Evolving Management Strategies for Moderate-to-Severe Atopic Dermatitis

Looking Beyond Barriers to Optimize Therapy

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.

Only health care professionals may attend this satellite symposium.

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

MARJOLEIN DE BRUIN-WELLER, MD, PhD

FACULTY

FACULTY

Head, National Expertise Center for Atopic Dermatitis Department of Dermatology/Allergology University Medical Center Utrecht Utrecht, The Netherlands

Dr. Marjolein de Bruin-Weller is head of the National Expertise Center for Atopic Dermatitis, situated in the Department of Dermatology and Allergology of the University Medical Center of Utrecht, The Netherlands.

Dr. de Bruin-Weller graduated from the University of Leiden. Thereafter she worked as a research fellow in Astmacentrum Heideheuvel (Hilversum) and the Department of Pulmonology, Academic Medical Center Amsterdam (Prof H.M. Jansen), leading to a PhD in 1997 (Prof J.G.R. de Monchy, University Medical Center Groningen). She completed her residency program in dermatology and venereology in the Department of Dermatology and Allergology at the University Medical Center Utrecht, after which she became a staff member.

Her major interest is clinical and translational research in atopic dermatitis. She is principal investigator in several studies focused on difficult-to-treat atopic dermatitis and systemic immunosuppressive and immunomodulating treatment.

Dr. de Bruin-Weller is a member of the Expertise Group Allergy and Eczema (Dutch Society of Dermatology and Venereology), the European Task Force of Atopic Dermatitis (ETFAD), and the International Eczema Council (IEC). She is chair of the advisory board of the Dutch Patient Society for Atopic Dermatitis (VMCE).

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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, 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.

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FACULTY

ANDREAS WOLLENBERG, MD, PhD Professor Department of Dermatology and Allergy Ludwig-Maximilian University of Munich Munich, Germany

Prof Dr. med. Dr. h.c. Andreas Wollenberg is a dermatologist and allergist and Professor in the Department of Dermatology and Allergy, Ludwig-Maximilian University of Munich, Germany. He is board certified in dermatology and venereology and holds subspecialty certification in allergology, andrology, and infectious diseases. He is a Doctor honoris causa of the Medical University of Cluj-Napoca.

Prof. Wollenberg is an international expert on atopic dermatitis. His research interests include dendritic cells in inflammatory skin diseases, topical immunomodulating therapy, and drug-induced skin toxicity. In addition to preclinical studies, he is involved in multiple clinical trials and translational research projects relating to atopic dermatitis, perioral dermatitis, pediatric dermatology, graft-versus host disease, and epidermal growth factor receptor inhibitor–induced skin toxicity. He coined the term ‘proactive therapy’ of atopic dermatitis.

Prof. Wollenberg is currently secretary of the International Society of Atopic Dermatitis (ISAD) and leads the European Task Force on Atopic Dermatitis (ETFAD) of the European Academy of Dermatology and Venerology (EADV). He has authored more than 180 papers in peer-reviewed international journals and on PubMed, achieved a Hirsch index of 48, and is an editorial board member and regular reviewer for many biomedical journals.

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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

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 atopic dermatitis can have a substantial effect on 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 As a result, the first biologic therapy is now available to treat patients with moderate-to-severe disease, and several other therapies are in late-stage clinical development.7-10 With novel therapies emerging for patients with difficultto-treat atopic dermatitis, dermatologists will stand to benefit from updates on the latest clinical trial data and practical recommendations on how to translate those results into daily clinical decision-making. In this Evidence-Based Best Practices™ program, internationally recognized experts will review the latest published evidence with a goal of providing recommendations to enhance overall patient outcomes. The expert faculty panel will discuss the pathophysiologic underpinnings of atopic dermatitis, share best practices related to comprehensive patient evaluations, and relay their own clinical experience in managing patients with moderate-to-severe disease.

REFERENCES

1. Nutten S. Ann Nutr Metab. 2015:66(suppl 1):8-16.

2. Brunner PM, et al. J Invest Dermatol. 2017;137(1):18-25.

3. Whiteley J, et al. Curr Med Res Opin. 2016;32(10):1645-1651.

4. Drucker AM, et al. J Invest Dermatol. 2017;137(1):26-30.

5. Mansouri Y, Guttman-Yassky E. J Clin Med. 2015;4(5):858-873.

6. Gandhi NA, et al. Nat Rev Drug Discov. 2016;15(1):35-50.

7. Simpson EL, et al. N Engl J Med. 2016;375(24):2335-2348.

8. de Bruin-Weller M, et al. Br J Dermatol. 2018;178(5):1083-1101.

9. Boguniewicz M. Allergy Clin Immunol Pract. 2017;5(6):1477-1487.

10. Cotter DG, et al. J Am Acad Dermatol. 2018;78(3S1):S53-S62.

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EDUCATIONAL OBJECTIVES

• Discuss atopic dermatitis pathophysiology, including clinically relevant molecular and cellular targets • Assess patients with atopic dermatitis longitudinally for uncontrolled symptoms, disease flares, comorbidities, and clinical responses to their current treatment regimens • Describe the clinical profiles of targeted biologic therapies for the treatment of moderate-to-severe atopic dermatitis • Optimize treatment regimens for patients with moderate-to-severe atopic dermatitis to reduce symptomatology, address comorbidities, maximize health-related quality of life, and minimize treatment-related side effects • Educate patients and caregivers to improve their understanding of atopic dermatitis to promote shared decision-making and treatment adherence

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.

This CME/CE activity complies with all requirements of the federal Physician Payment Sunshine Act. If a reportable event is associated with this activity, the accredited provider managing the program will provide the appropriate physician data to the Open Payments database.

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.

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PREAMBLE

After completing this activity, the participant should be better able to:

INSTRUCTIONS TO RECEIVE CREDIT

In order to receive credit for this activity, the participant must fill out and return the program evaluation form.

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: Marjolein de Bruin-Weller, MD, PhD Consultant/Advisor: AbbVie Inc. ; Regeneron Pharmaceuticals, Inc.; Sanofi Genzyme; Grant/Research Support: Regeneron Pharmaceuticals, Inc.; Sanofi Genzyme.

Eric L. Simpson, MD, MCR Consultant/Advisor: 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. Andreas Wollenberg, MD, PhD Consultant: Almirall Limited, Beiersdorf AG, Galderma S.A., LEO Pharma Inc., L’Oréal S.A., MedImmune, LLC, Pierre Fabre Laboratories, Pfizer Inc., Regeneron Pharmaceuticals, Inc., SanofiAventis Europe S.A.S.; Grant/Research: Beiersdorf AG, LEO Pharma Inc.; Speakers Bureau: Almirall Limited, Anacor Pharmaceuticals, Inc., Astellas Pharma Europe Ltd, Beierdsorf AG, Bioderma Laboratoire Dermatologique, Celgene Corporation, Chugai Pharmaceutical Co., Ltd., Galderma S.A., Hans Karrer GMBH, LEO Pharma Inc., L’Oréal S.A.; Meda AB, MedImmune, LLC, Merck Sharp & Dohme Corp., Novartis Pharma AG, Pierre Fabre Laboratories, Pfizer Inc., Regeneron Pharmaceuticals, Inc., Sanofi-Aventis Europe S.A.S. 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: Rose O’Connor, PhD, CMHCP

Nothing to disclose

Ashley Marostica, RN, MSN

Nothing to disclose

Lindsay Borvansky

Nothing to disclose

Andrea Funk

Nothing to disclose

Liddy Knight

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 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.

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

Wollenberg A, et al. J Eur Acad Dermatol Venereol. 2018;32(5):657-682. https://www.ncbi.nlm.nih.gov/pubmed/29676534

»»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. https://www.ncbi.nlm.nih.gov/pubmed/29878606

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RESOURCE CENTER

»»Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I.

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. 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. 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-form-for-age-8-years-andover.pdf

»»Investigator Global Assessment (IGA)

RESOURCE CENTER

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

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SUGGESTED READING

Atopic Dermatitis Overview and Pathogenesis

»»Epidemiology of atopic dermatitis in adults: results from an international study.

Barbarot S, et al. Allergy. 2018;73(6):1284-1293. https://www.ncbi.nlm.nih.gov/pubmed/29319189

»»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

»»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

»»Staphylococcus aureus density on lesional and nonlesional skin is strongly associated with disease severity in atopic dermatitis.

Tauber M, et al. J Allergy Clin Immunol. 2016;137(4):1272-1274. https://www.ncbi.nlm.nih.gov/pubmed/?term=26559326

»»Moving toward endotypes in atopic dermatitis: identification of patient clusters based on serum biomarker analysis.

Thijs JL, et al. J Allergy Clin Immunol. 2017;140(3):730-737. https://www.ncbi.nlm.nih.gov/pubmed/?term=28412391

Patient Burden and Comorbidities

RESOURCE CENTER

»»The self-assessed psychological comorbidities of prurigo in European patients: a multicentre study in 13 countries.

Brenaut E et al. J Eur Acad Dermatol Venereol. 2018 Jun 19. doi: 10.1111/jdv.15145.

[Epub ahead of print]. https://www.ncbi.nlm.nih.gov/pubmed/29923228

»»Patient burden is associated with alterations in quality of life in adult patients with atopic dermatitis: results from the ECLA study.

Misery L, et al. Acta Derm Venereol. 2018;98:713-714. https://www.ncbi.nlm.nih.gov/pubmed/29648674

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»»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

»»Conjunctivitis occurring in atopic dermatitis patients treated with dupilumab—clinical characteristics and treatment.

Wollenberg A, et al. J Allergy Clin Immunol Pract. 2018 Feb 9. doi: 10.1016/j. jaip.2018.01.034. [Epub ahead of print]. https://www.ncbi.nlm.nih.gov/pubmed/29432961

Management of Atopic Dermatitis

»»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 adults with atopic dermatitis with an inadequate response or intolerance to ciclosporin A, or when this treatment is medically inadvisable: a placebo-controlled, randomized phase III clinical trial (LIBERTY AD CAFÉ). de Bruin-Weller M, et al. Br J Dermatol. 2018;178(5):1083-1101. https://www.ncbi.nlm.nih.gov/pubmed/29193016

RESOURCE CENTER

»»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/

»»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

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»»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

»»Two phase 3 trials of dupilumab versus placebo in atopic dermatitis.

RESOURCE CENTER

Simpson EL, et al. N Engl J Med. 2016;375(24):2335-2348. https://www.ncbi.nlm.nih.gov/pubmed/27690741

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NOTES

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PREAMBLE

FACULTY

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