Clinical Issues in Atopic Dermatitis

Debates & Discussions About Managing Moderateto-Severe Disease

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

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

This symposium is independently organized and not an official part of the Skin Disease Education Foundation’s 42nd Hawaii Dermatology Seminar.

CME/CE credit is provided for this symposium.

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

MARK BOGUNIEWICZ, MD

FACULTY

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-toSevere 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.

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ERIC L. SIMPSON, MD, MCR FACULTY

Professor of Dermatology Director, Clinical Research Department of Dermatology Oregon Health & Science University Portland, Oregon

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.

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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.

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 patients’ 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-tosevere disease and several other agents are in late-stage clinical development.7 To best serve their patients with difficult-to-treat atopic dermatitis, 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 Issues™ 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.

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PREAMBLE

STATEMENT OF NEED/PROGRAM OVERVIEW

PREAMBLE

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 • 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

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 program evaluation.

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FEE INFORMATION & REFUND/CANCELLATION POLICY There is no fee for this educational activity.

DISCLOSURE OF CONFLICTS OF INTEREST

PREAMBLE

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: Mark Boguniewicz, MD Consultant/Independent Contractor: Pfizer Inc., Regeneron Pharmaceuticals, Inc., Sanofi Genzyme; Grant/Research Support: Regeneron Pharmaceuticals, Inc.; Speakers Bureau: Regeneron Pharmaceuticals, Inc., Sanofi Genzyme Eric L. Simpson, MD, MCR Consultant/Independent Contractor: AbbVie Inc., Eli Lilly and Company, Galderma Laboratories, L.P., LEO Pharma Inc., Menlo Therapeutics Inc., Pfizer Inc., Regeneron Pharmaceuticals, Inc., Sanofi Genzyme; Grant/Research Support: Eli Lilly and Company, GlaxoSmithKline, Novartis Pharmaceuticals Corporation, Regeneron Pharmaceuticals, Inc., Vanda Pharmaceuticals Inc. 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: Ashley Marostica, RN, MSN

Nothing to disclose

Lindsay Borvansky

Nothing to disclose

Andrea Funk

Nothing to disclose

Liddy Knight

Nothing to disclose

Rose O’Connor, PhD, CHCP

Nothing to disclose

DISCLOSURE OF UNLABELED USE

This educational activity may contain discussion of published and/or 7

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.

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.

PREAMBLE

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

»»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

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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

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SUGGESTED READING »»American Academy of Dermatology 75th Annual Meeting Posters. March 3-7, 2017. Orlando, Florida. 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. 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

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

»»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

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RESOURCE CENTER

»»Persistence of mild to moderate atopic dermatitis.

»»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. 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

RESOURCE CENTER

»»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

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Please visit the CLINICAL RESOURCE CENTER for additional information and resources

www.EXCHANGECME.com/ADRESOURCES18

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