Looking Beneath The Surface In Atopic Dermatitis

Only health care professionals may attend this satellite symposium.

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

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

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

JEFFREY M.

FACULTY

FACULTY

Weinberg, MD

Associate Clinical Professor of Dermatology Icahn School of Medicine at Mount Sinai New York, New York, USA Director, Division of Dermatology Jamaica Hospital Medical Center Richmond Hill, New York, USA Dr. Jeffrey 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 ColumbiaPresbyterian 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.

3

MICHAEL J. FACULTY

Cork, BSc, MB, PhD, FRCP Head, Sheffield Dermatology Research Department of Infection, Immunity & Cardiovascular Disease Faculty of Medicine, Dentistry and Health The University of Sheffield Medical School Sheffield, United Kingdom Professor Michael Cork is Head of the Academic Unit of Dermatology Research at the University of Sheffield and is a Consultant Dermatologist to Sheffield Children’s Hospital and to Sheffield Teaching Hospitals National Health Service (NHS) Foundation Trusts. His main research is on the prevention and treatment of atopic dermatitis/atopic eczema (AD). Understanding how we can prevent AD involves investigating the interaction of environmental agents, such as detergents, oils, and hard water, with the skin of a baby from birth. From this, we develop interventions such as new emollients and wash products, and we assess how they affect the skin barrier of a baby from birth and the development of AD. With Dr. Simon Danby and their Skin Barrier Team, Professor Cork has developed a research facility that uses a unique combination of techniques to assess how topical wash products, emollients, and topical/systemic pharmaceutical agents affect the integrity of the skin barrier and inflammation. They use this to compare the effects of different treatments for AD on multiple biomarkers to determine the most cost-effective and safe methods to use new and existing therapies for AD. In addition to being a Skin Barrier clinical research facility (CRF), Sheffield Dermatology Research collaborates closely with the CRFs for adult dermatology at Sheffield Teaching Hospitals and for children at Sheffield Children’s Hospital. Professor Cork has been the chief investigator for many of the clinical trials of biologic drugs for adults and children with AD in the United Kingdom. His team has recruited 2500 patients to clinical trials and experimental medicine studies of treatments and preventive regimens for AD in the past 5 years.

4

ERIC L.

FACULTY

Simpson, MD, MCR Professor of Dermatology Director, Clinical Research Department of Dermatology Oregon Health & Science University Portland, Oregon, USA Dr. Eric Simpson is a Professor of Dermatology at Oregon Health & Science University. As Director of the Clinical Studies Unit, he is involved in clinical research funded by the National Institutes of Health and industry partners to study new approaches to chronic skin disease treatment and prevention.

Dr. Simpson supports medical professional education and regularly instructs residents and medical students in dermatology. Additionally, he has published over 80 scientific articles in several high-impact peer-reviewed journals, including The New England Journal of Medicine and The Lancet.

Recognized internationally, he has spoken about his approach to patient care and research at over 20 international conferences in Europe, North and South America, and Asia.

Dr. Simpson volunteers in support of the National Eczema Association, where he serves as Co-Chair of the Scientific Advisory Committee. He also serves on the executive committee of Harmonizing Outcome Measures in Eczema (HOME)—a group of patients, providers, and other stakeholders whose mission is to improve the quality of eczema research to better suit the needs of patients and policy makers.

Dr. Simpson enjoys spending time with his wife and children, playing squash, camping, hiking, fishing, and biking.

5

TARGET AUDIENCE

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

PREAMBLE

STATEMENT of NEED/PROGRAM OVERVIEW

Atopic dermatitis is a chronic inflammatory condition that primarily manifests in the skin, although studies continue to elucidate effects in other organ systems throughout the body.1 An increasing prevalence over the last 2 decades has added to tremendous disease-related burdens faced by patients, family members, and caregivers.1,2 Current insights into atopic dermatitis pathophysiology and its widespread effects on patient health and quality of life support efforts to accelerate diagnoses and proactive management.3,4 Moreover, research into the dysregulated cellular and molecular immune processes underlying the pathogenesis and progression of atopic dermatitis has led to new approaches to disease characterization and treatment.5,6 This Interactive Exchange™ program will open with a brief 3D-animated video focused on the pathophysiologic underpinnings of atopic dermatitis. Expert faculty will then discuss best practices for comprehensive patient evaluations and the clinical profiles of systemic treatment options for patients with moderate-to-severe disease. With an overall goal of improving patient outcomes, this educational session has been designed to allow internationally recognized experts to translate the latest published evidence into actionable recommendations for individualized patient care.

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. 2017;137(3):603-613.

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

6

EDUCATIONAL OBJECTIVES

PREAMBLE

After completing this activity, the participant should be better able to: • Discuss pathophysiologic mechanisms and risk factors that contribute to atopic dermatitis development and persistence, including potential treatment targets • Evaluate patients with atopic dermatitis over time for persistent symptoms, comorbidities, and treatment responses • Describe the clinical profiles of current and emerging biologic therapies for moderate-to-severe atopic dermatitis • Tailor long-term therapy for moderate-to-severe atopic dermatitis to prevent exacerbations, maximize health-related quality of life, manage comorbidities, and minimize adverse events • Educate patients and caregivers to improve their understanding of atopic dermatitis, provide Action Plans to reduce exacerbations, and promote 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 1.5 AMA PRA Category 1 Credits™. 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 program evaluation form.

7

FEE INFORMATION & REFUND/CANCELLATION POLICY

There is no fee for this educational activity.

PREAMBLE

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 Regeneron Pharmaceuticals, Inc.

Grant/Research Support:

Michael J. Cork, BSc, MB, PhD, FRCP Consultant/Independent Contractor: AbbVie Inc., Astellas Pharma US, Inc., GlaxoSmithKline plc, Hyphens Pharma Pte Ltd., Johnson & Johnson Services, Inc., LEO Pharma Inc., Novartis Pharmaceuticals Corporation, Pfizer Inc., Regeneron Pharmaceuticals, Inc., sanofi-aventis U.S. LLC; Grant/Research Support: Astellas Pharma US, Inc., Johnson & Johnson Services, Inc., LEO Pharma Inc., Regeneron Pharmaceuticals, Inc., sanofi-aventis U.S. LLC; Honoraria: AbbVie Inc., Astellas Pharma US, Inc., GlaxoSmithKline plc, Hyphens Pharma Pte Ltd., Johnson & Johnson Services, Inc., LEO Pharma Inc., Novartis Pharmaceuticals Corporation, Pfizer Inc., Regeneron Pharmaceuticals, Inc., sanofi-aventis U.S. LLC. Eric L. Simpson, MD, MCR Consultant/Independent Contractor: Celgene Corporation, Dermira, Inc., Galderma Laboratories, L.P., Genentech, Inc., GlaxoSmithKline plc, Pfizer Inc., sanofi-aventis U.S. LLC; Grant/Research Support: Celgene Corporation, Dermira, Inc., Galderma Laboratories, L.P., Genentech, Inc., GlaxoSmithKline plc, Pfizer Inc., Regeneron Pharmaceuticals, Inc., sanofi-aventis U.S. LLC; Royalty: Regeneron Pharmaceuticals, Inc.

8

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: Andrea Funk

Nothing to disclose

Ashley Marostica RN, MSN

Nothing to disclose

Jim Kappler, PhD

Nothing to disclose

Rose O’Connor, PhD

Nothing to disclose

DISCLOSURE of UNLABELED USE

PREAMBLE

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 (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.

9

SLIDES

10

SLIDES

11

SLIDES

12

SLIDES

13

SLIDES

14

SLIDES

15

SLIDES

16

SLIDES

17

SLIDES

18

SLIDES

19

SLIDES

20

SLIDES

21

SLIDES

22

SLIDES

23

SLIDES

24

SLIDES

25

SLIDES

26

GUIDELINES »»Guidelines for treatment of atopic eczema (atopic dermatitis): part 1.

Ring J, et al. J Eur Acad Dermatol Venereol. 2012;26(8):1045-1060. http://onlinelibrary.wiley.com/ doi/10.1111/j.1468-3083.2012.04635.x/epdf

»»Guidelines for treatment of atopic eczema (atopic dermatitis): part 2.

Ring J, et al. J Eur Acad Dermatol Venereol. 2012;26(9):1176-1193. http://onlinelibrary.wiley.com/ doi/10.1111/j.1468-3083.2012.04636.x/epdf

»»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.

RESOURCE CENTER

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

27

PATIENT RESOURCES »»DermNet New Zealand DermNet New Zealand was founded in 1995 and has become a world-renowned resource all about the skin. Its mission is to make authoritative information about the skin accessible to anyone in the world with an Internet connection. http://www.dermnetnz.org/topics/atopic-eczema

»»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/

»»National Eczema Society

RESOURCE CENTER

Formed in 1975, the National Eczema Society has two principal aims: first, to provide people with independent and practical advice about treating and managing eczema; second, to raise awareness about the needs of those with eczema among health care professionals, teachers, and the government. http://www.eczema.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-reportform-for-age-8-years-and-over.pdf

28

»»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 »»American Academy of Dermatology 75th Annual Meeting Posters.

March 3-7, 2017; Orlando, FL, USA. https://www.aad.org/eposters/view/meeting.aspx?id=45

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

Arkwright PD, et al. J Allergy Clin Immunol. 2013;1(2):142-151. http://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, placebocontrolled, phase 3 trial.

RESOURCE CENTER

Blauvelt A, et al. Lancet. 2017;389(10086):2287-2303. https://www.ncbi.nlm.nih.gov/pubmed/28478972

»»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.

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

29

»»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. Pediatr 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. http://www.pubmed.gov/27690741

»»Eczema and cardiovascular risk factors in 2 US adult population studies.

RESOURCE CENTER

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

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

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

30

NOTES

31

NOTES

32

NOTES

33

NOTES

34

Please visit the CLINICAL RESOURCE CENTER for additional information and resources

www.EXCHANGECME.com/ADRESOURCES17

© 2017 Global Education Group and Integritas Communications.

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.