Looking Ahead: Optimizing Management Strategies in Moderate-to-Severe Atopic Dermatitis by Integritas Communications

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.

MEDICAL COMMUNICATIONS INQUIRIES info@integritasgrp.com integritasgrp.com

FACULTY FACULTY

Michael Ardern-Jones, BSc, MBBS, DPhil, FRCP Associate Professor, Consultant Dermatologist University of Southampton Southampton, United Kingdom

Dr. Michael Ardern-Jones trained in Dermatology at St Johnâ&#x20AC;&#x2122;s Institute of Dermatology, London, and subsequently at the Medical School at Oxford. His DPhil (PhD) at Oxford explored the immunology of atopic dermatitis. He was appointed to University Hospitals Southampton NHS (National Health Service) Trust and to the Faculty of Medicine, University of Southampton, in 2007. Dr. Ardern-Jones has long-standing research interest in all aspects of atopic eczema, including immunological mechanisms, immunotherapy, and the skin microbiome. He has a specific academic interest in inflammatory skin disease and leads the clinical service for eczema, skin allergy, and drug hypersensitivity reactions. His clinical unit, composed of post-doctoral scientists, doctoral students, clinical fellows, and technicians, undertakes clinical trials in atopic eczema and other skin diseases. Dr. Ardern-Jones previously served as President of the British Society for Medical Dermatology and Chair of the British Society for Investigative Dermatology. He chairs The Skin Investigation Society and is lead author of the atopic eczema chapters and coauthor of the drug allergy chapters in Rookâ&#x20AC;&#x2122;s Textbook of Dermatology. He is an expert advisor to the National Institute for Health & Care Excellence (NICE) and the Medicines and Healthcare products Regulatory Agency (MHRA) on dermatology.

Mark Boguniewicz, MD FACULTY

Professor, Division of Allergy-Immunology Department of Pediatrics, National Jewish Health and 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 cochair of the treatment section of the European Academy of Allergy and Clinical Immunology (EAACI)/AAAAI/Practical Allergy (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, cochaired 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, 2011-2012, 2012-2013, and 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.

Marjolein de Bruin-Weller, MD, PhD 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. After graduating from the University of Leiden, she worked as a research fellow in Astmacentrum Heideheuvel (Hilversum) and the Department of Pulmonology, Academic Medical Center Amsterdam (Prof H.M. Jansen), garnering her 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 research interest is clinical and translational investigation in atopic dermatitis. She is principal investigator for 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).

TARGET AUDIENCE

The educational design of this activity addresses the needs of allergists, clinical immunologists, and other clinicians involved in the management of patients with moderateto-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 potentially deleterious effects in other organ systems throughout the body.1,2 The disease-related physical and biopsychosocial burdens of this condition can have a substantial effect on patients’ quality of life, particularly in those with moderate-to-severe disease.3,4 A better understanding of disease 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 such therapies are in late-stage clinical development.7-10 With novel therapies emerging for patients with difficult-to-treat atopic dermatitis, attendees of the EAACI Congress will benefit from updates on the latest clinical trial data and practical recommendations on how to translate those results into daily clinical decision-making.11 In this Evidence-Based Best Practices™ program, a multidisciplinary panel of internationally recognized experts will review the latest published evidence with the goal of providing recommendations to enhance overall patient outcomes. The faculty panel will discuss the pathophysiologic underpinnings of atopic dermatitis, share best practices related to comprehensive patient evaluations, and convey their own clinical experience in managing patients with moderate-to-severe disease.

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):1-7. 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. de Bruin-Weller M, et al. Dupilumab with concomitant topical corticosteroid treatment 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). Br J Dermatol. 2018;178(5):1083-1101. 9. Boguniewicz M. Biologic therapy for atopic dermatitis: moving beyond the practice parameter and guidelines. J Allergy Clin Immunol Pract. 2017;5(6):1477-1487. 10. Cotter DG, et al. Emerging therapies for atopic dermatitis: JAK inhibitors. J Am Acad Dermatol. 2018;78(3 suppl 1):S53-S62. 11. Ariëns LFM, et al. Dupilumab in atopic dermatitis: rationale, latest evidence and place in therapy. Ther Adv Chronic Dis. 2018;9(9):159-170.

EDUCATIONAL OBJECTIVES

After completing this activity, the participant should be better able to: •• Discuss atopic dermatitis pathophysiology, including the mechanistic rationales and clinical evidence for targeted therapies in moderate-to-severe disease •• Comprehensively evaluate patients with atopic dermatitis over time for uncontrolled symptoms, sleep disturbances, quality-of-life impairment, and comorbid conditions •• Tailor treatment regimens for patients with moderate-to-severe atopic dermatitis based on disease severity, presence of comorbid conditions, and response to prior therapy

PREAMBLE

•• Partner with patients and caregivers to improve their recognition of flare triggers, increase treatment adherence, and promote shared decision-making

PROGRAM AGENDA 17:30–17:35

Introduction and Preassessment

17:35–18:00

Atopic Dermatitis: Mechanistic Rationales for Advances in Therapy

18:00–18:20

Comprehensive Patient Evaluations: From Triggers to Comorbidities

18:20–18:45

Long-term Management Strategies for Moderate-to-Severe Disease

18:45–19:00

Postactivity Questionnaire and Question & Answer Session

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. 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.

INSTRUCTIONS TO RECEIVE CREDIT

In order to receive credit for this activity, the participant must complete 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: Michael Ardern-Jones, BSc, MBBS, DPhil, FRCP Grant/Research Support: AbbVie Inc.; Honoraria: Regeneron Pharmaceuticals, Inc., Sanofi Genzyme; Speakers Bureau: Regeneron Pharmaceuticals, Inc., Sanofi Genzyme. Mark Boguniewicz, MD Consultant/Advisor: Regeneron Pharmaceuticals, Inc.; Sanofi Genzyme; Grant/Research Support: Regeneron Pharmaceuticals, Inc.; Speakers Bureau: Regeneron Pharmaceuticals, Inc.; Sanofi Genzyme. Marjolein de Bruin-Weller, MD, PhD Consultant/Advisor: AbbVie Inc., Sanofi Genzyme, Regeneron Pharmaceuticals, Inc.; Grant/Research Support: AbbVie Inc., LEO Pharma, Pfizer Inc., Regeneron Pharmaceuticals, Inc., Sanofi Genzyme. 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 Borvansky

Nothing to disclose

Andrea Funk

Nothing to disclose

Ashley Cann

Nothing to disclose

Stacey Ullman, MHS

Nothing to disclose

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 or the European Medicines Agency. Global Education Group (Global) and Integritas do not recommend the use of any agent outside of the labeled indications.

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 manufacturerâ&#x20AC;&#x2122;s product information, and comparison with recommendations of other authorities.

PREAMBLE

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.

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

»»Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I. Wollenberg A, et al. J Eur Acad Dermatol Venereol. 2018;32(5):657-682. https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdv.14891

»»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.

RESOURCE CENTER

https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdv.14888

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. http://www.eczemacouncil.org/for-patients/

»»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 »»Children’s Dermatology Life Quality Index (CDLQI)

CDLQI is 10-question patient-reported assessment tool designed to measure impact of any skin disease on the lives of children ages 4-16. Lewis-Jones MS, Finlay AY. Br J Dermatol. 1995;132(6):942-949. https://www.cardiff.ac.uk/medicine/resources/dermatology-questionnaires/childrensdermatology-life-quality-index

»»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-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

»»Patient-Oriented Eczema Measure (POEM)

RESOURCE CENTER

The POEM is a patient-oriented, self-assessed measurement tool for monitoring aspects of atopic dermatitis in routine clinical practice or in the clinical trial setting. Charman CR, et al. Arch Dermatol. 2004;140(12):1513-1519. https://www.nottingham.ac.uk/research/groups/cebd/resources/poem.aspx

»»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 Atopic Dermatitis Overview and Pathogenesis »»Bacterial superantigen facilitates epithelial presentation of llergen to T helper 2 cells.

Ardern-Jones MR, et al. Proc Natl Acad Sci U S A. 2007;104(13):5557-5562. https://www.pnas.org/content/104/13/5557

»»Identification of atopic dermatitis subgroups in children from 2 longitudinal birth cohorts. Paternoster L, et al. J Allergy Clin Immunol. 2018:141(3):964-971.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5840507/?report=reader

»»Pathogenesis of atopic dermatitis.

Peng W, Novak N. Clin Exp Allergy. 2015;45(3):566-574. https://onlinelibrary.wiley.com/doi/epdf/10.1111/cea.12495

Patient Burden and Comorbidities »»Childhood eczema and asthma incidence and persistence: a cohort study from childhood to middle age. Burgess JA, et al. J Allergy Clin Immunol. 2008;122(2):280-285. https://www.jacionline.org/article/S0091-6749(08)00954-8/fulltext

»»The price of pruritus: sleep disturbance and cosleeping in atopic dermatitis. Chamlin SL, et at. Arch Pediatr Adolesc Med. 2005;159(8):745-750. https://jamanetwork.com/journals/jamapediatrics/fullarticle/486092

RESOURCE CENTER

»»Bidirectional relationships between psychological health and dermatological conditions in children. Mitchell AE. Psychol Res Behav Manag. 2018;11:289-298.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6074762/pdf/prbm-11-289.pdf

»»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

»»Mental health comorbidity in patients with atopic dermatitis. Yaghmaie P, et al. J Allergy Clin Immunol. 2013;131(2):428-433.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3565469/pdf/nihms-429164.pdf

Management of Atopic Dermatitis »»Dupilumab in atopic dermatitis: rationale, latest evidence and place in therapy. Ariëns LFM, et al. Ther Adv Chronic Dis. 2018;9(9):159-170. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6116085/

»»Goblet cell scarcity and conjunctival inflammation during treatment with dupilumab in patients with atopic dermatitis. Bakker DS, et al. Br J Dermatol. 2019;180(5):1248-1249. https://onlinelibrary.wiley.com/doi/full/10.1111/bjd.17538

»»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

»»Atopic dermatitis yardstick: practical recommendations for an evolving therapeutic landscape. Boguniewicz M, et al. Ann Allergy Asthma Immunol. 2018;120(1):10-22. https://www.annallergy.org/article/S1081-1206(17)31260-7/pdf

»»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/

»»Treatment of Staphylococcus aureus colonization in atopic dermatitis decreases disease severity. Huang JT, et al. Pediatrics. 2009;123(5):e808-e814.

RESOURCE CENTER

https://www.ncbi.nlm.nih.gov/pubmed/19403473

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

NOTES 54

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