Beyond Scratching the Surface

This activity is jointly provided by Global Education Group and Integritas Communications.

This activity is supported by an educational grant from Genzyme, a Sanofi Company, and Regeneron Pharmaceuticals.

This symposium is independently organized and not an official part of the Skin Disease Education Foundation’s 41st Hawaii Dermatology Seminar. CME/CE credit is provided for this symposium.

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

FACULTY FACULTY

JEFFREY M. Weinberg, MD Associate Clinical Professor of Dermatology Mount Sinai School of Medicine New York, New York Director, Division of Dermatology Jamaica Hospital Medical Center Richmond Hill, New York

Dr. Jeffrey M. Weinberg is an associate clinical professor of dermatology at the Mount Sinai School of Medicine in New York City. In addition, he is acting director of the Division of Dermatology at Jamaica Hospital Medical Center. Dr. Weinberg graduated from the University of Pennsylvania School of Medicine in Philadelphia and completed an internship in medicine at Columbia-Presbyterian Medical Center in New York City. He then completed a residency in dermatology at the University of Pennsylvania School of Medicine.

Dr. Weinberg is a Fellow of the American Academy of Dermatology, where he has served on several committees, and a member of the Dermatology Foundation. He is a diplomate of the American Board of Dermatology.

Dr. Weinberg is on the editorial board and is a Senior Editor of Cutis. He is also an Associate Editor of the Journal of the American Academy of Dermatology. He is a member of the Medical Board of the National Psoriasis Foundation. His clinical research encompasses a variety of dermatology-related topics, including studies of diagnostic methods in the evaluation of onychomycosis. He has been principal or co-investigator for several clinical trials. In addition, he has written or co-authored numerous articles for professional journals such as Cutis, the Journal of the American Academy of Dermatology, and Blood, as well as reviews, book chapters, and abstracts.

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LAWRENCE F. Eichenfield, MD FACULTY

Professor of Dermatology and Pediatrics Vice Chair, Department of Dermatology University of California, San Diego, School of Medicine Chief, Pediatric and Adolescent Dermatology Rady Children’s Hospital and Health Center San Diego, California

Dr. Lawrence F. Eichenfield is Chief of Pediatric and Adolescent Dermatology at Rady Children’s Hospital- San Diego, Vice Chair of the Department of Dermatology, and Professor of Dermatology and Pediatrics at the University of California, San Diego (UCSD) School of Medicine. He received his medical degree from Mount Sinai School of Medicine in New York, was a pediatric resident and Chief Resident at Children’s Hospital of Philadelphia, and completed his dermatology residency at the Hospital of the University of Pennsylvania.

Dr. Eichenfield’s clinical interests include atopic dermatitis, acne, psoriasis, vascular lesions including port wine stains and hemangiomas, neonatal dermatology, laser surgery, nevi, and skin signs of systemic disease. He has authored more than 300 journal articles, chapters, abstracts, and books on these topics and has served as the senior editor of Neonatal and Infant Dermatology, published by Elsevier, as well as The Eczemas, published by Summit Communications. He is also Editor-in-Chief of Pediatric Dermatology and serves on the editorial boards of multiple journals and periodicals.

Dr. Eichenfield was honored as a member of the Alpha Omega Alpha Medical Honor Society during medical school, as a recipient of the Benjamin Ritter Award at Children’s Hospital of Philadelphia, and as a recipient of excellence in teaching awards from UCSD Pediatrics, UCSD Dermatology, and Rady Children’s Hospital- San Diego. Named one of the “Best Doctors in America” since 1994, Dr. Eichenfield is past president of the Society of Pediatric Dermatology, past Board member of the American Academy of Dermatology as well as Chair for the upcoming 69th Annual Meeting of the American Academy of Dermatology. Dr. Eichenfield is also a founding board member of the American Acne and Rosacea Society and the founder and Co-Chair of Pediatric Dermatology Research Alliance (PeDRA).

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HOWARD Sofen, MD FACULTY

Associate Clinical Professor of Medicine/ Dermatology and Pediatrics University of California, Los Angeles (UCLA) David Geffen School of Medicine Chief of Dermatology Los Angeles County/Olive View-UCLA Medical Center Los Angeles, California

Dr. Howard Sofen is a board-certified dermatologist who has been practicing in the Los Angeles area for over 30 years. He is an Associate Clinical Professor of Dermatology at the David Geffen School of Medicine and currently serves as the Dermatology Division Chief at UCLA- Olive View Medical Center. He completed his undergraduate degree at UCLA in biochemistry followed by graduate work in immunology. He subsequently completed his medical degree at Hahnemann University Medical College in Philadelphia, Pennsylvania, and his dermatology residency training at UCLA. He has been an author on many publications, and for over 12 years has served as a principal investigator for numerous clinical trials, focusing on inflammatory skin diseases such as atopic dermatitis, psoriasis, urticaria, and rosacea, as well as skin cancer.

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TARGET AUDIENCE The educational design of this activity addresses the needs of dermatologists and other healthcare professionals involved in the treatment of patients with atopic dermatitis.

PREAMBLE

STATEMENT of NEED/ PROGRAM OVERVIEW Atopic dermatitis is a chronic inflammatory condition with manifestations in the skin and other organ systems throughout the body.1 Increasing in prevalence over the last 2 decades, the disease places tremendous burdens on adult, adolescent, and pediatric patients, as well as family members and caregivers.1,2 A better understanding of disease pathophysiology and effects on patient health and quality of life highlight the need for prompt diagnosis and proactive management.3,4 Moreover, research into the mechanisms underlying atopic dermatitis pathogenesis and progression supports the development of new approaches to disease characterization, ongoing patient monitoring, and treatment.5,6 During this Evidence-Based Best Practices™ program, expert faculty will discuss clinically relevant disease pathophysiology; comprehensive patient evaluations; the efficacy and safety of current therapies for moderate-tosevere disease; and the latest evidence for emerging biologic agents. With the overall goal of improving outcomes for patients with active atopic dermatitis, the program will integrate clinical data and professional experience into actionable recommendations that can be used to individualize care and improve patient-clinician communication.

REFERENCES

1. Nutten S. Atopic dermatitis: global epidemiology and risk factors. Ann Nutr Metab.

2015:66(suppl 1):8-16.

2. 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.

3. Eichenfield LF, et al. Guidelines of care for the management of atopic dermatitis: section 1.

Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70(2):338-351.

4. Sidbury R, et al. Guidelines of care for the management of atopic dermatitis: section 3.

Management and treatment with phototherapy and systemic agents. J Am Acad Dermatol.

2014;71(2): 327-349.

5. Ungar B, et al. An integrated model of atopic dermatitis biomarkers highlights the systemic nature of the disease. J Invest Dermatol. 2016 Nov 4. [Epub ahead of print].

6. Simpson EL, et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis.

N Engl J Med. 2016;375(24):2235-2348.

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EDUCATIONAL OBJECTIVES After completing this activity, the participant should be better able to: • Discuss atopic dermatitis pathophysiology, focusing on clinically relevant disease mechanisms, risk factors, and novel therapeutic targets • Comprehensively assess patients with atopic dermatitis to determine symptom severity, characterize potential phenotypes, identify comorbidities, and document treatment responses

• Individualize therapy for moderate-to-severe atopic dermatitis to prevent outbreaks, maximize health-related quality of life, manage comorbidities, and minimize treatment-related adverse effects • Communicate with patients and, when necessary, caregivers to improve their understanding of atopic dermatitis and secondary complications, while facilitating shared 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.

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PREAMBLE

• Describe the clinical profiles of current and emerging biologic therapies for moderate-to-severe atopic dermatitis

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

FEE INFORMATION & REFUND/ CANCELLATION POLICY PREAMBLE

There is no fee for this educational activity.

DISCLOSURE of CONFLICTS of INTEREST Global Education Group (Global) requires instructors, planners, managers, and other individuals and their spouses/life partners who are in a position to control the content of this activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly vetted by Global for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations.

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 CME activity: Jeffrey M. Weinberg, MD Grant/Research Support: Regeneron Pharmaceuticals, Inc. Lawrence F. Eichenfield, MD Consultant/Independent Contractor: Anacor Pharmaceuticals, Inc.; Eli Lilly and Company; Genentech, Inc.; Medimetriks Pharmaceuticals, Inc.; Otsuka America Pharmaceutical, Inc.; Pfizer Inc.; Regeneron Pharmaceuticals, Inc.; sanofi-aventis U.S. LLC.; Top MD, Inc.; Valeant Pharmaceuticals International, Inc. Grant/Research Support: Regeneron Pharmaceuticals, Inc.; sanofi-aventis U.S. LLC. Howard Sofen, MD Consultant/Independent Contractor: Celgene Corporation; Regeneron Pharmaceuticals, Inc. Roche Laboratories, Inc. Grant/Research Support: AbbVie Inc.; AstraZeneca; Celgene Corporation; DermAvance Pharmaceuticals, Inc.; Glenmark Pharmaceuticals Inc.; Incyte Corporation; Pfizer Inc.; Regeneron Pharmaceuticals, Inc.; Roche Laboratories, Inc. Honoraria: Regeneron Pharmaceuticals, Inc. Speakers Bureau: Genentech, Inc.; Novartis Pharmaceuticals Corporation.

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The planners and managers 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 CME activity: Lindsay Scott

Nothing to disclose

Andrea Funk

Nothing to disclose

Laura Gilsdorf

Nothing to disclose

Jim Kappler, PhD

Nothing to disclose

Rose O’Connor, PhD

Nothing to disclose

PREAMBLE

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

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.

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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

PATIENT RESOURCES RESOURCE CENTER

»»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

»»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. http://www.nationaleczema.org

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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-form-for-age-8years-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

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

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

»»Translating atopic dermatitis management guidelines into practice for primary care providers.

Eichenfield LF, et al. Pediatrics. 2015;136(3):554-565.

RESOURCE CENTER

http://pediatrics.aappublications.org/content/pediatrics/136/3/554.full.pdf

»»Persistence of mild to moderate atopic dermatitis.

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

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»»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

»»Serious complications from staphylococcal aureus in atopic dermatitis.

Patel D, Jahnke MN. Ped Dermatol. 2015;32(6):792-796. http://www.pubmed.gov/26337792

»»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. http://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

»»Childhood atopic dermatitis and warts are associated with increased risk of infection: a US population-based study.

Silverberg JI, Silverberg NB. J Allergy Clin Immunol. 2014;133(4):1041-1047.

RESOURCE CENTER

http://www.jacionline.org/article/S0091-6749(13)01294-3/pdf

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Please visit the CLINICAL RESOURCE CENTER for additional information and resources

www.EXCHANGECME.com/ADResources

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All rights reserved. No part of this syllabus may be used or reproduced in any manner whatsoever without written permission except in the case of brief quotations embedded in articles or reviews.