Optimization of placebo use in clinical trials with systemic treatments for atopic dermatitis: an International Eczema Council survey-based position statement

Authors

Y. A. Leshem, Rabin Medical Center Israel
R. Bissonnette, Innovaderm Research Inc.
C. Paul, Universite Paul Sabatier Toulouse III
J. I. Silverberg, Northwestern University Feinberg School of Medicine
A. D. Irvine, Our Lady's Hospital for Sick Children
A. S. Paller, Northwestern University Feinberg School of Medicine
M. J. Cork, The Sheffield Medical School
E. Guttman-Yassky, Icahn School of Medicine at Mount Sinai

Document Type

Journal Article

Publication Date

5-1-2019

Journal

Journal of the European Academy of Dermatology and Venereology

Volume

33

Issue

5

DOI

10.1111/jdv.15480

Abstract

© 2019 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology. Background: As novel systemic therapeutics for patients with atopic dermatitis (AD) are developed, ethical and methodological concerns regarding placebo-controlled-trials (PCT) have surfaced. Objective: To guide the design and implementation of PCT in AD, focusing on trials with systemic medications. Methods: A subgroup of the International Eczema Council (IEC) developed a consensus e-survey, which was disseminated to IEC members. Results: The response rate was 43/82 (52%). Consensus was reached on 24/27 statements and on 3/11 options from multiple-selection statements, including: performing monotherapy studies in proof-of-concept phases; avoiding concomitant topical corticosteroids or calcineurin inhibitors until a predefined timepoint as rescue (borderline consensus); selection of sites and assessors with recognized expertise in AD clinical trials; clear definition and identification of baseline disease severity; minimizing time and proportion of patients on placebo; using daily emollients with several options provided; instigating open-label extension studies for enrolment after a predefined timepoint; and including outcomes which set a higher bar for disease clearance. Conclusion: Conducting PCT in AD requires balancing several, sometimes opposing principles, including ethics, methodology, regulatory requirements and real-world needs. This paper can provide a framework for conducting PCT with systemic medications for patients with AD.

APA Citation

Leshem, Y., Bissonnette, R., Paul, C., Silverberg, J., Irvine, A., Paller, A., Cork, M., & Guttman-Yassky, E. (2019). Optimization of placebo use in clinical trials with systemic treatments for atopic dermatitis: an International Eczema Council survey-based position statement. Journal of the European Academy of Dermatology and Venereology, 33 (5). http://dx.doi.org/10.1111/jdv.15480