A Breath of Fresh Air in Pediatric Asthma by Integritas Communications

A BREATH OF FRESH AIR IN PEDIATRIC ASTHMA JUNE 28, 2021 1:00 pm – 2:00 pm ET

JUNE 30, 2021 3:00 pm – 4:00 pm ET

This activity is jointly provided by Global Education Group and Integritas Communications. This activity is supported by an independent educational grant from Sanofi Genzyme and Regeneron Pharmaceuticals.

MEDICAL COMMUNICATIONS INQUIRIES info@integritasgrp.com integritasgrp.com

FACULTY FACULTY

Mario Castro, MD, MPH Chief, Pulmonary, Critical Care and Sleep Medicine Vice Chair for Clinical and Translational Research Director, Frontiers: University of Kansas Clinical and Translational Science Institute Director, Rainbow Clinical Trials Science Unit University of Kansas Medical Center Kansas City, Kansas Dr. Mario Castro is Professor of Medicine, Vice Chair for Clinical and Translational Research, Department of Medicine; Chief, Division of Pulmonary, Critical Care and Sleep Medicine at University of Kansas Medical Center (KUMC); Director of the Frontiers: University of Kansas Clinical and Translational Science Institute; and Adjunct Research Professor at the University of Missouri-Kansas City School of Medicine. He has been a leader of the Centers for Disease Control and Prevention (CDC) Controlling Asthma in American Cities, American Lung Association Airway Clinical Research Centers, and National Heart, Lung, and Blood Institute (NHLBI) Asthma Clinical Research Network, Severe Asthma Research Program, AsthmaNet and PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) research networks. His translational research projects in the Asthma and Airway Translational Research Unit (AATRU) are focused on the pathogenesis and treatment of asthma, especially severe disease. Recently, Dr. Castro has spearheaded several initiatives to combat the COVID-19 pandemic, serving as lead investigator for National Institutes of Health (NIH)/ National Institute of Allergy and Infectious Diseases (NIAID)-funded COVID-19 Prevention Network (CoVPN trial), ACTIV-2 trial, and the National Patient-Centered Clinical Research Network (PCORNET® Healthcare Worker Exposure Response and Outcomes (HERO) Registry and Hydroxychloroquine (HCQ) trial. The author of 30+ chapters/books and 300+ peer-reviewed articles, Dr. Castro has trained more than 40 junior clinical and translational scholars over the past 25+ years. He is widely recognized as an expert clinician, an excellent mentor, and a skilled educator with a significant commitment to the development of young investigators’ careers.

Wanda Phipatanakul, MD, MS FACULTY

Professor of Pediatrics Harvard Medical School Director, Clinical Research Center Division of Asthma, Allergy, Dermatology, Rheumatology, and Immunology Boston Children’s Hospital Boston, Massachusetts Dr. Wanda Phipatanakul, Director of the Asthma/Allergy Clinical Research Center at Boston Children’s Hospital and Professor of Pediatrics at Harvard Medical School, has dedicated her career to reducing and preventing asthma and allergic diseases. Originally from St. Louis, Missouri, she earned her medical degree from Loma Linda University in California, and completed her residency in pediatrics at Children’s Hospital Los Angeles in 1997. After a fellowship in immunology at Johns Hopkins University School of Medicine in Baltimore, Maryland, she joined the faculty of Boston Children’s Hospital and Harvard Medical School in the Division of Immunology and Allergy, where she has remained for 21 years. Dr. Phipatanakul has built a deep network of community relationships. She conducts both school- and home-based asthma studies in children and has had continuous NIH funding for 20 years. She leads the NIAID School Inner-City Asthma Intervention Study and the NHLBI Environmental Assessment of Sleep in Youth, and is overall principal investigator (PI) for a NIAID-funded, nationwide, multicenter asthma prevention study evaluating the anti-immunoglobulin E (IgE) omalizumab in preventing the atopic march and asthma. Most recently, she was awarded a NIAID U01 grant to evaluate whether patients carrying an interleukin-4 receptor alpha chain IL4RαR576 gene variant will have a greater response to dupilumab. She leads her Center as Pediatric PI in multiple NHLBI asthma and prevention networks, including Precise Severe Asthma Network and the Atopic Dermatitis Research Network, and has authored over 290 publications in scientific journals, such as the Journal of the American Medical Association, Lancet, and the New England Journal of Medicine. Passionate about mentoring the next generation of investigators, Dr. Phipatanakul has received multiple mentoring awards for her efforts and is a sought-after speaker both nationally and internationally. She also serves on the board of directors of the American Academy of Allergy, Asthma, and Immunology (AAAAI) and the American Board of Allergy and Immunology and on the editorial boards of several journals, including the Journal of Allergy and Clinical Immunology (JACI), JACI in Practice, and Chest. Further, she is an elected member of the American Society for Clinical Investigation, an honor research society. Dr. Phipatanakul is ardent about supporting her specialty and serving as a role model for others balancing work and family.

TARGET AUDIENCE The educational design of this activity addresses the needs of allergists/clinical immunologists, pulmonologists, and other clinicians involved in the management of patients with pediatric asthma.

Currently, more than 5.5 million children (age <18 years) in the United States have been diagnosed with asthma.1 An estimated 5% of this pediatric population suffer from severe asthma—disease that necessitates treatment with high-dose inhaled corticosteroids (ICS) plus a second controller and/or oral corticosteroids (OCS) to retain control, or which remains uncontrolled despite this therapy.2,3 These children are at a heightened risk of death from recurrent, life-threatening asthma exacerbations, increased morbidity, impaired lung function, and reduced healthrelated quality of life.4-7 Asthma is the leading cause of emergency department visits and among the top 3 reasons children are hospitalized.8 Therefore, there is great urgency not only to prevent the detrimental effects of asthma but to implement timely and effective treatment plans for the management of these young patients. During this Engaging the Patient™ program, two asthma specialists will share their interpretive insights on the characteristics of pediatric asthma, its underlying pathophysiology, and the rationale for targeted biologic therapies. Faculty will share clinical trial evidence for the use of newer biologic therapies within this pediatric population and detail the positioning of biologics within recently published guidelines. Interactive faculty discussions surrounding the management of young patients with severe asthma as well as key elements for shared decision-making will be included throughout the program, supporting the translation of information to practice. Lastly, prerecorded video vignettes of a parent’s testimonial and follow-up office visit will provide real-life perspectives on the immense burden of disease and the impact asthma has on patients and their families.

REFERENCES 1. Centers for Disease Control and Prevention. https://www.cdc.gov/asthma/most_recent_national_asthma_ data.htm. Accessed April 14, 2021. 2. Chung KF, et al. Eur Respir J. 2014;43(2):343-373. 3. Lang DM. Allergy Asthma Proc. 2015;36(6):418-424. 4. Moorman JE, et al. Vital Health Stat 3. 2012(35):1-58. 5. Sullivan SD, et al. Allergy. 2007;62(2):126-133. 6. Strine TW, et al. Chest. 2004;126(6):1849-1854. 7. Müllerová H, et al. J Asthma. 2020;1-12. 8. American Lung Association. https://www.lung.org/lung-health-diseases/lung-disease-lookup/asthma/ learn-about-asthma/asthma-children-facts-sheet. Accessed April 14, 2021.

PREAMBLE

STATEMENT OF NEED/PROGRAM OVERVIEW

EDUCATIONAL OBJECTIVES Upon completion of this activity, participants will be better able to do the following: • Discuss pathophysiologic inflammatory processes in pediatric asthma that support phenotypic classification, risk stratification, and targeted treatment • Longitudinally evaluate pediatric patients with asthma for disease severity, symptom control, lung function, and disease phenotypes

PREAMBLE

• Describe the clinical profiles and evidence for current and emerging biologic treatment options for pediatric asthma • Construct individualized treatment regimens for pediatric patients with moderateto-severe asthma based on symptoms, comorbidities, and shared clinical decision-making

PHYSICIAN ACCREDITATION STATEMENT This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Global Education Group (Global) and Integritas Communications. Global is accredited by the ACCME to provide continuing medical education for physicians.

PHYSICIAN CREDIT DESIGNATION Global Education Group designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit ™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

GLOBAL CONTACT INFORMATION For information about the accreditation of this program, please contact Global at 303-395-1782 or cme@globaleducationgroup.com.

INSTRUCTIONS TO RECEIVE CREDIT In order to receive credit for this activity, the participant must complete the pretest, posttest, and program evaluation.

Global Education Group (Global) adheres to the policies and guidelines, including the Standards for Integrity and Independence in Accredited CE, set forth to providers by the Accreditation Council for Continuing Medical Education (ACCME) and all other professional organizations, as applicable, stating those activities where continuing education credits are awarded must be balanced, independent, objective, and scientifically rigorous. All persons in a position to control the content of an accredited continuing education program provided by Global are required to disclose all financial relationships with any ineligible company within the past 24 months to Global. All financial relationships reported are identified as relevant and mitigated by Global in accordance with the Standards for Integrity and Independence in Accredited CE in advance of delivery of the activity to learners. The content of this activity was vetted by Global to assure objectivity and that the activity is free of commercial bias. All relevant financial relationships have been mitigated. The faculty have the following relevant financial relationships with ineligible companies: Mario Castro, MD, MPH Consultant: Genentech, Inc., Novartis International AG, Sanofi S.A., Teva Pharmaceuticals USA, Inc.; Contracted Research: AstraZeneca, GlaxoSmithKline plc, Novartis International AG, Pulmatrix, Inc., Sanofi S.A., Shionogi Inc.; Honoraria: AstraZeneca, Genentech, Inc., GlaxoSmithKline plc, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, Teva Pharmaceuticals USA, Inc.; Speakers Bureau: AstraZeneca, Genentech, Inc., GlaxoSmithKline plc, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, Teva Pharmaceuticals USA, Inc. Wanda Phipatanakul, MD, MS Consultant: Genentech, Inc., GlaxoSmithKline plc, Novartis International AG, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme The planners and managers have the following relevant financial relationships with ineligible companies: Lindsay Borvansky Andrea Funk Liddy Knight Ashley Cann Celeste Collazo, MD

Nothing to disclose Nothing to disclose Nothing to disclose Nothing to disclose Nothing to disclose

PREAMBLE

DISCLOSURE OF CONFLICTS OF INTEREST

DISCLOSURE OF UNLABELED USE This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the US Food and Drug Administration. Global Education Group (Global) and Integritas Communications do not recommend the use of any agent outside of the labeled indications.

PREAMBLE

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of any organization associated with this activity. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

DISCLAIMER Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed in this activity should not be used by clinicians without evaluation of patient conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

SLIDES

SHARED DECISION-MAKING TOOL » Helping families understand biologic therapy for severe pediatric asthma https://www.exchangecme.com/resourcePDF/asthma/Pediatric-AsthmaDecision-Aid.pdf

CLINICAL PRACTICE GUIDELINES » Global Strategy for Asthma Management and Prevention. Global Initiative for Asthma, 2021. https://ginasthma.org/wp-content/uploads/2021/04/GINA-2021-Main-Report_FINAL_21_04_28WMS.pdf

» Management of severe asthma: a European Respiratory Society/American Thoracic Society guideline. Holguin F, et al. Eur Respir J. 2020;55(1):1900588. https://erj.ersjournals.com/content/55/1/1900588.long

CLINICAL PRACTICE TOOLS » Clinical tools to assess asthma control in children. Dinakar C, et al. Pediatrics. 2017:139(1):e20163438. https://pediatrics.aappublications.org/content/139/1/e20163438

» Assessing Asthma Control and Adjusting Therapy in Children. The National Asthma Education and Prevention Program Expert Panel Report provides a stepwise approach to the assessment of asthma control in children as well as in adolescents within their 2007 Full Report (Figures 12-15).

RESOURCE CENTER

https://www.nhlbi.nih.gov/sites/default/files/media/docs/asthsumm.pdf

» Childhood Asthma Control Test (C-ACT) This questionnaire includes 4 pictorial items and 3 verbal items and is appropriate for helping to assess asthma control in children 4 to 11 years old. A score of <19 on the C-ACT suggests asthma that is uncontrolled. https://www.greenhillspeds.com/wp-content/uploads/2015/12/Asthma-Control-Test-4-to-11years.pdf

» Asthma Control Test (ACT) This 5-item questionnaire helps evaluate asthma control in children aged 12 years or older. A score of <20 on the ACT suggests asthma that is uncontrolled. https://getasthmahelp.org/documents/ACT_AdultEng.pdf

» Asthma Control Questionnaire (ACQ-6) This 6-item questionnaire helps assess asthma control in children aged 6 to 16 years and has a recall window of 1 week. Scores range from 1 (totally controlled) to 6 (severely uncontrolled). Juniper EF, et al. Eur Respir J. 2010;36(6):1410-1416. https://erj.ersjournals.com/content/36/6/1410.long

» Test for Respiratory and Asthma Control in Kids (TRACK) This 5-item questionnaire helps assess asthma control in children 0 to 5 years old. A score <80 suggests asthma that is uncontrolled. https://www.childrensmercy.org/contentassets/7ccb0994efaf4287ade19e193ddfab85/track.pdf

» American Academy of Pediatrics (AAP) Asthma Action Plans These asthma action plans have been developed for children aged 0 to 5 years (first link below) and those ≥6 years (second link below). https://www.aap.org/en-us/advocacy-and-policy/aap-health-initiatives/healthy-child-care/ Documents/AR_AsthmaAction0-5.pdf https://www.aap.org/en-us/advocacy-and-policy/aap-health-initiatives/healthy-child-care/ Documents/AR_AsthmaAction6.pdf

SUGGESTED READING » Asthma. Patel SJ, Teach SJ. Pediatr Rev. 2019;40(11):549-567. https://pedsinreview.aappublications.org/content/40/11/549

» Which child with asthma is a candidate for biological therapies? Bush A. J Clin Med. 2020;9(4):1237.

» Heterogeneity of severe asthma in childhood: confirmation by cluster analysis of children in the National Institutes of Health/National Heart, Lung, and Blood Institute Severe Asthma Research Program. Fitzpatrick AM, et al. J Allergy Clin Immunol. 2011;127(2):382-389. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3060668/

» Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. Lanier B, et al. J Allergy Clin Immunol. 2009;124(6):1210-1216. https://pubmed.ncbi.nlm.nih.gov/19910033/

RESOURCE CENTER

https://pubmed.ncbi.nlm.nih.gov/32344781/

» Long-term safety and pharmacodynamics of mepolizumab in children with severe asthma with an eosinophilic phenotype. Gupta A, et al. J Allergy Clin Immunol. 2019;144(5):1336-1342.e7. https://pubmed.ncbi.nlm.nih.gov/31425781/

» Predictors of enhanced response with benralizumab for patients with severe asthma: pooled analysis of the SIROCCO and CALIMA studies. FitzGerald JM, et al. Lancet Respir Med. 2018;6(1):51-64. https://pubmed.ncbi.nlm.nih.gov/28919200/

» Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. Castro M, et al. N Engl J Med. 2018;378(26):2486-2496. https://www.nejm.org/doi/10.1056/NEJMoa1804092

» Dupilumab efficacy and safety in children with uncontrolled, moderate-tosevere asthma: the phase 3 VOYAGE study. Bacharier LB, et al. ATS 2021. Abstract A1204. https://conference.thoracic.org/program/abstract-search.php?sid=P5839

» Efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma: results from the phase 3 NAVIGATOR study. Menzies-Gow A, et al. J Allergy Clin Immunol. 2021;147(2):AB249. https://els-jbs-prod-cdn.jbs.elsevierhealth.com/pb/assets/raw/Health%20Advance/journals/ ymai/AAAAI_2021_LateBreaking_Abstracts.pdf

PATIENT ADVOCACY ORGANIZATIONS AND RESOURCES

RESOURCE CENTER

» American Academy of Pediatrics (AAP) AAP’s healthychildren.org website is powered by pediatricians and is a trusted resource for parents of children with asthma and allergies. Resources include useful tips from pediatricians on mitigating triggers, evolving information on asthma therapies, patient education videos centered around the proper use of medication devices, and much more. https://www.healthychildren.org/English/health-issues/conditions/allergies-asthma/Pages/ default.aspx

» Asthma and Allergy Foundation of America (AAFA) AAFA is dedicated to improving the quality of life for people with asthma and allergic diseases through education, advocacy, and research. http://www.aafa.org/page/asthma.aspx

» American College of Allergy, Asthma & Immunology (ACAAI) The ACAAI fosters a culture of collaboration and congeniality in which members work toward the common goals of patient care, education, advocacy, and research. https://acaai.org/asthma

» American Lung Association The American Lung Association is the leading organization working to save lives by improving lung health and preventing lung disease through education, advocacy, and research. http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/asthma/

» American Thoracic Society (ATS) The mission of the ATS is to improve health worldwide by advancing research, clinical care, and public health in respiratory disease, critical illness, and sleep disorders. https://www.thoracic.org/patients/patient-resources/

» Chest Foundation The CHEST Foundation creates trusted patient education resources and disease awareness campaigns that empower patients to engage in better managing their health.

RESOURCE CENTER

foundation.chestnet.org/patient-education-resources/asthma/

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Please visit the CLINICAL RESOURCE CENTER for additional information and resources

www.ExchangeCME.com/ PEDSASTHMA

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