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

Y. A. Leshem*, R. Bissonnette, C. Paul, J. I. Silverberg, A. D. Irvine, A. S. Paller, M. J. Cork, E. Guttman-Yassky

*Corresponding author for this work

Research output: Contribution to journalArticle

2 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)807-815
Number of pages9
JournalJournal of the European Academy of Dermatology and Venereology
Volume33
Issue number5
DOIs
StatePublished - May 2019

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ASJC Scopus subject areas

  • Dermatology
  • Infectious Diseases

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