acompañada de rinitis alérgica y asma formando así la triada atópica. La dermatitis atópica suele ser más prevalente en países desarrollados y áreas urbanas por lo que se ha especulado que la exposición a contaminantes puede ser parte de su patogénesis. En Estados Unidos, la prevalencia de la dermatitis atópica en la población infantil alcanza hasta un 20% y aproximadamente un 3% en los adultos, lo que la convierte en la enfermedad inflamatoria crónica de la piel más común.

La piel de quienes padecen esta afección suele ser más sensible y propensa a la resequedad, lo que puede llevar a la aparición de enrojecimiento, inflamación, ampollas y

descamación. La picazón intensa es un síntoma característico y puede provocar un ciclo de rascado que empeora la inflamación. Factores de riesgo pueden incluir historial familiar de condiciones atópicas, historial personal de alergias y exposición ambiental a alergenos. La condición mayormente presenta antes de los 5 años pero puede presentarse a cualquier edad. De los síntomas comenzar antes de los dos años, se le denomina dermatitis atópica de inicio temprano. De iniciar luego de la pubertad, se denomina como dermatitis atópica de inicio tardío. Por otro lado, se le conoce como dermatitis atópica de inicio senil cuando los síntomas comienzan después de los 60 años. Los pacientes con inicio de síntomas antes de los 6 meses de vida tienden a tener un curso de enfermedad más severo.

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PATOFISIOLOGÍA La dermatitis atópica es una enfermedad compleja que resulta de la interacción entre factores genéticos, inmunológicos y ambientales. La piel de las personas con dermatitis atópica suele presentar una barrera cutánea disfuncional. La capa más externa de la piel, llamada estrato córneo, es responsable de mantener la humedad y proteger contra los alérgenos, irritantes y microorganismos. Se han identificado mutaciones en genes codificantes de proteínas de la epidermis como los son FLG, la cual codifica para filagrina, y SPINK. Las mutaciones en el gen filagrina (FLG) causan alteraciones en la barrera epidermal y se han asociado al desarrollo temprano y severo de la dermatitis atópica. Si la epidermis está comprometida, permite la pérdida de agua y la entrada de sustancias irritantes y alérgenos.

Adicional a esto, la dermatitis atópica está asociada a una respuesta inmunológica alterada, donde el sistema inmunológico reacciona exageradamente ante estímulos que normalmente no desencadenarían una respuesta significativa. En particular, se ha observado una mayor producción de ciertas citoquinas proinflamatorias, como interleucinas IL-4, IL-13 e IL-31.

Estas citoquinas desempeñan un papel importante en la inflamación y en la estimulación de las células T y células B involucradas en la respuesta inmune. La picazón intensa es uno de los síntomas más prominentes de la dermatitis atópica. Esto está relacionado con la liberación de mediadores inflamatorios,

como IL-31 e histamina, que actúan sobre los receptores de picazón en la piel creando un ciclo de rascado y picazón que irrita la piel y agrava la inflamación.

La dermatitis atópica aguda está mayormente asociada a la actividad de células T auxiliares tipo 2 (Th2), presencia de eosinofilia, aumento en la producción de inmunoglobulinas tipo E y disminución de péptidos antimicrobiales en la epidermis. Por otra parte, la dermatitis atópica crónica posee mayor presencia de células T auxiliares tipo 1 (Th1) con aumentos de moléculas de interferón tipo gama apuntando más hacia un estado de inflamación crónica.

DIAGNÓSTICO La dermatitis atópica se diagnostica clínicamente. La evaluación comienza con la toma de un historial clínico completo en el cual es esencial preguntar por la presencia de picor, incluyendo en el cuero cabelludo, y la presencia de al menos tres de los siguientes síntomas: piel reseca, historial de rinitis alérgica o asma, comienzo antes de los 2 años y/o historial de lesiones en pliegues cutáneos. Luego se procede a realizar un examen físico en busca de las características típicas como enrojecimiento, inflamación, resequedad, descamación y áreas de piel engrosada. Es importante notar la ubicación y distribución de las lesiones ya que son pistas para el diagnóstico.

la severidad de la condición. Lesiones agudas suelen ser pápulas o placas eritematosas y vesículas con costras que producen un picor severo. Lesiones subagudas o crónicas son pápulas o placas secas, eritematosas y escamosas o liquenificaciones y fisuras. Pacientes con piel oscura presentan con eritema marrón oscuro o violáceo y resequedad, mientras que aquellos con piel clara presentan eritema rosada. Dermatitis atópica en infantes menores de dos años presenta como picor y pápulas difusas, eritematosas, escamosas y costrosas en las mejillas, cuero cabelludo y regiones extensoras. Notablemente, las lesiones no presentan en el área del pañal. La condición se manifiesta en menores entre los 2 a 16 años como placas de liquenificación y en adultos como liquenificación local crónica en regiones flexoras. Otras características asociadas incluyen xerosis, queratosis pilar, líneas Dennie-Morgan, oscurecimiento periorbital (“ojeras alérgicas”) o pliegue nasal exagerado (el llamado “saludo alérgico”).

No hay pruebas de laboratorios específicas para diagnosticar la dermatitis atópica. Niveles elevados de eosinófilos y/o de IgE son sugestivos de la condición, pero su ausencia no la descarta. En casos pediátricos con dermatitis atópica severa o refractaria se podría considerar hacer pruebas para identificar hipersensibilidades a alimentos si hay una asociación entre alimentos y exacerbación de síntomas.

La presentación clínica puede variar por la edad y etnicidad del paciente y

TRATAMIENTO El tratamiento de la dermatitis atópica incluye farmacoterapia tópica y sistémica.

La selección dependerá de la severidad de la condición. Se suele categorizar la dermatitis atópica como leve en aquellos con áreas de piel seca, picor intermitente, poca afectación de sus actividades diarias, sueño y calidad de vida. La enfermedad moderara se considera aquella que posee áreas de piel seca, picor intermitente, enrojecimiento, impacto notable en actividades del diario vivir, perturbación del sueño y el malestar psicosocial. Se considera severa aquella enfermedad con áreas prominentes de piel seca, picor incesante, enrojecimiento, endurecimiento de la piel, fisuras y limitaciones en el diario vivir.

La educación al paciente y a los cuidadores, en caso de un paciente pediátrico, es fundamental. Los pacientes deben mantener su piel limpia e hidratada, identificar y evitar factores agravantes, y manejar infecciones lo más pronto posible. Al tener defectos en su barrera protectora de la piel, pacientes con dermatitis atópica deben utilizar humectantes luego de bañarse y lavarse las manos para preservar la integridad de la epidermis. Los humectantes en crema o ungüentos con bases en aceite son los más que protegen de la xerosis.

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Los corticoesteroides tópicos (CT) son muy importantes en el tratamiento de la dermatitis atópica. Para casos leves se recomiendan que sean de baja potencia. Para casos moderados a severos se recomienda corticosteroides tópicos de mediana a alta potencia.

Es importante señalar que la cara y pliegues son áreas de alto riesgo de sufrir de atrofia en la piel por corticosteroides por lo que se recomienda el uso de esteroides de baja potencia en estas zonas. Los inhibidores tópicos de la calcineurina, como el tacrolimus y el pimecrolimus, son agentes no esteroides e inmunomoduladores que no causan atrofia cutánea ni otros efectos adversos inducidos por corticosteroides. Pueden

ser utilizados como alternativa a los corticosteroides tópicos para el tratamiento de la dermatitis atópica leve a moderada en el rostro, incluyendo los párpados, el cuello y los pliegues cutáneos.

Uso de tratamientos sistémicos es considerado para pacientes con dermatitis atópica moderada o severa. La fototerapia con sus distintas modalidades de luz ultravioleta tiene propiedades antiinflamatorias que ayudan a reducir la picazón en casos recalcitrantes. Los anticuerpos monoclonales y los inhibidores de JAK modulan el sistema inmunológico de manera más dirigida. Entre los

anticuerpos monoclonales se encuentran dupilumab y tralokinumab. El dupilumab es un inhibidor de IL-4 e IL-13 aprobado para pacientes adultos y pediátricos mayores de 6 meses. El tralokinumab es un inhibidor de IL-13 aprobado para pacientes adultos mayores de 18 años.

Ambos son administrados de manera subcutánea. Entre los inhibidores de JAK se encuentran abrocitinib y upadacitinib para uso en pacientes adultos y pediátricos mayores de 12 años. Aprobado en Europa pero aún bajo escrutinio de la FDA, se encuentra también baricitinib. Estos inhibidores de JAK son medicamentos orales para considerarse en casos más severos o refractarios a otras terapias.

CONCLUSIÓN

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a dermatitis atópica es una condición crónica de la piel caracterizada por inflamación, disfunción de la barrera de la piel, picazón y resequedad. Su origen multifactorial involucra factores genéticos, inmunológicos y ambientales.

El síntoma principal es la picazón, con posterior desarrollo enrojecimiento hasta lesiones cutáneas visibles. El diagnóstico, basado en la evaluación clínica y la historia médica, es crucial para un tratamiento efectivo.

Enfoques terapéuticos incluyen hidratación, uso de corticosteroides tópicos, inmunomoduladores y estrategias de prevención. Si bien no existe una cura definitiva, un manejo multidisciplinario, con la orientación de profesionales de la salud, puede proporcionar alivio y mejorar la calidad de vida de quienes padecen esta afección.

REFERENCIAS Ashcroft, D. M., Dimmock, P., Garside, R., Stein, K., & Williams, H. C. (2005). Efficacy and tolerability of topical pimecrolimus and tacrolimus in the treatment of atopic dermatitis: meta analysis of randomised controlled trials. BMJ (Clinical Research Ed.), 330(7490), 516–522. https://doi. org/10.1136/BMJ.38376.439653.D3 Drucker, A. M., Ellis, A., Jabbar-Lopez, Z., Yiu, Z. Z. N., Arents, B. W. M., Burton, T., Spuls, P. I., Küster, D., Schmitt, J., & Flohr, C. (2018). Systemic immunomodulatory treatments for atopic dermatitis: protocol for a systematic review with network metaanalysis. BMJ Open, 8(8). https://doi. org/10.1136/BMJOPEN-2018-023061 Eichenfield, L. F., Tom, W. L., Berger, T. G., Krol, A., Paller, A. S., Schwarzenberger, K., Bergman, J. N., Chamlin, S. L., Cohen, D. E., Cooper, K. D., Cordoro, K. M., Davis, D. M., Feldman, S. R., Hanifin, J. M., Margolis, D. J., Silverman, R. A., Simpson, E. L., Williams, H. C., Elmets, C. A., … Sidbury, R. (2014).

Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. Journal of the American Academy of Dermatology, 71(1), 116–132. https://

doi.org/10.1016/J.JAAD.2014.03.023 Eichenfield, L. F., Tom, W. L., Chamlin, S. L., Feldman, S. R., Hanifin, J. M., Simpson, E. L., Berger, T. G., Bergman, J. N., Cohen, D. E., Cooper, K. D., Cordoro, K. M., Davis, D. M., Krol, A., Margolis, D. J., Paller, A. S., Schwarzenberger, K., Silverman, R. A., Williams, H. C., Elmets, C. A., … Sidbury, R. (2014). Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. Journal of the American Academy of Dermatology, 70(2), 338–351. https:// doi.org/10.1016/J.JAAD.2013.10.010 Ellis, C., Luger, T., Abeck, D., Allen, R., Graham-Brown, R. A., De Prost, Y., Eichenfield, L. F., Ferrandiz, C., Giannetti, A., Hanifin, J., Koo, J. Y., Leung, D., Lynde, C., Ring, J., Ruiz Maldonado, R., & Saurat, J. H. (2003). International Consensus Conference on Atopic Dermatitis II (ICCAD II): clinical update and current treatment strategies. The British Journal of Dermatology, 148 Suppl 63, 3–10. https:// doi.org/10.1046/J.1365-2133.148.

S63.1.X Gerner, T., Haugaard, J. H., Vestergaard, C., Deleuran, M., Jemec, G. B., Mortz, C.

G., Agner, T., Egeberg, A., Skov, L., & Thyssen, J. P. (2021). Disease severity and trigger factors in Danish children with atopic dermatitis: a nationwide study. Journal of the European Academy of Dermatology and Venereology : JEADV, 35(4), 948–957. https://doi. org/10.1111/JDV.17007 Giavina-Bianchi, M., & Giavina-Bianchi, P. (2019). Systemic Treatment for Severe Atopic Dermatitis.

Archivum Immunologiae et Therapiae Experimentalis, 67(2), 69–78. https://doi. org/10.1007/S00005-018-0521-Y Hulshof, L., Overbeek, S. A., Wyllie, A. L., Chu, M. L. J. N., Bogaert, D., de Jager, W., Knippels, L. M. J., Sanders, E. A. M., van Aalderen, W. M. C., Garssen, J., van’t Land, B., & Sprikkelman, A. B. (2018).

Exploring Immune Development in Infants With Moderate to Severe Atopic Dermatitis.

Frontiers in Immunology, 9(MAR). https:// doi.org/10.3389/FIMMU.2018.00630 Irvine, A. D., McLean, W. H. I., & Leung, D. Y. M. (2011). Filaggrin mutations associated with skin and allergic diseases. The New England Journal of Medicine, 365(14), 1315–1327. https://doi.org/10.1056/ NEJMRA1011040

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An IL-23 inhibitor for adults with moderate to severe plaque psoriasis (Ps)1

PICTURE WHAT IMPROVEMENT PICTURE WHAT IMPROVEMENT COULD LOOK LIKE COULD LOOK LIKE An IL-23 inhibitor for adults with moderate to severe plaque psoriasis (Ps)1

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ULTIMMA-1

88

ULTIMMA-2

% 75 5%

% 75 2%

% 88 8%

% 84 5%

(229/304)

(220/294)

(267/304)

84

(246/294)

(229/304) (5/102)

(220/294) (2 /98)

(267/304) (8/102)

(246/294) (5/98)

5%

2%

8%

5%

NRI=Non-Responder Imputation.

(5/102)

(2 /98)

NRI=Non-Responder Imputation.

MAINTENANCE OF RESPONSE1 MAINTENANCE In the randomized psoriasis 1 who trials, among patients OF RESPONSE

achieved PASI 90 at Week 16 In the randomized psoriasis trials, among patients who achieved PASI 290 at Week 16 STUDY DESIGN

(8/102)

(5/98)

88% 88%

MAINTAINED PASI 90 AT WEEK 52

(n=398/450)

MAINTAINED PASI 90 AT WEEK 52

(n=398/450)

UltIMMa-1 (N=506) and UltIMMa-2 (N=491) were replicate phase 3, randomized, double-blind, placebo- and active-controlled studies to evaluate the efficacy and 2 safety of SKYRIZI (150 mg) vs placebo over 16 weeks and biologic active control STUDY DESIGN over 52 weeks in adult patients with (N=491) moderate to severe plaque psoriasis.

SKYRIZI UltIMMa-1 (N=506) and UltIMMa-2 were replicate phase 3, randomized, (150 mg) was given as 2 subcutaneous injections at Weeks 0, 4, and 16, and every double-blind, placebo- and active-controlled studies to evaluate the efficacy and 12 weeks thereafter.

Co-primary endpoints were PASI 90 and sPGA 0/1 at safety of SKYRIZI (150 mg) vs placebo over 16 weeks and biologic active control Week vs placebo in patients each study (assessed imputation). over 5216weeks in adult with moderatebytonon-responder severe plaque psoriasis.

SKYRIZI (150 mg) was given as 2 subcutaneous injections at Weeks 0, 4, and 16, and every 12 weeks thereafter. Co-primary endpoints were PASI 90 and sPGA 0/1 at Week 16 vs placebo in each study (assessed by non-responder imputation).

PRESCRIBED BIOLOGIC IN

NEW AND SWITCHING

PLAQUE PSORIASIS PATIENTS

PRESCRIBED BIOLOGIC IN NEWdefined ANDasSWITCHING As of 10/2021. New patients bio-naïve; switch patients defined as bio-experienced switching biologics.

Source: Integrated PLAQUE PSORIASIS PATIENTS Symphony Health (PatientSource) and IQVIA (NSP) through proprietary method on diagnosis classification.1,3

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As of 10/2021. New patients defined as bio-naïve; switch patients defined as bio-experienced switching biologics. Source: Integrated Symphony Health (PatientSource) and IQVIA (NSP) through proprietary method on diagnosis classification.1,3

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ACTUAL PSORIASIS PATIENTS TREATED WITH SKYRIZI4 ACTUAL PSORIASIS PATIENTS TREATED WITH SKYRIZI4 WEEK 0 (BASELINE) WEEK 0 (BASELINE)

PATIENT FROM ILLINOIS

PATIENT FROM TEXAS

PATIENT FROM PENNSYLVANIA

PATIENT FROM ILLINOIS

PATIENT FROM TEXAS

PATIENT FROM PENNSYLVANIA

PATIENT FROM ILLINOIS

PATIENT FROM TEXAS

PATIENT FROM PENNSYLVANIA

WEEK 16 (AFTER 2 DOSES) PATIENT FROM ILLINOIS TEXAS PATIENT FROM PENNSYLVANIA Photos represent results captured atPATIENT baselineFROM and Week 16 from non–trial participant patients.

Co-primary endpoints for patients in the trial were PASI 90 and sPGA 0/1 at Week 16.2

WEEK 16 (AFTER 2 DOSES)

represent results captured at baseline and Week 16 from non–trial participant patients.

The patients depicted here have moderate to severe Actual SKYRIZI-treated patients.Photos PASI and/or sPGA achievement undefined.

Left: Photos courtesy Co-primary endpoints for patients in the trial courtesy were PASI at Week plaque0/1 psoriasis with16. an2 affected body surface area ≥10%. of Dr. Meyer Horn. Middle: Photos courtesy of Dr. Matthew Bruno, PA-C. Right: Photos of 90 and sPGA Dr. David Andrew Kasper.

The patients depicted here have moderate to severe Actual SKYRIZI-treated patients.

PASImore and/or sPGA courtesy Find realachievement patient undefined. imagesLeft: at Photos www.SkyriziHCP.com/dermatology plaque psoriasis with an affected body surface area ≥10%. of Dr. Meyer Horn. Middle: Photos courtesy of Dr. Matthew Bruno, PA-C. Right: Photos courtesy of Dr. David Andrew Kasper.

INDICATION1

Find more real patient images at www.SkyriziHCP.com/dermatology

SKYRIZI is indicated for the treatment of moderate to severe Tuberculosis (TB) plaque psoriasis in adults who are candidates for systemic therapy Prior to initiating treatment with SKYRIZI, evaluate for TB 1 or phototherapy. infection and consider treatment in patients with latent or INDICATION active TB for whom SKYRIZI is indicated for the treatment of moderate to severe Tuberculosis (TB) an adequate course of treatment cannot 1 be confirmed.

Monitor patients signs and symptoms of IMPORTANT SAFETY plaque psoriasis in adultsINFORMATION who are candidates for systemic therapy Prior to initiating treatment withfor SKYRIZI, evaluate for TB active TB during and after SKYRIZI treatment.

Do not Hypersensitivity or phototherapy. Reactions infection and consider treatment in patients with latent or administer SKYRIZI to patients active TB. SKYRIZI® (risankizumab-rzaa) is contraindicated in patients with a active TB for whom an adequatewith course of treatment cannot 1 to risankizumab-rzaa or history of serious hypersensitivity reaction Administration of Vaccines be confirmed. Monitor patients for signs and symptoms of IMPORTANT SAFETY INFORMATION any of the excipients.

Serious hypersensitivity reactions, including Avoid of live vaccines patients treated with SKYRIZI. activeuse TB during and after in SKYRIZI treatment.

Do not Hypersensitivity Reactions anaphylaxis, have been reported with the use of SKYRIZI. If a serious Medications that interact with the immune system may increase administer SKYRIZI to patients with active TB. SKYRIZI® (risankizumab-rzaa) is contraindicated in patients with a hypersensitivity occurs, discontinue and initiateor the risk of infection following administration of live vaccines. history of seriousreaction hypersensitivity reaction to SKYRIZI risankizumab-rzaa Administration of Vaccines appropriate therapy immediately.

Prior initiating SKYRIZI,incomplete age appropriate any of the excipients.

Serious hypersensitivity reactions, including Avoidto use of live vaccines patientsall treated with SKYRIZI. vaccinations according to current immunization guidelines.

Infection anaphylaxis, have been reported with the use of SKYRIZI. If a serious Medications that interact with the immune system may increase SKYRIZI may increase theoccurs, risk of infection.

DoSKYRIZI not initiate hypersensitivity reaction discontinue andtreatment initiate Adverse the risk ofReactions infection following administration of live vaccines. with SKYRIZItherapy in patients with a clinically important active infection appropriate immediately.

Most common (≥1%) adverse reactions with Prior to initiating SKYRIZI, complete all associated age appropriate until it resolves or is adequately treated.

SKYRIZI include upper respiratory infections, headache, vaccinations according to current immunization guidelines.

Infection site reactions, and tinea infections.

In patients with a chronic or a history of recurrent infection, fatigue, SKYRIZI may increase theinfection risk of infection.

Do not initiate treatment Adverseinjection Reactions consider the risks and benefits to prescribing Instruct with SKYRIZI in patients with aprior clinically importantSKYRIZI. active infection Most common (≥1%) phase adverse reactions associated In psoriatic arthritis 3 trials, the incidence of with hepatic patients to seekor medical advice iftreated. signs or symptoms of clinically until it resolves is adequately SKYRIZIwas include upper infections, headache, events higher withrespiratory SKYRIZI compared to placebo. important occur. infection If a patient an infection injection site reactions, and tinea infections.

In patientsinfection with a chronic or develops a history such of recurrent infection, fatigue, SKYRIZI is available in a 150 mg/mL prefilled syringe and pen. or is not responding to standard therapy, closely monitor and consider the risks and benefits prior to prescribing SKYRIZI. Instruct In psoriatic arthritis phase 3 trials, the incidence of hepatic discontinue SKYRIZI untiladvice the infection patients to seek medical if signs resolves. or symptoms of clinically events was higher with SKYRIZI compared to placebo. important If aof patient develops suchInformation an infection Please seeinfection the Brief occur.

Summary the Full Prescribing on the following SKYRIZIpage. is available in a 150 mg/mL prefilled syringe and pen. or is not responding to standard therapy, closely monitor and References: 1.

SKYRIZI [package insert].

North Chicago, IL: AbbVie Inc. 2.

Gordon KB, Strober B, Lebwohl M, et al.

Efficacy and safety of risankizumab in moderate-todiscontinue SKYRIZI until the infection resolves. severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet.

2018;392(10148):650-661. 3. Data on file, AbbVie Inc. In-play patient share. 2021. 4. Data on file, AbbVie Inc. Rep-fielded images. Presented: June 16, 2020.

Please see the Brief Summary of the Full Prescribing Information on the following page. © 2022 AbbVie. All rights reserved.

US-SKZD-220291

August 2022

Printed in U.S.A.

© 2022 AbbVie. All rights reserved.

US-SKZD-220291

August 2022

Printed in U.S.A.

References: 1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc. 2. Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-tosevere plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet.

2018;392(10148):650-661. 3. Data on file, AbbVie Inc. In-play patient share. 2021. 4. Data on file, AbbVie Inc. Rep-fielded images. Presented: June 16, 2020.

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SKYRIZI (sky-RIZZ-ee) (risankizumab-rzaa) injection, for subcutaneous use ®

150 mg/mL single-dose pen and prefilled syringe 600 mg/10 mL single-dose vial 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector INDICATIONS AND USAGE Plaque Psoriasis SKYRIZI® is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Psoriatic Arthritis SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.

Crohn’s Disease SKYRIZI is indicated for the treatment of moderately to severely active Crohn’s disease in adults.

CONTRAINDICATIONS SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients [see Warnings and Precautions].

WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately [see Adverse Reactions].

Infections SKYRIZI may increase the risk of infections [see Adverse Reactions].

Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer SKYRIZI until the infection resolves.

Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SKYRIZI. Across the Phase 3 psoriasis clinical studies, of the 72 subjects with latent TB who were concurrently treated with SKYRIZI and appropriate TB prophylaxis during the studies, none developed active TB during the mean follow-up of 61 weeks on SKYRIZI. Two subjects taking isoniazid for treatment of latent TB discontinued treatment due to liver injury. Of the 31 subjects from the PsO-3 study with latent TB who did not receive prophylaxis during the study, none developed active TB during the mean follow-up of 55 weeks on SKYRIZI. Consider anti-TB therapy prior to initiating SKYRIZI in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB. Hepatotoxicity in Treatment of Crohn’s Disease A serious adverse reaction of drug-induced liver injury was reported in a patient with Crohn’s disease (ALT 54x ULN, AST 30x ULN, and total bilirubin 2.2x ULN) following two intravenous doses of SKYRIZI 600 mg in conjunction with a rash that required hospitalization. The liver test abnormalities resolved following administration of steroids. SKYRIZI was subsequently discontinued.

For the treatment of Crohn’s disease, evaluate liver enzymes and bilirubin at baseline, and during induction at least up to 12 weeks of treatment. Monitor thereafter according to routine patient management.

Consider other treatment options in patients with evidence of liver cirrhosis.

Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded.

Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.

Administration of Vaccines Avoid use of live vaccines in patients treated with SKYRIZI. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy with SKYRIZI, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or inactive vaccines.

ADVERSE REACTIONS The following adverse reactions are discussed in other sections of labeling: • Hypersensitivity Reactions [see Warnings and Precautions] • Infections [see Warnings and Precautions] • Tuberculosis [see Warnings and Precautions] • Hepatotoxicity in Treatment of Crohn’s disease [see Warnings and Precautions] Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Plaque Psoriasis A total of 2234 subjects were treated with SKYRIZI in clinical development trials in plaque psoriasis. Of these, 1208 subjects with psoriasis were exposed to SKYRIZI for at least one year.

Data from placebo- and active-controlled trials were pooled to evaluate the safety of SKYRIZI for up to 16 weeks. In total, 1306 subjects were evaluated in the SKYRIZI 150 mg group.

Table 1 summarizes the adverse drug reactions that occurred at a rate of at least 1% and at a higher rate in the SKYRIZI group than the placebo group during the 16-week controlled period of pooled clinical trials.

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20070464 Skyrizi PB-7.625 x 10.5 (1.75).indd 1

Table 1. Adverse Drug Reactions Occurring in ≥ 1% of Subjects on SKYRIZI through Week 16 Adverse Drug Reactions a

SKYRIZI N = 1306 n (%)

Placebo N = 300 n (%)

Upper respiratory infections

170 (13.0)

29 (9.7)

Headacheb

46 (3.5)

6 (2.0)

Fatiguec

33 (2.5)

3 (1.0)

Injection site reactionsd

19 (1.5)

3 (1.0)

Tinea infectionse

15 (1.1)

1 (0.3)

a Includes: respiratory tract infection (viral, bacterial or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis b Includes: headache, tension headache, sinus headache, cervicogenic headache c Includes: fatigue, asthenia d Includes: injection site bruising, erythema, extravasation, hematoma, hemorrhage, infection, inflammation, irritation, pain, pruritus, reaction, swelling, warmth e Includes: tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, tinea infection, onychomycosis

Adverse drug reactions that occurred in < 1% but > 0.1% of subjects in the SKYRIZI group and at a higher rate than in the placebo group through Week 16 were folliculitis and urticaria.

Specific Adverse Drug Reactions Infections In the first 16 weeks, infections occurred in 22.1% of the SKYRIZI group (90.8 events per 100 subject-years) compared with 14.7% of the placebo group (56.5 events per 100 subject-years) and did not lead to discontinuation of SKYRIZI. The rates of serious infections for the SKYRIZI group and the placebo group were ≤0.4%. Serious infections in the SKYRIZI group included cellulitis, osteomyelitis, sepsis, and herpes zoster. In Studies PsO-1 and PsO-2, through Week 52, the rate of infections (73.9 events per 100 subject-years) was similar to the rate observed during the first 16 weeks of treatment.

Safety Through Week 52 Through Week 52, no new adverse reactions were identified, and the rates of the adverse reactions were similar to those observed during the first 16 weeks of treatment. During this period, serious infections that led to study discontinuation included pneumonia.

Psoriatic Arthritis The overall safety profile observed in subjects with psoriatic arthritis treated with SKYRIZI is generally consistent with the safety profile in subjects with plaque psoriasis. Additionally, in the Phase 3 placebo-controlled trials the incidence of hepatic events was higher in the SKYRIZI group (5.4%, 16.7 events per 100 patient years) compared to the placebo group (3.9%, 12.6 events per 100 patient years). Of these, the most common events that were reported more frequently in both the placebo group and the SKYRIZI group were ALT increased (placebo: n=12 (1.7%); SKYRIZI: n=16 (2.3%)), AST increased (placebo: n=9 (1.3%); SKYRIZI: n=13 (1.8%)), and GGT increased (placebo: n=5 (0.7%); SKYRIZI: n=8 (1.1%)). There were no serious hepatic events reported. The incidence of hypersensitivity reactions was higher in the SKYRIZI group (n=16, 2.3%) compared to the placebo group (n=9, 1.3%). In the Phase 3 placebo-controlled trials, hypersensitivity reactions reported at a higher rate in the SKYRIZI group included rash (placebo: n=4 (0.6%); SKYRIZI: n=5 (0.7%), allergic rhinitis (placebo: n=1 (0.1%); SKYRIZI: n=2 (0.3%), and facial swelling (placebo: n=0 (0.0%); SKYRIZI n=1 (0.1%). One case of anaphylaxis was reported in a subject who received SKYRIZI in the Phase 2 clinical trial.

Crohn’s Disease SKYRIZI was studied up to 12 weeks in subjects with moderately to severely active Crohn’s disease in two randomized, double-blind, placebo-controlled induction studies (CD-1, CD-2) and a randomized, double-blind, placebocontrolled, dose-finding study (CD-4; NCT02031276). Long-term safety up to 52 weeks was evaluated in subjects who responded to induction therapy in a randomized, double-blind, placebo-controlled maintenance study (CD-3).

In the two induction studies (CD-1, CD-2) and the dose finding study (CD-4), 620 subjects received the SKYRIZI intravenous induction regimen. In the maintenance study (CD-3), 142 subjects who achieved clinical response defined as a reduction in CDAI of at least 100 points from baseline after 12 weeks of induction treatment with intravenous SKYRIZI in studies CD-1 and CD-2, received SKYRIZI subcutaneously as a maintenance regimen.

Adverse reactions reported in > 3% of subjects in induction studies and at a higher rate than placebo are shown in Table 2.

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PROFESSIONAL BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION

Table 2. Adverse Drug Reactions Reported in > 3% of Subjects with Crohn’s Disease Treated with SKYRIZI in Placebo-Controlled 12-Week Induction Studies

Adverse Drug Reactions

SKYRIZI 600 mg Intravenous Infusiona N = 620 n (%)

Placebo N = 432 n (%)

Upper respiratory infectionsb

66 (10.6)

40 (9.3)

Headachec

41 (6.6)

24 (5.6)

Arthralgia

31 (5.0)

19 (4.4)

a SKYRIZI 600 mg as an intravenous infusion at Week 0, Week 4, and Week 8. b Includes: influenza like illness, nasopharyngitis, influenza, pharyngitis, upper respiratory tract infection, viral upper respiratory tract infection, COVID-19, nasal congestion, respiratory tract infection viral, viral pharyngitis, tonsillitis, upper respiratory tract inflammation c Includes: headache, tension headache

Adverse reactions reported in >3% of subjects in the maintenance study and at a higher rate than placebo are shown in Table 3.

Table 3. Adverse Reactions Reported in >3% of Subjects with Crohn’s Disease Treated with SKYRIZI in Placebo-Controlled 52-Week Maintenance Study (CD-3) Adverse Drug Reactions

SKYRIZI 360 mg Subcutaneous Injectiona N = 142 n (%)

Placebo N = 143 n (%)

Arthralgia

13 (9.2)

12 (8.4)

Injection site reactionsb,c

8 (5.6)

4 (2.8)

Abdominal paind

12 (8.5)

6 (4.2)

Anemia

7 (4.9)

6 (4.2)

Pyrexia

7 (4.9)

4 (2.8)

Back pain

6 (4.2)

3 (2.1)

Arthropathy

5 (3.5)

2 (1.4)

Urinary tract infection

5 (3.5)

4 (2.8)

a SKYRIZI 360 mg at Week 12 and every 8 weeks thereafter for up to an

additional 52 weeks b Includes: injection site rash, injection site erythema, injection site swelling, injection site urticaria, injection site warmth, injection site pain, injection site hypersensitivity, injection site reaction c Some subjects had multiple occurrences of injection site reactions. The adverse reaction is included only once per subject. dIncludes: abdominal pain, abdominal pain upper, abdominal pain lower Specific Adverse Drug Reactions Infections In the maintenance study (CD-3) through Week 52, the rate of infections was 36.6% (60.8 events per 100 subject-years) in subjects who received SKYRIZI compared to 36.4% (60.3 events per 100 subject-years) in subjects who received placebo after SKYRIZI induction. The rate of serious infections was 5.6% (7.4 events per 100 subject-years) in subjects who received SKYRIZI compared to 2.1% (2.4 events per 100 subject-years) in subjects who received placebo after SKYRIZI induction.

Lipid Elevations Elevations in lipid parameters (total cholesterol and low-density lipoprotein cholesterol [LDL-C]) were first assessed at 4 weeks following initiation of SKYRIZI in the induction trials (CD-1, CD-2). Increases from baseline and increases relative to placebo were observed at Week 4 and remained stable to Week 12. Following SKYRIZI induction, mean total cholesterol increased by 9.4 mg/dL from baseline to a mean absolute value of 175.1 mg/dL at Week 12. Similarly, mean LDL-C increased by 6.6 mg/dL from baseline to a mean absolute value of 92.6 mg/dL Week 12. Following maintenance treatment with SKYRIZI, mean LDL-C increased by 2.3 mg/dL from baseline to Week 52, to an absolute value of 102.2 mg/dL. Immunogenicity As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.

For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other products, including other risankizumab products, may be misleading.

Plaque Psoriasis

By Week 52, approximately 24% (263/1079) of subjects treated with SKYRIZI at the recommended dose developed antibodies to risankizumabrzaa. Of the subjects who developed antibodies to risankizumab-rzaa, approximately 57% (14% of all subjects treated with SKYRIZI) had antibodies that were classified as neutralizing. Higher antibody titers in approximately 1% of subjects treated with SKYRIZI were associated with lower risankizumab-rzaa concentrations and reduced clinical response.

Psoriatic Arthritis

By Week 28, approximately 12.1% (79/652) of subjects treated with SKYRIZI at the recommended dose developed antibodies to risankizumab-rzaa.

None of the subjects who developed antibodies to risankizumab-rzaa had antibodies that were classified as neutralizing. Antibodies to risankizumab-

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rzaa were not associated with changes in clinical response for psoriatic arthritis. A higher proportion of subjects with anti-drug antibodies experienced hypersensitivity reactions (6.3% (5/79)) and injection site reactions (2.5% (2/79)) compared to subjects without anti-drug antibodies (3.8% (22/574) with hypersensitivity reactions and 0.7% (4/574) with injection site reactions). None of these hypersensitivity and injection site reactions led to discontinuation of risankizumab-rzaa.

Crohn’s Disease

By Week 64, approximately 3.4% (2/58) of subjects treated with SKYRIZI at the recommended induction and maintenance dosages developed antibodies to risankizumab-rzaa. None of the subjects who developed antibodies to risankizumab-rzaa had antibodies that were classified as neutralizing.

Postmarketing Experience The following adverse reactions have been reported during post-approval of SKYRIZI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to SKYRIZI exposure: • Skin and subcutaneous tissue disorders: eczema and rash USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women who become pregnant while treated with SKYRIZI. Patients should be encouraged to enroll by calling 1-877-302-2161 or visiting http://glowpregnancyregistry.com.

Risk Summary Available pharmacovigilance and clinical trial data with risankizumab use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

Although there are no data on risankizumab-rzaa, monoclonal antibodies can be actively transported across the placenta, and SKYRIZI may cause immunosuppression in the in utero-exposed infant. There are adverse pregnancy outcomes in women with inflammatory bowel disease (see Clinical Considerations).

In an enhanced pre- and post-natal developmental toxicity study, pregnant cynomolgus monkeys were administered subcutaneous doses of 5 or 50 mg/kg risankizumab-rzaa once weekly during the period of organogenesis up to parturition. Increased fetal/infant loss was noted in pregnant monkeys at the 50 mg/kg dose (see Data). The 50 mg/kg dose in pregnant monkeys resulted in approximately 10 times the exposure (AUC) in humans administered the 600 mg induction regimen and 39 times the exposure (AUC) to the 360 mg maintenance doses, respectively.

No risankizumab-rzaa-related effects on functional or immunological development were observed in infant monkeys from birth through 6 months of age. The clinical significance of these findings for humans is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-associated maternal and embryo/fetal risk Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.

Fetal/Neonatal adverse reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Because risankizumab may interfere with immune response to infections, risks and benefits should be considered prior to administering live vaccines to infants exposed to SKYRIZI in utero. There are insufficient data regarding infant serum levels of risankizumab at birth and the duration of persistence of risankizumab in infant serum after birth. Although a specific timeframe to delay live virus immunizations in infants exposed in utero is unknown, a minimum of 5 months after birth should be considered because of the half-life of the product.

Data Animal Data An enhanced pre- and post-natal developmental toxicity study was conducted in cynomolgus monkeys. Pregnant cynomolgus monkeys were administered weekly subcutaneous doses of risankizumab-rzaa of 5 or 50 mg/kg from gestation day 20 to parturition, and the cynomolgus monkeys (mother and infants) were monitored for 6 months after

20070464 Skyrizi PB-7.625 x 10.5 (1.75).indd 2

delivery. No maternal toxicity was noted in this study. There were no treatment-related effects on growth and development, malformations, developmental immunotoxicology, or neurobehavioral development.

However, a dose-dependent increase in fetal/infant loss was noted in the risankizumab-rzaa-treated groups (32% and 43% in the 5 mg/kg and 50 mg/kg groups, respectively) compared with the vehicle control group (19%). The increased fetal/infant loss in the 50 mg/kg group was considered to be related to risankizumab-rzaa treatment. The no observed adverse effect level (NOAEL) for maternal toxicity was identified as 50 mg/kg and the NOAEL for developmental toxicity was identified as 5 mg/kg. On an exposure (AUC) basis, the 5 mg/kg dose in pregnant monkeys resulted in approximately 1.24 times the exposure in humans administered the 600 mg induction regimen and 5 times the exposure in humans administered the 360 mg maintenance doses, respectively. In the infants, mean serum concentrations increased in a dose-dependent manner and were approximately 17%-86% of the respective maternal concentrations. Following delivery, most adult female cynomolgus monkeys and all infants from the risankizumab-rzaa-treated groups had measurable serum concentrations of risankizumab-rzaa up to 91 days postpartum. Serum concentrations were below detectable levels at 180 days postpartum.

Lactation Risk Summary There are no data on the presence of risankizumab-rzaa in human milk, the effects on the breastfed infant, or the effects on milk production.

Endogenous maternal IgG and monoclonal antibodies are transferred in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to risankizumab-rzaa are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SKYRIZI and any potential adverse effects on the breastfed infant from SKYRIZI or from the underlying maternal condition.

Pediatric Use The safety and effectiveness of SKYRIZI have not been established in pediatric patients.

Geriatric Use Of the 2234 subjects with plaque psoriasis exposed to SKYRIZI, 243 subjects were 65 years or older and 24 subjects were 75 years or older. No overall differences in SKYRIZI exposure, safety, or effectiveness were observed between older and younger subjects who received SKYRIZI. However, the number of subjects aged 65 years and older was not sufficient to determine whether they respond differently from younger subjects.

Clinical studies of SKYRIZI for the treatment of Crohn’s disease did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.

No clinically meaningful differences in the pharmacokinetics of risankizumab-rzaa were observed in geriatric subjects compared to younger adult subjects with Crohn’s disease.

PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Hypersensitivity Reactions Advise patients to discontinue SKYRIZI and seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions].

Infections Inform patients that SKYRIZI may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to the healthcare provider and contacting their healthcare provider if they develop any symptoms of an infection [see Warnings and Precautions].

Hepatotoxicity in Treatment of Crohn’s Disease Inform patients that SKYRIZI may cause liver injury, especially during the initial 12 weeks of treatment. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of liver dysfunction. (e.g., unexplained rash, nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine) [see Warnings and Precautions].

Administration of Vaccines Advise patients that vaccination with live vaccines is not recommended during SKYRIZI treatment and immediately prior to or after SKYRIZI treatment. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Instruct patients to inform the healthcare practitioner that they are taking SKYRIZI prior to a potential vaccination [see Warnings and Precautions].

Administration Instruction Instruct patients or caregivers to perform the first self-injected dose under the supervision and guidance of a qualified healthcare professional for training in preparation and administration of SKYRIZI, including choosing anatomical sites for administration, and proper subcutaneous injection technique.

If using SKYRIZI 75 mg/0.83 mL, instruct patients or caregivers to administer two 75 mg single-dose syringes to achieve the full 150 mg dose of SKYRIZI. Instruct patients or caregivers in the technique of pen or syringe disposal.

Pregnancy Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to SKYRIZI during pregnancy and patients can call 1-877-302-2161 [see Use in Specific Populations].

Manufactured by: AbbVie Inc. North Chicago, IL 60064, USA US License Number 1889 SKYRIZI® is a registered trademark of AbbVie Biotechnology Ltd. © 2019-2022 AbbVie Inc. Ref: 20070464 Revised: June, 2022 LAB-7523 MASTER

US-SKZD-220291

/22/Jun2022 8:39 AM

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Acad Dermatol Venereol, Volume: 32, Issue: 7, Pages: 1111-1119, First published: 13 February 2018, DOI: (10.1111/jdv.14868)

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Revista Puertorriqueña de Medicina y Salud Pública

Lillian Rivera, MD Departamento de Dermatología Escuela de Medicina Ponce Health Sciences University Agosto 2023

María Vázquez, MSIII Departamento de Dermatología Escuela de Medicina Ponce Health Sciences University Agosto 2023

Lorna Torres, MD Departamento de Dermatología Escuela de Medicina Ponce Health Sciences University Agosto 2023

Fitzgeraldo Sánchez, MD FAAD Departamento de Dermatología Escuela de Medicina Ponce Health Sciences University Agosto 2023

EXPLORANDO LA PSORIASIS: ASPECTOS GENERALES DE LA ENFERMEDAD CUTÁNEA RESUMEN

L

a psoriasis es una enfermedad inflamatoria crónica con repercusiones significativas en la salud física y emocional de los pacientes. La enfermedad se asocia con comorbilidades potencialmente serias que requieren reconocimiento e intervención temprana. La psoriasis tiene una predisposición genética que en presencia de desencadenantes multifactoriales contribuyen a su desarrollo.

Un proceso complejo de activación y comunicación de citocinas conduce a la activación aumentada de células T, y sobreproducción de citocinas inflamatorias.

Estas citocinas son responsables de las características clínicas e histológicas de la enfermedad. Esta comprensión inmunológica ha llevado al desarrollo de terapias biológicas que se unen a las ya existentes para inhibir estos mecanismos y revierten los síntomas de la enfermedad. La coordinación entre médicos primarios, especialistas y dermatólogos es crucial para brindar una atención que mejore la calidad de vida de los pacientes.

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INTRODUCCIÓN La psoriasis afecta a una considerable cantidad de personas a nivel global, con un 3% (> 7.5 millones) de la población en Estados Unidos y 125 millones en todo el mundo. Aunque puede manifestarse en diversas edades, tiene una mayor incidencia en individuos entre 15 y 30 años. La enfermedad presenta varios subtipos, siendo la psoriasis en placa la más común, abarcando el 73.6% de los niños y el 74% de los adultos.

La enfermedad tiene una fuerte predisposición genética, pero se sabe que su manifestación clínica está relacionada a una interacción del individuo con el ambiente y diversos factores desencadenantes. Los hijos de un padre con psoriasis pueden tener un riesgo de 15% de desarrollo de la enfermedad, y 40% si ambos padres padecen la condición. El alelo HLACw6 es el factor genético más común asociado con la susceptibilidad a desarrollar psoriasis y está asociado al desarrollo temprano de la enfermedad en los pacientes. Estudios de asociación de todo el genoma

han identificado más de 80 loci asociados a la enfermedad. Se cree que estos diversos factores genéticos, junto con factores inmunológicos y ambientales contribuyen a esta sobreproducción de citocinas en la psoriasis.

Factores reconocidos como potenciales desencadenantes son el trauma, infecciones como la amigdalitis por estreptococo en psoriasis guttata y el HIV, el estrés, alcohol, fumar. Drogas como el litio, los bloqueadores de calcio, inhibidores de la enzima convertidora de angiotensina, bloqueadores de canales de calcio y antimaláricos también se han asociado a la psoriasis.

La psoriasis en placa se caracteriza por lesiones simétricas de placas bien demarcadas, eritematosas y con escamas de color blanco plateado en partes extensoras del cuerpo, predominantemente en codos, rodillas, tronco, área lumbosacral, periumbilical, anogenital y cuero cabelludo. Las mismas pueden ser localizadas o

distribuidas a través de todo el cuerpo.

Esta puede presentarse de manera asintomática en muchos pacientes, pero puede causar dolor debido al desarrollo de fisuras en la piel y picor significativo. El nivel de severidad entre pacientes varía desde síntomas leves y casi imperceptibles hasta enfermedad recalcitrante e incapacitante.

Los pacientes con psoriasis a menudo presentan comorbilidades, como la artritis en las articulaciones interfalángicas distales y proximales, dactilitis, entesitis particularmente el tendón de Aquiles y el codo, obesidad, síndrome metabólico, diabetes e hipertensión.

Los pacientes con psoriasis severa tienen una morbilidad y mortalidad mayor por eventos cardiovasculares. Los pacientes con psoriasis grave tienen mayor de riesgo de morir por infección que los pacientes sin psoriasis. Además, se ha notado una mayor predisposición a otras enfermedades como artritis reumatoide, enfermedad de Crohn, colitis ulcerativa y ciertos tipos de cáncer.

PATOFISIOLOGÍA

L

a psoriasis se creía que se originaba por un crecimiento excesivo de las células de la piel, pero investigaciones recientes han demostrado que está relacionada principalmente con una desregulación inmunológica en personas con predisposición genética y factores desencadenantes. Esto lleva a la sobreproducción de citocinas y a la inflamación crónica.

Las células dendríticas en la piel responden a la inflamación generando interleucina 12 (IL-12), que promueve la diferenciación de las células T auxiliares tipo 1 (Th1). Estas células Th1 liberan citocinas inflamatorias como INF-y, IL2, IL-6, IL-8 e IL-12, perpetuando la inflamación. Los queratinocitos en la piel también producen interleucina 23 (IL-23), que estimula la diferenciación y proliferación de células T auxiliares tipo 17 (Th17). Estas Th17 producen citocinas proinflamatorias como TNF-y, IL-17 e IL-22.

Cada una de estas citocinas contribuye a la inflamación y a los síntomas de la psoriasis al inducir la proliferación de células de la piel, el reclutamiento de neutrófilos y la angiogénesis. La

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interleucina 18 (IL-18) también colabora con IL-12 para amplificar respuestas Th1, estimulando la producción de INF-y por las células T. Las enzimas intracelulares llamadas quinasas de Janus (JAK) juegan un papel esencial en la transducción de señales y regulación de vías biológicas.

Son cruciales para transmitir señales de citocinas y moléculas señalizadoras.

Las JAK están involucradas en el crecimiento, proliferación y diferenciación de linfocitos, y en la producción de citocinas inflamatorias.

Las JAK pueden contribuir a la desregulación al transmitir señales en exceso, lo que resulta en una activación persistente de células inmunológicas.

Estos descubrimientos han permitido el desarrollo de tratamientos biológicos que inhiben estas cascadas inflamatorias en la psoriasis.

DIAGNÓSTICO El diagnóstico de la psoriasis es clínico y se manifiesta con placas demarcadas, eritematosas y con escamas que suelen tener una distribución simétrica. La enfermedad tiene periodos de remisión

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y exacerbación que pueden dilatar el diagnóstico. La evaluación de un paciente debe comenzar con historial detallado, enfocado en síntomas, historial familiar de condiciones autoinmunes e inflamatorias, infecciones, drogas, y exposición a posibles desencadenantes.

IMAGEN (POR M&S) Se debe realizar un examen físico de la piel en su totalidad, cuero cabelludo, las uñas y el área anogenital; enfatizando en áreas extensoras como los codos, las rodillas y la hendidura glútea comúnmente afectadas. El signo de Auspitz es una característica de la enfermedad el cual se presentan puntos de sangrado al raspar o retirar alguna de las escamas plateadas que cubren las lesiones, no es requerido reproducirlo en la evaluación. La Academia Americana de Dermatología recomienda cernir rutinariamente para artritis psoriásica mediante exploración de dolor en las articulaciones, rigidez o dolor de espalda en pacientes de psoriasis. El uso de biopsias debe limitarse a instancias donde el diagnóstico clínico no sea

concluyente. Es importante evaluar a los pacientes para otras comorbilidades mencionadas anteriormente.

TRATAMIENTO El tratamiento de la psoriasis se adapta a la gravedad de la enfermedad y a las necesidades individuales de cada paciente. La evaluación inicial incluye consideraciones como el tamaño de las áreas afectadas en la piel, el espesor de las placas, la intensidad del enrojecimiento y la descamación, además de otras comorbilidades y cómo la enfermedad impacta en la calidad de vida. Dado que la variabilidad clínica entre los pacientes puede ser amplia, esta evaluación puede ser compleja y debe ser realizada por un profesional de la salud, preferentemente un dermatólogo.

Para la psoriasis leve, que implica una afectación menor del 5% de la superficie corporal, los tratamientos tópicos suelen ser la primera línea de defensa. Los corticosteroides tópicos son comunes y funcionan como antiinflamatorios, reduciendo la inflamación, el enrojecimiento y la picazón en las lesiones cutáneas. También se utilizan otros agentes tópicos como derivados de la vitamina D (como el calcipotriol) y retinoides (como el tazaroteno) para reducir la proliferación celular excesiva y la inflamación.

En casos de psoriasis moderada a severa, en los cuales más del 5% de la piel está afectada, los tratamientos pueden volverse más agresivos. La fototerapia consiste en exponer la piel a dosis controladas de luz ultravioleta B (UVB) o al uso de Psoraleno junto con luz ultravioleta A (PUVA). Esta modalidad puede ser efectiva en el control de la psoriasis, pero su administración debe ser monitoreada por un dermatólogo debido al riesgo de desarrollar cáncer de piel.

Además de la fototerapia, hay opciones sistémicas que involucran medicamentos que afectan el sistema inmunológico.

Entre estos, los tratamientos no biológicos incluyen fármacos inmunosupresores como el metotrexato, que inhibe la proliferación celular y la respuesta de células T, y la ciclosporina, que suprime las células T. El Apremilast es otro enfoque, ya que es un inhibidor de la PDE4 que disminuye la producción de citocinas inflamatorias.

Los tratamientos biológicos son una parte importante del arsenal terapéutico, ya que se enfocan en intervenir específicamente en cascadas de inflamación desreguladas en la psoriasis. Los inhibidores de TNF-y, IL-23 y IL-17 son ejemplos de estos tratamientos. Actúan bloqueando estas citocinas inflamatorias, reduciendo

la inflamación y los síntomas de la enfermedad. Los inhibidores de JAK también se han introducido como una opción, pero tienen una caja negra de seguridad debido a riesgos potenciales.

Aunque estos tratamientos biológicos demuestran alta efectividad, el alto costo y los posibles efectos secundarios pueden limitar su accesibilidad. La decisión de optar por uno de estos tratamientos debe ser cuidadosamente evaluada por un dermatólogo, quien considerará la gravedad de la enfermedad, las necesidades individuales del paciente y las posibles alternativas.

En resumen, el tratamiento de la psoriasis es altamente individualizado y abarca una amplia gama de opciones, desde tratamientos tópicos hasta terapias sistémicas más avanzadas. La colaboración multidisciplinaria de salud es esencial para brindar un manejo óptimo a pacientes con psoriasis.

REFERENCIAS Berekméri, A., Mahmood, F., Wittmann, M., & Helliwell, P. S. (2018). Tofacitinib for the treatment of psoriasis and psoriatic arthritis. Expert Review of Clinical Immunology, 14(9), 719–730. https:// doi.org/10.1080/1744666x.2018.1512404 Chen, L., & Tsai, T. (2018). HLA‐Cw6and psoriasis. British Journal of Dermatology, 178(4), 854– 862. https://doi.org/10.1111/bjd.16083 Elmets et al. (2019). Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with awareness and attention to comorbidities. Journal of the American Academy of Dermatology 80(4), 1073–1113. https://doi. org/10.1016/j.jaad.2018.11.058 Godse, K. (2017). Secukinumab – first in class interleukin-17A inhibitor for the treatment of psoriasis. Indian Journal of Dermatology, 62(2), 195. https://doi.org/10.4103/ijd.ijd_233_16 Gooderham, M. J., Papp, K. A., & Lynde, C. W. (2018). Shifting the focus - the primary role of IL23 in psoriasis and other inflammatory disorders.

Journal of the European Academy of Dermatology and Venereology : JEADV, 32(7), 1111–1119. https://doi.org/10.1111/jdv.14868 Griffiths, C. E. M., Armstrong, A. W.,

Gudjonsson, J. E., & Barker, J. N. W. N. (2021).

Psoriasis. Lancet (London, England), 397(10281), 1301–1315. https://doi.org/10.1016/S01406736(20)32549-6 Kearns, D. G., Uppal, S., Chat, V. S., & Wu, J. J. (2021). Comparison of Guidelines for the Use of Interleukin-17 Inhibitors for Psoriasis in the United States, Britain, and Europe: A Critical Appraisal and Comprehensive Review. The Journal of clinical and aesthetic dermatology, 14(6), 55–59.

Menter, A., & Griffiths, C. (2007). Current and future management of psoriasis. The Lancet, 370(9583), 272–284. https://doi. org/10.1016/s0140-6736(07)61129-5 Michalak-Stoma, A., Bartosiyska, J., Kowal, M., Juszkiewicz-Borowiec, M., Gerkowicz, A., & Chodorowska, G. (2013). Serum levels of selected Th17 and Th22 cytokines in psoriatic patients.

Disease markers, 35(6), 625–631. https://doi. org/10.1155/2013/856056 Nestle, F. O., Turka, L. A., & Nickoloff, B. J. (1994). Characterization of dermal dendritic cells in psoriasis. Autostimulation of T lymphocytes and induction of Th1 type cytokines. Journal of Clinical Investigation, 94(1), 202–209. https://

doi.org/10.1172/jci117308 Papp, K., Cather, J. C., Rosoph, L., Sofen, H., Langley, R., Matheson, R., Hu, C., & Day, R. M. (2012). Efficacy of apremilast in the treatment of moderate to severe psoriasis: a randomised controlled trial. The Lancet, 380(9843), 738–746. https://doi.org/10.1016/s01406736(12)60642-4 Rendon, A., & Schäkel, K. (2019). Psoriasis pathogenesis and treatment. International Journal of Molecular Sciences, 20(6), 1475. https://doi. org/10.3390/ijms20061475 Schadler, E. D., Ortel, B., & Mehlis, S. (2019).

Biologics for the primary care physician: Review and treatment of psoriasis. Dm Disease-a-month, 65(3), 51–90. https://doi.org/10.1016/j. disamonth.2018.06.001 Scott, L. J., Dunn, C. J., & Goa, K. L. (2001).

Calcipotriol ointment. American Journal of Clinical Dermatology, 2(2), 95–120. https://doi. org/10.2165/00128071-200102020-00008 Takeshita, J., Grewal, S. K., Langan, S., Mehta, N. N., Ogdie, A., Van Voorhees, A. S., & Gelfand, J. M. (2017). Psoriasis and comorbid diseases.

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For moderate to severe rheumatoid arthritis (RA) in adult TNFi-IR patients1 For moderate to severe rheumatoid arthritis (RA) in adult TNFi-IR patients1

EXPECTATIONS EXPECTATIONS CHALLENGE TREATMENT GOALS IN RA WITH A ONCE-DAILY ORAL JAK INHIBITOR CHALLENGE TREATMENT GOALS IN RA WITH A ONCE-DAILY primary (ACR20 or ACR50 atORAL WeekJAK 12 orINHIBITOR 14)

RINVOQ met and ranked secondary endpoints in clinical trials, with some patients RINVOQ metACR20 as primary (ACR20 at Week 121-3,a,b or 14) achieving early as Week 1orinACR50 SELECT-BEYOND and ranked secondary endpoints in clinical trials, with some patients achieving ACR20 as early as Week 1 in SELECT-BEYOND1-3,a,b LONG-TERM REMISSION AND LOW DISEASE ACTIVITY DATA

observed up to 84 weeks with or without MTX1,3-6 • DAS28-CRP<2.6* and DAS28-CRP≤3.2 evaluated at Week 12 or 14, LONG-TERM REMISSION AND LOW DISEASE ACTIVITY DATA with response from 84 weeks SELECT-BEYOND and 1,3-6 observed up to 84 rates weeks with60 orto without MTX(in SELECT-MONOTHERAPY, respectively) • DAS28-CRP<2.6* and DAS28-CRP≤3.2 evaluated at Week 12 or 14, with response rates from 60 to 84 weeks (in SELECT-BEYOND and *Clinical remission does not mean drug-free remission or complete absence of SELECT-MONOTHERAPY, respectively) disease activity. *Clinical remission does not mean drug-free remission or complete absence of LONG-TERM SAFETY DATA disease activity.

AEs observed in long-term analysis with ~4.5 years maximum and ~2.6 years median exposure to RINVOQ 15 mg as of 6/30/207,a,b LONG-TERM SAFETY DATA c patients evaluated on upadacitinib, withmaximum >7000 patientAEs• >4400 observed in long-term analysis with ~4.5 years and 7,a,b years of long-term exposure to RINVOQ 15 mg of 6/30/20 7,a,b ~2.6 years median exposure to RINVOQ 15 mg as ofas 6/30/20 • >4400 patients evaluated on upadacitinib,c with >7000 patientyears of long-term exposure to RINVOQ 15 mg as of 6/30/207,a,b

Discover our commitment to exceptional access and patient support at RinvoqHCPPR.com Discover our commitment to exceptional access and patient support at RinvoqHCPPR.com

a SELECT-EARLY (RA-I; MTX-naïve) [primary endpoint at Week 12: ACR50 response vs MTX, select ranked secondary endpoint at Week 24: ΔmTSS vs MTX]; SELECT-MONOTHERAPY (RA-II; MTX-IR) [primary endpoint at Week 14: ACR20 response vs MTX, select ranked secondary endpoints at Week 14: DAS28-CRP<2.6 vs MTX, DAS28-CRP≤3.2 vs MTX]; SELECT-NEXT (RA-III; csDMARD-IR) [RINVOQ + csDMARD; primary endpoint at Week 12: a SELECT-EARLY (RA-I; MTX-naïve) [primary endpoint at Week 12: ACR50 response vs MTX, select ranked secondary endpoint at Week 24: ΔmTSS vs ACR20 response vs placebo + csDMARD]; SELECT-COMPARE (RA-IV; MTX-IR) [RINVOQ + MTX; primary endpoint at Week 12: ACR20 response vs placebo MTX]; MTX-IR) [primary endpoint Week 14: ACR20 response vs MTX, select ranked secondary at primary + MTX,SELECT-MONOTHERAPY select ranked secondary(RA-II; endpoints at Week 26: ΔmTSS vs at placebo + MTX]; SELECT-BEYOND (RA-V; bDMARD-IR) [RINVOQendpoints + csDMARD; 1,2 Week 14: DAS28-CRP<2.6 vs MTX, DAS28-CRP≤3.2 MTX]; SELECT-NEXT (RA-III; csDMARD-IR) [RINVOQ + csDMARD; primary endpoint at +Week 12: endpoint at Week 12: ACR20 response vs placebo +vs csDMARD, select ranked secondary endpoints at Week 12: DAS28-CRP≤3.2 vs placebo csDMARD.] bSELECT-CHOICE 8 ACR20 response vs placebo + csDMARD]; (RA-IV; MTX-IR) [RINVOQ + MTX; primary endpoint at vs Week 12: comparator ACR20 response vs placebo (bDMARD-IR) [RINVOQ +SELECT-COMPARE csDMARDs; primary endpoint at Week 12: ΔDAS28-CRP (noninferiority) active + csDMARDs]. c RINVOQ + MTX, select ranked secondary at Week vs placebo 15 mg; upadacitinib 30endpoints mg; RINVOQ 15 mg26: is ΔmTSS the approved dose.+1,7MTX]; SELECT-BEYOND (RA-V; bDMARD-IR) [RINVOQ + csDMARD; primary endpoint at Week 12: ACR20 response vs placebo + csDMARD, select ranked secondary endpoints at Week 12: DAS28-CRP≤3.2 vs placebo + csDMARD.] 1,2 bSELECT-CHOICE (bDMARD-IR) [RINVOQ + csDMARDs; primary endpoint at Week 12: ΔDAS28-CRP (noninferiority) vs active comparator + csDMARDs]. 8 c RINVOQ 15 mg; upadacitinib 1 30 mg; RINVOQ 15 mg is the approved dose.1,7 INDICATION

RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or 1 INDICATION intolerance to one or more tumor necrosis factor (TNF) blockers.

RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid (RA) who have had an inadequate response or Limitations of Use:arthritis RINVOQ is not recommended for use in combination intolerance to one or more tumor necrosis factordisease-modifying (TNF) blockers. with other Janus kinase (JAK) inhibitors, biologic antirheumatic drugs (bDMARDs), or with potent immunosuppressants such Limitations of Use: is not recommended for use in combination as azathioprine and RINVOQ cyclosporine. with other Janus kinase (JAK) inhibitors, biologic disease-modifying antirheumatic drugs (bDMARDs), or with potent immunosuppressants such 1 SAFETY CONSIDERATIONS as azathioprine and cyclosporine.

Malignancies: Malignancies have occurred in RINVOQ-treated patients.

A higher rate of lymphomas and lung cancer (in current or past smokers) was observed with another JAKi when compared with TNF blockers in RA Malignancies: Malignancies have occurred in RINVOQ-treated patients. patients.

A higher rate of lymphomas and lung cancer (in current or past smokers) was observed another JAKi when compared with blockers in RA Major Adversewith Cardiovascular Events: A higher rate ofTNF CV death, patients. infarction, and stroke was observed with a JAKi in a study myocardial comparing another JAKi with TNF blockers in RA patients ≥50 years with Major Adverse Cardiovascular Events: A higherrisk. rate of CV death, ≥1 CV risk factor.

History of smoking increases myocardial infarction, and stroke was observed with a JAKi in a study comparing another JAKi with TNF blockers in RA patients ≥50and years with Thrombosis: Deep venous thrombosis, pulmonary embolism, arterial ≥1 CV risk factor. ofin smoking risk.JAK inhibitors used to thrombosis have History occurred patientsincreases treated with treat inflammatory conditions. A higher rate of thrombosis was observed Thrombosis: venous thrombosis, embolism, and arterial with another Deep JAKi when compared withpulmonary TNF blockers in RA patients. thrombosis have occurred in patients treated with JAK inhibitors used to treat inflammatory conditions.

A higher rate of was observed Hypersensitivity: RINVOQ is contraindicated inthrombosis patients with with another JAKitowhen compared with TNF blockers in RA patients. hypersensitivity RINVOQ or its excipients.

Serious Infections: RINVOQ-treated patients are at increased risk of serious bacterial (including tuberculosis SAFETY CONSIDERATIONS1 [TB]), fungal, viral, and opportunistic infections leading to hospitalization or death.

Serious Infections: RINVOQ-treated patients are at increased risk Most patients who developed these infections were taking concomitant of serious bacterial (including [TB]), fungal, viral, and immunosuppressants, such astuberculosis methotrexate or corticosteroids. opportunistic infections leading to hospitalization or death.

Most patients who developed these mortality, infectionsincluding were taking concomitant Mortality: A higher rate of all-cause sudden Hypersensitivity: RINVOQ is contraindicated in patients with Other Serious Adverse Reactions: Hypersensitivity Reactions, immunosuppressants, suchwas as methotrexate cardiovascular (CV) death, observed withora corticosteroids.

Janus kinase inhibitor hypersensitivityPerforations, to RINVOQ or its excipients.

Gastrointestinal Laboratory Abnormalities, and Embryo-Fetal (JAKi) in a study comparing another JAKi with tumor necrosis factor Toxicity.

Mortality: A higher rate of all-cause mortality, including (TNF) blockers in rheumatoid arthritis (RA) patients ≥50 sudden years with ≥1 CV Other Serious Adverse Reactions: Hypersensitivity Reactions, cardiovascular (CV) death, was observed with a Janus kinase inhibitor risk factor.

Gastrointestinal Perforations, Laboratory Abnormalities, and Embryo-Fetal (JAKi) in a study comparing another JAKi with tumor necrosis factor Toxicity.

(TNF) blockers in rheumatoid arthritis (RA) patients ≥50 years with ≥1 CV risk factor.

Please see additional Important Safety Information, including BOXED WARNING on Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis, on the previous page of this advertisement.

Please Summary of fullSafety Prescribing Information on previous of this Please see see Brief additional Important Information, including BOXEDpages WARNING onadvertisement.

Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis, on the previous page of this advertisement.

ACR=American College of Rheumatology; AEs=adverse events; bDMARD=biologic DMARD; csDMARD=conventional synthetic DMARD; DAS28-CRP=Disease Activity Score 28 joints, C-reactive protein; DMARD=disease-modifying antirheumatic drug; HAQ-DI=Health Assessment

Please see Brief Summary of full Prescribing Information previous pages of this advertisement.

Questionnaire Disability Index; IR=intolerance or inadequate response;on JAK=Janus kinase; mTSS=modified total Sharp score; MTX=methotrexate; TNFi=tumor necrosis factor inhibitor.

ACR=American College of Rheumatology; AEs=adverse events; bDMARD=biologic DMARD; csDMARD=conventional synthetic DMARD; DAS28-CRP=Disease Activity Score 28 joints, C-reactive protein; DMARD=disease-modifying antirheumatic drug; HAQ-DI=Health Assessment Questionnaire Disability Index; IR=intolerance or inadequate response; JAK=Janus kinase; mTSS=modified total Sharp score; MTX=methotrexate; TNFi=tumor necrosis factor inhibitor.

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IMPORTANT SAFETY INFORMATION1 IMPORTANT SAFETY INFORMATION

1 SERIOUS INFECTIONS Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who SERIOUS INFECTIONS developed these infections were taking concomitant immunosuppressants, Patients treated with RINVOQ are at increased risk for developing serious such as methotrexate or corticosteroids.

If a serious infection develops, infectionsRINVOQ that mayuntil leadthe to hospitalization or death. Most patients who interrupt infection is controlled. developed these infections were taking concomitant immunosuppressants, Reported infections include: such as methotrexate or corticosteroids. If a serious infection develops, •interrupt Active tuberculosis (TB), mayis present with pulmonary or extrapulmonary RINVOQ until thewhich infection controlled. disease. Test patients for latent TB before RINVOQ use and during therapy.

Reported infections include: Consider treatment for latent TB infection prior to RINVOQ use.

• Active tuberculosis (TB), which may present with pulmonary or extrapulmonary • Invasive infections, including cryptococcosis and pneumocystosis. disease. fungal Test patients for latent TB before RINVOQ use and during therapy.

Consider treatment for latent TB infection prior to RINVOQ use.

• Bacterial, viral, including herpes zoster, and other infections due to opportunistic • Invasive fungalpathogens. infections, including cryptococcosis and pneumocystosis.

GASTROINTESTINAL PERFORATIONS Gastrointestinal (GI) perforations have been reported in clinical trials with RINVOQ. Monitor RINVOQtreated patients who may be at risk for gastrointestinal perforation (e.g., GASTROINTESTINAL patients with a history PERFORATIONS of diverticulitis and patients taking NSAIDs or corticosteroids).

Gastrointestinal (GI) perforations have been reported clinical trials Promptly evaluate patients presenting with new onsetinabdominal painwith for RINVOQ. early Monitor RINVOQtreated patients who may be at risk for gastrointestinal perforation (e.g., identification of GI perforation. patients with a history of diverticulitis and patients taking NSAIDs or corticosteroids).

LABORATORY ABNORMALITIES Promptly evaluate patients presenting with new onset abdominal pain for early Neutropenia identification of GI perforation.

Treatment with RINVOQ was associated with an increased incidence of neutropenia LABORATORY ABNORMALITIES (absolute neutrophil count [ANC] <1000 cells/mm3). Treatment with RINVOQ is not Neutropenia recommended in patients with an ANC <1000 cells/mm3. Evaluate neutrophil counts at Treatment with RINVOQaccording was associated with patient an increased incidence of neutropenia baseline and thereafter to routine management. (absolute neutrophil count [ANC] <1000 cells/mm3). Treatment with RINVOQ is not Lymphopenia 3 recommended in patients with an ANC <1000 cells/mm . Evaluate neutrophil counts at Absolute lymphocyte counts (ALC) <500 cells/mm3 were reported in RINVOQ-treated baseline and thereafter according to routine patient management. patients. Treatment with RINVOQ is not recommended in patients with an ALC <500 cells/ 3 Lymphopenia mm . Evaluate at baseline and thereafter according to routine patient management.

Absolute lymphocyte counts (ALC) <500 cells/mm3 were reported in RINVOQ-treated Anemia patients. Treatment with RINVOQ is not recommended in patients with an ALC <500 cells/ Decreases in hemoglobin levels to <8 g/dL were reported in RINVOQ-treated patients. mm3. Evaluate at baseline and thereafter according to routine patient management.

Treatment should not be initiated or should be interrupted in patients with hemoglobin Anemia levels <8 g/dL. Evaluate at baseline and thereafter according to routine patient Decreases in hemoglobin levels to <8 g/dL were reported in RINVOQ-treated patients. management.

Treatment should not be initiated or should be interrupted in patients with hemoglobin Lipids levels <8 g/dL. Evaluate at baseline and thereafter according to routine patient Treatment with RINVOQ was associated with increases in lipid parameters, including management. total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein Lipidscholesterol. Manage patients according to clinical guidelines for the management (HDL) Treatment with RINVOQ waspatients associated with increases in lipid including of hyperlipidemia.

Evaluate 12 weeks after initiation of parameters, treatment and thereafter total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein according to the clinical guidelines for hyperlipidemia.

(HDL) cholesterol. Manage patients according to clinical guidelines for the management Liver enzyme elevations of hyperlipidemia. Evaluate patients 12 weeks after initiation of treatment and thereafter Treatment with RINVOQ was associated with increased incidence of liver enzyme according to the clinical guidelines for hyperlipidemia. elevation compared to placebo. Evaluate at baseline and thereafter according to routine Liver enzyme elevations patient management.

Prompt investigation of the cause of liver enzyme elevation is Treatment with to RINVOQ associated increased incidence of liver enzyme in recommended identifywas potential caseswith of druginduced liver injury.

If increases elevation compared to placebo. at baseline and thereafter to routine aspartate aminotransferase (AST)Evaluate or alanine aminotransferase (ALT) according are observed during patient management.

Promptand investigation of the cause of is liver enzyme elevation is routine patient management drug-induced liver injury suspected, RINVOQ should recommended to identify potentialiscases of druginduced liver injury. If increases in be interrupted until this diagnosis excluded. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) are observed during EMBRYO-FETAL TOXICITY and drug-induced liver injury is suspected, RINVOQ should routine patient management Based on findings animal studies, be interrupted untilinthis diagnosis is RINVOQ excluded.may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females EMBRYO-FETAL TOXICITY of reproductive potential to use effective contraception during treatment with RINVOQ Based findings in animal studies, RINVOQ may cause fetalofharm when and foron 4 weeks after the final dose. Verify pregnancy status females ofadministered reproductive to a pregnant woman.

Advisetreatment pregnantwith women of the potential risk to a fetus. Advise females potential prior to starting RINVOQ. of reproductive potential to use effective contraception during treatment with RINVOQ VACCINATION and for 4 weeks after the final dose. Verify pregnancy status of females of reproductive Avoid useprior of live during, orwith immediately potential tovaccines starting treatment RINVOQ.prior to, RINVOQ therapy. Prior to initiating RINVOQ, patients should be brought up to date on all immunizations, including VACCINATION varicella zoster or prophylactic herpes zoster vaccinations, in agreement with current Avoid use of live vaccines during, or immediately prior to, RINVOQ therapy. Prior to immunization guidelines. initiating RINVOQ, patients should be brought up to date on all immunizations, including MEDICATION IN STOOL varicella zosterRESIDUE or prophylactic herpes zoster vaccinations, in agreement with current Reports of medication residue in stool or ostomy output have occurred in patients taking immunization guidelines.

RINVOQ. Most reports described anatomic or functional GI conditions with shortened GI MEDICATION RESIDUE IN STOOL transit times. Instruct patients to contact their healthcare provider if medication residue is Reports medicationMonitor residuepatients in stool or ostomyand output have alternative occurred intreatment patients taking observedofrepeatedly. clinically consider if there RINVOQ. Most reports described anatomic or functional GI conditions with shortened GI is an inadequate therapeutic response. transit times. Instruct patients to contact their healthcare provider if medication residue is observed repeatedly. Monitor patients clinically and consider alternative treatment if there LACTATION is an inadequate response.

There are no datatherapeutic on the presence of RINVOQ in human milk, the effects on the breastfed

Carefully consider the risksherpes and benefits treatment with RINVOQ • Bacterial, viral, including zoster,of and other infections due toprior toopportunistic initiating therapy in patients with chronic or recurrent infection. Monitor pathogens. patients closely for the development of signs and symptoms of infection during Carefully consider the risks and benefits of treatment with RINVOQ prior and after treatment with RINVOQ, including the possible development of TB in to initiating therapy patients with chronic or recurrent Monitor patients who tested in negative for latent TB infection prior infection. to initiating therapy. patients closely for the development of signs and symptoms of infection during MORTALITY and after treatment with RINVOQ, including the possible development of TB in In a large, randomized, postmarketing study comparing another Janus patients who tested negative for latentsafety TB infection prior to initiating therapy. kinase (JAK) inhibitor with tumor necrosis factor (TNF) blockers in rheumatoid MORTALITY arthritis (RA) patients ≥50 years old with at least one cardiovascular (CV) risk In a large, randomized, postmarketing safety study comparing Janus factor, a higher rate of all-cause mortality, including sudden CVanother death, was kinase (JAK) inhibitor tumorConsider necrosisthe factor (TNF)and blockers in the rheumatoid observed with the JAKwith inhibitor. benefits risks for individual arthritisprior (RA)to patients ≥50 old with at least one cardiovascular (CV) risk patient initiating or years continuing therapy with RINVOQ. factor, a higher rate of all-cause mortality, including sudden CV death, was MALIGNANCIES observed with the JAK inhibitor. Consider the benefits and risks for the individual Lymphoma other malignancies have beenwith observed in patients treated with patient priorand to initiating or continuing therapy RINVOQ. RINVOQ. MALIGNANCIES In a large, randomized, postmarketing safety comparing another JAKwith Lymphoma and other malignancies have beenstudy observed in patients treated inhibitor RINVOQ.with TNF blockers in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]), lymphomas, and lung cancer In acurrent large, randomized, postmarketing safety study comparing another JAK (in or past smokers) was observed with the JAK inhibitor.

Patients who inhibitor with RA a higher raterisk. of malignancies are current or TNF pastblockers smokersin are atpatients, additional increased (excluding non-melanoma skin cancer [NMSC]), lymphomas, and lung cancer With RINVOQ, consider the benefits and risks for the patient prior to (in current or past smokers) was observed with the individual JAK inhibitor.

Patients who initiating or continuing therapy, in patients with a known malignancy are current or past smokers areparticularly at additional increased risk. (other than a successfully treated NMSC), patients who develop a malignancy With RINVOQ, consider benefits and for the individual patient priorhave to when on treatment, andthe patients who arerisks current or past smokers.

NMSCs initiating or continuing therapy, particularly in patients with known malignancy been reported in patients treated with RINVOQ. Periodic skina examination is (other than a successfully NMSC), patients who a malignancy recommended for patientstreated who are at increased risk fordevelop skin cancer.

Advise when onto treatment, and patients are current or past clothing smokers.and NMSCs patients limit sunlight exposurewho by wearing protective usinghave been reported in patients treated with RINVOQ. Periodic skin examination is sunscreen. recommended for patients who are at increased risk for skin cancer. Advise MAJOR CARDIOVASCULAR EVENTS patients ADVERSE to limit sunlight exposure by wearing protective clothing and using In a large, randomized, postmarketing study comparing another JAK inhibitor sunscreen. with TNF blockers in RA patients ≥50 years old with at least one CV risk factor, MAJOR CARDIOVASCULAR EVENTSevents (MACE) (defined as a higherADVERSE rate of major adverse cardiovascular In a large, randomized, postmarketing study comparing JAK inhibitor cardiovascular death, myocardial infarction, and stroke)another was observed with with TNFinhibitor. blockersPatients in RA patients ≥50 years or oldpast withsmokers at least are oneat CV risk factor, the JAK who are current additional a higher rate of major adverse cardiovascular events (MACE) (defined as increased risk. Discontinue RINVOQ in patients that have experienced a cardiovascular death, or myocardial myocardial infarction stroke. infarction, and stroke) was observed with the JAK inhibitor. Patients who are current or past smokers are at additional Consider benefits and risks for the in individual prior to initiating aor increasedthe risk.

Discontinue RINVOQ patientspatient that have experienced continuing withorRINVOQ, myocardialtherapy infarction stroke. particularly in patients who are current or past smokers and patients with other CV risk factors. Patients should be informed about Consider the benefits andCV risks for the to occur. initiating or the symptoms of serious events andindividual the stepspatient to takeprior if they continuing therapy with RINVOQ, particularly in patients who are current or past infant, or the effects on milk production. Available data in animals have shown the LACTATION THROMBOSIS smokers and patients with other CV risk factors. Patients should be informed about excretion of RINVOQ in milk. Advise patients that breastfeeding is not recommended There are no datawith on the presence in human milk, the effects on the breastfed Thrombosis, venous thrombosis, pulmonary embolism, and the symptomsincluding of seriousdeep CV events and the steps to take if they occur. during treatment RINVOQ andof forRINVOQ 6 days after the last dose. infant, or the effects on milk production. Available data in animals have shown the arterial thrombosis have occurred in patients treated with JAK inhibitors used THROMBOSIS excretion IMPAIRMENT of RINVOQ in milk. Advise patients that breastfeeding is not recommended to treat inflammatory conditions. Many of these adverse events were serious HEPATIC Thrombosis, including deep venous thrombosis, pulmonary embolism, and during treatment with RINVOQfor and forin6patients days after thesevere last dose. and some resulted in death.

RINVOQ is not recommended use with hepatic impairment. arterial thrombosis have occurred in patients treated with JAK inhibitors used In a large, randomized, postmarketing study comparing another JAK inhibitor to treat inflammatory conditions. Many of these adverse events were serious ADVERSE REACTIONS HEPATIC IMPAIRMENT to TNF blockers in RA patients ≥50 years old with at least one CV risk factor, a and some resulted in death.

The mostiscommon adverse reactions clinical trialshepatic were upper respiratory RINVOQ not recommended for use in RINVOQ patients with severe impairment. higher rate of thrombosis was observed with the JAK inhibitor. Avoid RINVOQ tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, In patients a large, randomized, postmarketing study JAK inhibitor in at risk. Patients with symptoms ofcomparing thrombosisanother should discontinue ADVERSE REACTIONS acne, headache, increased blood creatine phosphokinase, hypersensitivity, folliculitis, to TNF blockers RA patients ≥50 years old with at least one CV risk factor, a RINVOQ and be in promptly evaluated.

The most common adverseweight, reactions in RINVOQ clinical trials weremyalgia, upper respiratory abdominal pain, increased influenza, fatigue, neutropenia, influenza-like higher rate of thrombosis was observed with the JAK inhibitor. Avoid RINVOQ tract infections, zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, illness, elevated herpes liver enzymes, rash, and anemia.

HYPERSENSITIVITY in patients at risk. Patients with symptoms of thrombosis should discontinue acne, headache, increased blood creatine phosphokinase, hypersensitivity, folliculitis, RINVOQ contraindicated in patients with known hypersensitivity to upadacitinib Inform patients that retinal detachment has been reported in clinical trials with RINVOQ. RINVOQis and be promptly evaluated. abdominal pain, increased weight, influenza, fatigue, neutropenia, myalgia, influenza-like or any of its excipients. Serious hypersensitivity reactions, such as anaphylaxis Advise patients to immediately inform their healthcare provider if they develop any illness, elevated liver enzymes, rash, and anemia.

HYPERSENSITIVITY and angioedema, were reported in patients receiving RINVOQ in clinical trials. If sudden changes in vision while receiving RINVOQ. RINVOQ is contraindicated in patients with known hypersensitivity to upadacitinib Inform patients that retinal detachment has been reported in clinical trials with RINVOQ. a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and Dosage Forms and Strengths: RINVOQ is available in 15 mg, 30ifmg, and 45 mgany or any of its excipients.

Serious hypersensitivity reactions, such as anaphylaxis Advise patients to immediately inform their healthcare provider they develop institute appropriate therapy. extended-release and angioedema, were reported in patients receiving RINVOQ in clinical trials. If sudden changes intablets. vision while receiving RINVOQ. a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and Forms and Strengths: RINVOQ is available inet 15al.mg, 30 and mg,efficacy and 45ofmg References: 1. RINVOQ [package ABVRRTI68885.

3. Genovese MC, Fleischmann R, Combe B, Safety upadacitinib institute appropriate therapy. insert]. North Chicago, IL: AbbVie Inc; 2022. 2. Data on file, AbbVie Inc.Dosage in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugsextended-release (SELECT-BEYOND): tablets. a double-blind, randomised controlled phase 3 trial. Lancet. 2018;391(10139): 2513-2524. 4. Smolen JS, Emery P, Rigby W, et al. Upadacitinib as monotherapy in patients with rheumatoid arthritis and prior inadequate response to methotrexate: results at 84 weeks from the SELECTMONOTHERAPY study. Poster presented at: The European Congress of Rheumatology; June 3-6, 2020; E-Congress. 5. Smolen JS, Pangan AL, Emery P, et al. Upadacitinib as monotherapy in patients with References: 1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc; 2022. 2. Data on file, AbbVie Inc. ABVRRTI68885.

3. Genovese MC, Fleischmann Combe B, et al.

Safety and efficacy of upadacitinib active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3R,study.

Lancet.

2019;393(10188):2303-2311.

Erratum in with active rheumatoid 6. arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet.

2018;391(10139): in:patients Lancet. 2019;393(10191):2590.

Genovese MC, Combe B, Hall S, et al. Upadacitinib in patients with rheumatoid arthritis and inadequate response or intolerance to biological DMARDs: Results at 60 2513-2524.

Smolen JS, Emery P,study.

RigbyPoster W, et al.

Upadacitinib as American monotherapy in patients with rheumatoid arthritis and prior7.inadequate to methotrexate: results 84 weeks safety from the SELECTweeks from4. the SELECT-BEYOND presented at: The College of Rheumatology; November 8-13, 2019.

Cohen SB, response van Vollenhoven R, Curtis JR, et al.atIntegrated profile of MONOTHERAPY presented at: The European Congress of Rheumatology; June 3-6, 2020; 5.Congress Smolen JS, AL, Emery P, et al.2021; Upadacitinib as monotherapy in patients with J, upadacitinib withstudy. up to Poster 4.5 years of exposure in patients with rheumatoid arthritis. Poster presented at: E-Congress.

The European of Pangan Rheumatology; June 2-5, E-Congress.

8. Rubbert-Roth A, Enejosa active arthritis and inadequate response methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019;393(10188):2303-2311. Erratum Panganrheumatoid AL, et al. Trial of upadacitinib or abatacept in to rheumatoid arthritis.

N Engl J Med. 2020;383(16):1511-1521. in: Lancet. 2019;393(10191):2590. 6. Genovese MC, Combe B, Hall S, et al. Upadacitinib in patients with rheumatoid arthritis and inadequate response or intolerance to biological DMARDs: Results at 60 weeks from the SELECT-BEYOND study. Poster presented at: The American College of Rheumatology; November 8-13, 2019. 7. Cohen SB, van Vollenhoven R, Curtis JR, et al. Integrated safety profile of upadacitinibPlease with up tosee 4.5 years of exposure in patients with rheumatoid arthritis.

Poster presentedon at: The European Congress of Rheumatology; June 2-5, 2021; E-Congress. 8. Rubbert-Roth A, Enejosa J, Brief Summary of full Prescribing Information previous pages of this advertisement.

Pangan AL, et al. Trial of upadacitinib or abatacept in rheumatoid arthritis. N Engl J Med. 2020;383(16):1511-1521.

© 2023 AbbVie. All rights reserved.

Please see Brief Summary ofUS-RNQR-230557 full Prescribing Information on previous pages of this advertisement.

July 2023 © 2023 AbbVie. All rights reserved.

US-RNQR-230557 July 2023

Revista Puertorriqueña de Medicina y Salud Pública

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RINVOQ (RIN-VOKE) (upadacitinib) extended-release tablets, for oral use ®

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions, Adverse Reactions]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

If a serious infection develops, interrupt RINVOQ until the infection is controlled.

Reported infections include: • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before RINVOQ use and during therapy. Treatment for latent infection should be considered prior to RINVOQ use.

• Invasive fungal infections, including cryptococcosis and pneumocystosis.

• Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

The risks and benefits of treatment with RINVOQ should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with RINVOQ, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy [see Warnings and Precautions].

MORTALITY In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor [see Warnings and Precautions].

MALIGNANCIES Lymphoma and other malignancies have been observed in patients treated with RINVOQ. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk [see Warnings and Precautions].

MAJOR ADVERSE CARDIOVASCULAR EVENTS In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.

Discontinue RINVOQ in patients that have experienced a myocardial infarction or stroke [see Warnings and Precautions].

THROMBOSIS Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with JAK inhibitors used to treat inflammatory conditions.

Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid RINVOQ in patients at risk. Patients with symptoms of thrombosis should discontinue RINVOQ and be promptly evaluated [see Warnings and Precautions].

INDICATIONS AND USAGE Rheumatoid Arthritis RINVOQ® is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.

• Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

Psoriatic Arthritis RINVOQ is indicated for the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.

• Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.

Atopic Dermatitis RINVOQ is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.

• Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.

Ulcerative Colitis RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers.

• Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for ulcerative colitis, or with potent immunosuppressants such as azathioprine and cyclosporine.

Crohn’s Disease RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more TNF blockers.

• Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for Crohn’s disease, or with potent immunosuppressants such as azathioprine and cyclosporine.

24

20078707 R1 Rinvoq PB-7.625 x 10.5 (4).indd 1

PROFESSIONAL BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION

Ankylosing Spondylitis RINVOQ is indicated for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.

• Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.

Non-radiographic Axial Spondyloarthritis RINVOQ is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy.

• Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.

CONTRAINDICATIONS RINVOQ is contraindicated in patients with known hypersensitivity to upadacitinib or any of its excipients [see Warnings and Precautions].

WARNINGS AND PRECAUTIONS Serious Infections Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported with RINVOQ included pneumonia and cellulitis [see Adverse Reactions].

Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis, were reported with RINVOQ. Avoid use of RINVOQ in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating RINVOQ in patients: • with chronic or recurrent infection • who have been exposed to tuberculosis • with a history of a serious or an opportunistic infection • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or • with underlying conditions that may predispose them to infection.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with RINVOQ. Interrupt RINVOQ if a patient develops a serious or opportunistic infection.

A patient who develops a new infection during treatment with RINVOQ should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be initiated, the patient should be closely monitored, and RINVOQ should be interrupted if the patient is not responding to antimicrobial therapy. RINVOQ may be resumed once the infection is controlled.

Tuberculosis Evaluate and test patients for latent and active tuberculosis (TB) infection prior to administration of RINVOQ. Patients with latent TB should be treated with standard antimycobacterial therapy before initiating RINVOQ. RINVOQ should not be given to patients with active TB. Consider anti-TB therapy prior to initiation of RINVOQ in patients with previously untreated latent TB or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.

Consultation with a physician with expertise in the treatment of TB is recommended to aid in the decision about whether initiating anti-TB therapy is appropriate for an individual patient.

During RINVOQ use, monitor patients for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.

Viral Reactivation Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster) and hepatitis B virus reactivation, were reported in clinical trials with RINVOQ [see Adverse Reactions]. The risk of herpes zoster appears to be higher in patients treated with RINVOQ in Japan. If a patient develops herpes zoster, consider temporarily interrupting RINVOQ until the episode resolves.

Screening for viral hepatitis and monitoring for reactivation should be performed in accordance with clinical guidelines before starting and during therapy with RINVOQ. Patients who were positive for hepatitis C antibody and hepatitis C virus RNA, were excluded from clinical trials. Patients who were positive for hepatitis B surface antigen or hepatitis B virus DNA were excluded from clinical trials. However, cases of hepatitis B reactivation were still reported in patients enrolled in the Phase 3 trials of RINVOQ. If hepatitis B virus DNA is detected while receiving RINVOQ, a liver specialist should be consulted.

Mortality In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed in patients treated with the JAK inhibitor compared with TNF blockers.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with RINVOQ. Malignancy and Lymphoproliferative Disorders Malignancies, including lymphomas, were observed in clinical trials of RINVOQ [see Adverse Reactions].

In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies (excluding NMSC) was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. In this study, current or past smokers had an additional increased risk of overall malignancies.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with RINVOQ, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy when on treatment, and patients who are current or past smokers.

Non-Melanoma Skin Cancer NMSCs have been reported in patients treated with RINVOQ. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

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Exposure to sunlight and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen.

Major Adverse Cardiovascular Events In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of major adverse cardiovascular events (MACE) defined as cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke was observed with the JAK inhibitor compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with RINVOQ, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue RINVOQ in patients that have experienced a myocardial infarction or stroke.

Thrombosis Thrombosis, including deep venous thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis, have occurred in patients treated for inflammatory conditions with JAK inhibitors, including RINVOQ. Many of these adverse events were serious and some resulted in death.

In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of overall thrombosis, DVT, and PE were observed compared to those treated with TNF blockers.

If symptoms of thrombosis occur, patients should discontinue RINVOQ and be evaluated promptly and treated appropriately. Avoid RINVOQ in patients that may be at increased risk of thrombosis.

Hypersensitivity Reactions Serious hypersensitivity reactions such as anaphylaxis and angioedema were reported in patients receiving RINVOQ in clinical trials. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy [see Adverse Reactions].

Gastrointestinal Perforations Gastrointestinal perforations have been reported in clinical trials with RINVOQ [see Adverse Reactions].

Monitor RINVOQ-treated patients who may be at risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis and those taking concomitant medications including NSAIDs or corticosteroids). Evaluate promptly patients presenting with new onset abdominal pain for early identification of gastrointestinal perforation.

Laboratory Abnormalities Neutropenia Treatment with RINVOQ was associated with an increased incidence of neutropenia (ANC less than 1000 cells/mm3).

Evaluate neutrophil counts at baseline and thereafter according to routine patient management. Avoid RINVOQ initiation and interrupt RINVOQ treatment in patients with a low neutrophil count (i.e., ANC less than 1000 cells/mm3).

Lymphopenia ALC less than 500 cells/mm3 were reported in RINVOQ-treated patients in clinical trials.

Evaluate lymphocyte counts at baseline and thereafter according to routine patient management. Avoid RINVOQ initiation or interrupt RINVOQ treatment in patients with a low lymphocyte count (i.e., less than 500 cells/mm3).

Anemia Decreases in hemoglobin levels to less than 8 g/dL were reported in RINVOQ-treated patients in clinical trials.

Evaluate hemoglobin at baseline and thereafter according to routine patient management. Avoid RINVOQ initiation or interrupt RINVOQ treatment in patients with a low hemoglobin level (i.e., less than 8 g/dL).

Lipids Treatment with RINVOQ was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol [see Adverse Reactions].

Elevations in LDL cholesterol decreased to pre-treatment levels in response to statin therapy. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.

Assess lipid parameters approximately 12 weeks after initiation of treatment, and thereafter according to the clinical guidelines for hyperlipidemia. Manage patients according to clinical guidelines for the management of hyperlipidemia.

Liver Enzyme Elevations Treatment with RINVOQ was associated with increased incidence of liver enzyme elevations compared to treatment with placebo.

Evaluate liver enzymes at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury.

If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.

Embryo-Fetal Toxicity Based on findings in animal studies, RINVOQ may cause fetal harm when administered to a pregnant woman. Administration of upadacitinib to rats and rabbits during organogenesis caused increases in fetal malformations.

Verify the pregnancy status of patients of reproductive potential prior to starting treatment. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception during treatment with RINVOQ and for 4 weeks following completion of therapy [see Use in Specific Populations].

Vaccinations Avoid use of live vaccines during or immediately prior to RINVOQ therapy initiation. Prior to initiating RINVOQ, it is recommended that patients be brought up to date with all immunizations, including varicella zoster or prophylactic herpes zoster vaccinations, in agreement with current immunization guidelines.

Medication Residue in Stool Reports of medication residue in stool or ostomy output have occurred in patients taking RINVOQ. Most reports described anatomic (e.g., ileostomy, colostomy, intestinal resection) or functional gastrointestinal conditions with shortened gastrointestinal transit times. Instruct patients to contact

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their healthcare provider if medication residue is observed repeatedly.

Monitor patients clinically and consider alternative treatment if there is an inadequate therapeutic response.

ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Infections [see Warnings and Precautions] • Mortality [see Warnings and Precautions] • Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions] • Major Adverse Cardiovascular Events [see Warnings and Precautions] • Thrombosis [see Warnings and Precautions] • Hypersensitivity Reactions [see Warnings and Precautions] • Gastrointestinal Perforations [see Warnings and Precautions] • Laboratory Abnormalities [see Warnings and Precautions] Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse Reactions in Patients with Rheumatoid Arthritis A total of 3833 patients with rheumatoid arthritis were treated with upadacitinib in the Phase 3 clinical trials of whom 2806 were exposed for at least one year.

Patients could advance or switch to RINVOQ 15 mg from placebo, or be rescued to RINVOQ from active comparator or placebo from as early as Week 12 depending on the trial design.

A total of 2630 patients received at least 1 dose of RINVOQ 15 mg, of whom 1860 were exposed for at least one year. In trials RA-I, RA-II, RA-III and RA-V, 1213 patients received at least 1 dose of RINVOQ 15 mg, of which 986 patients were exposed for at least one year, and 1203 patients received at least 1 dose of upadacitinib 30 mg, of which 946 were exposed for at least one year.

Table 1: Adverse Reactions Reported in ≥ 1% of Rheumatoid Arthritis Patients Treated with RINVOQ 15 mg in Placebo-controlled Trials Placebo RINVOQ 15 mg Adverse Reaction N = 1042 N = 1035 (%) (%) Upper respiratory tract infection (URTI)* 9.5 13.5 Nausea

2.2

3.5

Cough

1.0

2.2

Pyrexia

0

1.2

*URTI includes: acute sinusitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, viral upper respiratory tract infection Other adverse reactions reported in less than 1% of patients in the RINVOQ 15 mg group and at a higher rate than in the placebo group through Week 12 included pneumonia, herpes zoster, herpes simplex (includes oral herpes), and oral candidiasis.

Four integrated datasets are presented in the Specific Adverse Reaction section: Placebo-controlled Trials: Trials RA-III, RA-IV, and RA-V were integrated to represent safety through 12/14 weeks for placebo (n=1042) and RINVOQ 15 mg (n=1035). Trials RA-III and RA-V were integrated to represent safety through 12 weeks for placebo (n=390), RINVOQ 15 mg (n=385), and upadacitinib 30 mg (n=384). Trial RA-IV did not include the 30 mg dose and, therefore, safety data for upadacitinib 30 mg can only be compared with placebo and RINVOQ 15 mg rates from pooling trials RA-III and RA-V. MTX-controlled Trials: Trials RA-I and RA-II were integrated to represent safety through 12/14 weeks for MTX (n=530), RINVOQ 15 mg (n=534), and upadacitinib 30 mg (n=529).

12-Month Exposure Dataset: Trials RA-I, II, III, and V were integrated to represent the long-term safety of RINVOQ 15 mg (n=1213) and upadacitinib 30 mg (n=1203).

Exposure adjusted incidence rates were adjusted by trial for all the adverse events reported in this section.

Specific Adverse Reactions Infections Placebo-controlled Trials: In RA-III, RA-IV, and RA-V, infections were reported in 218 patients (95.7 per 100 patient-years) treated with placebo and 284 patients (127.8 per 100 patient-years) treated with RINVOQ 15 mg. In RA-III and RA-V, infections were reported in 99 patients (136.5 per 100 patient-years) treated with placebo, 118 patients (164.5 per 100 patient-years) treated with RINVOQ 15 mg, and 126 patients (180.3 per 100 patient-years) treated with upadacitinib 30 mg.

MTX-controlled Trials: Infections were reported in 127 patients (119.5 per 100 patient-years) treated with MTX monotherapy, 104 patients (91.8 per 100 patient-years) treated with RINVOQ 15 mg monotherapy, and 128 patients (115.1 per 100 patient-years) treated with upadacitinib 30 mg monotherapy.

12-Month Exposure Dataset: Infections were reported in 615 patients (83.8 per 100 patient-years) treated with RINVOQ 15 mg and 674 patients (99.7 per 100 patient-years) treated with upadacitinib 30 mg.

Serious Infections Placebo-controlled Trials: In RA-III, RA-IV, and RA-V, serious infections were reported in 6 patients (2.3 per 100 patient-years) treated with placebo, and 12 patients (4.6 per 100 patient-years) treated with RINVOQ 15 mg. In RA-III and RA-V, serious infections were reported in 1 patient (1.2 per 100 patientyears) treated with placebo, 2 patients (2.3 per 100 patient-years) treated with RINVOQ 15 mg, and 7 patients (8.2 per 100 patient-years) treated with upadacitinib 30 mg.

MTX-controlled Trials: Serious infections were reported in 2 patients (1.6 per 100 patient-years) treated with MTX monotherapy, 3 patients (2.4 per 100 patient-years) treated with RINVOQ 15 mg monotherapy, and 8 patients (6.4 per 100 patient-years) treated with upadacitinib 30 mg monotherapy.

12-Month Exposure Dataset: Serious infections were reported in 38 patients (3.5 per 100 patient-years) treated with RINVOQ 15 mg and 59 patients (5.6 per 100 patient-years) treated with upadacitinib 30 mg.

The most frequently reported serious infections were pneumonia and cellulitis.

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Tuberculosis Placebo-controlled Trials and MTX-controlled Trials: In the placebocontrolled period, there were no active cases of tuberculosis reported in the placebo, RINVOQ 15 mg, and upadacitinib 30 mg groups. In the MTXcontrolled period, there were no active cases of tuberculosis reported in the MTX monotherapy, RINVOQ 15 mg monotherapy, and upadacitinib 30 mg monotherapy groups.

12-Month Exposure Dataset: Active tuberculosis was reported for 2 patients treated with RINVOQ 15 mg and 1 patient treated with upadacitinib 30 mg.

Cases of extra-pulmonary tuberculosis were reported.

Opportunistic Infections (excluding tuberculosis) Placebo-controlled Trials: In RA-III, RA-IV, and RA-V, opportunistic infections were reported in 3 patients (1.2 per 100 patient-years) treated with placebo, and 5 patients (1.9 per 100 patient-years) treated with RINVOQ 15 mg.

In RA-III and RA-V, opportunistic infections were reported in 1 patient (1.2 per 100 patient-years) treated with placebo, 2 patients (2.3 per 100 patient-years) treated with RINVOQ 15 mg, and 6 patients (7.1 per 100 patient-years) treated with upadacitinib 30 mg.

MTX-controlled Trials: Opportunistic infections were reported in 1 patient (0.8 per 100 patient-years) treated with MTX monotherapy, 0 patients treated with RINVOQ 15 mg monotherapy, and 4 patients (3.2 per 100 patient-years) treated with upadacitinib 30 mg monotherapy.

12-Month Exposure Dataset: Opportunistic infections were reported in 7 patients (0.6 per 100 patient-years) treated with RINVOQ 15 mg and 15 patients (1.4 per 100 patient-years) treated with upadacitinib 30 mg.

Malignancies Placebo-controlled Trials: In RA-III, RA-IV, and RA-V, malignancies excluding NMSC were reported in 1 patient (0.4 per 100 patient-years) treated with placebo, and 1 patient (0.4 per 100 patient-years) treated with RINVOQ 15 mg. In RA-III and RA-V, malignancies excluding NMSC were reported in 0 patients treated with placebo, 1 patient (1.1 per 100 patient-years) treated with RINVOQ 15 mg, and 3 patients (3.5 per 100 patient-years) treated with upadacitinib 30 mg.

MTX-controlled Trials: Malignancies excluding NMSC were reported in 1 patient (0.8 per 100 patient-years) treated with MTX monotherapy, 3 patients (2.4 per 100 patient-years) treated with RINVOQ 15 mg monotherapy, and 0 patients treated with upadacitinib 30 mg monotherapy.

12-Month Exposure Dataset: Malignancies excluding NMSC were reported in 13 patients (1.2 per 100 patient-years) treated with RINVOQ 15 mg and 14 patients (1.3 per 100 patient-years) treated with upadacitinib 30 mg.

Gastrointestinal Perforations Placebo-controlled Trials: There were no gastrointestinal perforations (based on medical review) reported in patients treated with placebo, RINVOQ 15 mg, and upadacitinib 30 mg.

MTX-controlled Trials: There were no cases of gastrointestinal perforations reported in the MTX and RINVOQ 15 mg group through 12/14 weeks.

Two cases of gastrointestinal perforations were observed in the upadacitinib 30 mg group.

12-Month Exposure Dataset: Gastrointestinal perforations were reported in 1 patient treated with RINVOQ 15 mg and 4 patients treated with upadacitinib 30 mg.

Thrombosis Placebo-controlled Trials: In RA-IV, venous thrombosis (pulmonary embolism or deep vein thrombosis) was observed in 1 patient treated with placebo and 1 patient treated with RINVOQ 15 mg. In RA-V, venous thrombosis was observed in 1 patient treated with RINVOQ 15 mg. There were no observed cases of venous thrombosis reported in RA-III. No cases of arterial thrombosis were observed through 12/14 weeks.

MTX-controlled Trials: In RA-II, venous thrombosis was observed in 0 patients treated with MTX monotherapy, 1 patient treated with RINVOQ 15 mg monotherapy and 0 patients treated with upadacitinib 30 mg monotherapy through Week 14. In RA-II, no cases of arterial thrombosis were observed through 12/14 weeks. In RA-I, venous thrombosis was observed in 1 patient treated with MTX, 0 patients treated with RINVOQ 15 mg and 1 patient treated with upadacitinib 30 mg through Week 24. In RA-I, arterial thrombosis was observed in 1 patient treated with upadacitinib 30 mg through Week 24.

12-Month Exposure Dataset: Venous thrombosis events were reported in 5 patients (0.5 per 100 patient-years) treated with RINVOQ 15 mg and 4 patients (0.4 per 100 patient-years) treated with upadacitinib 30 mg. Arterial thrombosis events were reported in 0 patients treated with RINVOQ 15 mg and 2 patients (0.2 per 100 patient-years) treated with upadacitinib 30 mg.

Laboratory Abnormalities Hepatic Transaminase Elevations In placebo-controlled trials (RA-III, RA-IV, and RA-V) with background DMARDs, for up to 12/14 weeks, alanine transaminase (ALT) and aspartate transaminase (AST) elevations ≥ 3 x upper limit of normal (ULN) in at least one measurement were observed in 2.1% and 1.5% of patients treated with RINVOQ 15 mg, and in 1.5% and 0.7% of patients treated with placebo, respectively. In RA-III and RA-V, ALT and AST elevations ≥ 3 x ULN in at least one measurement were observed in 0.8% and 1.0% of patients treated with RINVOQ 15 mg, 1.0% and 0% of patients treated with upadacitinib 30 mg and in 1.3% and 1.0% of patients treated with placebo, respectively.

In MTX-controlled trials, for up to 12/14 weeks, ALT and AST elevations ≥ 3 x ULN in at least one measurement were observed in 0.8% and 0.4% of patients treated with RINVOQ 15 mg, 1.7% and 1.3% of patients treated with upadacitinib 30 mg and in 1.9% and 0.9% of patients treated with MTX, respectively.

Lipid Elevations Upadacitinib treatment was associated with dose-related increases in total cholesterol, triglycerides and LDL cholesterol. Upadacitinib was also associated with increases in HDL cholesterol. Elevations in LDL and HDL cholesterol peaked by Week 8 and remained stable thereafter. In controlled trials, for up to 12/14 weeks, changes from baseline in lipid parameters in patients treated with RINVOQ 15 mg and upadacitinib 30 mg, respectively, are summarized below: • Mean LDL cholesterol increased by 14.81 mg/dL and 17.17 mg/dL. • Mean HDL cholesterol increased by 8.16 mg/dL and 9.01 mg/dL. • The mean LDL/HDL ratio remained stable.

• Mean triglycerides increased by 13.55 mg/dL and 14.44 mg/dL. Creatine Phosphokinase Elevations In placebo-controlled trials (RA-III, RA-IV, and RA-V) with background DMARDs, for up to 12/14 weeks, dose-related increases in creatine phosphokinase (CPK) values were observed. CPK elevations > 5 x ULN were reported in 1.0%, and 0.3% of patients over 12/14 weeks in the RINVOQ

15 mg and placebo groups, respectively. Most elevations >5 x ULN were transient and did not require treatment discontinuation. In RA-III and RA-V, CPK elevations > 5 x ULN were observed in 0.3% of patients treated with placebo, 1.6% of patients treated with RINVOQ 15 mg, and none in patients treated with upadacitinib 30 mg.

Neutropenia In placebo-controlled trials (RA-III, RA-IV, and RA-V) with background DMARDs, for up to 12/14 weeks, dose-related decreases in neutrophil counts, below 1000 cells/mm3 in at least one measurement occurred in 1.1% and <0.1% of patients in the RINVOQ 15 mg and placebo groups, respectively. In RA-III and RA-V, decreases in neutrophil counts below 1000 cells/mm3 in at least one measurement occurred in 0.3% of patients treated with placebo, 1.3% of patients treated with RINVOQ 15 mg, and 2.4% of patients treated with upadacitinib 30 mg. In clinical trials, treatment was interrupted in response to ANC less than 1000 cells/mm3.

Lymphopenia In placebo-controlled trials (RA-III, RA-IV, and RA-V) with background DMARDs, for up to 12/14 weeks, dose-related decreases in lymphocyte counts below 500 cells/mm3 in at least one measurement occurred in 0.9% and 0.7% of patients in the RINVOQ 15 mg and placebo groups, respectively.

In RA-III and RA-V, decreases in lymphocyte counts below 500 cells/mm3 in at least one measurement occurred in 0.5% of patients treated with placebo, 0.5% of patients treated with RINVOQ 15 mg, and 2.4% of patients treated with upadacitinib 30 mg.

Anemia In placebo-controlled trials (RA-III, RA-IV, and RA-V) with background DMARDs, for up to 12/14 weeks, hemoglobin decreases below 8 g/dL in at least one measurement occurred in <0.1% of patients in both the RINVOQ 15 mg and placebo groups. In RA-III and RA-V, hemoglobin decreases below 8 g/dL in at least one measurement were observed in 0.3% of patients treated with placebo, and none in patients treated with RINVOQ 15 mg and upadacitinib 30 mg.

Adverse Reactions in Patients with Psoriatic Arthritis A total of 1827 patients with psoriatic arthritis were treated with upadacitinib in clinical trials representing 1639.2 patient-years of exposure, of whom 722 were exposed to upadacitinib for at least one year. In the two Phase 3 trials, 907 patients received at least 1 dose of RINVOQ 15 mg, of whom 359 were exposed for at least one year.

Two placebo-controlled trials were integrated (640 patients on RINVOQ 15 mg once daily and 635 patients on placebo) to evaluate the safety of RINVOQ 15 mg in comparison to placebo for up to 24 weeks after treatment initiation.

Overall, the safety profile observed in patients with active psoriatic arthritis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis. During the 24-week placebo-controlled period, the frequencies of herpes zoster and herpes simplex were ≥1% (1.1% and 1.4%, respectively) with RINVOQ 15 mg and 0.8% and 1.3%, respectively with placebo. A higher incidence of acne and bronchitis was also observed in patients treated with RINVOQ 15 mg (1.3% and 3.9%, respectively) compared to placebo (0.3% and 2.7%, respectively).

Adverse Reactions in Patients with Atopic Dermatitis Three Phase 3 (AD-1, AD-2, and AD-3) and one Phase 2b (AD-4) randomized, double-blind, placebo-controlled, multicenter trials evaluated the safety of RINVOQ in patients with moderate-to-severe atopic dermatitis.

The majority of patients were White (68%) and male (57%). The mean age was 34 years (ranged from 12 to 75 years) and 13% of the patients were 12 to less than 18 years. In these 4 trials, 2612 patients were treated with RINVOQ 15 mg or 30 mg orally once daily, with or without concomitant topical corticosteroids (TCS).

In the Phase 3 clinical trials (AD-1, AD-2, and AD-3), a total of 1239 patients received RINVOQ 15 mg, of whom 791 were exposed for at least one year and 1246 patients received RINVOQ 30 mg, of whom 826 were exposed for at least one year.

Trials AD-1, AD-2, and AD-4 compared the safety of RINVOQ monotherapy to placebo through Week 16. Trial AD-3 compared the safety of RINVOQ + TCS to placebo + TCS through Week 16.

Weeks 0 to 16 (Trials AD-1 to AD-4) In RINVOQ trials with and without TCS (Trials AD-1, 2, 3 and 4) through Week 16, the proportion of patients who discontinued treatment because of adverse reactions in the RINVOQ 15 mg, 30 mg and placebo groups were 2.3%, 2.9% and 3.8%, respectively. Table 2 summarizes the adverse reactions that occurred at a rate of at least 1% in the RINVOQ 15 mg or 30 mg groups during the first 16 weeks of treatment.

Table 2: Adverse Reactions Reported in ≥ 1% of Patients with Atopic Dermatitis Treated with RINVOQ 15 mg or 30 mg Adverse Reaction Upper respiratory tract infection (URTI)* Acne** Herpes simplex*** Headache Increased blood creatine phosphokinase Cough Hypersensitivity**** Folliculitis Nausea Abdominal pain***** Pyrexia Increased Weight Herpes zoster****** Influenza Fatigue Neutropenia Myalgia

Placebo RINVOQ RINVOQ 15 mg 30 mg N = 902 N = 899 N = 906 (%) (%) (%) 17 23 25 2 10 16 2 4 8 4 6 6 2 5 6 1 3 3 2 2 3 1 2 3 1 3 3 1 3 2 1 2 2 1 2 2 1 2 2 <1 2 2 1 1 2 <1 1 2 1 1 2

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Placebo RINVOQ RINVOQ 15 mg 30 mg Adverse Reaction N = 902 N = 899 N = 906 (%) (%) (%) Influenza like illness 1 1 2 * Includes: laryngitis, laryngitis viral, nasopharyngitis, oropharyngeal pain, pharyngeal abscess, pharyngitis, pharyngitis streptococcal, pharyngotonsillitis, respiratory tract infection, respiratory tract infection viral, rhinitis, rhinolaryngitis, sinusitis, tonsillitis, tonsillitis bacterial, upper respiratory tract infection, viral pharyngitis, viral upper respiratory tract infection ** Includes: acne and dermatitis acneiform *** Includes: genital herpes, genital herpes simplex, herpes dermatitis, herpes ophthalmic, herpes simplex, nasal herpes, ophthalmic herpes simplex, herpes virus infection, oral herpes **** Includes anaphylactic reaction, anaphylactic shock, angioedema, dermatitis exfoliative generalized, drug hypersensitivity, eyelid oedema, face oedema, hypersensitivity, periorbital swelling, pharyngeal swelling, swelling face, toxic skin eruption, type I hypersensitivity, urticaria ***** Includes abdominal pain and abdominal pain upper ****** Includes herpes zoster and varicella Other adverse reactions reported in less than 1% of patients in the RINVOQ 15 mg and/or 30 mg group and at a higher rate than in the placebo group through Week 16 included anemia, oral candidiasis, pneumonia, nonmelanoma skin cancer, and the adverse event of retinal detachment.

The safety profile of RINVOQ through Week 52 was generally consistent with the safety profile observed at Week 16.

Overall, the safety profile observed in patients with AD treated with RINVOQ was similar to the safety profile in patients with RA. Other specific adverse reactions that were reported in patients with AD included eczema herpeticum/Kaposi’s varicelliform eruption.

Eczema Herpeticum/Kaposi’s Varicelliform Eruption Placebo-controlled Period (16 weeks): Eczema herpeticum was reported in 4 patients (1.6 per 100 patient-years) treated with placebo, 6 patients (2.2 per 100 patient-years) treated with RINVOQ 15 mg and 7 patients (2.6 per 100 patient-years) treated with RINVOQ 30 mg.

12-Month Exposure (Weeks 0 to 52): Eczema herpeticum was reported in 18 patients (1.6 per 100 patient-years) treated with RINVOQ 15 mg and 17 patients (1.5 per 100 patient-years) treated with RINVOQ 30 mg.

Adverse Reactions in Patients with Ulcerative Colitis RINVOQ was studied up to 8 weeks in patients with moderately to severely active ulcerative colitis in two randomized, double-blind, placebo-controlled induction studies (UC-1, UC-2) and a randomized, double-blind, placebo controlled, dose-finding study (UC-4; NCT02819635). Long term safety up to 52-weeks was evaluated in patients who responded to induction therapy in a randomized, double-blind, placebo-controlled maintenance study (UC-3) and a long-term extension study.

In the two induction studies (UC-1, UC-2) and a dose finding study (UC-4), 1097 patients were enrolled of whom 719 patients received RINVOQ 45 mg once daily.

In the maintenance study (UC-3), 746 patients were enrolled of whom 250 patients received RINVOQ 15 mg once daily and 251 patients received RINVOQ 30 mg once daily.

Adverse reactions reported in ≥2% of patients in any treatment arm in the induction and maintenance studies are shown in Tables 3 and 4, respectively.

Table 3: Adverse Reactions Reported in ≥2% of Patients with Ulcerative Colitis Treated with RINVOQ 45 mg in Placebo-Controlled Induction Studies (UC-1, UC-2 and UC-4) RINVOQ Placebo 45 mg Once Daily N = 378 N = 719 (%) (%) 7 9 1 6 1 5 <1 5 1 4 2 3 1 3 1 2 <1 2

Adverse Reaction

Upper respiratory tract infection* Acne* Increased blood creatine phosphokinase Neutropenia* Rash* Elevated liver enzymes** Lymphopenia* Folliculitis Herpes simplex* * Composed of several similar terms ** Elevated liver enzymes composed of elevated ALT, AST, GGT, ALP, liver transaminases, hepatic enzymes, bilirubin, drug-induced liver injury and cholestasis.

Other adverse reactions reported in less than 2% of patients in the RINVOQ 45 mg group and at a higher rate than in the placebo group through Week 8 included herpes zoster and pneumonia.

Table 4: Adverse Reactions Reported in ≥2% of Patients with Ulcerative Colitis Treated with RINVOQ 15 mg or 30 mg in the Placebo-Controlled Maintenance Study (UC-3)1

Adverse Reaction Upper respiratory tract infection* Increased blood creatine phosphokinase Neutropenia* Elevated liver enzymes** Rash* Herpes zoster Folliculitis Hypercholesterolemia*

26

Placebo N = 245 (%) 18 2

RINVOQ RINVOQ 15 mg Once 30 mg Once Daily Daily N = 250 N = 251 (%) (%) 16 20 6 8

2 1 4 0 2 1

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3 6 5 4 2 2

6 4 5 4 4 4

RINVOQ RINVOQ 15 mg Once 30 mg Once Placebo Daily Daily Adverse Reaction N = 245 N = 250 N = 251 (%) (%) (%) Influenza 1 3 3 Herpes simplex* 1 2 3 Lymphopenia* 2 3 2 Hyperlipidemia* 0 2 2 1 Patients who were responders to 8 weeks induction therapy with RINVOQ 45 mg once daily * Composed of several similar terms ** Elevated liver enzymes composed of elevated ALT, AST, GGT, ALP, liver transaminases, hepatic enzymes, bilirubin, drug-induced liver injury, and cholestasis.

The adverse reaction of non-melanoma skin cancer was reported in 1% of patients in the RINVOQ 30 mg group and none of the patients in the RINVOQ 15 mg or placebo group through Week 52.

The safety profile of RINVOQ in the long-term extension study was similar to the safety profile observed in the placebo-controlled induction and maintenance periods.

Overall, the safety profile observed in patients with ulcerative colitis treated with RINVOQ was generally similar to the safety profile in patients with RA and AD. Specific Adverse Reactions Serious Infections Induction Studies: In UC-1, UC-2, and UC-4, serious infections were reported in 5 patients (8.4 per 100 patient-years) treated with placebo and 9 patients (8.4 per 100 patient-years) treated with RINVOQ 45 mg through 8 weeks.

Placebo-controlled Maintenance Study: In UC-3, serious infections were reported in 8 patients (6.3 per 100 patient-years) treated with placebo, 8 patients (4.5 per 100 patient-years) treated with RINVOQ 15 mg, and 6 patients (3.1 per 100 patient-years) treated with RINVOQ 30 mg through 52 weeks.

Laboratory Abnormalities Hepatic Transaminase Elevations In studies UC-1, UC-2, and UC-4, elevations of ALT to ≥ 3 x ULN in at least one measurement were observed in 1.5% of patients treated with RINVOQ 45 mg, and 0% of patients treated with placebo for 8 weeks. AST elevations to ≥ 3 x ULN occurred in 1.5% of patients treated with RINVOQ 45 mg, and 0.3% of patients treated with placebo. Elevations of ALT to ≥ 5 x ULN occurred in 0.4% of patients treated with RINVOQ 45 mg and 0% of patients treated with placebo.

In UC-3, elevations of ALT to ≥ 3 x ULN in at least one measurement were observed in 4% of patients treated with RINVOQ 30 mg, 2% of patients treated with RINVOQ 15 mg, and 0.8% of patients treated with placebo for 52 weeks. Elevations of AST to ≥ 3 x ULN in at least one measurement were observed in 2% of patients treated with RINVOQ 30 mg, 1.6% of patients treated with RINVOQ 15 mg and 0.4% of patients treated with placebo.

Elevations of ALT to ≥ 5 x ULN were observed in 0.8% of patients treated with 30 mg, 0.4% of patients treated with 15 mg, and 0.4% of patients treated with placebo.

Overall, laboratory abnormalities observed in patients with ulcerative colitis treated with RINVOQ were similar to those described in patients with RA. Adverse Reactions in Patients with Crohn’s Disease RINVOQ was studied up to 12 weeks in patients with moderately to severely active CD in two randomized, double-blind, placebo-controlled induction studies (CD-1, CD-2). Long term safety up to 52 weeks was evaluated in patients who responded to induction therapy in a randomized, double-blind, placebo-controlled maintenance study (CD-3), with additional data provided from a long-term extension (LTE) period.

In the two induction studies (CD-1, CD-2), 1021 patients were enrolled, of whom 674 patients received RINVOQ 45 mg once daily during the placebocontrolled period.

In the maintenance study (CD-3), 673 patients were enrolled, of whom 221 patients received RINVOQ 15 mg once daily and 229 patients received RINVOQ 30 mg once daily during the randomized, placebo-controlled period.

Overall, the safety profile observed in patients with Crohn’s disease treated with RINVOQ was consistent with the known safety profile for RINVOQ in other indications.

Adverse reactions reported in ≥2% of patients treated with RINVOQ and at a higher rate than placebo in the induction and maintenance studies are shown in Tables 5 and 6, respectively.

Table 5: Adverse Reactions Reported in ≥2% of Patients with Crohn’s Disease Treated with RINVOQ 45 mg in Placebo-Controlled Induction Studies (CD-1 and CD-2) Adverse Reaction Upper respiratory tract infection* Anemia* Acne* Pyrexia Increased blood creatine phosphokinase Influenza Herpes simplex* Leukopenia* Neutropenia* Herpes zoster * Composed of several similar terms

Placebo 45 mgRINVOQ Once Daily N = 347 N = 674 (%) (%) 8 13 6 7 2 6 3 4 1 3 1 3 1 3 1 2 <1 2 0 2

Adverse reactions reported in less than 2% of patients in the RINVOQ 45 mg group and at a higher rate than in the placebo group through Week 12 included folliculitis, hypercholesterolemia, bronchitis, pneumonia, oral candidiasis, and hyperlipidemia.

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Table 6: Adverse Reactions Reported in ≥2% of Patients with Crohn’s Disease Treated with RINVOQ 15 mg or 30 mg in the Placebo-Controlled Maintenance Study (CD-3)1

Adverse Reaction

RINVOQ RINVOQ Placebo 15 mg Once 30 mg Once Daily Daily N = 223 N = 221 N = 229 (%) (%) (%) 11 14 12

Upper respiratory tract infection* Pyrexia 2 3 7 Herpes zoster* 2 3 5 Headache* 1 3 5 Acne* 3 2 5 Gastroenteritis* 2 3 3 Fatigue 2 3 3 Increased blood creatine 1 2 3 phosphokinase 2 <1 2 3 Elevated liver enzymes Leukopenia* <1 1 2 Neutropenia* <1 1 2 Bronchitis* 0 1 2 Pneumonia* 1 4 1 Cough 2 3 1 1 Patients who were responders to 12 weeks induction therapy with RINVOQ 45 mg once daily.

2 Elevated liver enzymes includes alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, transaminases increased, blood bilirubin increased. * Composed of several similar terms Adverse reactions reported in less than 2% of patients in the RINVOQ 15 mg or 30 mg group and at a higher rate than in the placebo group through Week 52 included hyperlipidemia, oral candidiasis, and hypercholesterolemia.

The safety profile of RINVOQ in the long-term extension study was similar to the safety profile observed in the placebo-controlled induction and maintenance periods.

Specific Adverse Reactions Serious Infections Induction Studies: In CD-1 and CD-2, serious infections were reported in 6 patients (8 per 100 patient-years) treated with placebo and 13 patients (9 per 100 patient-years) treated with RINVOQ 45 mg through 12 weeks of the placebo-controlled period.

Maintenance Study/LTE: In the long-term placebo-controlled period, serious infections were reported in 10 patients (7 per 100 patient-years) treated with placebo, 7 patients (4 per 100 patient-years) treated with RINVOQ 15 mg, and 13 patients (6 per 100 patient-years) treated with RINVOQ 30 mg.

Gastrointestinal Perforations Induction Studies: During the induction studies in all patients treated with RINVOQ 45 mg (N=938), gastrointestinal perforation was reported in 4 patients (2 per 100 patient-years). In the placebo-controlled induction period, in CD-1 and CD-2, gastrointestinal perforation was reported in no patients treated with placebo (N=347) and 1 patient (1 per 100 patientyears) treated with RINVOQ 45 mg (N=674) through 12 weeks.

Maintenance Study/LTE: In the long-term placebo-controlled period, gastrointestinal perforation was reported in 1 patient (1 per 100 patient-years) treated with placebo, 1 patient (<1 per 100 patient-years) treated with RINVOQ 15 mg, and 1 patient (<1 per 100 patient-years) treated with RINVOQ 30 mg.

Patients who received placebo or RINVOQ 15 mg for maintenance therapy and lost response were treated with rescue RINVOQ 30 mg (N=336).

Among these patients, gastrointestinal perforation was reported in 3 patients (1 per 100 patient-years) through long-term treatment.

Adverse Reactions in Patients with Ankylosing Spondylitis A total of 596 patients with ankylosing spondylitis were treated with RINVOQ 15 mg in the two clinical trials representing 577.3 patient-years of exposure, of whom 220 were exposed to RINVOQ 15 mg for at least one year.

Overall, the safety profile observed in patients with active ankylosing spondylitis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis and psoriatic arthritis.

During the 14-week placebo-controlled period in Trial AS-I, the frequency of headache was 5.4% with RINVOQ 15 mg and 2.1% with placebo. During the 14-week placebo-controlled period in Trial AS-II, the frequency of headache was 3.3% with RINVOQ 15 mg and 1.4% with placebo.

Adverse Reactions in Patients with Non-radiographic Axial Spondyloarthritis A total of 187 patients with non-radiographic axial spondyloarthritis were treated with RINVOQ 15 mg in the clinical trial representing 116.6 patient-years of exposure, of whom 31 were exposed to RINVOQ 15 mg for at least one year.

Overall, the safety profile observed in patients with active non-radiographic axial spondyloarthritis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

DRUG INTERACTIONS Strong CYP3A4 Inhibitors Upadacitinib exposure is increased when RINVOQ is co-administered with a strong CYP3A4 inhibitor (such as ketoconazole, clarithromycin, and grapefruit), which may increase the risk of RINVOQ adverse reactions.

Monitor patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondylarthritis closely for adverse reactions when co-administering RINVOQ 15 mg once daily with strong CYP3A4 inhibitors. Food or drink containing grapefruit should be avoided during treatment with RINVOQ. For patients with atopic dermatitis, coadministration of RINVOQ 30 mg once daily with strong CYP3A4 inhibitors is not recommended.

For patients with ulcerative colitis or Crohn’s disease taking strong CYP3A4 inhibitors, reduce the RINVOQ induction dosage to 30 mg once daily. The recommended maintenance dosage is 15 mg once daily.

Strong CYP3A4 Inducers Upadacitinib exposure is decreased when RINVOQ is co-administered with strong CYP3A4 inducers (such as rifampin), which may lead to reduced therapeutic effect of RINVOQ. Coadministration of RINVOQ with strong CYP3A4 inducers is not recommended.

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USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary Available data from the pharmacovigilance safety database and postmarketing case reports on use of RINVOQ in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage. Based on animal studies, RINVOQ has the potential to adversely affect a developing fetus. Advise patients of reproductive potential and pregnant patients of the potential risk to the fetus.

In animal embryo-fetal development studies, oral upadacitinib administration to pregnant rats and rabbits at exposures equal to or greater than approximately 1.6 and 15 times the 15 mg dose, 0.8 and 7.6 times the 30 mg dose, and 0.6 and 5.6 times the maximum recommended human dose (MRHD) of 45 mg (on an AUC basis) resulted in dose-related increases in skeletal malformations (rats only), an increased incidence of cardiovascular malformations (rabbits only), increased post-implantation loss (rabbits only), and decreased fetal body weights in both rats and rabbits. No developmental toxicity was observed in pregnant rats and rabbits treated with oral upadacitinib during organogenesis at exposures approximately 0.29 and 2.2 times the 15 mg dose, 0.15 times and 1.1 times the 30 mg dose, and at 0.11 and 0.82 times the MRHD (on an AUC basis).

In a pre- and post-natal development study in pregnant female rats, oral upadacitinib administration at exposures approximately 3 times the 15 mg dose, 1.4 times the 30 mg dose, and the same as the MRHD (on an AUC basis) resulted in no maternal or developmental toxicity (see Data).

The background risks of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages are 2-4% and 15-20%, respectively.

Report pregnancies to the AbbVie Inc.’s Adverse Event reporting line at 1-800-633-9110, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis or inflammatory bowel disease. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.

Data Animal Data In an oral embryo-fetal development study, pregnant rats received upadacitinib at doses of 5, 25, and 75 mg/kg/day during the period of organogenesis from gestation day 6 to 17. Upadacitinib was teratogenic (skeletal malformations that consisted of misshapen humerus and bent scapula) at exposures equal to or greater than approximately 1.7 times the 15 mg dose, 0.9 times the 30 mg dose, and 0.6 times the MRHD (on an AUC basis at maternal oral doses of 5 mg/kg/day and higher). Additional skeletal malformations (bent forelimbs/ hindlimbs and rib/vertebral defects) and decreased fetal body weights were observed in the absence of maternal toxicity at an exposure approximately 84 times the 15 mg dose, 43 times the 30 mg dose, and 31 times the MRHD (on an AUC basis at a maternal oral dose of 75 mg/kg/day).

In a second oral embryo-fetal development study, pregnant rats received upadacitinib at doses of 1.5 and 4 mg/kg/day during the period of organogenesis from gestation day 6 to 17. Upadacitinib was teratogenic (skeletal malformations that included bent humerus and scapula) at exposures approximately 1.6 times the 15 mg dose, 0.8 times the 30 mg dose, and 0.6 times the MRHD (on an AUC basis at maternal oral doses of 4 mg/kg/day).

No developmental toxicity was observed in rats at an exposure approximately 0.29 times the 15 mg dose, 0.15 times the 30 mg dose, and 0.11 times the MRHD (on an AUC basis at a maternal oral dose of 1.5 mg/kg/day).

In an oral embryo-fetal developmental study, pregnant rabbits received upadacitinib at doses of 2.5, 10, and 25 mg/kg/day during the period of organogenesis from gestation day 7 to 19. Embryolethality, decreased fetal body weights, and cardiovascular malformations were observed in the presence of maternal toxicity at an exposure approximately 15 times the 15 mg dose, 7.6 times the 30 mg dose, and 5.6 times the MRHD (on an AUC basis at a maternal oral dose of 25 mg/kg/day). Embryolethality consisted of increased post-implantation loss that was due to elevated incidences of both total and early resorptions. No developmental toxicity was observed in rabbits at an exposure approximately 2.2 times the 15 mg dose, 1.1 times the 30 mg dose, and 0.82 times the MRHD (on an AUC basis at a maternal oral dose of 10 mg/kg/day).

In an oral pre- and post-natal development study, pregnant female rats received upadacitinib at doses of 2.5, 5, and 10 mg/kg/day from gestation day 6 through lactation day 20. No maternal or developmental toxicity was observed in either mothers or offspring, respectively, at an exposure approximately 3 times the 15 mg dose, 1.4 times the 30 mg dose, and at approximately the same exposure as the MRHD (on an AUC basis at a maternal oral dose of 10 mg/kg/day).

Lactation Risk Summary There are no data on the presence of upadacitinib in human milk, the effects on the breastfed infant, or the effects on milk production. Available pharmacodynamic/toxicological data in animals have shown excretion of upadacitinib in milk (see Data). When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the potential for serious adverse reactions in the breastfed infant, advise patients that breastfeeding is not recommended during treatment with RINVOQ, and for 6 days (approximately 10 half-lives) after the last dose.

Data A single oral dose of 10 mg/kg radiolabeled upadacitinib was administered to lactating female Sprague-Dawley rats on post-partum days 7-8. Drug exposure was approximately 30-fold greater in milk than in maternal plasma based on AUC0-t values. Approximately 97% of drug-related material in milk was parent drug.

Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to starting treatment with RINVOQ [see Use in Specific Populations].

Contraception Females Based on animal studies, upadacitinib may cause embryo-fetal harm when administered to pregnant women [see Use in Specific Populations]. Advise female patients of reproductive potential to use effective contraception during treatment with RINVOQ and for 4 weeks after the final dose.

20078707 R1 Rinvoq PB-7.625 x 10.5 (4).indd 4

Pediatric Use Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis The safety and effectiveness of RINVOQ in pediatric patients with juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis have not been established.

Atopic Dermatitis The safety and effectiveness of RINVOQ in pediatric patients 12 years of age and older weighing at least 40 kg with atopic dermatitis have been established. A total of 344 pediatric patients aged 12 to 17 years with moderate to severe atopic dermatitis were randomized across three trials (AD-1, AD-2 and AD-3) to receive either RINVOQ 15 mg (N=114) or 30 mg (N=114) or matching placebo (N=116) in monotherapy or combination with topical corticosteroids. Efficacy was consistent between the pediatric patients and adults. The adverse reaction profile in the pediatric patients was similar to the adults [see Adverse Reactions].

The safety and effectiveness of RINVOQ in pediatric patients less than 12 years of age with atopic dermatitis have not been established.

Ulcerative Colitis and Crohn’s Disease The safety and effectiveness of RINVOQ in pediatric patients with ulcerative colitis and Crohn’s disease have not been established.

Geriatric Use Rheumatoid Arthritis and Psoriatic Arthritis Of the 4381 patients treated in the five clinical trials, a total of 906 rheumatoid arthritis patients were 65 years of age or older, including 146 patients 75 years and older. Of the 1827 patients treated in the two psoriatic arthritis Phase 3 clinical trials, a total of 274 patients were 65 years of age or older, including 34 patients 75 years and older. No differences in effectiveness were observed between these patients and younger patients; however, there was a higher rate of overall adverse events, including serious infections, in patients 65 years of age and older.

Atopic Dermatitis Of the 2583 patients treated in the three Phase 3 clinical trials, a total of 120 patients with atopic dermatitis were 65 years of age or older, including 6 patients 75 years of age. No differences in effectiveness were observed between these patients and younger patients; however, there was a higher rate of serious infections and malignancies in those patients 65 years of age or older in the 30 mg dosing group in the long-term trials.

Ulcerative Colitis Of the 1097 patients treated in the controlled clinical trials, a total of 95 patients with ulcerative colitis were 65 years and older. Clinical studies of RINVOQ did not include sufficient numbers of patients 65 years of age and older with ulcerative colitis to determine whether they respond differently from younger adult patients.

Crohn’s Disease Of the 1021 patients who were treated in the controlled induction clinical trials, a total of 39 patients with Crohn’s disease were 65 years of age or older, and no patients were 75 years of age or older. Clinical studies of RINVOQ did not include sufficient numbers of patients 65 years of age and older with Crohn’s disease to determine whether they respond differently from younger adult patients.

Ankylosing Spondylitis Of the 607 patients treated in the controlled clinical trials, a total of 32 patients with ankylosing spondylitis were 65 years and older. Clinical studies of RINVOQ did not include sufficient numbers of patients 65 years of age and older with ankylosing spondylitis to determine whether they respond differently from younger adult patients.

Non-radiographic Axial Spondyloarthritis Of the 313 patients treated in a phase 3 clinical trial, a total of 9 patients with non-radiographic axial spondyloarthritis were 65 years and older.

Clinical studies of RINVOQ did not include sufficient numbers of patients 65 years of age and older with non-radiographic axial spondyloarthritis to determine whether they respond differently from younger adult patients.

Renal Impairment For patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis, no dosage adjustment is needed in patients with mild (eGFR 60 to < 90 mL/min/1.73 m2), moderate (eGFR 30 to < 60 mL/min/1.73 m2), or severe renal impairment (eGFR 15 to < 30 mL/min/1.73 m2).

For patients with atopic dermatitis, the maximum recommended dosage is 15 mg once daily for patients with severe renal impairment. No dosage adjustment is needed in patients with mild or moderate renal impairment.

For patients with ulcerative colitis or Crohn’s disease, the recommended dosage for severe renal impairment is 30 mg once daily for induction and 15 mg once daily for maintenance. No dosage adjustment is needed in patients with mild or moderate renal impairment.

RINVOQ has not been studied in patients with end stage renal disease (eGFR <15 mL/min/1.73m2). Use in patients with atopic dermatitis, ulcerative colitis, or Crohn’s disease with end stage renal disease is not recommended.

Hepatic Impairment The use of RINVOQ has not been studied in patients with severe hepatic impairment (Child Pugh C), and therefore not recommended for use in patients with rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, and nonradiographic axial spondyloarthritis.

For patients with rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis no dosage adjustment is needed in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment.

For patients with ulcerative colitis or Crohn’s disease, the recommended dosage for mild to moderate hepatic impairment is 30 mg once daily for induction and 15 mg once daily for maintenance.

PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Serious Infections Inform patients that they may be more likely to develop infections when taking RINVOQ. Instruct patients to contact their healthcare provider immediately during treatment if they develop any signs or symptoms of an infection [see Warnings and Precautions].

Advise patients that the risk of herpes zoster is increased in patients taking RINVOQ and in some cases can be serious [see Warnings and Precautions].

Malignancies Inform patients that RINVOQ may increase their risk of certain cancers and that periodic skin examinations should be performed while using RINVOQ. Advise patients that exposure to sunlight and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen [see Warnings and Precautions].

Major Adverse Cardiovascular Events Inform patients that RINVOQ may increase their risk of major adverse cardiovascular events (MACE) including myocardial infarction, stroke, and cardiovascular death. Instruct all patients, especially current or past smokers or patients with other cardiovascular risk factors, to be alert for the development of signs and symptoms of cardiovascular events [see Warnings and Precautions].

Thrombosis Inform patients that events of deep venous thrombosis and pulmonary embolism have been reported in clinical trials with RINVOQ. Instruct patients to seek immediate medical attention if they develop any signs or symptoms of a DVT or PE [see Warnings and Precautions].

Hypersensitivity Reactions Advise patients to discontinue RINVOQ and seek immediate medical attention if they develop any signs and symptoms of allergic reactions [see Warnings and Precautions].

Gastrointestinal Perforations Inform patients that gastrointestinal perforations have been reported in clinical trials with RINVOQ and that risk factors include the use of NSAIDs, corticosteroids, or history of diverticulitis. Instruct patients to seek medical care immediately if they experience new onset of abdominal pain, fever, chills, nausea, or vomiting [see Warnings and Precautions].

Retinal Detachment Inform patients that retinal detachment has been reported in clinical trials with RINVOQ. Advise patients to immediately inform their healthcare provider if they develop any sudden changes in vision while receiving RINVOQ [see Adverse Reactions].

Laboratory Abnormalities Inform patients that RINVOQ may affect certain lab tests, and that blood tests are required before and during RINVOQ treatment [see Warnings and Precautions].

Vaccinations Advise patients to avoid use of live vaccines with RINVOQ. Instruct patients to inform their healthcare practitioner that they are taking RINVOQ prior to a potential vaccination [see Warnings and Precautions].

Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential that exposure to RINVOQ during pregnancy may result in fetal harm. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions and Use in Specific Populations].

Advise females of reproductive potential that effective contraception should be used during treatment and for 4 weeks following the final dose of upadacitinib [see Use in Specific Populations].

Advise females patients who are exposed to RINVOQ during pregnancy to contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Lactation Advise women not to breastfeed during treatment with RINVOQ and for 6 days after the last dose [see Use in Specific Populations].

Administration Advise patients not to chew, crush, or split RINVOQ tablets.

Advise patients to avoid food or drink containing grapefruit during treatment with RINVOQ [see Drug Interactions].

Medication Residue in Stool Instruct patients to notify their healthcare provider if they repeatedly notice medication residue (e.g., intact RINVOQ tablet or fragments) in stool or ostomy output [see Warnings and Precautions].

Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA RINVOQ® is a registered trademark of AbbVie Biotechnology Ltd. ©2019-2023 AbbVie Inc. Ref: 20078707 R1

Revised: May 2023

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Revista Puertorriqueña de Medicina y Salud Pública

Karelys Burgos Irizarry M.D. Programa de Adiestramiento en Gastroenterología Escuela de Medicina de la Universidad de Puerto Rico Recinto de Ciencias Médicas

La

Nutrición y la Enfermedad Inflamatoria

Intestinal

En años recientes hemos visto un alta en la prevalencia de la enfermedad inflamatoria intestinal (EII) y la nutrición ha tomado importancia en el manejo de la condición.

Se sugiere que la dieta occidental ha contribuido a este aumento en incidencia. La ingesta de fibra, comidas no procesadas y dieta alta en ácidos grasos n-3 tienen un rol protectivo para el desarrollo de la enfermedad.

Palabras Clave: Enfermedad inflamatoria intestinal, enfermedad de Crohn, colitis ulcerosa, nutrición, macronutrientes, micronutrientes, fibra, probióticos, hierro, vitamina D, ostomía, síndrome de intestino corto.

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RESUMEN

E

n pacientes con enfermedad inflamatoria activa se recomienda aumentar el consumo de proteína hasta 1.5 g/kg/día.

Se recomienda el cernimiento para deficiencia de hierro y vitamina D y reemplazarlas de ser necesario para prevenir complicaciones. Para pacientes en remisión no es necesario disminuir el consumo de fibra. Pacientes con enfermedad de fenotipo estenosante y/o historial previo de obstrucción deben limitarse a menos de 5g de fibra por día. No existe una dieta específica para promover remisión en pacientes con EII y se recomienda que la nutrición sea supervisada por un profesional e individualizada para cada paciente. Pacientes con presencia de ostomía o síndrome de intestino corto deben tener una nutrición ajustada a su condición INTRODUCCIÓN

L

a enfermedad inflamatoria intestinal (EII) es una condición mediada por el sistema inmune caracterizada por inflamación crónica del tracto digestivo.

Se compone de dos desórdenes principales, la colitis ulcerosa (CU) y la enfermedad de Crohn (EC). En años recientes hemos visto un aumento en la prevalencia de la EII y el rol de la nutrición ha tomado auge en el manejo de la condición. Se sospecha que la dieta occidental, caracterizada por el consumo elevado de comidas procesadas, dulces, alimentos fritos, etc,

ha jugado un papel importante en este fenómeno.

En un repaso narrativo acerca de la nutrición en EII, se describió que un consumo elevado de grasa animal puede predisponer a CU, mientras que el consumo de comida enlatada, grasas saturadas y azúcares puede predisponer más a EC.1 El estudio de cohorte de EPICOM demostró que el consumo diario de comidas rápidas y altas en azúcar contribuye a una disbiosis en el microbioma intestinal y está asociado a

un desarrollo temprano de EII, aumento en severidad de la enfermedad y mayor probabilidad de cirugía en CU.3 Por otra parte, una ingesta balanceada de fibra y comidas no procesadas tiene un rol protectivo y se ha visto que una dieta alta en ácidos grasos poliinsaturados n-3 y baja en poliinsaturados n-6 pueden disminuir el riesgo de desarrollar EII.2,4 Este artículo provee un resumen sobre aspectos importantes relacionados al rol de la nutrición en las EII.

DISCUSIÓN Macronutrientes Los macronutrientes son un grupo de nutrientes necesarios para la producción de energía.

Están compuestos principalmente de carbohidratos, proteínas y grasas. Se ha descrito que los pacientes de EII pueden tener un requerimiento alterado de proteína.1 De acuerdo con las guías de ESPEN para la nutrición clínica en pacientes de EII, se recomienda el consumo de 1.2-1.5 g/kg/día de proteína en presencia de enfermedad activa de para contrarrestar la respuesta catabólica del proceso inflamatorio. Sin embargo, pacientes en remisión clínica pueden seguir las guías de la población general en donde se recomienda un consumo de 1g/kg/día de proteína.

Micronutientes Micronutrientes se definen como vitaminas y minerales requeridos para funciones celulares. Entre ellos se encuentran hierro, yodo, zinc, vitamina A y vitamina D. Los pacientes con EII están a riesgo aumentado de deficiencias de micronutrientes, especialmente en presencia de enfermedad activa.

Se recomienda el cernimiento para deficiencias de micronutrientes, tales como hierro y vitamina D.1 La deficiencia en vitamina D suele ser prevalente en EII y se ha relacionado a 30

la actividad de la enfermedad, relapsos y respuesta anormal a biológicos, entre otros.5 Al momento no hay dosis terapéutica de vitamina D en EII y se siguen las recomendaciones de la población general. Existen algoritmos, como el propuesto por Nielsen et al. en su publicación sobre el manejo de deficiencia en vitamina D en EII, en donde se busca determinar una dosis adecuada y si esa meta no se alcanza a los 3 meses, entonces se pueden considerar dosis semanales hasta alcanzar la meta.5 La suplementación es necesaria para prevenir complicaciones como osteopenia u osteoporosis, especialmente en pacientes con factores de riesgo adicionales para disminución en densidad mineral ósea, como el uso prolongado de esteroides. En cuanto a la deficiencia de hierro, se recomienda reemplazo, ya sea oral o intravenoso, según la actividad de la enfermedad, la tolerancia al hierro y los niveles de hemoglobina.

Fibra Se ha descrito que un consumo de fibra de hasta 24 g/día, principalmente de origen frutal, puede disminuir hasta un 40% el riesgo de desarrollar EC por su acción anti-inflamatoria, reducción en la permeabilidad del colon y efecto beneficioso en el microbioma.1,4

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Los pacientes que se encuentran en remisión y no tienen enfermedad estenosante o historial de obstrucción intestinal pueden ingerir 14 g fibra por cada 1000 calorías, ya que se ha observado que puede tener un rol en el mantenimiento de la remisión.2,7 Sin embargo, pacientes con enfermedad de fenotipo estenosante y/o historial previo de obstrucción intestinal deben limitarse a menos de 5 g de fibra por día.7 En pacientes con enfermedad inflamatoria activa, las comidas altas en fibra pudiesen empeorar síntomas y ser más difíciles de digerir, por lo cual también se sugiere disminuir el consumo de ser necesario.

Dietas específicas Al momento no hay una dieta específica recomendada para promover la remisión en pacientes con EII. Se han estudiado varias dietas incluyendo la dieta anti-inflamatoria (IBD-AID, UMass), dieta baja en FODMAP y dieta de carbohidratos específicos, entre otras, sin embargo no se ha podido dar ninguna recomendación con suficiente nivel de evidencia .4 Como parte del cuidado multidisciplinario, cada paciente de EII debe recibir un cuidado individualizado, preferiblemente supervisado por un nutricionista o dietista, en donde se evalúe el fenotipo y la actividad de la enfermedad, se

realice cernimiento para deficiencias en micronutrientes, se evalúe accesibilidad a diferentes tipos de alimentos y se cree un plan que se ajuste a la realidad económica del paciente y sus necesidades.

Probióticos De acuerdo con las guías para la nutrición clínica en la enfermedad inflamatoria del intestino, se recomienda el uso de Escherichia coli N1917 o probióticos a base de Bifidobacterium, Lactobacillus y Streptococcus (VSL#3® o Visbiome®) en pacientes con CU de moderada a severa.2,8 Sin embargo, no se ha visto beneficio cuando son usados para el tratamiento de EC activa.2,8 Se necesitan estudios subsiguientes para evaluar el beneficio de probióticos en EII, principalmente cuando sabemos que el desequilibrio del microbioma intestinal puede contribuir con el desarrollo de EII. SITUACIONES ESPECIALES Presencia de estoma

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os pacientes portadores de ostomías tienen un riesgo aumentado de deshidratación y por ende fallo renal, a consecuencia de una descarga aumentada por la ostomía. La descarga normal de una ileostomía reciente es de alrededor 1200 mL/día y ya madura de 600-800 mL/d. Una colostomía puede variar entre 200-600 mL/día.9 Se define como ‘ostomía de alta descarga’, cuando la descarga es mayor de 1500 mL/día.9,10,11 Este fenómeno puede desencadenar disturbios electrolíticos y deficiencias nutricionales que aumentan la morbilidad de los pacientes portadores de ostomía.10 En adición a medicamentos, disminución de factores de riesgo y descartar detonantes, la dieta juega un papel importante en el

control de la descarga. En pacientes con ostomía de alta descarga, se recomienda la ingesta de carbohidratos complejos, tales como: pasta, arroz, papas, pan, etc, y evitar los azúcares simples como los postres, siropes, dulces, gelatina endulzada, jugo de frutas, bebidas azucaradas, alto consumo de frutas y suplementos nutricionales, entre otros.

En adición, se recomienda disminuir la ingesta de líquidos con las comidas y limitar los fluidos hipotónicos.9 Para más información acerca de las ostomías y su manejo, puede referirse a la guía, en línea, de las Asociaciones Unidas de Ostomía de América.

Síndrome de intestino corto El síndrome del intestino corto es un

CONCLUSIONES • La dieta occidental se ha asociado al aumento en incidencia de EII en los últimos años.

• Tanto la obesidad como la malnutrición contribuyen a un peor pronóstico y mayor riesgo de complicaciones que pueden afectar la calidad del paciente con EII. • La nutrición debe ser integrada en el manejo multidisciplinario en pacientes con EII y debe ser supervisada por un nutricionista o dietista e individualizada para cada paciente.

• Pacientes con EII pueden tener un requerimiento alterado de proteína en base a la actividad de la enfermedad.

• Se debe hacer cernimiento para niveles de hierro y vitamina D en pacientes con EII y reemplazar de ser necesario.

• No existe una dieta específica para promover remisión en pacientes con EII. • Pacientes con ostomía y/o síndrome de intestino corto están a un mayor riesgo de malabsorción, deshidratación y otras complicaciones que pueden poner su vida en riesgo, por lo cual es importante la concientización sobre la importancia de la nutrición para la prevención de éstas.

problema de malabsorción mayormente causado por una resección quirúrgica extensa de intestino delgado para enfermedad de Crohn, isquemia intestinal, malignidad, etc. Para estos pacientes se recomienda una dieta alta en carbohidratos complejos, tales como: pan, pasta, frutas, papa, brócoli, entre otros.11,12 El resto de las especificaciones en la dieta están ligados a si el paciente tiene colon presente o no. Para pacientes con colon en continuidad se recomienda bajar el consumo de grasas, especialmente en presencia de esteatorrea, y restringir el consumo de alimentos ricos en oxalato para reducir el riesgo de cálculos renales de oxalato de calcio.11,12 Entre la lista de alimentos ricos en oxalato, se encuentran té, chocolate, espinaca y ruibarbo.

REFERENCIAS 1.

Roncoroni L, Gori R, Elli L, Tontini GE, Doneda L, Norsa L, Cuomo M, Lombardo V, Scricciolo A, Caprioli F, Costantino A, Scaramella L, Vecchi M. Nutrition in Patients with Inflammatory Bowel Diseases: A Narrative Review.

Nutrients. 2022 Feb 10;14(4):751. doi: 10.3390/nu14040751. PMID: 35215401; PMCID: PMC8879392.

2.

Forbes A, Escher J, Hébuterne X, KłOk S, Krznaric Z, Schneider S, Shamir R, Stardelova K, Wierdsma N, Wiskin AE, Bischoff SC. ESPEN guideline: Clinical nutrition in inflammatory bowel disease. Clin Nutr. 2017 Apr;36(2):321-347. doi: 10.1016/j.clnu.2016.12.027. Epub 2016 Dec 31. Erratum in: Clin Nutr.

2019 Jun;38(3):1486. Erratum in: Clin Nutr. 2019 Jun;38(3):1485. PMID: 28131521.

3.

Burisch J, Pedersen N, Cukovic-Cavka S, Turk N, Kaimakliotis I, Duricova D, Bortlik M, Shonová O, Vind I, Avnstrøm S, Thorsgaard N, Krabbe S, Andersen V, Dahlerup JF, Kjeldsen J, Salupere R, Olsen J, Nielsen KR, Manninen P, Collin P, Katsanos KH, Tsianos EV, Ladefoged

K, Lakatos L, Ragnarsson G, Björnsson E, Bailey Y, O’Morain C, Schwartz D, Odes S, Giannotta M, Girardin G, Kiudelis G, Kupcinskas L, Turcan S, Barros L, Magro F, Lazar D, Goldis A, Nikulina I, Belousova E, MartinezAres D, Hernandez V, Almer S, Zhulina Y, Halfvarson J, Arebi N, Tsai HH, Sebastian S, Lakatos PL, Langholz E, Munkholm P EpiCom-group.

Environmental factors in a populationbased inception cohort of inflammatory bowel disease patients in Europe--an ECCO-EpiCom study. J Crohns Colitis .

2014;8:607–616.

4.

De Castro MM, Pascoal LB, Steigleder KM, Siqueira BP, Corona LP, Ayrizono MLS, Milanski M, Leal RF. Role of diet and nutrition in inflammatory bowel disease. World J Exp Med. 2021 Jan 20;11(1):1-16. doi: 10.5493/wjem.v11.i1.1. PMID: 33585174; PMCID: PMC7852575.

5.

Nielsen OH, Hansen TI, Gubatan JM, Jensen KB, Rejnmark L. Managing vitamin D deficiency in inflammatory bowel disease. Frontline Gastroenterol. 2019 Oct;10(4):394400. doi: 10.1136/

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Revista Puertorriqueña de Medicina y Salud Pública

What can What can What can What can What can look like for your look like for your patients living with look like for your patients living with look like for your Crohn’s disease? patients living with look like for your Crohn’s disease? patients living with Crohn’s disease? patients living with Crohn’s disease?

Crohn’s disease?

Revista Puertorriqueña de Medicina y Salud Pública

33

FOR ADULTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE (CD) FOR ADULTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE (CD) FOR ADULTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE (CD) FOR ADULTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE (CD) FOR ADULTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE (CD) FOR ADULTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE (CD) SKYRIZI provides the opportunity for endoscopic and symptom control. For your patients, that’s everything.

SKYRIZI provides the opportunity for endoscopic and symptom control. For your patients, that’s everything.

SKYRIZI provides the opportunity for endoscopic and symptomprovides control. For patients, everything.

SKYRIZI the your opportunity forthat’s endoscopic and symptomprovides control. For patients, everything.

SKYRIZI the your opportunity forthat’s endoscopic and symptom control.

For your patients, that’s everything.

SKYRIZI provides the opportunity for endoscopic and symptom control. For your patients, that’s everything.

The FIRST and Only IL-23 Specific Inhibitor in Crohn’s Disease The FIRST and Only IL-23 Specific Inhibitor in Crohn’s Disease

INDICATION AND IMPORTANT SAFETY INFORMATION FOR SKYRIZI® (risankizumab-rzaa)1 1 INDICATIONThe FIRST and Only IL-23 Specific Inhibitor in Crohn’s Disease ®

INDICATION AND IMPORTANT SAFETY INFORMATION FOR SKYRIZI (risankizumab-rzaa)1 Tuberculosis (TB) SKYRIZI is indicated for the treatment of moderately to severely

The FIRST and Only IL-23 SpecificPrior Inhibitor in Crohn’s Disease to initiating treatment with SKYRIZI, evaluate for TB infection The FIRST and Only IL-23 Specificand Inhibitor in Crohn’s Disease 1 for consider treatment in®patients with latent or active TB 1 INDICATION AND IMPORTANT SAFETY INFORMATION FOR SKYRIZI (risankizumab-rzaa) Tuberculosis (TB) SKYRIZI is indicated for the treatment of moderately to severely IMPORTANT SAFETY INFORMATION whom an adequate course of treatment cannot be confirmed. active Crohn’s The disease in adults. and Only IL-23 Specific FIRST Inhibitor Crohn’s Disease ® with SKYRIZI, Prior toFOR initiating treatment evaluate forduring TB1 infection 1 Reactions Hypersensitivity Monitor patients forin signs and symptoms of active TB and INDICATION AND IMPORTANT SAFETY INFORMATION SKYRIZI (risankizumab-rzaa) INDICATION 1 active Crohn’s disease in adults.

INDICATION

and consider patients with latent or active TB for 1 ® after SKYRIZItreatment treatment.in® Do not administer SKYRIZI to patients IMPORTANT INFORMATION is contraindicated in patients with a SKYRIZI 1 1 SAFETY Tuberculosis (TB) SKYRIZI is(risankizumab-rzaa) indicated for the treatment of moderately to severely whom an adequate course of(risankizumab-rzaa) treatment cannot be confirmed.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR SKYRIZI INDICATION with active TB. historyCrohn’s of serious hypersensitivity active disease in adults. reaction to risankizumab-rzaa or Hypersensitivity Reactions Prior to initiating treatment with SKYRIZI,of evaluate forduring TB1 infection Monitor patients for signs®and symptoms active TB and 1 Tuberculosis (TB) SKYRIZI isexcipients. indicated for the treatment of moderately to severely any of the Serious hypersensitivity reactions, including Hepatotoxicity in Treatment of Crohn’s Disease INDICATION AND IMPORTANT SAFETY INFORMATION FOR SKYRIZI (risankizumab-rzaa) INDICATION and consider treatment inDo patients with latent or active TB for ® after SKYRIZI treatment. not administer SKYRIZI to patients 1 (risankizumab-rzaa) iswith contraindicated in patients with a SKYRIZI active Crohn’s disease in adults.

IMPORTANT SAFETY INFORMATION Prior to initiating treatment with SKYRIZI, evaluate for TB infection anaphylaxis, have been reported the use of SKYRIZI. If a serious whom an adequate coursewas of treatment be confirmed.

1 hypersensitivity with active TB.(TB) Drug-induced liver injury reported cannot in a patient with Crohn’s Tuberculosis SKYRIZI indicated for the treatment of moderately to severely or history ofisserious reaction to SKYRIZI risankizumab-rzaa INDICATION and consider treatment in patients with latent or active TB forand hypersensitivity reaction occurs, discontinue and initiate 1 Hypersensitivity Reactions Monitor patients for signs and symptoms of active TB disease who was hospitalized for a rash during induction dosing active Crohn’s disease in adults.

IMPORTANT SAFETY INFORMATION Prior to initiating treatment with SKYRIZI, evaluate forduring TB infection any of the excipients.

Serious hypersensitivity reactions, including Hepatotoxicity in Treatment of Crohn’s Disease whom an adequate course of treatment cannot be confirmed. appropriate therapy immediately.

Tuberculosis (TB) SKYRIZI ®is indicated for the treatment of moderately to severely after SKYRIZI treatment.

Do not administer SKYRIZI to patients of SKYRIZI. For the treatment of Crohn’s disease, evaluate liver (risankizumab-rzaa) contraindicated in patients with a SKYRIZI and consider treatment in patients with latent or active TB for anaphylaxis, haveReactions been reportediswith the use of1SKYRIZI. If a serious Hypersensitivity Monitor patients forinjury signswas and symptoms TB during and Drug-induced liver reported inof a active patient with Crohn’s active disease in adults.

IMPORTANT SAFETY INFORMATION Prior toan initiating treatment with SKYRIZI, evaluate for TB(12 infection Infection with active TB.bilirubin enzymes and at baseline and during induction weeks); historyCrohn’s of® serious hypersensitivity reaction to SKYRIZI risankizumab-rzaa whom adequate course of treatment cannot be confirmed. hypersensitivity reaction occurs, discontinue and initiateor after SKYRIZI treatment.

Do notfor administer SKYRIZI to patients disease who was hospitalized awith rashlatent during induction dosing (risankizumab-rzaa) is contraindicated in patients with a SKYRIZI and consider treatment in patients or active TB for 1 monitor thereafter according to routine patient management.

Hypersensitivity Reactions any of the excipients.

Serious hypersensitivity reactions, including Monitor patients for signs andofsymptoms of active TB during and appropriate immediately.

SKYRIZI maytherapy increase the risk of infection. Do not initiate treatment Hepatotoxicity Disease IMPORTANT INFORMATION with active TB. of SKYRIZI. For in theTreatment treatment ofCrohn’s Crohn’scannot disease, evaluate liver history of seriousSAFETY hypersensitivity reaction to risankizumab-rzaa or whom an adequate course of treatment be confirmed.

34

anaphylaxis, have been reported the use of SKYRIZI. If ainfection serious ® with SKYRIZI in patients with aiswith clinically important active contraindicated in patients with a SKYRIZI Infection Hypersensitivity Reactions any of the (risankizumab-rzaa) excipients.

Serious hypersensitivity reactions, including hypersensitivity occurs, discontinue SKYRIZI and initiateor until it resolves orreaction is adequately treated. history of serious hypersensitivity reaction to risankizumab-rzaa anaphylaxis, been reported with the use of SKYRIZI. If a serious ®mayhave SKYRIZI increase the risk of infection.

Do not initiate treatment is contraindicated in patients with a appropriate therapy immediately. any of the (risankizumab-rzaa) excipients.

Serious hypersensitivity reactions, including In patients with chronic infection or a history of recurrent infection, hypersensitivity reaction occurs, discontinue SKYRIZI and initiate with SKYRIZI in apatients with a clinically important active infection history of serious hypersensitivity reaction to risankizumab-rzaa or anaphylaxis, have been reported with the use of SKYRIZI. If a serious Infection consider the risks and benefits prior to prescribing SKYRIZI. Instruct appropriate therapy until resolves or is immediately. adequately treated. any ofit the excipients.

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If a patient develops such an infection or is with SKYRIZI in patients with aprior clinically important active infection hypersensitivity reaction occurs, discontinue SKYRIZI and initiate consider the risks and benefits to prescribing SKYRIZI. Instruct SKYRIZI may increase the risk of infection.

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If a patient such an infection or is In patients with amedical chronic infection or a or history of recurrent infection, until it resolves or is adequately treated. patients to seek advice if signs symptoms of clinically not responding to standard therapy, closely monitorSKYRIZI. and discontinue consider the risks and benefits prior to prescribing Instruct important infection occur. infection Ifresolves. a patient such an infection or is In patients with chronic or develops a or history of recurrent infection, SKYRIZI until theamedical infection patients to seek advice if signs symptoms of clinically not responding to standard therapy, closely monitorSKYRIZI. and discontinue consider the risks and benefits prior to prescribing Instruct important infection occur. Ifresolves. a patient develops such an infection or is SKYRIZI until themedical infection patients to seek advice if signs or symptoms of clinically not responding to standard therapy, closely monitor and discontinue important infection occur. Ifresolves. a patient develops such an infection or is SKYRIZI until the infection not responding to standard therapy, closely monitor and discontinue Revista Puertorriqueña de Medicina y Salud Pública SKYRIZI until the infection resolves.

Consider an alternate treatment for patients with evidence of after SKYRIZI treatment.

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Hepatotoxicity of SKYRIZI. For in theTreatment treatmentof ofCrohn’s Crohn’sDisease disease, evaluate liver monitor thereafter according patient management. suspected, until this diagnosistofor isroutine excluded.

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FIRST Approved Product in CD With Endoscopic Response as a Co-Primary Endpoint1-3 FIRST Approved Product in CD 1-3 With Endoscopic Response asAcross a Co-Primary Endpoint Endoscopic and Symptom Control FIRST Approved ProductCo-Primary in CD Endpoints 1-3 FIRST Approved Product in CD Endpoint With Endoscopic Response as a Co-Primary ADVANCE MOTIVATE FORTIFY Endoscopic and Symptom Control Across Co-Primary Endpoints FIRSTResponse Approvedas Product in CD Endpoint1-3 With Endoscopic a Co-Primary ADVANCE MOTIVATE FORTIFY1-3 Endoscopic and Symptom Control Across Co-Primary Endpoints FIRST Approved Product in CD Endpoint With Endoscopic Response as a Co-Primary 1-3 Endoscopic andADVANCE Symptom Control Co-PrimaryEndpoint Endpoints With Endoscopic Response asAcross a Co-Primary MOTIVATE FORTIFY ENDOSCOPIC Mixed Population*

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p<0.001 n=135 n=175 n=336% n=130 n=117 p<0.001 p<0.05 p<0.05 n=187 n=191 CONTROL % 46 20 % % 0 100 20 80 n=175 n=336 n=187 n=191 n=117 n=130 n=135 Clinical Remission SYMPTOM 60 40 § Co-Primary Endpoint (CDAI) % CONTROL 46% p<0.05 SKYRIZIp<0.05 % 25% p<0.001 Placebo 180 mg SC Placebo SKYRIZI 600 mg IV p<0.001 80 Clinical Remission SYMPTOM 60 20% 400 (Induction Responders) § 360 mg SC 20 n=175 n=336 n=187 n=191 n=117 n=130 Co-Primary Endpoint (CDAI) n=135 SKYRIZI CONTROL % 46 All p-values are SKYRIZI treatment% arms vs placebo. % 25% Clinical Remission SYMPTOM 60 20 % 40 p<0.001 Placebo p<0.05 SKYRIZI p<0.05 180 mg SC Placebo SKYRIZI 600 mg IV p<0.001 20 ‡(CDAI)§ Co-Primary Endpoint %from baseline, Endoscopic response was defined as a decrease in SES-CD >50% or a decrease of% at least 2 points for subjects a baseline score of 4 and CONTROL %Responders) 46with 0 (Induction 25%

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25

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Adverse Reactions to initiating all ageabdominal appropriate vaccinations arthralgia inSKYRIZI, inductioncomplete and arthralgia, pain, injection the risk of infection administration of live vaccines.

Prior Most common (>3%)following adverse reactions associated withand SKYRIZI according to current immunization guidelines. site reactions, anemia, pyrexia, back pain, arthropathy, urinary to initiating SKYRIZI, all age appropriate in Crohn’s disease arecomplete upper respiratory infections,vaccinations headache, and tract infection in maintenance.

Adverse Reactions the risk of in infection administration of live vaccines.

Prior according to induction currentfollowing immunization guidelines. arthralgia and arthralgia, abdominal pain, injection Lipid Elevations: Increases from baseline and increases relative to Most common (>3%) adverse reactions associated withand SKYRIZI to initiating SKYRIZI, complete all age appropriate vaccinations site reactions, anemia, pyrexia, back pain, arthropathy, urinary Adverse Reactions placebo were observed at Week 4 and remained stable to Week 12 the risk of infection following administration of live vaccines.

Prior in Crohn’s disease are upper respiratory infections, headache, and according to current immunization guidelines. tract infection in maintenance. in patients with SKYRIZI Crohn’s disease.

Most common (>3%) adverse reactions associated with SKYRIZI to initiating SKYRIZI, complete allinage appropriate vaccinations arthralgia intreated induction and arthralgia, abdominal pain, injection Adverse Reactions Lipid Elevations: Increases from baseline and increases relative to in Crohn’s disease areimmunization upper respiratory infections, headache, and according to current guidelines. site reactions, anemia, pyrexia, back pain, arthropathy, and urinary Dosage Forms and Strengths: SKYRIZI is available in a 600 mg/10 mL placebo were observed at Week 4 andabdominal remained stable toSKYRIZI Week 12 Most common (>3%) adverse reactions associated with arthralgia in induction and arthralgia, pain, injection tract infection in maintenance. single-dose vial for intravenous infusion and adisease.

180 mg/1.2 mL or Adverse Reactions patients treated withupper SKYRIZI in Crohn’s in Crohn’s disease are respiratory infections, headache, and site reactions, anemia, pyrexia, back pain, arthropathy, and urinary 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector.

Lipid Elevations: Increases from baseline and increases relative to Most common (>3%) adverse reactions associated with SKYRIZI arthralgia in induction and arthralgia, abdominal pain, injection tract infection in maintenance.

Dosage Forms and Strengths: SKYRIZI is available in a 600 mg/10 mL placebo were observed at Week 4 and remained stable to Week 12 Please see the Brief Summary of the full Prescribing Information in Crohn’s disease are upper respiratory infections, headache, and site reactions, pyrexia,infusion back pain, arthropathy, andorurinary single-dose vialanemia, forIncreases intravenous andand adisease.

180 mg/1.2 mL Lipid Elevations: from baseline increases relative to in patients treated withand SKYRIZI in Crohn’s on following arthralgia inmL induction arthralgia, abdominal pain, injection tract infection inpage. maintenance.

360the mg/2.4 single-dose prefilled cartridge with on-body placebo were observed at Week 4 and remained stable toinjector.

Week 12 site reactions, anemia, pyrexia, back pain, arthropathy, and urinary Dosage Forms and Strengths: SKYRIZI is available in a 600 mg/10 mLto Lipid Elevations: Increases from baseline and increases relative Placebo (Induction Responders): Patients who achieved CDAIPrescribing clinical response (CR-100) to SKYRIZI in patients treated with SKYRIZI in Crohn’s disease.

Please see the Brief Summary of the full Information tract infection informaintenance. single-dose vial intravenous infusion a 180 mg/1.2 induction therapy and observed were randomized receive placebo the maintenance study.mL placebo were attoWeek 4 andinand remained stable to or Week 12 on the following page.

Dosage Forms and Strengths: SKYRIZI isresponse, available inresponse, a 600ormg/10 mLto * The mixed population includes patients who had inadequate loss ofon-body intolerance 360 mg/2.4 mL single-dose prefilled cartridge with injector.

Lipid Elevations: Increases from baseline and increases relative in patients treated with SKYRIZI in Crohn’s disease. to one or more biologics (biologic failure), as wellinfusion as patients and who had never mg/1.2 demonstrated inadequate single-dose vial for intravenous a 180 mL or Placebo (Induction Responders): Patients who achieved CDAI clinical response (CR-100) to SKYRIZI placebo were observed at Week 4 and remained stable to Week response, loss of response, or intolerance to a biologic (bio-naive; includes 13% in ADVANCE and 8% in12 Please see theand Brief SummarySKYRIZI of the full Prescribing Information Dosage Forms Strengths: isinavailable in astudy.

600 mg/10 mL 360 mg/2.4 mL single-dose prefilled with on-body injector. induction therapy and were randomized to receive placebo the maintenance FORTIFY who were bio-exposed). in patients treated with SKYRIZI incartridge Crohn’s disease. on the following page. single-dose vial for intravenous and a or180 mg/1.2 mL or * The mixed population includes patients who hadinfusion inadequate response, loss of response, or or intolerance Prior biologic failure includes inadequate response, loss of response, intolerance to one Please see the Brief Summary of full Prescribing Information to onebiologics. or more biologics (biologic failure), as well as the patients had never demonstrated inadequate more Dosage Forms and Strengths: SKYRIZI iswho available in ina(CR-100) 600 mg/10 mL 360 mg/2.4 mLResponders): single-dose prefilled cartridge with on-body injector.

Placebo (Induction Patients who achieved CDAI clinical response toand SKYRIZI response, loss of response, or intolerance to a biologic (bio-naive; includes 13% ADVANCE 8% in on the following page.

Clinical response was defined as a reduction of CDAI ≥100 points from baseline. single-dose forrandomized intravenous infusion and a 180 mg/1.2 inductionwho therapy and were to receive placebo in the maintenance study.mL or FORTIFY werevial bio-exposed).

Please see theincludes Briefindex; Summary of SC=subcutaneous; the full Prescribing Information CDAl=Crohn’s disease activity IV=intravenous; SES-CD=simple endoscopic score * The mixed population patients who had inadequate response, ofon-body response, or or intolerance Prior biologic failure includes inadequate response, loss of response, orloss intolerance to one 360 mg/2.4 mLResponders): single-dose prefilled cartridge with for Crohn’s disease.

Placebo (Induction Patients who achieved CDAI clinical response (CR-100)injector. to SKYRIZI on the following page.failure), to one or more biologics (biologic as well as patients who had never demonstrated inadequate more biologics. induction therapy and were randomized to receive placebo in the maintenance study. response, loss of response, or intolerance to aofbiologic (bio-naive; includes 13% in ADVANCE and 8% in Please see the Brief of the full Information Clinical response was defined asSummary a reduction CDAI ≥100 pointsPrescribing from baseline. * FORTIFY The mixedwho population includes patients who had inadequate response, loss of response, or intolerance were bio-exposed).

Placebo (Induction Responders): Patients who achieved CDAI clinicalSES-CD=simple response (CR-100) to SKYRIZI CDAl=Crohn’s disease activity index; IV=intravenous; endoscopic score on the following page. to one or more biologics (biologic failure), as well as SC=subcutaneous; patients who had never demonstrated inadequate Prior biologic failure includes inadequate response, loss of response, or intolerance to one or induction therapy and were randomized to receive placebo in the maintenance study.

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for Crohn’sloss disease. response, of response, or intolerance to a biologic (bio-naive; includes 13% in ADVANCE and 8% in moremixed biologics. * The population includes patients who had inadequate response, loss of response, or intolerance FORTIFY who were bio-exposed).

II || Placebo (Induction Responders): Patients who achieved CDAI clinical response (CR-100) to SKYRIZI Clinical response was defined as a reduction of CDAI ≥100 points from baseline. †to one or more biologics (biologic failure), as well as patients who had never demonstrated inadequate Prior biologic failure includes inadequate to response, of response, or intolerance to one or induction therapy and were randomized receive loss placebo in the maintenance study. response, loss of response, or intolerance to a biologic (bio-naive; includes 13% in ADVANCE and 8% in CDAl=Crohn’s more biologics.disease activity index; IV=intravenous; SC=subcutaneous; SES-CD=simple endoscopic score * The mixedwho population includes patients who had inadequate response, loss of response, or intolerance FORTIFY were bio-exposed). for Crohn’s disease. || Clinical response was defined as a reduction of CDAI ≥100 points from baseline. †to one or more biologics (biologic failure), as well as patients who had never demonstrated inadequate Prior biologic failure includes inadequate response, loss of response, or intolerance to one or response, loss of response, or intolerance to a biologic (bio-naive; includes 13% in ADVANCE and 8% in CDAl=Crohn’s more biologics.disease activity index; IV=intravenous; SC=subcutaneous; SES-CD=simple endoscopic score FORTIFY who were bio-exposed). for Crohn’s disease. || Clinical response was defined as a reduction of CDAI ≥100 points from baseline. † Prior biologic failure includes inadequate response, loss of response, or intolerance to one or CDAl=Crohn’s more biologics.disease activity index; IV=intravenous; SC=subcutaneous; SES-CD=simple endoscopic score for Crohn’s disease. || Clinical response was defined as a reduction of CDAI ≥100 points from baseline.

CDAl=Crohn’s disease activity index; IV=intravenous; SC=subcutaneous; SES-CD=simple endoscopic score for Crohn’s disease.

dose), risankizumab-rzaa 1200 mg or placebo at Weeks 0, 4, and 8.

12-week, randomized, placebo-controlled studies prior treatment failure double-blind, to conventional and/or biologic treatment.

FORTIFY (N=382) study was aInduction 52-week study that ADVANCE (N=850) and (N=569) studies were that evaluated theMaintenance efficacy and safety of SKYRIZI patients with Patients received an IV MOTIVATE infusion of SKYRIZI 600 mgin(recommended evaluated the and safety ofplacebo-controlled SKYRIZI in patients who 12-week, randomized, studies moderately to efficacy severelydouble-blind, active Crohn’s diseaseat who demonstrated dose), risankizumab-rzaa 1200 mg or placebo Weeks 0, 4, and 8.

ADVANCE (N=850) andtoMOTIVATE (N=569) Induction studies were achieved clinical response (decrease in CDAI ≥100) from SKYRIZI that evaluated the efficacy and safety of SKYRIZI in patients with prior treatment failure conventional and/or biologic treatment.

FORTIFY (N=382) Maintenance study was astudies.

52-week study that 12-week, randomized, placebo-controlled studies induction into theseverely ADVANCE andCrohn’s MOTIVATE Patients moderately active disease who Patients received an IVdouble-blind, infusion of SKYRIZI 600 mg demonstrated (recommended evaluated the efficacy and safety of(N=569) SKYRIZI in Weeks patients who ADVANCE (N=850) and MOTIVATE Induction studies were that evaluated the and safety of SKYRIZI in mg patients with were randomized toefficacy SKYRIZI 180mg mgor SC, SKYRIZI 360 SC, prior treatment failure to conventional and/or biologic treatment. dose), risankizumab-rzaa 1200 placebo at 0, 4,or and 8. achieved clinical response (decrease inthereafter.

CDAI 600 ≥100) from SKYRIZI 12-week, randomized, placebo-controlled studies moderately to severely active disease who demonstrated placebo Week 12an and every 8Crohn’s weeks Patientsatreceived IVdouble-blind, infusion of SKYRIZI mg (recommended FORTIFY (N=382) Maintenance study was a 52-week study that induction in thethe ADVANCE andmg MOTIVATE studies. that evaluated efficacy safety of SKYRIZI in Patients patients with prior treatment failure to conventional and/or biologic dose), risankizumab-rzaa 1200 orIL:placebo Weeks 0, 4, and References: 1. SKYRIZI [package insert].

North Chicago, AbbVie Inc. at 2.

D’Haens G, treatment.

Panaccione R, 8. evaluated the safety of SKYRIZI in patients who Baert F, et al. Risankizumab as therapy formg Crohn’s disease: results fromdemonstrated the 3 or ADVANCE were randomized to SKYRIZI 180 SC, SKYRIZI 360 mgphase SC, moderately to efficacy severely active Crohn’s disease who Patients received aninduction IVand infusion of SKYRIZI 600 mg (recommended FORTIFY (N=382) Maintenance study was a 52-week study that and MOTIVATEclinical trials.

Lancet. 2022;399(10340):2015-2030.

3.≥100) Data onfrom file, AbbVie Inc. achieved response (decrease CDAI SKYRIZI placebo atinduction Weekfailure 12 and 8 mg weeks thereafter. prior treatment toevery conventional and/or biologic dose), risankizumab-rzaa 1200 orinplacebo at Weekstreatment.

0, 4, and 8.

ABVRRTI74186. evaluated the efficacy and safety SKYRIZI in mg patients who induction in the ADVANCE and MOTIVATE studies.

Patients Patients an IV infusion ofof SKYRIZI 600 (recommended References: 1.received SKYRIZI [package insert].

North Chicago, IL: AbbVie Inc. 2. D’Haens G, Panaccione R, FORTIFY (N=382)response Maintenance was aresults 52-week that achieved clinical (decrease inplacebo CDAI ≥100) from SKYRIZI Baert F, et al. Risankizumab as induction therapy forstudy Crohn’s disease: from the phase ADVANCE were randomized to SKYRIZI 180mg mg SKYRIZI 360 mgstudy SC,4,3 or dose), risankizumab-rzaa 1200 orSC, at Weeks 0, and 8. and MOTIVATE in induction trials. Lancet.

2022;399(10340):2015-2030.

3.

Data file,Patients AbbVie who Inc. evaluated the efficacy and safety of SKYRIZI in onpatients induction the ADVANCE and MOTIVATE studies. placebo at Week 12 and every 8 weeks thereafter.

ABVRRTI74186.

FORTIFY (N=382)response study a≥100) 52-week study achieved clinical (decrease in was CDAI from SKYRIZI were randomized toMaintenance SKYRIZI 180 mg SC, SKYRIZI 360 mg SC, orthat References: 1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc. 2. D’Haens G, Panaccione R, evaluated the efficacy and safety of SKYRIZI in patients For more information about CD induction in the ADVANCE and MOTIVATE Patients Baert F, et al.at Risankizumab as and induction therapy Crohn’s disease:studies. results fromtreating the phasewho 3 ADVANCE placebo Week 12 every 8 for weeks thereafter. and MOTIVATEclinical induction trials.

Lancet. 2022;399(10340):2015-2030.

3.≥100) Data onfrom file, AbbVie Inc. achieved response (decrease in CDAI SKYRIZI were randomized to SKYRIZI 180 mgscan SC, SKYRIZI 360code. mg SC, or R, with SKYRIZI, the References: 1. SKYRIZI [package insert].

North Chicago, IL: AbbVie Inc. 2.QR D’Haens G, Panaccione ABVRRTI74186. induction inWeek the ADVANCE and MOTIVATE Patients Baert F, et al.at Risankizumab induction therapy Crohn’sthereafter. disease:studies. results from the phase 3 ADVANCE placebo 12as and every 8 for weeks and MOTIVATE induction trials.

Lancet.

2022;399(10340):2015-2030.

3.

Data on file, AbbVie Inc. CD For more 180 information about were randomized to SKYRIZI mg SC, SKYRIZI 360treating mg SC, or R, References: 1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc. 2. D’Haens G, Panaccione ABVRRTI74186.

Baert F, et al.

Risankizumab as induction therapy for Crohn’s disease: results from the phase placebo at Week 12 and SKYRIZI, every 8 weeks thereafter. with scan the QR code. 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022;399(10340):2015-2030. 3. Data on file, AbbVie Inc. References: 1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc. 2. D’Haens G, Panaccione R, ABVRRTI74186. © 2022F,AbbVie. All rights reserved.

Baert et al. Risankizumab as induction therapy for Crohn’s disease: results from the phase 3 ADVANCE ® and MOTIVATE trials.

Lancet. trademarks 2022;399(10340):2015-2030.

3. Data on file, AbbVie Inc. SKYRIZI and itsinduction design are registered of AbbVie Biotechnology Ltd. ABVRRTI74186. October 2022 US-SKZG-220621

For more information about treating CD with SKYRIZI, scan the QR code.

For more information about treating CD © 2022 AbbVie. All rights reserved. with SKYRIZI, scan the QRLtd.code.

SKYRIZI and its design are registered trademarks of AbbVie Biotechnology For more information about treating CD US-SKZG-220621 October 2022 with SKYRIZI, scan the QR code.

For more information about treating CD © 2022 AbbVie. All rights reserved.

SKYRIZI and its design are registered trademarks of AbbVie Biotechnology Ltd. SKYRIZI, scan the QR code.

US-SKZG-220621 Octoberwith 2022 ®

®

© 2022 AbbVie. All rights reserved.

SKYRIZI ® and its design are registered trademarks of AbbVie Biotechnology Ltd. US-SKZG-220621 October 2022 © 2022 AbbVie. All rights reserved.

SKYRIZI ® and its design are registered trademarks of AbbVie Biotechnology Ltd. US-SKZG-220621 October 2022 © 2022 AbbVie. All rights reserved.

Revista Puertorriqueña de Medicina y Salud Pública SKYRIZI ® and its design are registered trademarks of AbbVie Biotechnology Ltd. US-SKZG-220621 October 2022

35

DO NOT RE-SIZE US-SKZG-220621

SKYRIZI® (sky-RIZZ-ee) (risankizumab-rzaa) injection, for subcutaneous use

PROFESSIONAL BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION

150 mg/mL single-dose pen and prefilled syringe 600 mg/10 mL single-dose vial 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector INDICATIONS AND USAGE Plaque Psoriasis SKYRIZI® is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Psoriatic Arthritis SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.

Crohn’s Disease SKYRIZI is indicated for the treatment of moderately to severely active Crohn’s disease in adults.

CONTRAINDICATIONS SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients [see Warnings and Precautions].

WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately [see Adverse Reactions].

Infections SKYRIZI may increase the risk of infections [see Adverse Reactions].

Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer SKYRIZI until the infection resolves.

Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SKYRIZI. Across the Phase 3 psoriasis clinical studies, of the 72 subjects with latent TB who were concurrently treated with SKYRIZI and appropriate TB prophylaxis during the studies, none developed active TB during the mean follow-up of 61 weeks on SKYRIZI. Two subjects taking isoniazid for treatment of latent TB discontinued treatment due to liver injury. Of the 31 subjects from the PsO-3 study with latent TB who did not receive prophylaxis during the study, none developed active TB during the mean follow-up of 55 weeks on SKYRIZI. Consider anti-TB therapy prior to initiating SKYRIZI in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment.

Do not administer SKYRIZI to patients with active TB. Hepatotoxicity in Treatment of Crohn’s Disease A serious adverse reaction of drug-induced liver injury was reported in a patient with Crohn’s disease (ALT 54x ULN, AST 30x ULN, and total bilirubin 2.2x ULN) following two intravenous doses of SKYRIZI 600 mg in conjunction with a rash that required hospitalization. The liver test abnormalities resolved following administration of steroids. SKYRIZI was subsequently discontinued.

For the treatment of Crohn’s disease, evaluate liver enzymes and bilirubin at baseline, and during induction at least up to 12 weeks of treatment. Monitor thereafter according to routine patient management.

Consider other treatment options in patients with evidence of liver cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.

Administration of Vaccines Avoid use of live vaccines in patients treated with SKYRIZI. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy with SKYRIZI, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or inactive vaccines.

ADVERSE REACTIONS The following adverse reactions are discussed in other sections of labeling: • Hypersensitivity Reactions [see Warnings and Precautions] • Infections [see Warnings and Precautions] • Tuberculosis [see Warnings and Precautions] • Hepatotoxicity in Treatment of Crohn’s disease [see Warnings and Precautions] Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Plaque Psoriasis A total of 2234 subjects were treated with SKYRIZI in clinical development trials in plaque psoriasis. Of these, 1208 subjects with psoriasis were exposed to SKYRIZI for at least one year.

Data from placebo- and active-controlled trials were pooled to evaluate the safety of SKYRIZI for up to 16 weeks. In total, 1306 subjects were evaluated in the SKYRIZI 150 mg group.

Table 1 summarizes the adverse drug reactions that occurred at a rate of at least 1% and at a higher rate in the SKYRIZI group than the placebo group during the 16-week controlled period of pooled clinical trials.

Table 1. Adverse Drug Reactions Occurring in ≥ 1% of Subjects on SKYRIZI through Week 16 Adverse Drug Reactions

SKYRIZI N = 1306 n (%)

Placebo N = 300 n (%)

Upper respiratory infectionsa

170 (13.0)

29 (9.7)

Headacheb

46 (3.5)

6 (2.0)

Fatiguec

33 (2.5)

3 (1.0)

Injection site reactionsd

19 (1.5)

3 (1.0)

Tinea infectionse

15 (1.1)

1 (0.3)

a

Includes: respiratory tract infection (viral, bacterial or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis b Includes: headache, tension headache, sinus headache, cervicogenic headache c Includes: fatigue, asthenia d Includes: injection site bruising, erythema, extravasation, hematoma, hemorrhage, infection, inflammation, irritation, pain, pruritus, reaction, swelling, warmth e Includes: tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, tinea infection, onychomycosis Adverse drug reactions that occurred in < 1% but > 0.1% of subjects in the SKYRIZI group and at a higher rate than in the placebo group through Week 16 were folliculitis and urticaria.

Specific Adverse Drug Reactions Infections In the first 16 weeks, infections occurred in 22.1% of the SKYRIZI group (90.8 events per 100 subject-years) compared with 14.7% of the placebo group (56.5 events per 100 subject-years) and did not lead to discontinuation of SKYRIZI. The rates of serious infections for the SKYRIZI group and the placebo group were ≤0.4%. Serious infections in the SKYRIZI group included cellulitis, osteomyelitis, sepsis, and herpes zoster. In Studies PsO-1 and PsO-2, through Week 52, the rate of infections (73.9 events per 100 subject-years) was similar to the rate observed during the first 16 weeks of treatment.

Safety Through Week 52 Through Week 52, no new adverse reactions were identified, and the rates of the adverse reactions were similar to those observed during the first 16 weeks of treatment. During this period, serious infections that led to study discontinuation included pneumonia.

Psoriatic Arthritis The overall safety profile observed in subjects with psoriatic arthritis treated with SKYRIZI is generally consistent with the safety profile in subjects with plaque psoriasis. Additionally, in the Phase 3 placebocontrolled trials the incidence of hepatic events was higher in the SKYRIZI group (5.4%, 16.7 events per 100 patient years) compared to the placebo group (3.9%, 12.6 events per 100 patient years). Of these, the most common events that were reported more frequently in both the placebo group and the SKYRIZI group were ALT increased (placebo: n=12 (1.7%); SKYRIZI: n=16 (2.3%)), AST increased (placebo: n=9 (1.3%); SKYRIZI: n=13 (1.8%)), and GGT increased (placebo: n=5 (0.7%); SKYRIZI: n=8 (1.1%)). There were no serious hepatic events reported. The incidence of hypersensitivity reactions was higher in the SKYRIZI group (n=16, 2.3%) compared to the placebo group (n=9, 1.3%). In the Phase 3 placebo-controlled trials, hypersensitivity reactions reported at a higher rate in the SKYRIZI group included rash (placebo: n=4 (0.6%); SKYRIZI: n=5 (0.7%), allergic rhinitis (placebo: n=1 (0.1%); SKYRIZI: n=2 (0.3%), and facial swelling (placebo: n=0 (0.0%); SKYRIZI n=1 (0.1%). One case of anaphylaxis was reported in a subject who received SKYRIZI in the Phase 2 clinical trial.

Crohn’s Disease SKYRIZI was studied up to 12 weeks in subjects with moderately to severely active Crohn’s disease in two randomized, double-blind, placebo-controlled induction studies (CD-1, CD-2) and a randomized, double-

blind, placebo-controlled, dose-finding study (CD-4; NCT02031276). Long-term safety up to 52 weeks was evaluated in subjects who responded to induction therapy in a randomized, double-blind, placebo-controlled maintenance study (CD-3).

In the two induction studies (CD-1, CD-2) and the dose finding study (CD-4), 620 subjects received the SKYRIZI intravenous induction regimen. In the maintenance study (CD-3), 142 subjects who achieved clinical response defined as a reduction in CDAI of at least 100 points from baseline after 12 weeks of induction treatment with intravenous SKYRIZI in studies CD-1 and CD-2, received SKYRIZI subcutaneously as a maintenance regimen.

Adverse reactions reported in > 3% of subjects in induction studies and at a higher rate than placebo are shown in Table 2.

Table 2. Adverse Drug Reactions Reported in > 3% of Subjects with Crohn’s Disease Treated with SKYRIZI in Placebo-Controlled 12-Week Induction Studies

Adverse Drug Reactions

Placebo N = 432 n (%)

Upper respiratory infectionsb

66 (10.6)

40 (9.3)

Headachec

41 (6.6)

24 (5.6)

Arthralgia

31 (5.0)

19 (4.4)

a SKYRIZI 600 mg as an intravenous infusion at Week 0, Week 4, and Week 8. b

Includes: influenza like illness, nasopharyngitis, influenza, pharyngitis, upper respiratory tract infection, viral upper respiratory tract infection, COVID-19, nasal congestion, respiratory tract infection viral, viral pharyngitis, tonsillitis, upper respiratory tract inflammation c Includes: headache, tension headache Adverse reactions reported in >3% of subjects in the maintenance study and at a higher rate than placebo are shown in Table 3.

Table 3. Adverse Reactions Reported in >3% of Subjects with Crohn’s Disease Treated with SKYRIZI in Placebo-Controlled 52-Week Maintenance Study (CD-3) Adverse Drug Reactions

SKYRIZI 360 mg Subcutaneous Injectiona N = 142 n (%)

Placebo N = 143 n (%)

Arthralgia

13 (9.2)

12 (8.4)

Injection site reactionsb,c

8 (5.6)

4 (2.8)

Abdominal paind

12 (8.5)

6 (4.2)

Anemia

7 (4.9)

Pyrexia

7 (4.9)

4 (2.8)

Back pain

6 (4.2)

3 (2.1)

Arthropathy

5 (3.5)

2 (1.4)

Urinary tract infection

5 (3.5)

4 (2.8)

a

6 (4.2)

SKYRIZI 360 mg at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks

b Includes: injection site rash, injection site erythema, injection site swelling, injection site urticaria, injection

site warmth, injection site pain, injection site hypersensitivity, injection site reaction c Some subjects had multiple occurrences of injection site reactions. The adverse reaction is included only once per subject. dIncludes: abdominal pain, abdominal pain upper, abdominal pain lower

Specific Adverse Drug Reactions Infections In the maintenance study (CD-3) through Week 52, the rate of infections was 36.6% (60.8 events per 100 subject-years) in subjects who received SKYRIZI compared to 36.4% (60.3 events per 100 subject-years) in subjects who received placebo after SKYRIZI induction. The rate of serious infections was 5.6% (7.4 events per 100 subject-years) in subjects who received SKYRIZI compared to 2.1% (2.4 events per 100 subject-years) in subjects who received placebo after SKYRIZI induction.

Lipid Elevations Elevations in lipid parameters (total cholesterol and low-density lipoprotein cholesterol [LDL-C]) were first assessed at 4 weeks following initiation of SKYRIZI in the induction trials (CD-1, CD-2). Increases from baseline and increases relative to placebo were observed at Week 4 and remained stable to Week 12. Following SKYRIZI induction, mean total cholesterol increased by 9.4 mg/dL from baseline to a mean absolute value of 175.1 mg/dL at Week 12. Similarly, mean LDL-C increased by 6.6 mg/dL from baseline to a mean absolute value of 92.6 mg/dL Week 12. Following maintenance treatment with SKYRIZI, mean LDL-C increased by 2.3 mg/dL from baseline to Week 52, to an absolute value of 102.2 mg/dL. Immunogenicity As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.

For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other products, including other risankizumab products, may be misleading.

Plaque Psoriasis

By Week 52, approximately 24% (263/1079) of subjects treated with SKYRIZI at the recommended dose developed antibodies to risankizumab-rzaa. Of the subjects who developed antibodies to risankizumabrzaa, approximately 57% (14% of all subjects treated with SKYRIZI) had antibodies that were classified as neutralizing. Higher antibody titers in approximately 1% of subjects treated with SKYRIZI were associated with lower risankizumab-rzaa concentrations and reduced clinical response.

Psoriatic Arthritis

By Week 28, approximately 12.1% (79/652) of subjects treated with SKYRIZI at the recommended dose developed antibodies to risankizumab-rzaa. None of the subjects who developed antibodies to risankizumabrzaa had antibodies that were classified as neutralizing. Antibodies to risankizumab-rzaa were not associated with changes in clinical response for psoriatic arthritis. A higher proportion of subjects with anti-drug antibodies experienced hypersensitivity reactions (6.3% (5/79)) and injection site reactions (2.5% (2/79)) compared to subjects without anti-drug antibodies (3.8% (22/574) with hypersensitivity reactions and 0.7% (4/574) with injection site reactions). None of these hypersensitivity and injection site reactions led to discontinuation of risankizumab-rzaa.

Crohn’s Disease

By Week 64, approximately 3.4% (2/58) of subjects treated with SKYRIZI at the recommended induction and maintenance dosages developed antibodies to risankizumab-rzaa. None of the subjects who developed antibodies to risankizumab-rzaa had antibodies that were classified as neutralizing.

Postmarketing Experience The following adverse reactions have been reported during post-approval of SKYRIZI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to SKYRIZI exposure: • Skin and subcutaneous tissue disorders: eczema and rash USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women who become pregnant while treated with SKYRIZI. Patients should be encouraged to enroll by calling 1-877-302-2161 or visiting http://glowpregnancyregistry.com.

Risk Summary Available pharmacovigilance and clinical trial data with risankizumab use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Although there are no data on risankizumab-rzaa, monoclonal antibodies can be actively transported across the placenta, and SKYRIZI may cause immunosuppression in the in utero-exposed infant. There are adverse pregnancy outcomes in women with inflammatory bowel disease (see Clinical Considerations).

In an enhanced pre- and post-natal developmental toxicity study, pregnant cynomolgus monkeys were administered subcutaneous doses of 5 or 50 mg/kg risankizumab-rzaa once weekly during the period of organogenesis up to parturition. Increased fetal/infant loss was noted in pregnant monkeys at the 50 mg/kg dose (see Data). The 50 mg/kg dose in pregnant monkeys resulted in approximately 10 times the exposure (AUC) in humans administered the 600 mg induction regimen and 39 times the exposure (AUC) to the 360 mg maintenance doses, respectively. No risankizumab-rzaa-related effects on functional or immunological development were observed in infant monkeys from birth through 6 months of age. The clinical significance of these findings for humans is unknown.

20070464 Skyrizi PB-10.5x13(1).indd 1

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SKYRIZI 600 mg Intravenous Infusiona N = 620 n (%)

Revista Puertorriqueña de Medicina y Salud Pública

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-associated maternal and embryo/fetal risk Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.

Fetal/Neonatal adverse reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Because risankizumab may interfere with immune response to infections, risks and benefits should be considered prior to administering live vaccines to infants exposed to SKYRIZI in utero. There are insufficient data regarding infant serum levels of risankizumab at birth and the duration of persistence of risankizumab in infant serum after birth. Although a specific timeframe to delay live virus immunizations in infants exposed in utero is unknown, a minimum of 5 months after birth should be considered because of the half-life of the product.

Data Animal Data An enhanced pre- and post-natal developmental toxicity study was conducted in cynomolgus monkeys.

Pregnant cynomolgus monkeys were administered weekly subcutaneous doses of risankizumab-rzaa of 5 or 50 mg/kg from gestation day 20 to parturition, and the cynomolgus monkeys (mother and infants) were monitored for 6 months after delivery. No maternal toxicity was noted in this study. There were no treatment-related effects on growth and development, malformations, developmental immunotoxicology, or neurobehavioral development. However, a dose-dependent increase in fetal/infant loss was noted in the risankizumab-rzaa-treated groups (32% and 43% in the 5 mg/kg and 50 mg/kg groups, respectively) compared with the vehicle control group (19%). The increased fetal/infant loss in the 50 mg/kg group was considered to be related to risankizumab-rzaa treatment. The no observed adverse effect level (NOAEL) for maternal toxicity was identified as 50 mg/kg and the NOAEL for developmental toxicity was identified as 5 mg/kg. On an exposure (AUC) basis, the 5 mg/kg dose in pregnant monkeys resulted in approximately 1.24 times the exposure in humans administered the 600 mg induction regimen and 5 times the exposure in humans administered the 360 mg maintenance doses, respectively. In the infants, mean serum concentrations increased in a dose-dependent manner and were approximately 17%-86% of the respective maternal concentrations. Following delivery, most adult female cynomolgus monkeys and all infants from the risankizumab-rzaa-treated groups had measurable serum concentrations of risankizumab-rzaa up to 91 days postpartum. Serum concentrations were below detectable levels at 180 days postpartum.

Lactation Risk Summary There are no data on the presence of risankizumab-rzaa in human milk, the effects on the breastfed infant, or the effects on milk production. Endogenous maternal IgG and monoclonal antibodies are transferred in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to risankizumab-rzaa are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SKYRIZI and any potential adverse effects on the breastfed infant from SKYRIZI or from the underlying maternal condition.

Pediatric Use The safety and effectiveness of SKYRIZI have not been established in pediatric patients.

Geriatric Use Of the 2234 subjects with plaque psoriasis exposed to SKYRIZI, 243 subjects were 65 years or older and 24 subjects were 75 years or older. No overall differences in SKYRIZI exposure, safety, or effectiveness were observed between older and younger subjects who received SKYRIZI. However, the number of subjects aged 65 years and older was not sufficient to determine whether they respond differently from younger subjects.

Clinical studies of SKYRIZI for the treatment of Crohn’s disease did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.

No clinically meaningful differences in the pharmacokinetics of risankizumab-rzaa were observed in geriatric subjects compared to younger adult subjects with Crohn’s disease.

PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Hypersensitivity Reactions Advise patients to discontinue SKYRIZI and seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions].

Infections Inform patients that SKYRIZI may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to the healthcare provider and contacting their healthcare provider if they develop any symptoms of an infection [see Warnings and Precautions].

Hepatotoxicity in Treatment of Crohn’s Disease Inform patients that SKYRIZI may cause liver injury, especially during the initial 12 weeks of treatment. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of liver dysfunction. (e.g., unexplained rash, nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine) [see Warnings and Precautions].

Administration of Vaccines Advise patients that vaccination with live vaccines is not recommended during SKYRIZI treatment and immediately prior to or after SKYRIZI treatment. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Instruct patients to inform the healthcare practitioner that they are taking SKYRIZI prior to a potential vaccination [see Warnings and Precautions].

Administration Instruction Instruct patients or caregivers to perform the first self-injected dose under the supervision and guidance of a qualified healthcare professional for training in preparation and administration of SKYRIZI, including choosing anatomical sites for administration, and proper subcutaneous injection technique.

If using SKYRIZI 75 mg/0.83 mL, instruct patients or caregivers to administer two 75 mg single-dose syringes to achieve the full 150 mg dose of SKYRIZI. Instruct patients or caregivers in the technique of pen or syringe disposal.

Pregnancy Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to SKYRIZI during pregnancy and patients can call 1-877-302-2161 [see Use in Specific Populations].

Manufactured by: AbbVie Inc. North Chicago, IL 60064, USA US License Number 1889 SKYRIZI® is a registered trademark of AbbVie Biotechnology Ltd. © 2019-2022 AbbVie Inc. Ref: 20070464 Revised: June, 2022 LAB-7524 MASTER

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Treatment and Management Treatment Management of EPI withand CREON Treatment Management of EPI withand CREON Treatment and Management of EPI with CREON CREON treats EPITreatment by replacing the and enzymes necessary to improve fat absorption Management of EPI with CREON CREON treats EPIof by replacing the enzymes necessary to improve fat absorption EPI with CREON

1,2

Access and Coverage

10+ Years' Experience

Patient Support

1,2

CREON treats by replacing theStudy enzymes improve fat absorption Chronic Pancreatitis andEPI Pancreatectomy Pivotal Trial Design necessary Access and Coverage 10+ Years'to Experience Patient Support Randomized, double-blind, multicenter, placebo-controlled, parallel-group study of CREON in patients aged 32 to 75 years with EPI due 1,2 CREON treats EPI by replacing the enzymes to improve fat absorption to chronic pancreatitis or pancreatectomy.

Patients entered a 5-day placebonecessary run-in10+ period, followed by pancreatic enzyme replacement Access and Coverage Years' Experience Patient Support Chronic Pancreatitis and Pancreatectomy Pivotal Trial Study Design 1,2 Randomized, double-blind, multicenter, placebo-controlled, parallel-group study of CREON into patients aged 32 fat to 75absorption years with EPI due CREON treats EPI by replacing the enzymes necessary improve Access and Coverage 10+ Years' Experience Patient Support randomized to the double-blind period.

A total of 54 patients were randomized to receive CREON 72K lipase units per main meal (3 main Chronic Pancreatectomy Pivotalentered Trial Study Design to chronicPancreatitis pancreatitis and or pancreatectomy.

Patients a 5-day placebo run-in period, followed by pancreatic enzyme replacement meals) and 36K lipase units multicenter, per snack (2placebo-controlled, snacks), or matching placebo for 7study days.ofPatients consumed of years fat perwith dayEPI during Randomized, double-blind, parallel-group CREON in Experience patients≥100 agedgrams 32 to 75 due Access and Coverage 10+ Years' Patient Support Chronic Pancreatitis and Pancreatectomy Pivotal Trial Study Design to chronic pancreatitis or pancreatectomy.

Patients 5-dayrandomized placebo run-in period,CREON followed by lipase pancreatic randomized to the double-blind period. A total of 54entered patientsa were to receive 72K units enzyme per mainreplacement meal (3 main 1,2 Randomized, double-blind, parallel-group CREONconsumed in patients≥100 aged 32 to 75 due meals) and 36K lipase units multicenter, per snack (2placebo-controlled, snacks), or matching placebo for 7study days.ofPatients grams of years fat perwith dayEPI during Chronic Pancreatitis and Pancreatectomy Pivotalentered Trial Study Design to chronic pancreatitis or pancreatectomy.

Patients a 5-day placebo run-in period, followed by pancreatic randomized to the double-blind period. A total of 54 patients were randomized to receive CREON 72K lipase units enzyme per mainreplacement meal (3 main Randomized, double-blind, multicenter, placebo-controlled, parallel-group study of CREON in patients aged 32 to 75 years with EPI due 1,2 meals) and 36K lipase units per snack (2 snacks), or matching placebo for 7 days. Patients consumed ≥100 grams of fat per day during to chronic pancreatitis or pancreatectomy.

Patients 5-dayrandomized placebo run-in period,CREON followed by lipase pancreatic randomized to the double-blind period. A total of 54entered patientsa were to receive 72K units enzyme per mainreplacement meal (3 main 1,2 meals) and 36K lipase units per snack (2 snacks), or matching placebo for 7 days. Patients consumed ≥100 grams of fat per day during 1 randomized to the double-blind period. A total of 54 patients were randomized to receive CREON 72K lipase units per main meal (3 main 1,2 meals) and 36K lipase units per snack (2 snacks), or matching placebo for 7 days. Patients consumed ≥100 grams of fat per day during 1 Video Website CREON 36K capsules may be an appropriate dosing strength for many adult exocrine pancreatic 1,2

Consider CREON 36K Consider CREON 36K1 CREON 36K mayunit be an appropriate compared tocapsules lower lipase capsules.

Consider CREON 36K1dosing strength for many adult exocrine pancreatic Consider CREON 36K1dosing strength for many adult exocrine pancreatic CREON 36K mayunit be an appropriate compared tocapsules lower lipase capsules.

Consider CREON 36K dosing strength for1 many CREON 36K mayunit be an appropriate adult exocrine pancreatic compared tocapsules lower lbcapsules. 1 capsule capsule Getting Started with lipase110 CREON 36K may be anlbappropriate dosing strength for many snacks adult exocrine pancreatic Remember— during meals during to unit <160 compared tocapsules lower lipase 110 lbcapsules. 1 capsule 1 capsule CREON Getting Started with EPI patients compared to lower lipase unit capsules.

Remember— during meals during snacks to <160 lb snack!

110 lb 1 capsule 1 capsule Getting Started with 36K CREON EPI patients Instruct patients Remember— during meals during snacks to <160 lb 110 lb 1 capsule 1 capsule Lipase Unit 160 2 capsules snack!

Getting Started with to ALWAYS take CREON EPI patients 36K Remember— Capsules during snacks during meals Instruct patients to <160 lb CREON with meals 315 lb 110 lb 1 capsule 1 capsule Getting Started with snack!

Lipase Unit CREON 160 lb 2 capsules 1 capsule EPI patients to ALWAYS take AND snacks 36K Remember— during meals during snacks to <160 patients Capsules during meals during snacks Instruct CREON with meals snack! to160 315lblblb CREON Lipase Unit 2 capsules 1 capsule EPI patients 36K to ALWAYS take AND snacks Instruct patients snack!

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Website

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* *

The initial CREON dosage you prescribe should be individualized based on weight and CREON is also available * in 3K, 6K, 12K, and 24K lipase unit capsules. adjusted based on clinical symptoms, the degree of steatorrhea present, and the fat This chart is intended to be a guide. CREON capsules represent nearest capsule count of content of the diet. Dosing of Pancreatic Enzymes is based on the guidelines established CREON 36K within recommended dosing range. Patients weighing <110 lb may require a lower * by the Cystic Fibrosis Foundation (CFF). The CFFbeguidelines also provide dosing based lipase unit dose. Patients weighing >315 may require a higher lipase unit starting dose.

The initial CREON dosage you prescribe should individualized based on weight and CREON is starting also available in 3K, 6K, 12K, and 24Klblipase unit capsules. on fat ingested day. symptoms, the degree of steatorrhea adjusted basedper on clinical present, and the fat to ALWAYS take This chart is intended to be a guide. CREON capsules represent nearest capsule count of AND snacks content of the diet. Dosing of Pancreatic Enzymes is based on the guidelines established * CREON 36K within recommended dosing range. Patients weighing <110 lb may require a lower CREON with meals The initial CREON dosage you prescribe should individualized based on weight and CREON is starting also available in 3K, 6K, 12K, and 24Klblipase unit capsules. by the Cystic Fibrosis Foundation (CFF). The CFFbeguidelines also provide dosing based lipase unit dose. Patients weighing >315 may require a higher lipase unit starting dose. adjusted basedper on clinical present, and the fat on fat ingested day. symptoms, the degree of steatorrhea This chart is intended to be a guide. CREON capsules represent nearest capsule count of AND snacks content of the diet.

Dosing of Pancreatic Enzymes is based on the guidelines established CREON 36K within recommended range. weighing <110 lb may require a lower The initial CREON dosage you prescribe should individualized based on weight and CREON is also available in 3K, 6K,dosing 12K, and 24KPatients lipase unit capsules. by the Cystic Fibrosis Foundation (CFF). The CFFbeguidelines also provide dosing based lipase unit starting dose. Patients weighing >315 lb may require a higher lipase unit starting dose. adjusted basedper on clinical This chart is intended to be a guide. CREON capsules represent nearest capsule count of on fat ingested day. symptoms, the degree of steatorrhea present, and the fat ® content of thewhich diet. Dosing of Enzymes isof based on the guidelines established CREON (pancrelipase) Delayed-Release Capsules isa alower pancrelipase is you a Pancreatic combination porcine-derived CREON 36K within recommended range. weighing <110 lb may require The initial CREON dosage prescribe should individualized based on weight and CREON is also available in 3K, 6K,dosing 12K, and 24KPatients lipase unit capsules. by the Cystic Fibrosis Foundation (CFF). The CFFbeguidelines also provide dosing based lipase unit starting dose. Patients weighing >315 lb may require a higher lipase unit starting dose. adjusted basedper on clinical This chart is intended to be a guide. CREON capsules represent nearest capsule count of on fat ingested day. symptoms, the degree of steatorrhea present, and the fat content of the diet.

Dosing of Pancreatic Enzymes is based on the guidelines established ® CREON 36K within recommendedpancreatectomy, dosing range. Patients weighing <110 lb may require chronic pancreatitis, or other conditions.

CREON (pancrelipase) Delayed-Release Capsules isa alower pancrelipase is a combination of porcine-derived by the Cystic which Fibrosis Foundation (CFF). The CFF guidelines also provide dosing based lipase unit starting dose. Patients weighing >315 lb may require a higher lipase unit starting dose. on fat ingested per day.

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Indications Indications

Indications ® Important Safetypancreatectomy, Information CREON (pancrelipase) Delayed-Release Capsules is a pancrelipase which is a combination of porcine-derived chronic pancreatitis, or other conditions.

Indications

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Important Safetypancreatectomy, Information • To avoid irritation of oral mucosa, care should be taken to ensure that CREON is not crushed, chewed, or retained • meal Fibrosing colonopathy is associated with high-dose use of pancreatic greater than 10,000 lipase units/kg ofconditions. body weight per day). enzyme replacement in the treatment of chronic pancreatitis, pancreatectomy, or Important Safety Information in the(or mouth.

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•Important To avoid irritation ofInformation oral should taken that CREON is not crushed, chewed, or retained Fibrosing colonopathy is mucosa, associated with high-dose useto ofensure pancreatic enzyme replacement in the treatment of Safety meal (or greater than 10,000 lipasecare units/kg of be body weight per day). in the mouth. CREON should always be taken with food.

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US-CREO-220088 Puerto in Rico. (or greater than 10,000 lipase units/kg of body weight per day). in the mouth. CREON should always be taken with food.

• meal To avoid irritation of oral mucosa, care should taken to ensure that CREON is not crushed, chewed, or retained (or greater than 10,000 lipase units/kg of be body weight day). © 2022 AbbVie. All rights March 2022 per US-CREO-220088 Printed in Puerto Rico. in the mouth. CREON should always bereserved. taken with food.

• To avoid irritation of oral mucosa, care should be taken to ensure that CREON is not crushed, chewed, or retained © 2022should AbbVie. always All rights March 2022 US-CREO-220088 Printed in Puerto Rico. in the mouth. CREON bereserved. taken with food.

A-F 16-7439 US-CREO-220088 Ad.indd 2

© 2022 AbbVie.

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Diagnosis Diagnosis Diagnosis Diagnosis Diagnosis Diagnosis Diagnosis Diagnosis

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2010;105(10):2276-2286.

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Am JAm Gastroenterol.

J Gastroenterol.

2010;105(10):2276-2286.

2010;105(10):2276-2286.

3. IMS 3. IMS Health Health Xponent Xponent Prescribing Prescribing Data.Data.

References: References: 1. 2021.

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Inc. Whitcomb 2.Markets Whitcomb DC, Lehman GA, Vasileva GA, G, etG, al.et Pancrelipase al.2019 Pancrelipase delayed-release delayed-release capsules capsules (CREON) (CREON) for exocrine for 10/02/2020 exocrine pancreatic pancreatic November November 2021.

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• Porcine-derived • Porcine-derived pancreatic pancreatic products products contain contain purines. purines.

Caution should should be be exercised exercised prescribing prescribing November November 2021.

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Important Important Safety Safety Information Information (continued) (continued) Important Important Safety Safety Information Information (continued) (continued)

••Important Porcine-derived •Important pancreatic pancreatic enzyme products products contain contain purines. purines.

Caution Caution should should be be exercised exercised when when prescribing prescribing There • Porcine-derived There is theoretical is Safety theoretical riskInformation risk of viral ofenzyme viral transmission transmission with with all all pancreatic pancreatic enzyme enzyme products products including including CREON. CREON. Safety Information (continued) (continued) CREON CREON to patients to patients with with gout, gout, renal renal impairment, impairment, or hyperuricemia. or hyperuricemia.

•• Exercise • Porcine-derived Exercise caution caution when when administering administering pancrelipase pancrelipase to ato patient apurines. patient with with a known ashould known allergy allergy to proteins to proteins of prescribing porcine of prescribing porcine origin. origin.

Porcine-derived •Important pancreatic pancreatic enzyme enzyme products products contain contain purines.

Caution Caution should be be exercised exercised when when Important Safety Information Information (continued) (continued) • There • There is to theoretical is Safety theoretical risk risk of viral of viral transmission transmission with with allhyperuricemia. all pancreatic pancreatic enzyme enzyme products products including including CREON. CREON. CREON CREON patients to patients with with gout, gout, renal renal impairment, impairment, or or hyperuricemia.

• • •Important Porcine-derived •Important pancreatic pancreatic enzyme enzyme products products contain contain purines.

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Safety Safety Information Information (continued) (continued) were vomiting, dizziness, dizziness, and and cough. cough.

There There is vomiting, theoretical is theoretical risk risk of viral of viral transmission transmission with with allto all pancreatic pancreatic enzyme enzyme products products including including CREON. CREON. CREON CREON to patients to patients with with gout, gout, renal renal impairment, impairment, or hyperuricemia. or hyperuricemia.

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CREON CREON to patients to patients with with gout, gout, renal renal impairment, impairment, or hyperuricemia. or hyperuricemia.

• Exercise ••• Exercise caution caution when when administering administering pancrelipase pancrelipase atopancreatitis patient a patient with a pancreatectomy known a products known allergy allergy to proteins to proteins of porcine ofthan porcine bowel movements, movements, and and nasopharyngitis. nasopharyngitis.

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• •• CREON CREON is not is not interchangeable interchangeable with with any any other other pancrelipase pancrelipase product. product.

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A-F 16-7439 US-CREO-220088 Ad.indd 3 A-F 16-7439 US-CREO-220088 Ad.indd 3

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CREON® (krē ´ŏn) (pancrelipase) Delayed-Release Capsules, for oral use INDICATIONS AND USAGE CREON® conditions.

DOSAGE AND ADMINISTRATION CREON is not interchangeable with other pancrelipase products.

CREON is orally administered. Therapy should be initiated at the lowest recommended dose and gradually increased. The dosage of CREON should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet as described in the Limitations on Dosing below [see Dosage and Administration and Warnings and Precautions].

Administration Infants (up to 12 months) CREON should be administered to infants immediately prior to each feeding, using a dosage of 3,000 lipase units per 120 mL of formula or prior to breastfeeding. Contents of the capsule may be administered directly to the mouth or with a small amount of applesauce. Administration should be followed by breast milk or formula. Contents of the capsule should not be should be taken to ensure that CREON is not crushed or chewed or retained in the mouth, to avoid irritation of the oral mucosa.

Children and Adults CREON capsules and capsule contents should not be crushed or chewed. Capsules should be swallowed whole.

For patients who are unable to swallow intact capsules, the capsules may be carefully opened and the contents added to a small amount of acidic soft food with a pH of 4.5 or less, such as applesauce, at room temperature. The CREON-soft food mixture should be swallowed immediately without crushing or chewing, and followed with water or juice to ensure complete ingestion.

Care should be taken to ensure that no drug is retained in the mouth.

Dosage Dosage recommendations for pancreatic enzyme replacement therapy were published following the Cystic Fibrosis Foundation Consensus Conferences. CREON should be administered in a manner consistent with the recommendations of the Cystic Fibrosis Foundation Consensus Conferences (also known as Conferences) provided in the following paragraphs, except for infants. Although the Conferences recommend doses of 2,000 to 4,000 lipase units in infants up to 12 months, CREON is available in a 3,000 lipase unit capsule. Therefore, the recommended dose of CREON in infants up to 12 months is 3,000 lipase units per 120 mL of formula or per breastfeeding. Patients may be dosed on a fat ingestion-based or actual body weight-based dosing scheme.

Additional recommendations for pancreatic enzyme therapy in patients

WARNINGS AND PRECAUTIONS Fibrosing Colonopathy Fibrosing colonopathy has been reported following treatment with different pancreatic enzyme products. Fibrosing colonopathy is a rare, serious adverse reaction initially described in association with high-dose pancreatic enzyme use, usually over a prolonged period of time and most commonly products exceeding 6,000 lipase units/kg of body weight per meal have been associated with colonic stricture in children less than 12 years of age. some patients may be at risk of progressing to stricture formation. It is recommended, unless clinically indicated, that enzyme doses should be less than 2,500 lipase units/kg of body weight per meal (or less than 10,000 lipase units/kg of body weight per day) or less than 4,000 lipase units/g fat ingested per day [see Dosage and Administration].

Doses greater than 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day) should be used with caution and only if they are documented to be effective by 3-day fecal fat Patients receiving higher doses than 6,000 lipase units/kg of body weight per meal should be examined and the dosage either immediately decreased or titrated downward to a lower range.

Potential for Irritation to Oral Mucosa Care should be taken to ensure that no drug is retained in the mouth. CREON should not be crushed or chewed or mixed in foods having a pH greater than 4.5. These actions can disrupt the protective enteric coating resulting in early release of enzymes, irritation of oral mucosa, and/or loss of enzyme activity [see Dosage and Administration and Patient Counseling Information].

For patients who are unable to swallow intact capsules, the capsules may be carefully opened and the contents added to a small amount of acidic soft food with a pH of 4.5 or less, such as applesauce, at room temperature. The CREON-soft food mixture should be swallowed immediately and followed with water or juice to ensure complete ingestion.

Potential for Risk of Hyperuricemia Caution should be exercised when prescribing CREON to patients with gout, renal impairment, or hyperuricemia. Porcine-derived pancreatic enzyme products contain purines that may increase blood uric acid levels.

Potential Viral Exposure from the Product Source CREON is sourced from pancreatic tissue from swine used for food consumption. Although the risk that CREON will transmit an infectious agent to humans has been reduced by testing for certain viruses during manufacturing and by inactivating certain viruses during manufacturing, there is a theoretical risk for transmission of viral disease, including diseases

pancreatectomy are based on a clinical trial conducted in these populations.

Infants (up to 12 months) CREON is available in the strength of 3,000 USP units of lipase thus infants may be given 3,000 lipase units (one capsule) per 120 mL of formula or per breastfeeding. Do not mix CREON capsule contents directly into formula or breast milk prior to administration [see Administration].

Children Older than 12 Months and Younger than 4 Years Enzyme dosing should begin with 1,000 lipase units/kg of body weight

of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported.

Allergic Reactions Caution should be exercised when administering pancrelipase to a patient with a known allergy to proteins of porcine origin. Rarely, severe allergic reactions including anaphylaxis, asthma, hives, and pruritus, have been reported with other pancreatic enzyme products with different formulations of

units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Children 4 Years and Older and Adults Enzyme dosing should begin with 500 lipase units/kg of body weight per meal

CREON treatment in patients with severe allergy should be taken into consideration with the overall clinical needs of the patient.

ADVERSE REACTIONS The most serious adverse reactions reported with different pancreatic enzyme products of the same active ingredient (pancrelipase) that are described

body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Usually, half of the prescribed CREON dose for an individualized full meal

allergic reactions [see Warnings and Precautions].

Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly

approximately three meals plus two or three snacks per day.

Enzyme doses expressed as lipase units/kg of body weight per meal should be decreased in older patients because they weigh more but tend to ingest less fat per kilogram of body weight.

the rates observed in practice.

The short-term safety of CREON was assessed in clinical trials conducted in

Pancreatectomy The initial starting dose and increases in the dose per meal should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet.

In one clinical trial, patients received CREON at a dose of 72,000 lipase units per meal while consuming at least 100 g of fat per day]. Lower starting doses recommended in the literature are consistent with the 500 lipase units/kg of body weight per meal lowest starting dose recommended for adults in the Cystic Fibrosis Foundation Consensus Conferences Guidelines. Usually, half of the prescribed CREON dose for an individualized full meal should be given with each snack.

Limitations on Dosing Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines. If symptoms and signs of steatorrhea persist, the dosage may be increased by the healthcare professional. Patients should be instructed not to increase the dosage on their own. There is great inter-individual variation in response to enzymes; thus, a range of doses is recommended. Changes in dosage may require an adjustment period of several days. If doses are to exceed 2,500 lipase units/kg of body weight per meal, further investigation is warranted. Doses greater than 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day) should be used with caution and only if they are documented to be effective by

or pancreatectomy were treated with CREON. Cystic Fibrosis Studies 1 and 2 were randomized, double-blind, placebo-controlled, crossover studies of 49 patients, ages 7 to 43 years, with EPI due to CF. Study 1 included 32 patients ages 12 to 43 years and Study 2 included 17 patients ages 7 to 11 years. In these studies, patients were randomized to receive CREON at a dose of 4,000 lipase units/g fat ingested per day or matching placebo for 5 to 6 days of treatment, followed by crossover to the alternate treatment for an additional 5 to 6 days. The mean exposure to CREON during these studies was 5 days.

In Study 1, one patient experienced duodenitis and gastritis of moderate severity 16 days after completing treatment with CREON. Transient neutropenia without clinical sequelae was observed as an abnormal

of fat absorption. Doses greater than 6,000 lipase units/kg of body weight

than or equal to 4%) in Cystic Fibrosis (Studies 1 and 2)

colonopathy, in children less than 12 years of age [see Warnings and Precautions]. Patients currently receiving higher doses than 6,000 lipase units/kg of body weight per meal should be examined and the dosage either immediately decreased or titrated downward to a lower range.

CONTRAINDICATIONS None.

42

PROFESSIONAL BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION

In Study 2, adverse reactions that occurred in at least 2 patients (greater than or equal to 12%) treated with CREON were vomiting and headache. Vomiting occurred in 2 patients treated with CREON and did not occur in patients treated with placebo; headache occurred in 2 patients treated with CREON and did not occur in patients treated with placebo.

The most common adverse reactions (greater than or equal to 4%) in Studies 1 and 2 were vomiting, dizziness, and cough. Table 1 enumerates adverse reactions that occurred in at least 2 patients (greater than or equal to 4%) treated with CREON at a higher rate than with placebo in Studies 1 and 2.

Adverse Reaction

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CREON Capsules n = 49 (%)

Placebo n = 47 (%)

3 (6)

1 (2)

2 (4)

1 (2)

2 (4)

0

An additional open-label, single-arm study assessed the short-term safety and tolerability of CREON in 18 infants and children, ages 4 months to pancreatic enzyme replacement therapy (mean dose of 7,000 lipase units/kg/day for a mean duration of 18.2 days) followed by CREON (mean dose of 7,500 lipase units/kg/day for a mean duration of 12.6 days).

There were no serious adverse reactions. Adverse reactions that occurred in patients during treatment with CREON were vomiting, irritability, and decreased appetite, each occurring in 6% of patients.

Chronic Pancreatitis or Pancreatectomy A randomized, double-blind, placebo-controlled, parallel group study was conducted in 54 adult patients, ages 32 to 75 years, with EPI due to chronic pancreatitis or pancreatectomy. Patients received single-blind placebo treatment during a 5-day run-in period followed by an intervening period of up to 16 days of investigator-directed treatment with no restrictions on pancreatic enzyme replacement therapy. Patients were then randomized to receive CREON or matching placebo for 7 days. The CREON dose was 72,000 lipase units per main meal (3 main meals) and 36,000 lipase units per snack (2 snacks). The mean exposure to CREON during this study was 6.8 days in the 25 patients that received CREON. The most common adverse reactions reported during the study were related to glycemic control and were reported more commonly during CREON treatment than during placebo treatment.

Table 2 enumerates adverse reactions that occurred in at least 1 patient (greater than or equal to 4%) treated with CREON at a higher rate than with placebo.

Table 2: Adverse Reactions in at Least 1 Patient (greater than or equal to 4%) in the Chronic Pancreatitis or Pancreatectomy Trial Adverse Reaction

CREON Capsules n = 25 (%)

Placebo n = 29 (%)

2 (8)

2 (7)

1 (4)

1 (3)

1 (4)

1 (3)

1 (4)

0

1 (4)

0

1 (4)

0

1 (4)

0

Postmarketing Experience Postmarketing data from this formulation of CREON have been available post approval use of this formulation of CREON. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. constipation and nausea), skin disorders (including pruritus, urticaria and rash), blurred vision, myalgia, muscle spasm, and asymptomatic elevations of liver enzymes have been reported with this formulation of CREON. Delayed- and immediate-release pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase) have been used for

intestinal obstruction syndrome (DIOS), recurrence of pre-existing carcinoma, and severe allergic reactions including anaphylaxis, asthma, hives, and pruritus.

DRUG INTERACTIONS been conducted.

USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary Published data from case reports with pancrelipase use in pregnant women or other adverse maternal or fetal outcomes. Pancrelipase is minimally absorbed systematically; therefore, maternal use is not expected to result in fetal exposure to the drug. Animal reproduction studies have not been conducted with pancrelipase.

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Lactation Risk Summary There are no data on the presence of pancrelipase in either human or animal milk, the effects on the breastfed infant or the effects on milk production.

Pancrelipase is minimally absorbed systemically following oral administration; therefore, maternal use is not expected to result in clinically relevant exposure breastfeeding should be considered along with the mother’s clinical need for CREON and any potential adverse effects on the breastfed infant from CREON or from the underlying maternal condition.

Pediatric Use The short-term safety and effectiveness of CREON were assessed in two randomized, double-blind, placebo-controlled, crossover studies of 49 Study 1 included 8 adolescents between 12 and 17 years of age. Study 2 in pediatric patients in these studies were similar to adult patients [see Adverse Reactions and Clinical Studies].

An open-label, single-arm, short-term study of CREON was conducted in 18 infants and children, ages 4 months to six years of age, with EPI due to therapy (mean dose of 7,000 lipase units/kg/day for a mean duration of 18.2 days) followed by CREON (mean dose of 7,500 lipase units/kg/day for a mean duration of 12.6 days). The mean daily fat intake was 48 grams during treatment with usual pancreatic enzyme replacement therapy and 47 grams

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during treatment with CREON. When patients were switched from their usual pancreatic enzyme replacement therapy to CREON, they demonstrated similar spot fecal fat testing results; the clinical relevance of spot fecal fat testing has not been demonstrated. Adverse reactions that occurred in patients during treatment with CREON were vomiting, irritability, and decreased appetite [see Adverse Reactions]. formulations of pancrelipase consisting of the same active ingredient (lipases, proteases, and amylases) for treatment of children with exocrine pancreatic literature and through clinical experience.

Dosing of pediatric patients should be in accordance with recommended guidance from the Cystic Fibrosis Foundation Consensus Conferences [see Dosage and Administration]. Doses of other pancreatic enzyme products exceeding 6,000 lipase units/kg of body weight per meal have been than 12 years of age [see Warnings and Precautions].

Geriatric Use 65 and over to determine whether they respond differently from younger responses between the elderly and younger patients.

OVERDOSAGE There have been no reports of overdose in clinical trials or postmarketing surveillance with this formulation of CREON. Chronic high doses of pancreatic colonic strictures [see Dosage and Administration and Warnings and Precautions]. High doses of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricemia, and should be used with caution in patients with a history of hyperuricemia, gout, or renal impairment [see Warnings and Precautions].

MA-F 16-7439 US-CREO-220088 Ad.indd 5

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, genetic toxicology, and animal fertility studies have not been performed with pancrelipase.

PATIENT COUNSELING INFORMATION Dosing and Administration • Instruct patients and caregivers that CREON should only be taken as directed by their healthcare professional. Patients should be advised that the total daily dose should not exceed 10,000 lipase units/kg body weight/ day unless clinically indicated. This needs to be especially emphasized for patients eating multiple snacks and meals per day. Patients should be informed that if a dose is missed, the next dose should be taken with the next meal or snack as directed. Doses should not be doubled [see Dosage and Administration (2)].

• Instruct patients and caregivers that CREON should always be taken with food. Patients should be advised that CREON delayed-release capsules and the capsule contents must not be crushed or chewed as doing so could cause early release of enzymes and/or loss of enzymatic activity. Patients should swallow the intact capsules with adequate amounts of liquid at mealtimes. If necessary, the capsule contents can also be sprinkled on soft acidic foods [see Dosage and Administration].

Manufactured by: Abbott Laboratories GmbH Hannover, Germany Marketed by: AbbVie Inc. North Chicago, IL 60064, U.S.A. © 2009-2020 AbbVie Inc. Ref: 03-C054-R4 Revised March, 2020 LAB-3604 MASTER

US-CREO-220088

Fibrosing Colonopathy Advise patients and caregivers to follow dosing instructions carefully, as doses of pancreatic enzyme products exceeding 6,000 lipase units/kg of body weight per meal have been associated with colonic strictures in children below the age of 12 years [see Dosage and Administration].

Allergic Reactions Advise patients and caregivers to contact their healthcare professional immediately if allergic reactions to CREON develop [see Warnings and Precautions].

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7/14/22 4:25 PM

DOLOR DE ESPALDA BAJA: APRENDIENDO A COMBATIR AL ENEMIGO

Dr. Roberto J. Pérez Román Neurocirujano de columna mínimamente invasiva

¿TIENES O HAS TENIDO DOLOR DE ESPALDA QUE TE IMPIDE REALIZAR LAS LABORES COTIDIANAS? ¿SIENTES UNA CONTINUA MOLESTIA EN EL CUELLO O LA COLUMNA VERTEBRAL CUANDO TE LEVANTAS DE LA CAMA O DE ESTAR SENTADO? ESTE ARTÍCULO TE AYUDARÁ A CONSEGUIR LAS RESPUESTAS PARA RESOLVER ESE PROBLEMA.

E

l dolor de espalda baja, o lumbago, es una de las condiciones musculoesqueléticas más comunes y la principal causa de discapacidad a nivel mundial. Esta dolencia afecta a millones de personas en el presente y se estima que al menos el 80% de la población experimentará dolor de espalda baja en algún momento de su vida. Aunque esta afección no discrimina en términos de edad, se ve con más frecuencia en adultos de edad media o alta.

El lumbago puede tener diversas causas y a menudo es el resultado de una combinación de factores.

Actividades extenuantes como lo son el levantar objetos pesados, movimientos bruscos o una mala postura pueden provocar lesiones en los músculos o ligamentos localizados en la espalda.

En adición, la degeneración de diversos componentes de la columna vertebral producto del envejecimiento pueden resultar en dolor. Por último, la falta de actividad física la cual provoca la debilidad de los músculos de la espalda puede contribuir al padecimiento crónico.

El dolor de espalda puede ser debilitante y limitar la calidad de vida de quienes lo padecen. Los síntomas varían en intensidad y duración. Uno de los más comunes es la rigidez, especialmente por la mañana o después de períodos prolongados de inactividad.

También se puede experimentar una limitación en el movimiento lumbosacral. Frecuentemente los síntomas de lumbago son acompañados por un dolor que se irradia hacia las piernas, causando lo que se conoce como ciática.

La prevención es clave para reducir el riesgo de este padecimiento. Es importante mantener una postura adecuada especialmente durante el trabajo para así reducir la tensión en el área lumbar. Realizar ejercicios que fortalezcan los músculos de la espalda y el abdomen ayudan a mantener la columna vertebral en una posición saludable. También cabe recalcar que, al levantar objetos pesados, se recomienda que se utilicen las piernas en lugar de la espalda para realizar la fuerza. El sobrepeso puede aumentar la presión sobre los componentes de la

columna, por lo que mantener un peso saludable es clave.

Los tratamientos disponibles varían según la causa y la gravedad de los síntomas. Inicialmente estos incluyen modos conservadores como lo es el descanso de corta duración y una reducción en las actividades que agravan el dolor. Los ejercicios y técnicas de terapia física pueden ayudar a fortalecer los músculos y mejorar la flexibilidad de los tejidos, resultando en una disminución de dolor.

Los analgésicos y los antinflamatorios orales o inyectados pueden aliviar el dolor y la inflamación a corto plazo.

En casos donde el dolor sea severo, existan déficits neurológicos o cuando las otras alternativas de tratamiento han fallado, pudiera ser necesaria una intervención quirúrgica por parte de un neurocirujano subespecialista en columna. Gracias a los avances tecnológicos, hoy en día existen técnicas mínimamente invasivas para tratar la gran mayoría de condiciones que afectan la columna vertebral asegurando así una recuperación más rápida y eficaz de los pacientes.

Si padece de estos síntomas debería ser evaluado por un profesional de la salud.

El Dr. Roberto J. Pérez Román, neurocirujano subespecialista en cirugía mínimamente invasiva de columna, lo puede evaluar en el Hospital Pavía en Arecibo. Para citas puede llamar al 787-434-3599.

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Revista Puertorriqueña de Medicina y Salud Pública

Revista Puertorriqueña de Medicina y Salud Pública

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CON DUPIXENT, ESTOY UN PASO ADELANTE DEL ECZEMA. DUPIXENT es un tratamiento revolucionario para el eczema, que ayuda a sanar tu piel desde adentro. DUPIXENT bloquea una fuente principal de inflamación en el interior de tu cuerpo, que puede causar eczema (dermatitis atópica) moderado a grave no controlado.

Disponible para niños de 6 meses o más.

Alivio rápido de la picazón * Una piel con menos lesiones por más tiempo** No es un esteroide o inmunosupresor *A las 2 semanas, el 18% de los adultos que usaron DUPIXENT + corticosteroides tópicos (CST) presentó menos picazón frente al 8% que usó CST únicamente. **A las 16 semanas, el 39% de los adultos que usaron DUPIXENT + CST presentó una piel sin lesiones o casi sin lesiones frente al 12% que usó CST únicamente. El 22% presentó una piel sin lesiones o casi sin lesiones a las 16 y las 52 semanas frente al 7%, respectivamente.

CRISTAL

INSTRUCTORA DE BAILE Y PACIENTE REAL

Los resultados individuales pueden variar.

HABLA CON TU ESPECIALISTA EN ECZEMA Y APRENDE MÁS EN DUPIXENT.COM Hoy es un buen día para averiguar si DUPIXENT, Especialmente, infórmale a tu proveedor de Los efectos secundarios más comunes en pacientes un medicamento biológico, podría ser adecuado atención médica si estás tomando medicamentos con eczema son reacciones en el lugar de la inyección, corticosteroides orales, tópicos o inhalados, o si tienes inflamación de los ojos y los párpados, que incluyen para ti. dermatitis atópica y asma y usas un medicamento para enrojecimiento, hinchazón y picazón, a veces con visión el asma. No cambies ni suspendas tu medicamento borrosa, herpes en la boca o en los labios, y un alto INDICACIÓN DUPIXENT es un medicamento de venta con receta corticosteroide u otro medicamento para el asma recuento de ciertos glóbulos blancos (eosinofilia). que se utiliza para tratar a adultos y niños de 6 meses sin hablar primero con tu proveedor de atención Infórmale a tu proveedor de atención médica si sufres médica. Esto puede hacer que reaparezcan otros o más con eczema (dermatitis atópica o DA) moderado síntomas que fueron controlados por el medicamento algún efecto secundario que te cause malestar o a grave, que no puede controlarse correctamente corticosteroide u otro medicamento para el asma. que no desaparezca. Estos no son todos los efectos con terapias recetadas que se aplican sobre la piel secundarios posibles de DUPIXENT. Llama a tu médico (tópicas) o en casos en los que no se puedan utilizar DUPIXENT puede causar efectos secundarios para obtener consejos médicos sobre los efectos terapias tópicas. DUPIXENT puede utilizarse con o sin graves, que incluyen: secundarios. Te recomendamos informar sobre los corticosteroides tópicos. Se desconoce si DUPIXENT Reacciones alérgicas. DUPIXENT puede causar efectos secundarios negativos de los medicamentos es seguro y eficaz en niños menores de 6 meses que reacciones alérgicas que algunas veces pueden de venta con receta a la Administración de Alimentos tengan dermatitis atópica. ser graves. Deja de usar DUPIXENT e infórmale a y Medicamentos de los Estados Unidos (Food and tu proveedor de atención médica o busca atención Drug Administration, FDA). Visita www.fda.gov/ INFORMACIÓN IMPORTANTE DE SEGURIDAD de emergencia de inmediato si tienes alguno de los siguientes signos o síntomas: Problemas respiratorios medwatch o llama al 1-800-FDA-1088.

No uses este medicamento si eres alérgico al dupilumab o sibilancias, inflamación del rostro, los labios, la boca, Usa DUPIXENT exactamente según lo prescrito o a alguno de los ingredientes en DUPIXENT®. la lengua o la garganta, desmayos, mareos, sensación por tu proveedor de atención médica. DUPIXENT Antes de usar DUPIXENT, infórmale a tu proveedor de mareo, pulso acelerado, fiebre, urticaria, dolor en es una inyección que se administra debajo de la piel de atención médica sobre todas tus afecciones las articulaciones, malestar general, picazón, erupción (inyección subcutánea). Tu proveedor de atención médicas, incluyendo: si tienes problemas oculares; si cutánea, ganglios linfáticos inflamados, náuseas o médica decidirá si tú o tu cuidador pueden inyectar tienes una infección parasitaria (helmintos); si tienes vómitos, o calambres en el área del estómago.

DUPIXENT. No intentes preparar e inyec tar programado recibir alguna vacuna. No debes recibir Problemas oculares. Infórmale a tu proveedor de DUPIXENT hasta que tú o tu cuidador hayan sido una “vacuna viva” antes o durante el tratamiento con atención médica si tienes problemas oculares nuevos capacitados por tu proveedor de atención médica. En DUPIXENT; si estás embarazada o planeas quedar o si notas un empeoramiento de los problemas que niños de 12 años o más, se recomienda que DUPIXENT embarazada. Se desconoce si DUPIXENT dañará a tenías, incluido dolor ocular o cambios en la visión, tu bebé en gestación. Un registro de embarazo para como visión borrosa. Tu proveedor de atención médica sea administrado por un adulto o bajo la supervisión mujeres que usan DUPIXENT durante el embarazo puede referirte a un oftalmólogo para que te realicen de un adulto. En niños de 6 meses a menos de 12 años, un cuidador deberá administrar DUPIXENT. recopila información sobre tu salud y la de tu bebé. un examen de la vista, si es necesario.

Para inscribirte o para obtener más información, llama Dolores en las articulaciones. Algunas personas que Por favor, consulta el resumen breve en la al 1-877-311-8972 o visita https://mothertobaby.org/ usan DUPIXENT han tenido dificultades para caminar página siguiente. ongoing-study/dupixent/; si estás amamantando o o moverse debido a los síntomas en sus articulaciones planeas amamantar. Se desconoce si DUPIXENT se y, en algunos casos, debieron ser hospitalizados. transmite a través de la leche materna.

Infórmale a tu proveedor de atención médica sobre Infórmale a tu proveedor de atención médica sobre cualquier síntoma nuevo en las articulaciones o si © 2022 Sanofi y Regeneron Pharmaceuticals, Inc. todos los medicamentos que tomas, incluidos los empeoran los síntomas que tenías. Tu proveedor de Todos los derechos reservados . medicamentos de venta libre y de venta con receta, atención médica puede interrumpir el tratamiento con las vitaminas y los suplementos a base de hierbas. DUPIXENT si desarrollas síntomas en las articulaciones. DUP.22.09.0118

PODRÍAS SER ELEGIBLE PARA UNCOPAGO TAN BAJO COMO $0.* LLAMA AL 1-844-DUPIXENT (1-844-387-4936) *NO ES UN SEGURO. No es válido para recetas pagadas, en su totalidad o en parte, por Medicaid, Medicare, VA, DOD, TRICARE u otros programas federales o estatales, incluidos los programas estatales de asistencia farmacéutica. El programa tiene un máximo anual de $13,000. Se aplican términos y condiciones adicionales.

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Revista Puertorriqueña de Medicina y Salud Pública

Resumen breve de información importante para pacientes sobre DUPIXENT® (dupilumab) Inyección para uso subcutáneo ¿Qué es DUPIXENT? • DUPIXENT es un medicamento con receta utilizado para lo siguiente: – Tratar a adultos y niños de 6 meses o más con eczema (dermatitis atópica o DA) moderado a grave, que no puede controlarse correctamente con terapias recetadas que se aplican sobre la piel (tópicas) o en casos en los que no se puedan utilizar terapias tópicas. DUPIXENT puede utilizarse con o sin corticosteroides tópicos.

• DUPIXENT actúa bloqueando dos proteínas que contribuyen a un tipo de inflamación que desempeña un papel importante en la dermatitis atópica.

• Se desconoce si DUPIXENT es seguro y eficaz en niños menores de 6 meses que tengan dermatitis atópica. ¿Quiénes no deberían usar DUPIXENT? No utilices DUPIXENT si eres alérgico al dupilumab o a cualquiera de los ingredientes de DUPIXENT. Observa el final de este resumen de información para conocer la lista completa de ingredientes de DUPIXENT. ¿Qué debo informarle a mi proveedor de atención médica antes de usar DUPIXENT? Antes de usar DUPIXENT, infórmale a tu proveedor de atención médica sobre todas tus afecciones médicas, lo que incluye: • Si tienes problemas oculares.

• Si tienes una infección parasitaria (helmintos).

• Si tienes programado recibir algún tipo de vacuna. No debes recibir ninguna “vacuna viva” justo antes o mientras recibes tratamiento con DUPIXENT. • Si estás embarazada o tienes planes de quedar embarazada. Se desconoce si DUPIXENT puede dañar a tu bebé en gestación.

– Registro de exposición durante el embarazo. Hay un registro de exposición para mujeres que toman DUPIXENT durante el embarazo.

El objetivo de este registro es reunir información sobre tu salud y la de tu bebé. Tu proveedor de atención médica puede inscribirte en este registro.

También puedes inscribirte por tu cuenta u obtener más información sobre el registro llamando al 1-877-311-8972 o ingresando en https://mothertobaby.org/ongoing-study/dupixent/.

• Si estás amamantando o tienes planes de hacerlo. Se desconoce si DUPIXENT se transmite a través de la leche materna.

Informa a tu proveedor de atención médica todos los medicamentos que tomas, incluidos los medicamentos de venta libre y de venta con receta, las vitaminas y los suplementos a base de hierbas.

Informa a tu proveedor de atención médica en especial en los siguientes casos: • Si estás tomando corticosteroides orales, tópicos o inhalados.

• Si tienes dermatitis atópica y asma y usas un medicamento para el asma.

No cambies ni interrumpas la administración del medicamento corticosteroide u otro medicamento para el asma sin hablar primero con tu proveedor de atención médica. Esto puede hacer que reaparezcan otros síntomas que fueron controlados con el medicamento corticosteroide u otro medicamento para el asma. ¿Cómo debo utilizar DUPIXENT? • Consulta las “Instrucciones de uso” detalladas que se proporcionan con DUPIXENT para obtener información sobre cómo preparar e inyectar DUPIXENT y cómo almacenar y tirar (desechar) las jeringas y plumas precargadas usadas de DUPIXENT. • Utiliza DUPIXENT exactamente como te lo recetó tu proveedor de atención médica.

• Tu proveedor de atención médica te dirá cuánto DUPIXENT debes inyectar y con qué frecuencia debes hacerlo.

• DUPIXENT viene en una jeringa precargada de dosis única con protector de aguja o en una pluma precargada.

– La pluma precargada de DUPIXENT es solo para uso en adultos y niños a partir de los 12 años o más.

– La jeringa precargada de DUPIXENT es solo para uso en adultos y niños a partir de los 6 meses o más.

• DUPIXENT se administra como una inyección debajo de la piel (inyección subcutánea).

• Si tu proveedor de atención médica decide que tú o un cuidador pueden administrar las inyecciones DUPIXENT, tú o tu cuidador deben recibir capacitación sobre la manera correcta de preparar e inyectar DUPIXENT. No intentes inyectar DUPIXENT hasta que tu proveedor de atención médica te haya mostrado la manera correcta de hacerlo. En niños de 12 años o más, se recomienda que un adulto coloque o supervise la administración de DUPIXENT. En niños de 6 meses a menos de 12 años, un cuidador deberá administrar DUPIXENT. • Si tu cronograma de dosis es semana de por medio y omites una dosis de DUPIXENT: Administra la inyección de DUPIXENT dentro de los 7 días posteriores a la dosis omitida y, luego, continúa con el cronograma original. Si la dosis omitida no se administra dentro de los 7 días, espera hasta la siguiente dosis programada para administrar la inyección de DUPIXENT.

Solo con receta médica

• Si tu cronograma de dosis es cada cuatro semanas y omites una dosis de DUPIXENT: Administra la inyección de DUPIXENT dentro de los 7 días posteriores a la dosis omitida y, luego, continúa con el cronograma original.

Si la dosis omitida no se administra dentro de los 7 días, comienza un nuevo cronograma de dosis cada 4 semanas desde el momento en que recuerdes administrarte la inyección de DUPIXENT. • Si inyectas más DUPIXENT de lo que se recetó (sobredosis), busca ayuda médica o comunícate inmediatamente con un experto del Centro de Toxicología llamando al 1-800-222-1222.

• Es posible que tu proveedor de atención médica te recete otros medicamentos para utilizar con DUPIXENT. Utiliza los otros medicamentos recetados exactamente como te lo indique tu proveedor de atención médica. ¿Cuáles son los efectos secundarios posibles de DUPIXENT? DUPIXENT puede provocar efectos secundarios graves, incluidos los siguientes: • Reacciones alérgicas. DUPIXENT puede causar reacciones alérgicas que algunas veces pueden ser graves. Deja de usar DUPIXENT e infórmale a tu proveedor de atención médica o busca atención de emergencia de inmediato si tienes alguno de los siguientes síntomas: Problemas respiratorios o sibilancias, pulso acelerado, fiebre, malestar general, ganglios linfáticos inflamados, inflamación del rostro, los labios, la boca, la lengua o la garganta, urticaria, picazón, náuseas o vómitos, desmayos, mareos, sensación de mareo, dolor en las articulaciones, erupción cutánea o calambres en el área del estómago.

• Problemas oculares. Informa a tu proveedor de atención médica si tienes problemas oculares nuevos o si notas un empeoramiento de los problemas que tenías, incluido el dolor ocular o cambios en la visión, como visión borrosa. Tu proveedor de atención médica puede referirte a un oftalmólogo para que te realicen un examen de la vista, si es necesario.

• Dolores en las articulaciones. Las personas que utilizan DUPIXENT pueden experimentar dolores en las articulaciones. Algunas personas han tenido dificultades para caminar o moverse debido a los síntomas en sus articulaciones y, en algunos casos, debieron ser hospitalizados. Informa a tu proveedor de atención médica sobre cualquier síntoma nuevo en las articulaciones o si empeoran los síntomas que tenías. Tu proveedor de atención médica puede interrumpir el tratamiento con DUPIXENT si desarrollas síntomas en las articulaciones.

Los efectos secundarios más comunes de DUPIXENT en pacientes con eczema son: Reacciones en el lugar de la inyección, inflamación de los ojos y los párpados (que incluye enrojecimiento, hinchazón y picazón) a veces con visión borrosa, herpes en la boca o en los labios y un alto recuento de ciertos glóbulos blancos (eosinofilia).

Se han informado los siguientes efectos secundarios adicionales con el uso de DUPIXENT: Erupción facial o enrojecimiento.

Informa a tu proveedor de atención médica si sufres algún efecto secundario que te cause malestar o que no desaparezca.

Estos no son todos los efectos secundarios posibles de DUPIXENT. Llama a tu médico para obtener consejos médicos sobre los efectos secundarios. Puedes informar los efectos secundarios a la FDA. Visita www.fda.gov/medwatch o llama al 1-800-FDA-1088. ¿Cómo debo conservar DUPIXENT? • Conserve DUPIXENT en el refrigerador a una temperatura de 36ºF a 46ºF (de 2ºC a 8ºC).

• Conserve DUPIXENT en el envase original para protegerlo de la luz.

• DUPIXENT se puede conservar a temperatura ambiente a una temperatura de hasta 77°F (25°C) durante un período máximo de 14 días. Deseche el DUPIXENT que haya estado a temperatura ambiente más de 14 días.

• No caliente ni exponga DUPIXENT a la luz directa del sol.

• No congele ni agite.

Mantenga DUPIXENT y todos los medicamentos fuera del alcance de los niños.

Información general sobre el uso seguro y eficaz de DUPIXENT. A veces, los medicamentos se recetan para fines diferentes a los indicados en un prospecto de Información para el paciente. No use DUPIXENT para una afección para la que no se haya recetado. No administre DUPIXENT para otras personas, incluso si tienen los mismos síntomas que usted. Podría dañarles.

Este es un resumen corto de la información más importante de DUPIXENT para este uso. Si desea obtener más información, hable con su proveedor de atención médica.

Puede preguntar a su farmacéutico o proveedor de atención médica para obtener más información sobre DUPIXENT que se haya escrito para profesionales de atención médica.

Para obtener más información sobre DUPIXENT, visite www.DUPIXENT.com o llame al 1-844-DUPIXENT (1-844-387-4936) ¿Cuáles son los componentes de DUPIXENT? Principio activo: dupilumab Componentes inactivos: Clorhidrato de L-arginina, L-histidina, polisorbato 80, acetato de sodio, sacarosa y agua para inyección Fabricado por: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591 N.º de licencia en EE.UU. 1760; Comercializado por sanofi-aventis U.S. Comercializado por sanofi-aventis U.S. DUPIXENT® es una marca comercial registrada de Sanofi Biotechnology/©2022 LLC.Todos los derechos reservados.

Fecha de publicación: Noviembre de 2022 DUP.22.11.0210 Revista Puertorriqueña de Medicina y Salud Pública

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SOLEDAD Y AISLAMIENTO SOCIAL: MCS Solutions SUS EFECTOS EN LA SALUD FÍSICA te ayuda Y MENTAL DEL ADULTOtu MAYOR a cuidar salud mental.

Dra. Florencia Velázquez Morales Directora Ejecutiva Proyecto Plenitud Colaboradora de MCS y FHC

Los profesionales de la salud tienen una oportunidad única para identificar a los pacientes en riesgo y referirlos a recursos para recibir ayuda.

SITUACIÓN SOCIODEMOGRÁFICA Al abordar la discusión sobre los efectos de la soledad y el aislamiento social en la población de adultos mayores es importante poner en contexto su situación sociodemográfica.

Los pasados seis años han estado marcados por eventos naturales, que sumados a la pandemia del COVID 19 y la situación socioeconómica del país, han jugado un papel importante en la transición demográfica. Estos eventos traen como consecuencia un alza en la emigración de la población joven, menor tasa de nacimientos y un alza en la tasa de mortalidad, convirtiéndose en la antesala de las necesidades actuales y emergentes de los adultos mayores.

Nacional sobre el Envejecimiento establece que ambos sentimientos se reflejan en el deterioro de la salud física y mental del individuo, resultando en problemas cardiacos, depresión, deterioro cognitivo, un mayor riesgo de hospitalizaciones, readmisiones al hospital y hasta de una muerte prematura, entre otras complicaciones de salud. Igualmente, el Behavioral Risk Factor Surveillance System (2020) revela datos estrechamente relacionados: las enfermedades más comunes en este grupo son la artritis (46.2%), diabetes (34.0%), depresión (18.3%), prediabetes (16.2 %) y enfermedad coronaria (10.6%).

• presentan económicos

ROL DEL PROFESIONAL DE LA SALUD EN LA IDENTIFICACIÓN

• compartir en actividades con otras personas, como voluntariado o en la comunidad

problemas

MEDIDAS PARA REDUCIR LOS EFECTOS A pesar de los efectos dramáticos de la soledad y el aislamiento en la salud física y mental de los adultos mayores, se pueden tomar medidas proactivas para reducirlos, por los que deberían motivarlos a: • practicar alguna actividad física, ejercicio o pasatiempo • comer saludable y descanso apropiado

La longevidad es un fenómeno que La atención médica cobra un rol está influenciado por factores sociales, protagónico en la identificación de • programar espacios diarios genéticos y estilos de vida. Ciertamente la soledad y el aislamiento social y para contactar a los amigos y familiares Solutions dedebienestar dirigido resulta MCS alentador pensar queeselun serprograma la prevención las complicaciones • integrar las redes sociales y humanoal pueda vivir másde tiempo, pero mental asociadas. con Sonservicios muchos loscomo: casos cuidado tu salud tecnología a su día a día a su vez, con los años se suman nuevos donde una visita al médico es la retos físicos y sociales que impactan la única interacción social que tiene • Línea de apoyo disponible 24/7 con profesionales • adoptar una mascota salud y calidad de vida. individuo, por lo que es vital estar especializados en salud un mental alertas para identificar pacientes en • Programa de manejo casoseducarlos sobre la importancia IMPACTO EN LA SALUD FÍSICA Y deriesgo, MENTAL• Manejo de caso individual y personalizado de la conexión social y conectarlos con medios de ayuda, ya sean profesionales • Terapias grupales individuales Las Academias Nacionales e de de la conducta o recursos comunitarios.

Ciencias,• Estrategias Ingeniería yde Medicina autocuidado, tratamientos y (NASEM) alternativas indican que más de una disponibles De acuerdo al Instituto Nacional tercera parte de los adultos de 45 años el Envejecimiento, los pacientes Apoyosolos, en el proceso de sobre recuperación o más se• sienten y se considera que casi una cuarta parte de los adultos a mayor riesgo de sufrir de soledad o Para tener salud completa, es importante de 65 años o más se encuentran en aislamiento social son aquellos que:

quesocial. también aislamiento Amboscuides términostu se salud mental.

• viven solos, sufren pérdidas relacionan entre sí, ya que la soledad cercanas o un cambio de vida es la sensación de sentirse solo, 1.866.627.4327 significativo independientemente del contacto o conexión social que tenga el individuo.

• padecen de alguna enfermedad Por su parte, el aislamiento social es psicológica tienen complicaciones por www.mcs.com la falta de conexión social, lo que, falta de movilidad, visión o audición eventualmente, podría convertirse en • son cuidadores un sentimiento de soledad. El Instituto 48

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La historia de vida y el cernimiento de los recursos existentes es de vital importancia para conectar @MCSPuertoRico al adulto mayor con los servicios adecuados para mantener su calidad de vida.

MCS Solutions te ayuda a cuidar tu salud mental.

MCS Solutions es un programa de bienestar dirigido al cuidado de tu salud mental con servicios como: • Línea de apoyo disponible 24/7 con profesionales especializados en salud mental • Programa de manejo de casos • Manejo de caso individual y personalizado • Terapias grupales e individuales • Estrategias de autocuidado, tratamientos y alternativas disponibles • Apoyo en el proceso de recuperación Para tener salud completa, es importante que también cuides tu salud mental.

1.866.627.4327 www.mcs.com

@MCSPuertoRico

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¿Qué es SARCLISA?

Busque ayuda médica de inmediato si desarrolla alguno de los siguientes síntomas de reacción a la infusión durante o después de una infusión de SARLCISA:

SARCLISA es un medicamento recetado usado en combinación con: • Pomalidomida y dexametasona para tratar a adultos que han recibido al menos 2 terapias previas, incluidos lenalidomida y un inhibidor de

— falta de aliento, sibilancia o dificultad para respirar — hinchazón de la cara, la boca, la garganta o la lengua

• Los medicamentos carfilzomib y dexametasona, para tratar a adultos con funcionaron o han dejado de funcionar.

• Información de Seguridad Importante No reciba SARCLISA si isatuximab-irfc o a cualquiera de los ingredientes de SARCLISA (vea una lista de los ingredientes en la Información completa para la Prescripción).

Antes de recibir SARCLISA, infórmele a su profesional del cuidado de la salud acerca de todas sus condiciones médicas, incluido si usted: • Tiene problemas cardiacos, si su profesional del cuidado de la salud le receta SARCLISA en combinación con carfilzomib y dexametasona.

• Ha tenido culebrilla (herpes zóster). hacerle daño al feto. No debe recibir SARCLISA durante el embarazo.

— Las mujeres que pueden quedar embarazadas deben usar un método de cuidado de la salud acerca de los métodos de control del embarazo que Déjele saber a su profesional del cuidado de la salud de inmediato si cree que está embarazada o si queda embarazada durante el tratamiento de SARCLISA. • Está lactando o piensa lactar. No se conoce si SARCLISA pasa a la leche materna. No debe lactar durante el tratamiento con SARCLISA. Déjele saber a su profesional del cuidado de la salud acerca de todos los medicamentos que usa, incluidos los recetados o los que no requieren receta, vitaminas y suplementos naturales. ¿Cómo recibiré SARCLISA? •

SARCLISA lo administra su profesional del cuidado de la salud por vía intravenosa (IV) en una vena.

• SARCLISA se administra en ciclos de tratamientos de 28 días (4 semanas), junto con las medicinas pomalidomida y dexametasona, o carfilzomib y dexametasona.

— En el ciclo 1, SARCLISA se administra, por lo general, semanalmente.

— Comenzando en el ciclo 2, SARCLISA se administra, por lo general, cada 2 semanas.

• Si no asiste a alguna cita, llame a su profesional del cuidado de la salud lo antes posible para reprogramar su cita.

• Su profesional del cuidado de la salud le dará medicinas antes de cada dosis de SARCLISA, para ayudar a reducir el riesgo de reacciones a la infusión (hacerlas menos frecuentes y severas). ¿Cuáles son los efectos secundarios posibles de SARCLISA? SARCLISA puede causar efectos secundarios graves, entre ellos: • Reacciones a la infusión. Las reacciones a la infusión son comunes con SARCLISA, y algunas veces son severas o mortales.

— Su profesional del cuidado de la salud le recetará medicinas antes de cada infusión de SARCLISA para ayudar a reducir el riesgo de las reacciones a la infusión o para ayudar a que cualquier reacción a la infusión sea menos severa. Se le dará seguimiento por la posibilidad de reacciones a la infusión durante cada dosis de SARCLISA. — Su profesional del cuidado de la salud puede reducir la velocidad o detener la infusión, o suspender el tratamiento de SARCLISA

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•

•

— apretamiento de la garganta — palpitaciones — mareo, aturdimiento o desmayo — dolor de cabeza

— — — —

tos erupción o picor náuseas goteo o

— escalofríos

Disminución del recuento de glóbulos blancos. La disminución del recuento de glóbulos blancos es común con SARCLISA y ciertos glóbulos blancos pueden disminuir de manera severa. Puede correr un mayor riesgo de adquirir ciertas infecciones, como infecciones del tracto respiratorio superior e inferior e infecciones del tracto urinario.

Su profesional del cuidado de la salud verificará sus recuentos de células sanguíneas durante el tratamiento con SARCLISA. Su profesional del cuidado infección, o una medicina para ayudar a aumentar sus recuentos de glóbulos blancos durante el tratamiento con SARCLISA. Déjele saber a su profesional del cuidado de la salud de inmediato si desarrolla alguna fiebre o síntomas de infección durante el tratamiento con SARCLISA. Riesgo de cánceres nuevos. Han ocurrido cánceres nuevos en personas durante el tratamiento con SARCLISA. Su profesional del cuidado de la salud le dará seguimiento por la posibilidad de cánceres nuevos durante el tratamiento con SARCLISA. Cambios en las pruebas de sangre. SARCLISA puede afectar los resultados sangre antes de comenzar el tratamiento con SARCLISA. Déjele saber a todos sus profesionales del cuidado de la salud que está recibiendo tratamiento con SARCLISA antes de recibir transfusiones de sangre.

Los efectos secundarios más comunes de SARCLISA en combinación con pomalidomida y dexametasona incluyen: • • •

• infección del tracto respiratorio superior infección pulmonar (neumonía) • diarrea

disminución del recuento de glóbulos rojos (anemia) disminución del recuento de plaquetas (trombocitopenia)

Los efectos secundarios más comunes de SARCLISA en combinación con carfilzomib y dexametasona incluyen: • • • •

infección del tracto respiratorio superior cansancio y debilidad presión arterial alta problemas para dormir

• •

tos dolor de espalda

• • • • •

diarrea infección pulmonar (neumonía) dificultad para respirar disminución del recuento de glóbulos rojos (anemia) disminución del recuento de plaquetas (trombocitopenia)

Puede producirse un fallo cardiaco durante el tratamiento con SARCLISA en combinación con carfilzomib y dexametasona. Déjele saber a su profesional del cuidado de la salud de inmediato si desarrolla alguno de los siguientes síntomas: • •

dificultad para respirar tos

•

hinchazón de tobillos, pies o piernas

Estos no son todos los efectos secundarios posibles de SARCLISA. Para más información, pregúntele a su profesional del cuidado de la salud o al

© 2023 sanofi-aventis U.S. LLC. Derechos reservados. MAT-US-2307073-v1.0-10/2023

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Tuve Tuve Tuve suerte. suerte. suerte.

“Estaba “Estaba ocupada “Estaba ocupada – trabajando ocupada – trabajando – ytrabajando disfrutando y disfrutando y disfrutando de la vida. de la Ya vida. deme laYa vida. tocaba meYa tocaba hacerme me tocaba hacerme la hacerme prueba la prueba dela prueba de de Papanicolaou Papanicolaou Papanicolaou para verificar para verificar para si tenía verificar si cáncer teníasi cáncer tenía de cuello cáncer de cuello de cuello uterino. uterino.

Cuando uterino.

Cuando meCuando hicieron me hicieron me la prueba, hicieron la prueba, creímos la prueba, creímos quecreímos que que podríapodría tenerpodría tener cáncer cáncer tener de cuello cáncer de cuello uterino. de cuello uterino.

Finalmente, uterino.

Finalmente, Finalmente, me llegaron me llegaron me resultados llegaron resultados buenos resultados buenos – ¡no buenos tuve – ¡nocáncer! tuve – ¡nocáncer! tuve cáncer!

Mujeres, Mujeres, por Mujeres, favor por favor háganse por háganse favor la háganse prueba la prueba para la prueba detectar para detectar para detectar el cáncer el cáncer deelcuello cáncer de cuello uterino. de cuello uterino.

Infórmense uterino.

Infórmense Infórmense sobresobre el sobre el el cáncer cáncer ginecológico.” cáncer ginecológico.” ginecológico.”

Cote Cote De Pablo, De Cote Pablo, Actriz De Pablo, ActrizActriz

Los cánceres Los cánceres Losginecológicos cánceres ginecológicos ginecológicos incluyen: incluyen: cáncer incluyen: cáncer cáncer de cuello de cuello uterino, de cuello uterino, deuterino, ovario, de ovario, de de útero, ovario, de útero, de devagina útero, de vagina de vagina y de vulva. y de vulva. ySolo de vulva. el Solo cáncer el Solo cáncer de el cuello cáncer de cuello uterino de cuello uterino se uterino se se puede puede detectar puede detectar a través detectar a través deauna través deprueba. una deprueba. una prueba.

Aprenda Aprenda cuáles Aprenda cuáles soncuáles los sonsíntomas los son síntomas los síntomas y quéypuede quéypuede qué hacer puede hacer parahacer para prevenir prevenir para prevenir los cánceres los cánceres los ginecológicos. cánceres ginecológicos. ginecológicos.

http://www.cdc.gov/spanish/ http://www.cdc.gov/spanish/ http://www.cdc.gov/spanish/ cancer/knowledge cancer/knowledge cancer/knowledge 1-800-CDC-INFO 1-800-CDC-INFO 1-800-CDC-INFO

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www.medicinaysaludpublica.com @revistaMSP

@revistaMSP

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El Capitolio de Puerto Rico se enciende de verde por los pacientes de Dermatitis Atópica El Capitolio de Puerto Rico se iluminó de verde en una emotiva conmemoración que celebró tanto el Día Mundial de la Dermatitis Atópica como la histórica firma de la Ley 83 de 2022, la cual establece oficialmente el 14 de septiembre como el Día de la Concienciación de la Dermatitis Atópica en la isla, fecha que fue oficialmente declarada por parte del gobernador el pasado mes de agosto.

“Todo inició por las conversaciones con el Dr. José González Chávez, el cual estaba preocupado por la prevalencia de la complicaciones del creciente aumento de los pacientes con dermatitis atópica, incluyendo depresión, ansiedad y hasta pensamientos El Capitolio de Puerto Rico iluminado de verde por el nombramiento del día de suicidas. Me expresa la necesidad de crear un grupo de apoyo concienciación de la Dermatitis Atópica en Puerto Rico. Foto por: Israel Mojica para estos pacientes y yo, como uno de ellos, entendí cuál era la necesidad de ser suplida. Aceptamos el reto y le pusimos por nombre Alianza de Apoyo al Paciente de Dermatitis atópica”, manifestó Brenda Gerena, directora ejecutiva de AAPDA. “Consideré que ese grupo de apoyo era muy importante por razones que estos pacientes, estuvieron por muchos años desesperanzados porque su condición no se les reconocía como algo serio, ahora tenemos esta ley y este grupo.

Verdaderamente, siento un gran logro en mi corazón de haber contribuido en esto”, expresó el Dr. José Gónzalez Chávez, dermatólogo.

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CeraVe lanza iniciativa educativa para ayudar a elegir el limpiador adecuado para su tipo de piel La marca CeraVe, desarrollada en colaboración con dermatólogos, se enfoca en instruir a la población puertorriqueña sobre cómo iniciar su régimen de cuidado de la piel siguiendo enfoques profesionales.

En el contexto de la iniciativa educativa “Cleanse Like a Derm”, la marca de productos dermatológicos busca dotar a los individuos con la capacidad de comprender y aceptar las particularidades únicas de su piel, permitiéndoles proveer el cuidado apropiado que esta requiere.

Después del individuo, nadie conoce las necesidades de la piel tan bien como un dermatólogo. Es recomendable acudir a consultas al menos una vez al año para recibir orientación personalizada en función del tipo de piel y las inquietudes específicas.

La comprensión de los ingredientes clave en la rutina de cuidado ayuda en la elección del limpiador más adecuado para fortalecer la barrera cutánea. Foto: suministrada.

Estudio clínico ofrece oportunidad de tratamiento innovador a pacientes con cirrosis descompensada El FDI Clinical Research anunció que está reclutando pacientes con cirrosis descompensada para participar en el estudio clínico de un tratamiento innovador que busca combatir los daños causados por esta condición.

“En FDI Clinical Research, estamos comprometidos en desarrollar tratamientos que mejoren la calidad de vida de quienes padecen cirrosis descompensada. Nuestro equipo de investigadores está realizando estudios clínicos que buscan desarrollar terapias que logren revertir algunos de los daños causados por esta condición, hasta ahora considerada irreversible”, explicó el Dr. José Rodríguez Orengo, CEO del FDI Clinical Research.

La cirrosis descompensada es una enfermedad crónica e irreversible del hígado que puede tener consecuencias graves para la salud. Entre las complicaciones que pueden surgir destacan problemas de coagulación, acumulación excesiva de líquido en el abdomen (ascitis), sangrado de varices del esófago y encefalopatía hepática.

Las personas interesadas en participar del estudio se deben comunicar al FDI Clinical Research al (787) 7221248.

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Aunque existen diversos tipos de piel, no existe una solución única para su cuidado. Identificar el limpiador ideal para su tipo de piel puede lograrse completando la evaluación proporcionada por CeraVe en su página web. Recuerde la importancia de consultar a su dermatólogo al menos una vez al año o cuando surjan nuevas inquietudes en la piel.

Abren convocatoria para prestar servicios de salud enfocados en Susan G. Komen Puerto Rico®. Foto. cáncer de seno en Twitter / Susan G. Komen Puerto Rico®.

Puerto Rico A través de un comunicado, la organización Susan G. Komen Puerto Rico® informó que iniciará un nuevo ciclo de su Programa de Ayudas para financiar propuestas de organizaciones sin fines de lucro enfocadas en brindar cuidado de salud y de cáncer de seno en la Isla.

La iniciativa va dirigida a cualquier organización sin fines de lucro con fuertes lazos en la comunidad, que tenga el propósito de mejorar las condiciones sociales, culturales y financieras que impiden a la población en Puerto Rico recibir atención médica y tratamientos de calidad.

La organización explicó que estos programas atienden el componente físico con los tratamientos y el manejo de efectos secundarios con la ayuda de del programa de apoyo.

Hasta el momento, se han otorgado más de $3 millones en ayudas, donde se han beneficiado cerca de 264 organizaciones a través de toda la Isla, incluyendo las islas de los municipios de Vieques y Culebra.

MSP / REVISTAMSP.COM

Dr. Edwin Rosado Hernández, cirujano ortopeda, Dr. Jorge Pelet, cirujano general, Dra. Yolianne Lozada, ginecóloga, Dra. Daniela Carlos Pons, uroginecóloga y el Dr. Ricardo Reina, cirujano ortopeda. Foto: Revista Medicina y Salud Pública.

TRANSCURRIÓ EL PANEL “CIRUGÍA 2.0: UNA NUEVA ERA EN LA CIRUGÍA ROBÓTICA” El Dr. Jorge Pelet, cirujano general, destacó durante el evento educativo que “la cirugía robótica se puede implementar en básicamente todos los procedimientos que se hacen en laparoscopia. Ha habido una evolución de la cirugía convencional y surgen alternativas de hacer cirugías mínimamente invasivas con accesos pequeños y utilizando una plataforma más ergonómica para el médico y que provea mayor facilidad de obtener una visualización mucho más exacta de las áreas que se están evaluando en cirugía”.

Por su parte, la Dra. Yolianne Lozada, ginecóloga, mencionó que dentro de su especialidad médica, la cirugía robótica se implementa en la remoción de masas pélvicas, cirugías de endometriosis, miomas, quistes en los ovarios e histerectomías, con excelentes resultados.

Según el Dr. Edwin Rosado Hernández, cirujano ortopeda, quien implementa esta tecnología en el tratamiento de pacientes con problemas de movilidad en sus articulaciones.

“El robot nos ha ayudado a ser más objetivos en la cirugía y ver como por ejemplo un reemplazo de rodilla va a quedar al final. Son muchos los beneficios para los pacientes, quienes pueden contar con un menor tiempo de recuperación”.

Los médicos concluyen que hay esperanza en el campo de la cirugía robótica e instan a las nuevas generaciones de especialistas a aprovechar las ventajas de esta nueva tecnología para el tratamiento de varias condiciones de salud en Puerto Rico.

Dr. Álvaro Aranda, presidente de la Coalición de Asma y Otras Condiciones Respiratorias en Puerto Rico, y el Dr. Jesse Román, neumólogo. Fotos: Revista Medicina y Salud Pública.

Exitosa la convención de la Coalición de Asma y Otras Condiciones Respiratorias en Puerto Rico

El Congreso Respiratorio Anual abordó las últimas actualizaciones en la salud respiratoria de los puertorriqueños.

El implante de córnea artificial permite que el paciente tenga una rehabilitación visual más rápida y se evita la necesidad de realizar otros trasplantes.

Fotos: suministradas a la Revista Medicina y Salud Pública.

Realizan con éxito el primer trasplante primario de córnea artificial en Puerto Rico En Puerto Rico se llevó a cabo el primer trasplante primario de córnea artificial. Este procedimiento quirúrgico marca un avance significativo en el campo de la cirugía ocular del país, ya que ofrece una técnica innovadora y más eficiente para los pacientes.

El procedimiento se realizó en las instalaciones de Vista Ophthalmic Ambulatory Center en Guaynabo, con el Dr. José de la Cruz, oftalmólogo y especialista en trasplantes complejos de córnea.

El paciente, quien padecía una condición inflamación crónica en su córnea, fue sometido al procedimiento y a la fecha se encuentra en proceso de recuperación, experimentando una mejoría inmediata en su visión.

El experto informó que los pacientes implantados con córneas artificiales suelen tener de 3 hasta incluso 12 trasplantes fallidos antes de ser candidatos a trasplante de córnea artificial.

Estos procedimientos pueden retrasar la rehabilitación visual y aumentar el riesgo de otras complicaciones como el glaucoma.

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Med Centro transforma edificio histórico en vanguardista centro de tecnología de información de salud Med Centro, guiado por su visión de “Siempre hacia nuevas fronteras”, ha anunciado una inversión de casi $6.5 millones destinada a la transformación de un edificio histórico de la década de 1930 en el ultra moderno Centro de Tecnología de Información de Salud (Health Information Technology Center / HITC).

El HITC contará con 20 cubículos para sesiones de Telemedicina / Teleconsulta, así como un Centro de Comunicación con el paciente, dotado de 15 cubículos adicionales, La noticia fue dada a conocer por Allan Cintrón Salichs, Director Ejecutivo de Med Centro, durante la ceremonia para la gestión de citas, seguimiento de de inauguración a la que también asistieron el gobernador de Puerto Rico, Pedro Pierluisi, legisladores y alcaldes tratamientos y coordinación de referidos de la zona sur. Foto: Suministrada. clínicos. Cada cubículo estará equipado con tecnología computarizada de vanguardia y sistemas especializados de información digital, todos interconectados.

El HITC operará con energía renovable gracias a un sofisticado sistema de placas solares y baterías. En conjunto, esta infraestructura eléctrica genera un total de 150KW/H en 110-220V, garantizando la operatividad del centro al 100% durante 24 horas al día, los 365 días del año.

AbbVie anunció resultados prominentes de Risankizumab en estudio fase 3 para Enfermedad de Crohn AbbVie anunció los resultados destacados del estudio clínico de fase 3, SEQUENCE, que evaluó el risankizumab (SKYRIZI®, 600 mg intravenosos [IV] en inducción en la semana 0, 4 y 8; y 360 mg en inyección subcutánea [SC] comenzando en la semana 12 y cada 8 semanas de ahí en adelante) versus ustekinumab (STELARA®, dosis intravenosa en la semana 0 y 90 mg subcutáneos cada 8 semanas de ahí en adelante).

Ambos fármacos fueron analizados hasta la semana 48 en pacientes con la enfermedad de Crohn activa de moderada a severa que no habían respondido a uno o más anti TNF.

Nueva campaña educativa de la Asociación de Urología de Puerto Rico contra el cáncer de próstata

El risankizumab logró la no inferioridad en remisión clínica (CDAI <150) en la semana 24 con un 59% en el grupo que recibió risankizumab y un 40% en el grupo que recibió ustekinumab.

La Asociación de Urología de Puerto Rico (PRUA) lanzó su campaña “Que no te prenda el check engine” el pasado viernes mediante un torneo de golf con el objetivo de recaudar fondos para continuar llevando a cabo campañas de concienciación y prevención de enfermedades urológicas.

Por otra parte, la remisión endoscópica en la semana 48 fue superior con un 32% en el grupo de risankizumab y un 16% en el grupo de ustekinumab.

Esta iniciativa busca motivar a los hombres mayores de 40 años a que visiten al urólogo a tiempo para realizarse las pruebas de detección necesarias, además de educar y concienciar sobre los riesgos asociados al cáncer de próstata.

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For additional information 787-504-3655 Email: ivettecolon@icplannerspr.com

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Asociación de Salud Primaria de Puerto Rico hace un llamado a renovar la cubierta médica de Medicaid La Asociación de Salud Primaria de Puerto Rico urgió a los beneficiarios del Programa Medicaid, Plan Vital y Medicare Platino a que acuden a sus citas de seguimiento y renueven llamando al 787-641-4224 de lunes a viernes de 8:00 a.m. a 6:00 p.m.

A raíz de los terremotos y la pandemia por COVID-19, el proceso de renovación del Programa Medicaid fue suspendido. Pero en abril 2023, se reactivó el trámite y los beneficiarios deben someter evidencias o acudir a sus citas para renovar la cobertura médica. Las personas con discapacidad auditiva pueden comunicarse con Medicaid al 787-625-6955.

“No esperes a la próxima cita médica con el pediatra o con médico primario.

El trámite debe realizarse lo antes posible para actualizar la cobertura como beneficiario del Plan Vital y Platino y que no se interrumpa el cuidado médico”, comentó la Dra. Darielys Cordero, Directora Ejecutiva de la ASPPR

FDA aprueba Reblozyl® como tratamiento de primera línea de la anemia en el síndrome mielodisplásico La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) aprobó Reblozyl ® (luspatercept-aamt) para el tratamiento de la anemia sin el uso previo de agentes estimulantes de la eritropoyesis en pacientes adultos con síndromes mielodisplásicos de riesgo muy bajo a intermedio que pueden requerir transfusiones regulares de glóbulos rojos.

Esta indicación ampliada para el entorno de primera línea se basa en los resultados provisionales del ensayo pivotal de fase 3 COMMANDS, en el que Reblozyl demostró una eficacia superior de la independencia concurrente de la transfusión de glóbulos rojos (RBC-TI) y el aumento de la hemoglobina (Hb) en comparación con la epoetina alfa, un AEE, independientemente del estado del sideroblasto en anillo.

La aprobación de Reblozyl en el tratamiento de primera línea de la anemia para pacientes con SMD de menor riesgo representa un paso crucial para hacer posible la independencia transfusional para más pacientes.

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Nuevo tratamiento para la disfunción eréctil: innovador sistema de prótesis de pene inflable AMS 700™

El dispositivo consiste de un par de cilindros implantados en el pene. Dr. Ramphis Morales, urólogo y especialista en urología reconstructiva. Foto: suministrada.

La disfunción eréctil afecta a la mitad de los hombres entre 40 y 70 años. De hecho, se estima que el 40 % de los mayores de 40 años han presentado alguna vez los síntomas de la impotencia.

Además de afectar la calidad de vida, la disfunción eréctil puede suceder a cualquier edad, sin embargo, existen nuevos tratamientos disponibles para esta afección, uno de los más recientes y disponibles en Puerto Rico es la prótesis de pene inflable AMS 700™.

Esta línea de prótesis inflables es la más reconocida y ofrece una combinación de características centradas tanto en la satisfacción del cirujano como en la del paciente.

Cabe mencionar que en un estudio de 200 personas se evaluó la tasa de satisfacción global en relación con la prótesis de pene inflable AMS 700™ de los pacientes y sus parejas. Los resultados indicaron 92 % y 96 % respectivamente.

La serie AMS 700™ es la línea de prótesis de pene inflable (PPI) líder en el mercado que los urólogos eligieron para más de medio millón de pacientes como un tratamiento para la disfunción eréctil clínicamente probado, duradero y permanente.

MSP / REVISTAMSP.COM

El Hospital Oncológico Isaac González Martínez incorpora al primer fisiatría especializado en cáncer El Dr. Víctor Rosado Torres, realizó la subespecialidad de un año en Rehabilitación de Pacientes con Cáncer en The Ohio State University Wexner Medical Campus en Ohio, Estados Unidos. Foto: Suministrada.

El Hospital Oncológico Isaac González Martínez, situado en el Centro Médico de Puerto Rico en Río Piedras, ha anunciado oficialmente la incorporación del Dr. Víctor Rosado Torres a su equipo de profesionales de la salud, convirtiéndose en el primer fisiatra especializado en cáncer para atender a pacientes adultos.

El director ejecutivo del hospital, Lic. Orlando Rivera De León, expresó: “Nuestro objetivo en el Hospital Oncológico Dr. Isaac González Martínez es convertirnos en la principal opción para servicios oncológicos en Puerto Rico y el Caribe. Para lograrlo, contamos con un destacado equipo humano y tecnológico. Estamos encantados de dar la bienvenida al Dr. Víctor Rosado, fisiatra oncólogo, a nuestro cuerpo médico”.

En las primeras consultas de los pacientes con los especialistas del Hospital Oncológico, se recomendará una evaluación funcional con el fisiatra para desarrollar un plan de rehabilitación personalizado. Esto se centra en abordar quejas o lesiones musculoesqueléticas que puedan afectar sus actividades diarias.

Las citas médicas para la consulta del Dr. Víctor Rosado Torres ya están disponibles para los días lunes, martes y viernes, y se pueden programar llamando al teléfono 787 763-4149, extensión 1561.

Estudio revela deficiencia de 128 plazas de médicos residentes en Puerto Rico Como parte del esfuerzo para educar sobre los Centros Médicos Académicos Regionales y su rol en la educación médica graduada en Puerto Rico, el Centro Médico Académico Regional del Sur Oeste, celebró el primer Simposio Sobre Jornada Educativa bajo el lema: “Trabajando para la Educación Médica del Futuro”, el pasado 26 de agosto.

El encuentro permitió orientar y actualizar sobre el desarrollo de los Centros Médicos Académicos Regionales a los profesionales que intervienen diariamente con todo lo relacionado con la educación médica graduada en Puerto Rico.

El estudio presentado demostró que en Puerto Rico hay una deficiencia de 128 plazas de médicos residentes.

Además, se dijo que, mientras que en los Estados Unidos existe un espacio para residencia por cada estudiante matriculado en una escuela de medicina, en Puerto Rico solo existe medio espacio por cada estudiante de medicina.

Dra. Carmen Zorrilla recibe reconocimiento y subvenciones para la investigación en Puerto Rico Dra. Carmen Zorrilla, ginecóloga-obstetra, investigadora y catedrática del Recinto de Ciencias Médicas de la Universidad de Puerto Rico.

Foto: Revista Medicina y Salud Pública.

La Dra. Carmen Zorrilla, actual decana interina de Investigación y Catedrática de Obstetricia y Ginecología en la Escuela de Medicina del Recinto de Ciencias Médicas, es galardonada con el Outstanding District Service Award (Premio de Servicio Sobresaliente) otorgado por el Distrito IV del Colegio Americano de Obstetricia y Ginecología (ACOG).

La entrega oficial del premio se realizará en la reunión anual del Distrito IV del ACOG, programada para el 22 de octubre de 2023 en Washington, D.C. El CEMI también ha sido beneficiario de dos importantes auspicios de fondos federales competitivos para respaldar su esencial labor en el ámbito de la salud materno-infantil. Uno de estos fondos que asciende a $450.000 respaldará un innovador estudio sobre el impacto de la telemedicina en el mejoramiento de servicios para individuos con VIH. Cabe mencionar que la Dra. Carmen Zorrilla ha sido reconocida internacionalmente por liderar en Puerto Rico en la eliminación de la transmisión de VIH de madres seropositivas a sus infantes.

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Johnson & Johnson comienza una Nueva Era como una Compañía Global de Cuidado de la Salud con una Identidad Visual actualizada.

La identidad visual de la marca demuestra lo mejor del cuidado y humanidad de Johnson & Johnson, al tiempo que captura la pasión y determinación de la compañía por mejorar la salud a nivel mundial.

New Brunswick, New Jersey – Por más de 135 años, Johnson & Johnson (la “Compañía”) (NYSE: JNJ) ha proporcionado productos y soluciones para el cuidado de la salud a personas en todo el mundo. Ahora, con su enfoque exclusivo en innovación en el cuidado de la salud y abordando los desafíos más difíciles en salud, la Compañía actualiza su marca y une sus segmentos farmacéuticos y de medtech bajo la marca Johnson & Johnson para demostrar su fuerza colectiva en el cuidado de la salud.

El anuncio marca una nueva era para Jonhson & Johnson, que esta aprovechando su experiencia en medicina de innovación y tecnología médica para prevenir, tratar y curar enfermedades complejas e introducir soluciones que son más inteligentes, menos invasivas y más personalizadas.

“Nuestro enfoque exclusivo en soluciones de Innovative Medicine y MedTech nos permite innovar a lo largo de un amplio espectro del cuidado de la salud en una forma que ninguna otra compañía puede”, dijo Joaquín Duato, Chairman de la Junta Directiva y Principal Oficial Ejecutivo (CEO).

“Uniendo nuestros diversos negocios bajo una marca actualizada de Johnson & Johnson refleja nuestra habilidad única para re imaginar el cuidado de la salud a través de innovación transformacional, mientras nos mantenemos fieles a los valores de Nuestro Credo y al nivel de cuidado que pacientes y doctores esperan de nosotros”.

Mirando hacia el futuro, los dos segmentos de negocio de la compañía estarán más conectados a la marca Johnson & Johnson. Con el tiempo, Janssen, el segmento farmacéutico de la compañía, transicionará a Johnson & Johnson Innovative Medicine, y el segmento de tecnología medica

continuará como Johnson & Johnson interfaces digitales. La marca también se mostrará en movimiento y responderá a MedTech. diferentes entornos.

Nuestro segmento farmacéutico está Color. Johnson & Johnson continuará liderando el rumbo de la medicina, desarrollando tratamientos innovadores aprovechando el color rojo, inclinándose para transformar el futuro de la salud. hacia un color renovado, brillante Johnson & Johnson Innovative Medicine y contemporáneo que habla de la aplica su ciencia rigurosa con empatía capacidad de responder urgentemente para abordar con confianza los a los desafíos de salud, evolucionar con desafíos más complejos en Oncología, los tiempos y marcar el ritmo.

Inmunología, Neurociencias, Ampersand (“&”). El nuevo ampersand Enfermedades Cardiovasculares, Hipertensión Pulmonar y Retina y para captura una naturaleza humana y afable. desarrollar los medicamentos potenciales Ahora se presenta como un símbolo que se puede reconocer a nivel mundial y del mañana. representa la apertura de la marca, así Nuestro segmento de tecnología como las conexiones que dan vida al médica está trabajando para resolver propósito de la Compañía. los desafíos más urgentes en salud Dirección de Arte. Los elementos en el con innovaciones donde confluyen la biología y la tecnología. Johnson & estilo de dirección de arte, que incluyen Johnson MedTech aprovecha su profundo ilustración, fotografía y más, han sido conocimiento en cirugía, ortopedia, diseñados para despertar energía, visión y soluciones interventivas para optimismo e inclusión, al tiempo que desarrollar soluciones en salud que son ofrecen un enfoque único y distintivo en más inteligentes, menos invasivas y más el cuidado de la salud. personalizadas.

“Nuestra identidad de marca de La nueva identidad de marca de Johnson & Johnson comunica nuestro Johnson & Johnson se construye en el enfoque audaz hacia la innovación legado de la Compañía a la vez que en el cuidado de la salud, mientras moderniza elementos clave para mostrar nos mantenemos fieles a la atención la innovación en el cuidado de la salud que tenemos para nuestros pacientes de una manera que sea inclusiva y traiga en todo el mundo”. Dijo Vanessa a la vida la naturaleza cálida y cercana Broadhurst, Vicepresidenta Ejecutiva de Global Corporate Affairs. “Nos de la Compañía. enorgullece liderar el cuidado de la Logotipo. El nuevo logotipo se salud por más de un siglo y estamos moderniza para este próximo capítulo. apalancándonos en nuestra ciencia para Cada letra se dibuja con un trazo impactar profundamente la salud de la de lápiz, creando un contraste que humanidad” ofrece una sensación de inesperado El nuevo logotipo, los colores y la y humanidad. La compañía adoptará las versiones de formato largo y fuente se implementarán en todos los corto del logotipo, expandiendo y materiales de la compañía, empaques construyendo más equidad en torno a y los activos de marca a lo largo del un ‘J&J’ de formato corto para aparecer tiempo. Para obtener más información de una manera más agradable y sobre la nueva marca de Johnson & contemporánea, especialmente en Johnson, visite nuestro centro de medios.

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MSP / MUNDO DIGITAL RCM acredita programas de Citotecnología, Tecnología Veterinaria y Técnico en Oftalmología El Recinto de Ciencias Médicas de la Universidad de Puerto Rico logró la reacreditación de los programas de Citotecnología, Tecnología Veterinaria y Tecnología Oftálmica.

Preocupación por negativa de MMM de contratar con el Hospital del Centro Comprensivo de Cáncer

El programa de Citotecnología fue reacreditado por la Commission on Accreditation of Allied Health Education Programs (CAAHEP), el de Tecnología Veterinaria por el Committee on Veterinary Technician Education Activities of the American Veterinary Medical Association (CVTEA-AVMA) y Tecnología Oftálmica por el International Council of Accreditation (ICA).

La directora ejecutiva del Centro Comprensivo de Cáncer de la Universidad de Puerto Rico (CCCUPR), Marcia Cruz Correa, expresó su profunda preocupación ante la negativa de la aseguradora MMM Healthcare para otorgar el contrato de proveedor a esta institución oncológica bajo la cubierta de Medicare Advantage y Platino.

Tanto la CAAHEP y el ICA han otorgado la reacreditación continua al programa de Citotecnología y de Tecnología Oftálmica respectivamente por alrededor de 30 años sin señalamientos.

Esta distinción se basa en el cumplimiento demostrado por ambos programas con los rigurosos estándares establecidos por sus respectivas agencias acreditadoras.

Para Cruz Correa, el asunto resulta “aún más alarmante cuando se considera que el Congreso de los Estados Unidos aprueba estos fondos para que el pueblo de Puerto Rico pueda tener acceso a los beneficios de cubierta médica, incluyendo a los beneficiarios de MMM”.

El programa de Tecnología Veterinaria lleva también más de 20 años acreditado. La acreditación continua de estos programas asegura la calidad y la excelencia de la educación en el campo de la Citotecnología y Tecnología Oftálmica, así como de la Tecnología Veterinaria.

Al momento, la mayoría de los planes médicos con cubierta Medicare Advantage han contratado con el CCCUPR para brindar servicios a sus asegurados, incluyendo MCS, Triple S y Tricare, y una amplia cobertura para los planes comerciales.

Dr. Carlos Mellado López, secretario del Departamento de Salud de Puerto Rico.

Foto: archivo de la Revista Medicina y Salud Pública.

Realizarán estudio clínico LatAmSecretario de Salud FINGERS en Puerto Rico para la insta al Congreso prevención del deterioro cognitivo a fiscalizar las aseguradoras bajo el El Recinto de Ciencias Médicas (RCM) de la programa Medicare Universidad de Puerto Rico (UPR) ha establecido Advantage una colaboración pionera con la Alzheimer’s

Por medio de una carta enviada a los congresistas, el secretario del Departamento de Salud, Carlos Mellado López, pidió atender la falta de jurisdicción que tiene el Gobierno de Puerto Rico para fiscalizar las aseguradoras bajo el contrato de Medicare Advantage y poder combatir los abusos al programa que afecta la población de la Isla.

En reuniones previas del funcionario con los 27 congresistas, ha enfatizado en la disparidad de fondos que recibe la isla y las prácticas desleales de aseguradoras que afectan los servicios que recibe el 93 % de la población de Medicare.

La carta del Secretario de Salud está dirigida a 27 congresistas, a quienes les solicitó aumentar el financiamiento “permanente” y cerrar las brechas de cobertura del plan de salud federal a los ciudadanos estadounidenses que residen en la isla.

Actualmente, hay alrededor de 648,000 beneficiarios de Medicare Advantage en la Isla, lo que representa el 93 % de los beneficiarios de Medicare elegibles para las Partes A y B. Esto representa la penetración más alta de Medicare Advantage en la nación.

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Association de Estados Unidos para realizar el estudio clínico “LatAm-FINGERS”. Este proyecto tiene como objetivo principal generar evidencia en la población latinoamericana que permita implementar intervenciones preventivas en grupos con riesgo de deterioro cognitivo y demencia.

Para participar en el estudio clínico LatAm-FINGERS, se requiere cumplir con los siguientes requisitos: • Tener entre 60 y 77 años de edad.

• Gozar de buena salud sin problemas mayores de memoria.

• Contar con disponibilidad horaria flexible de lunes a viernes o ser una persona retirada.

• Tener acceso a transportación.

Los interesados en participar u obtener más información sobre el estudio clínico “LatAm-FINGERS” pueden comunicarse con el equipo de investigación a través de los siguientes medios de contacto: www. latam-fingers-upr.com o al correo electrónico: info@ latam-fingers-upr.com, o llamar al 787-759-0306, ext 221, o al 787-750-8920.

GRUPO DE APOYO Dermatitis Atópica Puerto Rico Vivir con Dermatitis Atópica

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MSP / MUNDO DIGITAL

XIX Edición de Lazos Creando Fuerzas 2023, el evento de VIH más importante en Puerto Rico La XIX edición de “Lazos Creando Fuerzas”, el evento educativo dirigido a profesionales de la salud, educadores, academia y la comunidad, dedicado a abordar temas relacionados con el VIH, se llevará a cabo los días 27 y 28 de octubre en el prestigioso Hotel Caribe Hilton de San Juan.

El encuentro es organizado por Puerto Rico Community Network for Clinical Services, Research and Health Advancement, Inc. (PRCONCRA) y este año Lazos Creando Fuerzas tendrá un enfoque especial en “Calidad de vida y bienestar en la adultez mayor con VIH”, prometiendo brindar una plataforma enriquecedora para la discusión y el intercambio de conocimientos.

En los últimos años, la investigación médica ha logrado importantes avances en el tratamiento antirretroviral, permitiendo que las personas que viven con VIH lleven vidas más largas y saludables.

Esta es la razón de que una cantidad significativa de las personas con VIH en Puerto Rico tenga 50 años o más de edad. No obstante, la investigación ha demostrado que esta población puede experimentar envejecimiento prematuro.

Dr. Federico Rodríguez, presidente de la Asociación Puertorriqueña de Gastroenterología. Fotomontaje: Revista Medicina y Salud Pública.

Fructífera la convención anual de la Transcurrió Asociación de Médicos Pediatras la educación Región Oeste continua sobre gastroenterología y hepatología para médicos primarios en Puerto Rico Dr. Orlando Brinn, pediatra. Fotomontaje: Revista Medicina y Salud Pública.

El objetivo de la Asociación Puertorriqueña de Gastroenterología fue fomentar la educación en el manejo de condiciones gastrointestinales para los galenos.

Con la participación de genetistas pediátricos y otros médicos que atienden la salud infantil se llevó a cabo la convención.

FDA aprueba Jardiance® para el tratamiento de adultos con enfermedad renal crónica

La Administración de Alimentos y Medicamentos de Estados Unidos (FDA) aprobó las tabletas de 10 mg de Jardiance® (empagliflozina) para reducir el riesgo de disminución sostenida en la tasa de filtración glomerular estimada (eGFR), enfermedad renal terminal, muerte cardiovascular y hospitalización en adultos con enfermedad renal crónica.

Cabe mencionar que no se recomienda el uso de Jardiance para mejorar el control glucémico en pacientes con diabetes tipo 1, ya que puede aumentar el riesgo de cetoacidosis diabética en estos pacientes.

Tampoco se recomienda su uso para mejorar el control glucémico en pacientes con diabetes tipo 2 con una TFGe inferior a 30 ml/min/1,73 m2, debido a que es probable que Jardiance sea ineficaz en este entorno según su mecanismo de acción.

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MSP / REVISTAMSP.COM Llega a las librerías Puntos Clave, la disrupción positiva al sistema de salud de Puerto Rico El doctor Jorge Martínez Trabal es un distinguido médico y pilar de la educación médica.

Fotomontaje: Revista Medicina y Salud Pública.

El doctor Jorge Martínez Trabal, reconocido por su destacada trayectoria en el campo de la medicina y su compromiso con el mejoramiento del sistema de salud en la Isla, publica su primer libro titulado Puntos Clave ‘La disrupción positiva al sistema de salud de Puerto Rico’.

El libro explora los desafíos que enfrenta el sistema de salud de Puerto Rico y cómo ha evolucionado a lo largo de los años, presentando un detallado análisis de las problemáticas claves y ofreciendo recomendaciones concretas para afrontar los retos actuales.

Esta obra, de lectura alternativa, enfatiza la importancia de ejecutar un esfuerzo conjunto y coordinado entre diferentes sectores y profesionales del campo de la salud para lograr soluciones efectivas y duraderas.

A través de una mirada clínica y profunda, el doctor Martínez Trabal examina los diversos factores que han contribuido a la complejidad del actual estado del sistema de salud, incluyendo la economía local, la política, la educación, los patrones de práctica médica, la cultura y las preocupaciones, en general, sobre la salud pública.

Investigarán medicamento que podría reducir daños en pulmones de pacientes afectados por COVID-19 Dr. Marcos J. Ramos-Benítez, catedrático Auxiliar de Ponce Health Sciences University (PHSU) e investigador principal del Immunology and Molecular Pathogenesis Lab del Ponce Research Institute (PRI). Foto: suministrada.

Una subvención de 250 mil dólares otorgada al Dr. Marcos J. Ramos-Benítez, catedrático Auxiliar de Ponce Health Sciences University (PHSU), permitirá respaldar un proyecto de investigación que se centra en comprender cómo el medicamento llamado Fostamatinib podría contribuir a la reducción de daños en los pulmones de pacientes afectados por el COVID-19.

“Este estudio es de gran relevancia, ya que apoya directamente las observaciones de estudios clínicos activos que investigan a Fostamatinib como tratamiento para el COVID-19 severo. Se espera que este trabajo contribuya a proporcionar datos que respalden la aprobación del medicamento, informar sobre su mejor uso y determinar qué pacientes podrían beneficiarse más de su aplicación”, expresó el Dr. Ramos-Benítez.

El experto indicó además que el estudio cuenta con la colaboración de destacados investigadores locales y del Instituto Nacional de Salud de los Estados Unidos (NIH), incluyendo al Dr. Wilfredo De Jesús-Rojas, Dra. Vanessa Rivera, Dr. Jeffrey R. Strich y el Dr. Daniel Chertow.

Departamento de Salud de Puerto Rico emite alerta por presencia de bacterias en piscinas El Departamento de Salud de Puerto Rico emitió una alerta a la ciudadanía tras detectar la bacteria escherichia coli (E. coli) y coliformes totales en muestras de agua obtenidas de piscinas no tratadas adecuadamente, frecuentes en la temporada de verano.

Según el Laboratorio de Salud Pública, la alerta está asociada a un evento de una facilidad recreativa en San Juan, sin embargo, reconociendo que las familias están en su periodo de vacaciones, el llamado de la autoridad sanitaria es a prevenir situaciones que incluyan actividades acuáticas.

“Ante esta situación, hacemos un llamado a todos los visitantes de parques acuáticos o piscinas públicas a estar alerta si comienzan a presentar algunos de estos síntomas.

Debe ser evaluado por un proveedor de salud y recibir atención médica de inmediato”, afirmó Melissa Marzán, principal oficial de epidemiología del Departamento de Salud.

Fideicomiso para Ciencia, Tecnología e Investigación anuncia su primer Congreso de Salud e Investigación Dra. Amarilys Silva, directora ejecutiva del Puerto Rico Consortium for Clinical Investigation (PRCCI). Foto: suministrada.

El Fideicomiso para Ciencia, Tecnología e Investigación de Puerto Rico (FCTIPR) invita a todos los interesados en salud pública e investigación a participar en el primer Congreso de Salud e Investigación.

Este innovador evento, presentado por tres de los programas destacados del FCTIPR: el Fideicomiso de Salud Pública (PRPHT), la Unidad de Control de Vectores (PRVCU) y el Puerto Rico Clinical Consortium for Investigations (PRCCI), se llevará a cabo el 26 de octubre del 2023 en el Ballroom del Hotel Caribe Hilton, en San Juan.

El Congreso de Salud e Investigación está en consonancia con la misión del FCTIPR de invertir, facilitar y desarrollar las capacidades necesarias para avanzar continuamente la economía de Puerto Rico y el bienestar de sus ciudadanos a través de la innovación, la ciencia, la tecnología, la investigación y las iniciativas de salud pública.

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MSP / MUNDO DIGITAL El Dr. Gino Natalicchio es nombrado presidente de Ponce Health Sciences University El anuncio del nombramiento del Dr. Gino Natalicchio, Ph.D., como presidente de Ponce Health Sciences University (PHSU) fue realizado por el Dr. David Lenihan, Principal Oficial Ejecutivo de PHSU. En su nuevo rol, el Dr. Natalicchio asumirá la responsabilidad de supervisar todas las operaciones de PHSU. El Dr. Natalicchio cuenta con una extensa trayectoria de más de 25 años en alta gerencia, durante la cual ha liderado exitosamente el desarrollo e implementación de estrategias de educación en línea en instituciones de educación superior tanto en Puerto Rico como en los Estados Unidos continentales.

En este nuevo rol, el Dr. Lenihan continuará liderando iniciativas destinadas a expandir la presencia global de la empresa, promoviendo avances y oportunidades adicionales para PHSU. Asimismo, la Dra. Elizabeth Rivera seguirá desempeñando su papel como vicepresidenta de Asuntos Académicos, posición que asumió previamente en el marco de cambios organizacionales.

Hito académico por los resultados de las clases graduandas de 2023 y 2024 de la UPR en el INBDE Estos logros son considerados históricos a nivel institucional, ya que el alto porcentaje de aprobación alcanzado por los estudiantes de las clases de 2023 y 2024 es un testimonio irrefutable de la calidad y excelencia. Foto: Medicina Dental RCM

La Escuela de Medicina Dental del Recinto de Ciencias Médicas (RCM) de la Universidad de Puerto Rico (UPR) se complace en anunciar los resultados sobresalientes obtenidos por las clases graduandas de 2023 y 2024 del Programa Doctoral en Medicina Dental en el Integrated National Board of Dental Examination (INBDE).

El INBDE es ampliamente reconocido como el examen nacional requerido para obtener la licencia de dentista en los Estados Unidos. En su última edición, 59 de los 63 estudiantes de la clase de 2023 lograron aprobar con éxito este riguroso examen.

Estos logros son considerados históricos a nivel institucional, ya que el alto porcentaje de aprobación alcanzado por los estudiantes de las clases de 2023 y 2024 es un testimonio irrefutable de la calidad y excelencia que caracterizan a los alumnos de la Escuela de Medicina Dental del RCM de la UPR.

Asociación de la Industria Farmacéutica de Puerto Rico presentó evento regulatorio La Asociación de la Industria Farmacéutica de Puerto Rico (PIA-PR) presentó recientemente un evento con una amplia gama de temas regulatorios para la industria biofarmacéutica local.

Diversos líderes presentaron temas como las actualizaciones en la calidad farmacéutica, tendencias en las inspecciones de la industria biofarmacéutica de parte de la FDA, inspección visual de medicamentos estériles, inspección visual automatizada, la inteligencia artificial y el aprendizaje automático, entre otros.

Kevin O´Donell, gerente de Cumplimiento de Mercado de la agencia regulatoria independiente HPRA, Irlanda, con una presentación en modo remoto. Foto: suministrada a la Revista Medicina y Salud Pública.

Hospital UPR Dr. Federico Trilla reafirma su compromiso con la odontología inclusiva y comunitaria

La salud oral es un gran desafío para pacientes con discapacidades. De acuerdo con datos del Negociado del Censo de los Estados Unidos, en el 2022 en Puerto Rico, el 22 % de la población reportó alguna modalidad de necesidad especial. Esta cifra pone en perspectiva la necesidad de un acceso a un cuidado dental preventivo para la población.

En este contexto, el Hospital UPR Dr. Federico Trilla emerge como un faro de esperanza y acción. Con una visión proactiva y comunitaria, el hospital se convierte en sede para la iniciativa “Sonrisas Especiales”, una actividad dirigida por el Programa Graduado en Odontología General de la Escuela de Medicina Dental.

La Lcda. Yelitza Sánchez, directora ejecutiva del Hospital UPR Dr. Federico Trilla, mencionó: “Esta iniciativa representa el corazón y la misión de nuestro Hospital. No solo abogamos por la atención de calidad, sino que también buscamos ser agentes de cambio y esperanza a beneficio de nuestra comunidad. Es un honor formar parte de Sonrisas Especiales y hacer la diferencia para estos pacientes y sus familias”.

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Ser mujer y endocrinóloga: la carrera médica de la Dra. Leticia Hernández La Dra. Leticia Hernández ha asumido el reto de posicionarse como una especialista en endocrinología en una carrera dominada por hombres, siendo madre, esposa y amante de los animales.

Igualmente ha sido firme vocal sobre la necesidad de continuar educando sobre el tratamiento a tiempo de la diabetes, condiciones metabólicas, el rol terapéutico de la nutrición en estas condiciones, y hasta las ilegalidades detrás de medicamentos que pretenden combatir la obesidad.

“El ser mujer en el campo de la medicina representa cierto reto en términos que nosotras tenemos que cumplir ciertos roles como madres, esposas, además los roles en términos de nuestro campo de salud, donde nos tenemos que mantener al día sobre lo que son las guías y el manejo adecuado de las condiciones que tratamos” expresó la Dra. Hernández.

Aunque la Dra. Hernández en algún momento de su vida no tenía claro en qué especialidad se iba a enfocar, afirmó que, “ser especialista en endocrinología es un sueño cumplido, siempre me cautivó este campo de la medicina por todo lo que abarca en términos de lo que es el cuidado de las personas y por las condiciones que nosotros en este campo”.

Además, la especialista resalta la importancia del apoyo de las familias, compañeros de trabajo y aquellos que se encargan de formar a los profesionales.

Dra. Leticia Hernández Dra. Leticia Hernández Dávila, endocrinóloga y presidenta de la Sociedad Puertorriqueña de Endocrinología y Diabetología.

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“Si yo fuera a dar un mensaje a las mujeres y las niñas de mi país, les dejaría con una frase que mi mamá me decía cuando pequeña y es ‘para el que quiere no hay imposibles’ no podemos permitir que las circunstancias de la vida se interpongan en esas metas que tenemos. Tenemos que continuar luchando, continuar trabajando y esforzándonos por alcanzar nuestras metas y que sí vamos a encontrar escollos en la vida, pero hay que levantarse y hay que seguir luchando para lograr esos sueños que tenemos”, concluyó.

Por tal razón, nos enorgullece incluir a esta profesional de la salud, como presidenta de la Sociedad Puertorriqueña de Endocrinología y Diabetología en nuestra sección de A Ciencia Cierta.

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