Clinical Issues in Atopic Dermatitis by Integritas Communications

RESOURCE CENTER ExchangeCME.com/ ADRESOURCES19 This activity is provided by Integritas Communications. This activity is supported by an educational grant from Sanofi Genzyme and Regeneron Pharmaceuticals. This program is independent and is not part of the official AAD Summer Meeting, as planned by its Scientific Assembly Committee. This live activity will not offer continuing medical education (CME) credit.

MEDICAL COMMUNICATIONS INQUIRIES info@integritasgrp.com integritasgrp.com

FACULTY

April W. Armstrong, MD, MPH

FACULTY

Associate Dean, Clinical Research Professor of Dermatology Keck School of Medicine University of Southern California Los Angeles, California

Dr. April Armstrong is Professor of Dermatology and Associate Dean at the University of Southern California (USC). She also serves as Vice Chair in the dermatology department at USC. Dr. Armstrong obtained her medical degree from Harvard Medical School, Boston, Massachusetts, where she further completed her dermatology residency before obtaining her Master of Public Health degree from Harvard School of Public Health, Boston, Massachusetts. Prior to joining the faculty at the USC, Dr. Armstrong was Vice Chair at the University of California Davis in Sacramento and later at the University of Colorado in Denver. Dr. Armstrongâ&#x20AC;&#x2122;s clinical expertise lies in inflammatory skin diseases. She has conducted over 100 clinical trials and published over 200 articles in scientific journals. She holds multiple leadership positions at professional societies and has served on the editorial boards for the Journal of the American Medical Association (JAMA) Dermatology and the Journal of the American Academy of Dermatology.

Peter A. Lio, MD FACULTY

Clinical Assistant Professor of Dermatology and Pediatrics Feinberg School of Medicine Northwestern University Director, Chicago Integrative Eczema Center Founding Partner, Medical Dermatology Associates of Chicago Chicago, Illinois Dr. Peter Lio is a Clinical Assistant Professor of Dermatology and Pediatrics at Northwestern University Feinberg School of Medicine. Dr. Lio received his medical degree from Harvard Medical School, Boston, Massachusetts, and completed his internship in Pediatrics at Boston Childrenâ&#x20AC;&#x2122;s Hospital and his dermatology training at Harvard, where he served as Chief Resident in Dermatology. While at Harvard, he received formal training in acupuncture. Dr. Lio is the founding director of the Chicago Integrative Eczema Center, and currently serves as a board member and scientific advisory committee member for the National Eczema Association. He has over 100 publications in the peer-reviewed literature.

Linda Stein Gold, MD

FACULTY

Director of Dermatology Clinical Research Henry Ford Health System Detroit, Michigan Division Head of Dermatology Henry Ford Health System West Bloomfield, Michigan Dr. Linda Stein Gold is Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan, as well as Division Head of Dermatology at Henry Ford Health System in West Bloomfield, Michigan. Dr. Stein Gold earned her medical degree from the University of Pennsylvania School of Medicine and completed her residency in dermatology at Henry Ford Hospital. Dr. Stein Gold conducts clinical research on a variety of dermatologic conditions, including the treatment of chronic plaque-type psoriasis, actinic keratosis, atopic dermatitis, acne vulgaris, seborrheic dermatitis, and rosacea. She has published articles in journals such as the Journal of the American Academy of Dermatology and the Journal of Drugs in Dermatology. She is a frequent national and international lecturer on acne, rosacea, psoriasis, viral infections, atopic dermatitis, and fungal infections. She is on the Board of Directors of the American Academy of Dermatology and serves on the Academyâ&#x20AC;&#x2122;s executive committee and priorities committee. She has been on the Board of Directors for the National Psoriasis Foundation and the American Acne and Rosacea Society.

TARGET AUDIENCE

The educational design of this activity addresses the needs of dermatologists, allergists/ clinical immunologists, and other clinicians who treat patients with severe atopic dermatitis.

PREAMBLE

STATEMENT OF NEED/PROGRAM OVERVIEW

Atopic dermatitis is a common, chronic, inflammatory disease that manifests primarily in the skin, although research has uncovered potentially deleterious effects in other organ systems throughout the body.1,2 The disease-related physical and biopsychosocial burdens of this condition can have a substantial effect on patient and parent/caregiver quality of life.3,4 A better understanding of disease etiology has supported the development of new approaches to disease characterization and targeted therapies.5,6 As a result, the first biologic therapy is now FDA-approved to treat adolescent and adult patients 12 years and older, with moderate-to-severe disease.7,8 In this Clinical Issues â&#x201E;˘ program, an expert faculty panel will discuss and debate the pathophysiologic underpinnings of atopic dermatitis, considerations related to comprehensively evaluating patients, and recommended therapeutic strategies for adolescents and adults with moderate-tosevere disease. With novel therapies emerging for patients with difficult-to-treat atopic dermatitis, attendees will benefit from updates on the newest clinical trial data, evolving treatment guidelines, and practical recommendations that may be applied to daily clinical decision-making.9,10 Attendees will leave this dynamic and engaging program wellequipped to translate the latest information and new perspectives on disease management into next-day practice.

REFERENCES

1. Nutten S. Atopic dermatitis: global epidemiology and risk factors. Ann Nutr Metab. 2015:66(suppl 1):8-16. 2. Brunner PM, et al. Increasing comorbidities suggest that atopic dermatitis is a systemic disorder. J Invest Dermatol. 2017;137(1):18-25. 3. Carroll CL, et al. The burden of atopic dermatitis: impact on the patient, family, and society. Pediatr Dermatol. 2005;22(3):192-199. 4. Drucker AM, et al. The burden of atopic dermatitis: summary of a report for the National Eczema Association. J Invest Dermatol. 2017;137(1):26-30. 5. Mansouri Y, Guttman-Yassky E. Immune pathways in atopic dermatitis, and definition of biomarkers through broad and targeted therapeutics. J Clin Med. 2015;4(5):858-873. 6. Gandhi NA, et al. Targeting key proximal drivers of type 2 inflammation in disease. Nat Rev Drug Discov. 2016;15(1):35-50. 7. Simpson EL, et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335-2348. 8. Simpson EL, et al. Dupilumab efficacy and safety in adolescents with moderate-to-severe atopic dermatitis: results from a multicenter, randomized, placebo-controlled, double-blind, parallel-group, phase 3 study. Presented at the 27th EADV Congress. September 12-16, 2018; Paris, France. Poster #4640. 9. Renert-Yuval Y, Guttman-Yassky E. Whatâ&#x20AC;&#x2122;s new in atopic dermatitis. Dermatol Clin. 2019;37(2):205-213. 10. AriĂŤns LFM, et al. Dupilumab in atopic dermatitis: rationale, latest evidence and place in therapy. Ther Adv Chronic Dis. 2018;9(9):159-170.

EDUCATIONAL OBJECTIVES

Upon completion of this activity, participants will be better able to do the following: •• Describe the pathophysiologic mechanisms and risk factors that contribute to atopic dermatitis development and persistence, with a focus on specific targets of current and emerging systemic treatments •• Assess patients with atopic dermatitis over time for uncontrolled symptoms, sleep disturbances, comorbid conditions, and treatment responses

•• Individualize long-term therapeutic regimens for moderate-to-severe atopic dermatitis to prevent exacerbations, manage comorbidities, maximize health-related quality of life, and minimize treatment-related side effects •• Communicate with patients and caregivers to improve their understanding of atopic dermatitis and the importance of treatment adherence and to promote shared decision-making

PROGRAM AGENDA 6:30 pm – 7:00 pm

Registration and Dinner

7:00 pm – 7:20 pm

Introduction to Atopic Dermatitis Pathophysiology

7:20 pm – 7:55 pm Comprehensive Patient Evaluations: From Triggers to Comorbidities 7:55 pm – 8:30 pm Individualizing Long-term Therapy for Patients With Moderate-to-Severe Atopic Dermatitis 8:30 pm – 8:45 pm Choose-a-Case: Case Study Discussion 8:45 pm – 9:00 pm Question and Answer Session

DISCLOSURE OF CONFLICTS OF INTEREST

It is the policy of Integritas Communications that all faculty, instructors, and planners disclose any real or apparent conflicts of interest relating to the topics of this educational activity. The faculty reported the following financial relationships or relationships to products or devices they or their spouses/life partners have with commercial interests related to the content of this activity:

PREAMBLE

•• Describe the mechanistic rationales and clinical evidence for current and emerging biologic therapies in the treatment of moderate-to-severe atopic dermatitis

PREAMBLE

April W. Armstrong, MD, MPH Consultant/Independent Contractor: Abbvie Inc., Bristol-Myers Squibb, Dermavant Sciences, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., LEO Pharma Inc., Modernizing Medicine, Inc., Novartis Corporation, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, Science 37, Inc.; Grant/Research Support: Abbvie Inc., Bristol-Myers Squibb, Dermira, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Kyowa Hakko Kirin Co., Ltd., LEO Pharma Inc., Novartis Corporation, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, UCB Biopharma Peter A. Lio, MD Consultant/Independent Contractor: Abbvie Inc., Altus Labs, LLC, AOBiome, Dermavant Sciences, Inc., Eli Lilly and Company, Galderma Laboratories, L.P., IntraDerm Pharmaceuticals, Johnson & Johnson, Kiniksa Pharmaceuticals, Ltd., La Roche-Posay, Menlo, Micreos, Pfizer Inc., Pierre Fabre Laboratories, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, Theraplex, UCB Biopharma, Unilever; Grant/Research Support: Abbvie Inc., AOBiome, The Atopic Dermatitis Foundation, Regeneron Pharmaceuticals, Inc.; Honoraria: Abbvie Inc., Altus Labs, LLC, AOBiome, Dermavant Sciences, Inc., Eli Lilly and Company, Galderma Laboratories, L.P., IntraDerm Pharmaceuticals, Johnson & Johnson, Kiniksa Pharmaceuticals, Ltd., La Roche-Posay, Menlo Therapeutics Inc., Micreos BV, Pfizer Inc., Pierre Fabre Laboratories, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, Theraplex, UCB Biopharma, Unilever; Speakers Bureau: La Roche-Posay, Pfizer Inc., Pierre Fabre Laboratories, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme; Stock Shareholder: Altus Labs, LLC, Franklin Bioscience, Micreos BV, Syncere Skin Systems, Theraplex Linda Stein Gold, MD Consultant/Independent Contractor: Abbvie Inc., Dermavant Sciences, Inc., LEO Pharma Inc., Valeant Phamaceuticals International, Inc.; Grant/Research Support: Abbvie Inc., Dermavant Sciences, Inc., LEO Pharma Inc., Valeant Phamaceuticals International, Inc.; Speakers Bureau: LEO Pharma Inc., Pfizer Inc., Valeant Phamaceuticals International, Inc.

Nonfaculty

Jim Kappler, PhD; Rose Oâ&#x20AC;&#x2122;Connor, PhD, CHCP; and Stacey Ullman, MHS, hereby state that neither they nor their spouses/life partners have any financial relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.

PROVIDER 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 providership of Integritas Communications.

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. Integritas Communications and Sanofi Genzyme and Regeneron Pharmaceuticals do not recommend the use of any agent outside of the labeled indications.

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 or suggested in this activity should not be used by clinicians without evaluation of their patientsâ&#x20AC;&#x2122; conditions and possible contraindications or dangers in use, review of any applicable manufacturerâ&#x20AC;&#x2122;s product information, and comparison with recommendations of other authorities.

PREAMBLE

DISCLAIMER

SLIDES

GUIDELINES »»Guidelines of care for the management of atopic dermatitis: part 1. Diagnosis and assessment of atopic dermatitis. Eichenfield LF, et al. J Am Acad Dermatol. 2014;70(2):338-351.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4410183/pdf/nihms598033.pdf

»»Guidelines of care for the management of atopic dermatitis: part 2. Management and treatment of atopic dermatitis with topical therapies. Eichenfield LF, et al. J Am Acad Dermatol. 2014;71(1):116-132.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4326095/pdf/nihms598590.pdf

»»Guidelines of care for the management of atopic dermatitis: part 3. Management and treatment with phototherapy and systemic agents. Sidbury R, et al. J Am Acad Dermatol. 2014;71(2):327-349.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4410179/pdf/nihms-598620.pdf

»»Guidelines of care for the management of atopic dermatitis: part 4. Prevention of disease flares and use of adjunctive therapies and approaches. Sidbury R, et al. J Am Acad Dermatol. 2014;71(6):1218-1233.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4430554/pdf/nihms685688.pdf

»»Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I. Wollenberg A, et al. J Eur Acad Dermatol Venereol. 2018;32(5):657-682. https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdv.14891

»»Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part II. Wollenberg A, et al. J Eur Acad Dermatol Venereol. 2018;32(6):850-878.

PATIENT RESOURCES »»International Eczema Council

Founded in late 2014, the International Eczema Council (IEC) is a global nonprofit organization led by dermatology experts on atopic dermatitis. The IEC is dedicated to increasing the understanding of atopic dermatitis and promoting its optimal management through research, education, and patient/family care. http://www.eczemacouncil.org/for-patients/

RESOURCE CENTER

https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdv.14888

»»National Eczema Association

The National Eczema Association is a nonprofit organization founded in 1988 to improve the health and quality of life for individuals with eczema through research, support, and education. www.nationaleczema.org

CLINICAL ASSESSMENT TOOLS »»Children’s Dermatology Life Quality Index (CDLQI)

CDLQI is 10-question patient-reported assessment tool designed to measure impact of any skin disease on the lives of children ages 4-16. Lewis-Jones MS, Finlay AY. Br J Dermatol. 1995;132(6):942-949. https://www.cardiff.ac.uk/medicine/resources/quality-of-life-questionnaires/childrensdermatology-life-quality-index

»»Eczema Area and Severity Index (EASI)

EASI is a clinician assessment tool designed to measure clinical severity of atopic dermatitis. Severity scores can range from 0 (clear) to 72 (very severe). Hanifin JM, et al. Exp Dermatol. 2001;10(1):11-18.

http://www.homeforeczema.org/documents/easi-case-report-form-for-age-8-years-and-over.pdf

»»Investigator Global Assessment (IGA)

The IGA is a clinician assessment strategy designed to provide a snapshot of overall disease severity in dermatologic clinical trials. Futamura M, et al. J Am Acad Dermatol. 2016;74(2):288-294. http://www.pubmed.gov/26685719

»»Patient-Oriented Eczema Measure (POEM)

RESOURCE CENTER

The POEM is a patient-oriented, self-assessed measurement tool for monitoring aspects of atopic dermatitis in routine clinical practice or in the clinical trial setting. Charman CR, et al. Arch Dermatol. 2004;140(12):1513-1519. https://www.nottingham.ac.uk/research/groups/cebd/resources/poem.aspx

»»Scoring Atopic Dermatitis (SCORAD)

SCORAD is a clinical tool used to assess the extent and severity of eczema. Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31. http://adserver.sante.univ-nantes.fr/Compute.html

SUGGESTED READING Atopic Dermatitis Overview and Pathogenesis »»Atopic dermatitis endotypes and implications for targeted therapeutics. Czarnowicki T, et al. J Allergy Clin Immunol. 2019;143(1):1-11.

https://www.jacionline.org/article/S0091-6749(18)31572-0/fulltext

»»Identification of atopic dermatitis subgroups in children from 2 longitudinal birth cohorts. Paternoster L, et al. J Allergy Clin Immunol. 2018:141(3):964-971.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5840507/?report=reader

»»Age-specific changes in the molecular phenotype of patients with moderateto-severe atopic dermatitis. Zhou L, et al. J Allergy Clin Immunol. 2019;144(1):144-156.

https://www.jacionline.org/article/S0091-6749(19)30107-1/fulltext

»»Pathogenesis of atopic dermatitis.

Peng W, Novak N. Clin Exp Allergy. 2015;45(3):566-574. https://onlinelibrary.wiley.com/doi/epdf/10.1111/cea.12495

Patient Burden and Comorbidities »»Determinants of disease severity among patients with atopic dermatitis: association with components of the atopic march. Holm JG, et al. Arch Dermatol Res. 2019;311(3):173-182.

https://link.springer.com/article/10.1007%2Fs00403-019-01895-z

»»Persistence of atopic dermatitis (AD): A systematic review and meta-analysis Kim JP, et al. J Am Acad Dermatol. 2016;75(4):681-687.

»»Bidirectional relationships between psychological health and dermatological conditions in children. Mitchell AE. Psychol Res Behav Manag. 2018;11:289-298.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6074762/pdf/prbm-11-289.pdf

»»The atopic march and atopic multimorbidity: many trajectories, many pathways. Paller AS, et al. J Allergy Clin Immunol. 2019;143(1):46-55.

https://www.jacionline.org/article/S0091-6749(18)31638-5/fulltext

RESOURCE CENTER

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5216177/

»»Association of inadequately controlled disease and disease severity with patient-reported disease burden in adults with atopic dermatitis. Simpson EL, et al. JAMA Dermatol. 2018;154(8):903-912.

https://jamanetwork.com/journals/jamadermatology/fullarticle/2686155

Management of Atopic Dermatitis »»Goblet cell scarcity and conjunctival inflammation during treatment with dupilumab in patients with atopic dermatitis. Bakker DS, et al. Br J Dermatol. 2019;180(5):1248-1249. https://onlinelibrary.wiley.com/doi/full/10.1111/bjd.17538

»»Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Blauvelt A, et al. Lancet. 2017;389(10086):2287-2303. https://www.ncbi.nlm.nih.gov/pubmed/28478972

»»Atopic dermatitis yardstick: practical recommendations for an evolving therapeutic landscape. Boguniewicz M, et al. Ann Allergy Asthma Immunol. 2018;120(1):10-22. https://www.annallergy.org/article/S1081-1206(17)31260-7/pdf

»»Use of systemic corticosteroids for atopic dermatitis: International Eczema Council consensus statement. Drucker AM, et al. Br J Dermatol. 2018;178(3):768-775. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5901393/

»»Effectiveness and safety of dupilumab for the treatment of atopic dermatitis in a real-life French multicenter adult cohort. Faiz S, et al. J Am Acad Dermatol. 2019;81(1):143-151.

https://www.jaad.org/article/S0190-9622(19)30345-7/fulltext

»»Application of moisturizer to neonates prevents development of atopic dermatitis. Horimukai K, et al. J Allergy Clin Immunol. 2014;134(4):824-830. https://www.ncbi.nlm.nih.gov/pubmed/25282564

»»Anti-interleukin-31 receptor A antibody for atopic dermatitis. Ruzicka T, et al. N Engl J Med. 2017;376(9):826-835. https://www.ncbi.nlm.nih.gov/pubmed/?term=28249150

FACULTY

»»Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical corticosteroids: A randomized, placebo-controlled phase II trial (TREBLE). Simpson EL, et al. J Am Acad Dermatol. 2018;78(5):863-871. https://www.jaad.org/article/S0190-9622(18)30102-6/fulltext

»»When does atopic dermatitis warrant systemic therapy? Recommendations from an expert panel of the International Eczema Council. Simpson EL, et al. J Am Acad Dermatol. 2017;77(4):623-633. https://www.jaad.org/article/S0190-9622(17)31944-8/pdf

PREAMBLE

»»Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. Simpson EL, et al. N Engl J Med. 2016;375(24):2335-2348. www.pubmed.gov/27690741

»»Treatment of atopic dermatitis with tralokinumab, an anti-IL-13 mAb. Wollenberg A, et al. J Allergy Clin Immunol. 2019;143(1):135-141.

RESOURCE CENTER

https://www.jacionline.org/article/S0091-6749(18)30850-9/fulltext

NOTES

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