Clinical Issues in Atopic Dermatitis by Integritas Communications

Debates & Discussions About Managing Moderateto-Severe Disease

This activity is provided by Integritas Communications. This activity is supported by an independent educational grant from Sanofi Genzyme and Regeneron Pharmaceuticals. This program is not sponsored or programmed by the AAAAI/WAO. This live activity will not offer continuing medical education (CME) credit.

CME/MEDICAL COMMUNICATIONS INQUIRIES info@integritasgrp.com integritasgrp.com

LISA A. BECK, MD

FACULTY

Deanâ&#x20AC;&#x2122;s Professor of Dermatology Departments of Dermatology and Medicine Divisions of Dermatology, Allergy/Immunology, and Rheumatology University of Rochester Medical Center Rochester, New York Dr. Lisa A. Beck is driven by a passion to improve the lives of people who suffer from life-altering skin diseases, dedicating more than 25 years to the quest for safe, effective treatments for patients with atopic dermatitis (or eczema) and chronic urticaria (or hives). Internationally recognized as an eczema expert, she conducted research that was instrumental in the development of the first biologic drug, dupilumab, for the treatment of adults with moderate-to-severe eczema. She was the lead author of a 2014 New England Journal of Medicine paper that set the stage for the US Food and Drug Administration approval of this drug in March 2017. Dr. Beck is currently involved in a National Institutes of Health (NIH)â&#x20AC;&#x201C;funded study to determine why certain atopic dermatitis patients are susceptible to widespread skin infections with herpes simplex virus or with the bacteria Staphylococcus aureus. Dr. Beck received her undergraduate degree from Mount Holyoke College and her medical degree from the State University of New York at Stony Brook.

MARK BOGUNIEWICZ, MD FACULTY

Professor, Division of Pediatric Allergy-Immunology Department of Pediatrics National Jewish Health University of Colorado School of Medicine Denver, Colorado

Dr. Mark Boguniewicz is a Professor in the Division of Allergy-Immunology, Department of Pediatrics, at National Jewish Health and University of Colorado School of Medicine. After obtaining his medical degree in Warsaw, Poland, he completed his residency in pediatrics at Children’s Hospital of Michigan in Detroit and fellowships in allergy-immunology and rheumatology at Children’s Hospital and Harvard Medical School in Boston, Massachusetts. He is board certified in pediatrics and allergy-immunology. Dr. Boguniewicz is a Fellow of the American Academy of Allergy, Asthma, and Immunology (AAAAI), past Chair of the Dermatologic and Ocular Diseases Interest Section, past Chair of the Eczema Committee, and on the editorial board of Journal of Allergy and Clinical Immunology: In Practice. He is also a Fellow of the American College of Allergy, Asthma, and Immunology (ACAAI). He served on the Joint Task Force on Topical Calcineurin Inhibitors of the AAAAI and ACAAI and was co-chair of the treatment section of the European Academy of Allergy and Clinical Immunology (EAACI)/AAAAI/PRACTALL Consensus Group for atopic dermatitis. He served on the Joint Task Force of the AAAAI/ACAAI for the 2004 and 2012 Practice Parameter for Atopic Dermatitis, co-chaired the Expert Panel on Management of Moderate-to-Severe Atopic Dermatitis, and chaired the Atopic Dermatitis Yardstick project. Dr. Boguniewicz’s research focuses on immunopathogenesis and new treatments for atopic dermatitis. He is an investigator of the National Institutes of Health (NIH) Atopic Dermatitis Research Network. He has lectured at many national and international meetings and has over 350 published, peer-reviewed articles, reviews, chapters, and abstracts. He received the 1998-1999, 2010-2011, 20112012, 2012-2013, 2015-2017 Pediatric Allergy-Immunology Fellows Outstanding Teacher Award, the 2002 Faculty Clinician of the Year Award, the 2006 AAAAI’s Richard S. Farr Memorial Lectureship, and the 2013 AAAAI Distinguished Clinical Award. He has also been selected for Best Doctors in America 2003-2018.

CHARLES N. ELLIS, MD

FACULTY

William B. Taylor Professor of Clinical Dermatology Associate Chair, Department of Dermatology University of Michigan Medical School Ann Arbor, Michigan Dr. Charles N. Ellis is the William B. Taylor Professor in the Department of Dermatology at the University of Michigan Medical School and Chief of the Dermatology Service at the Ann Arbor Veterans Affairs Health System, both in Ann Arbor, Michigan. In the University of Michigan Department of Dermatology, he served as the Director of Residency Training Program for 30 consecutive years and has been Associate Chair for 15 years; for the University of Michigan Health System, Dr. Ellis has served as Director of the Department of Service Excellence. In 2000, Dr. Ellis initiated the service excellence program in the Department of Dermatology. Since then, the Department continuously has ranked number one in patient satisfaction in the University of Michigan Health System. Dr. Ellis has coached departments and health systems from coast to coast on providing the best in customer service. Dr. Ellis received his medical degree from the University of Michigan Medical School, receiving the Dean’s Award for Research. Following his residency in the University’s Department of Dermatology, he became a diplomate of the American Board of Dermatology. Named one of the Best Doctors in America each year since 1994, he is listed in the Guide to Top Doctors and the Guide to America’s Top Physicians and recognized as a “doctor’s doctor” in the University of Michigan Health System. Dr. Ellis has published more than 250 journal articles and book chapters. A citation analysis found him to be among the dozen most-referenced dermatologists in the world, reflecting the importance of his published papers in both dermatology and high-impact general medical journals (including The New England Journal of Medicine), in which he has published 5 papers. For his papers published in high-impact general medical journals, he is the third-most cited first author with two of his papers each cited over 200 times. Dr. Ellis has received the University of Michigan H. R. Johnson Award for Leadership in Diversity, and the Director’s Award at the Ann Arbor Veterans Affairs Health System. A member of numerous professional organizations, he has held a number of visiting professorships and served on the editorial boards of various journals. 5

TARGET AUDIENCE

The educational design of this activity addresses the needs of allergists/clinical immunologists, dermatologists, 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 potential deleterious effects in other organ systems throughout the body.1,2 The multifactorial biopsychosocial burdens of atopic dermatitis often markedly reduce patientsâ&#x20AC;&#x2122; quality of life, particularly in those with moderate-to-severe disease.3,4 A better understanding of atopic dermatitis etiology has supported the development of new approaches to disease characterization and targeted therapies.5,6 Indeed, the first biologic medication is now available to treat patients with moderate-to-severe disease and several other agents are in late-stage clinical development.7 To best serve their patients with difficult-to-treat atopic dermatitis, allergists/clinical immunologists and dermatologists can benefit from updates on the latest clinical trial data and practical recommendations on how the growing evidence pool should be translated into daily clinical decision-making for patient assessment and treatment.7,8 In this Clinical Issuesâ&#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 moderate-to-severe disease. Attendees are sure to leave this lively and engaging program with new information and a fresh perspective on the evolving best practices for managing patients with atopic dermatitis.

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. Whiteley J, et al. The burden of atopic dermatitis in US adults: results from the 2013 National Health and Wellness Survey. Curr Med Res Opin. 2016;32(10):1645-1651.

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. Ungar B, et al. An integrated model of atopic dermatitis biomarkers highlights the systemic nature of the disease. J Invest Dermatol. 2017;137(3):603-613.

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 • Describe the mechanistic rationales and clinical evidence for current and emerging biologic therapies in the treatment of moderate-to-severe atopic dermatitis • Individualize long-term therapeutic regimens for moderate-to-severe atopic dermatitis to prevent exacerbations, manage comorbidities, maximize healthrelated 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 6:00 pm – 6:30 pm

Registration and Dinner

6:30 pm – 6:50 pm

Introduction to Atopic Dermatitis Pathophysiology

6:50 pm – 7:10 pm Comprehensive Patient Evaluations of Severe Disease Manifestations 7:10 pm – 7:30 pm

I ndividualizing Therapy for Patients With Moderate-to-Severe Atopic Dermatitis

7:30 pm – 7:50 pm Long-term Management of Patients With Moderate-to-Severe Atopic Dermatitis 7:50 pm – 8:10 pm

Case Study Discussion

8:10 pm – 8:30 pm

Postassessment and Question and Answer Session

DISCLOSURE OF CONFLICTS OF INTEREST

It is the policy of the Integritas Communications that all faculty, instructors, and planners disclose any real or apparent conflicts of interest relating to the topics of this educational activity.

PREAMBLE

EDUCATIONAL OBJECTIVES

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

Lisa A. Beck, MD Consultant/Advisor: AbbVie Inc.; AnaptysBio, Inc.; Asana BioSciences, LLC; Boehringer-Ingelheim Pharmaceuticals, Inc.; Celgene Corporation; Eli Lilly and Company; GlaxoSmithKline; Janssen Pharmaceuticals, Inc.; Novan, Inc.; Novartis Pharmaceuticals Corporation; Realm Therapeutics, Inc.; Regeneron Pharmaceuticals, Inc.; Sanofi Genzyme; Stock Ownership: Medtronic plc; Pfizer Inc.; Grant/Research Support: AbbVie Inc.; Regeneron Pharmaceuticals, Inc. Mark Boguniewicz, MD Consultant/Advisor: Pfizer Inc.; Regeneron Pharmaceuticals, Inc.; Sanofi Genzyme; Grant/Research Support: Regeneron Pharmaceuticals, Inc.; Speakers Bureau: Regeneron Pharmaceuticals, Inc.; Sanofi Genzyme Charles N. Ellis, MD Consultant/Advisor: AbbVie Inc.; Gilead Sciences, Inc.; GlaxoSmithKline; Medimetriks Pharmaceuticals, Inc.; Novartis Pharmaceuticals Corporation; Otsuka America Pharmaceutical, Inc.; Perrigo Company plc.

Nonfaculty

Rose Oâ&#x20AC;&#x2122;Connor, PhD, CHCP and Jim Kappler, PhD 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 INFORMATION

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

DISCLAIMER

PREAMBLE

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.

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

»»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. www.eczemacouncil.org

RESOURCE CENTER

PATIENT RESOURCES

»»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 »»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-formfor-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. https://www.ncbi.nlm.nih.gov/pubmed/26685719

»»Patient-Oriented Eczema Measure (POEM)

The POEM is a patient-administered measurement tool designed to assess occurrence and frequency of atopic dermatitis symptoms during the previous week through a simple 5-point scale, with a maximum total score of 28. Charman CR, et al. Arch Dermatol. 2004;140(12):1513-1519. https://jamanetwork.com/journals/jamadermatology/ fullarticle/480876

»»Scoring Atopic Dermatitis (SCORAD)

RESOURCE CENTER

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 »»Management of difficult-to-treat atopic dermatitis.

Arkwright PD, et al. J Allergy Clin Immunol. 2013;1(2):142-151. www.pubmed.gov/24565453

»»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

»»Dupilumab with concomitant topical corticosteroids in adult patients with atopic dermatitis who are not adequately controlled with or are intolerant to ciclosporin A, or when this treatment is medically inadvisable: a placebo-controlled, randomized phase 3 clinical trial (LIBERTY AD CAFÉ). de Bruin-Weller M, et al. Br J Dermatol. November 2017. [Epub ahead of print.] http://onlinelibrary.wiley.com/doi/10.1111/bjd.16156/epdf

»»Translating atopic dermatitis management guidelines into practice for primary care providers. Eichenfield LF, et al. Pediatrics. 2015;136(3):554-565. http://pediatrics.aappublications.org/content/pediatrics/136/3/554.full.pdf

»»Persistence of mild to moderate atopic dermatitis.

»»Association between atopic dermatitis and serious cutaneous, multiorgan and systemic infections in US adults. Narla S, Silverberg JI. Ann Allergy Asthma Immunol. 2018;120(1):66-72. http://www.annallergy.org/article/S1081-1206(17)31186-9/pdf

»»Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. Paller AS, et al. J Am Acad Dermatol. 2016;75(3):494-503. http://www.jaad.org/article/S0190-9622(16)30330-9/pdf

RESOURCE CENTER

Margolis JS, et al. JAMA Dermatol. 2014;150(6):593-600. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4352328/pdf/nihms665922.pdf

»»Serious complications from staphylococcal aureus in atopic dermatitis. Patel D, Jahnke MN. Ped Dermatol. 2015;32(6):792-796. www.pubmed.gov/26337792

»»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

»»Patient burden of moderate to severe atopic dermatitis (AD): insights from a phase 2b clinical trial of dupilumab in adults. Simpson EL, et al. J Am Acad Dermatol. 2016;74(3):491-498. http://www.jaad.org/article/S0190-9622(15)02471-8/pdf

»»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

»»Eczema and cardiovascular risk factors in 2 US adult population studies. Silverberg JI, Greenland P. J Allergy Clin Immunol. 2015;135(3):721-728. http://www.jacionline.org/article/S0091-6749(14)01677-7/pdf

»»The burden of atopic dermatitis in US adults: results from the 2013 National Health and Wellness Survey.

RESOURCE CENTER

Whiteley J, et al. Curr Med Res Opin. 2016;32(10):1645-1651. https://www.ncbi.nlm.nih.gov/pubmed/?term=27240604

Please visit the CLINICAL RESOURCE CENTER for additional information and resources

www.EXCHANGECME.com/ADRESOURCES18

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