@article{09eb1e4df60944f9bfe576ce15716c5c,
title = "Optimization of placebo use in clinical trials with systemic treatments for atopic dermatitis: an International Eczema Council survey-based position statement",
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.",
author = "Leshem, {Y. A.} and R. Bissonnette and C. Paul and Silverberg, {J. I.} and Irvine, {A. D.} and Paller, {A. S.} and Cork, {M. J.} and E. Guttman-Yassky",
note = "Funding Information: Pharmaceuticals Inc., Sienna Biopharmaceuticals, and Vitae Pharmaceuticals. Robert Bissonnette is also an employee and shareholder of lnnovaderm Research. Carle Paul is an investigator, consultant, or speaker for and/ or received honoraria from AbbVie Inc., Allgen Pharmaceuticals, Astellas Pharma US, Inc., Boehringer Ingelheim Pharm, Inc., Celgene, Janssen Pharmaceutical Eli Lilly and Co, Leo Pharma, Novartis Pharmaceuticals, Pierre Fabre Pharmaceuticals Inc., and Sanofi and Regeneron Pharmaceuticals Inc. Jonathan Silverberg is a consultant, or advisory board member for and/or received honoraria from AbbVie Inc., Eli Lilly and Co, Galderma, GlaxoSmithKline-Stiefel, Leo Pharma, Kiniksa Pharmaceuticals, Menlo Therapeutics, Pfizer, RealM Pharmaceuticals, Sanofi and Regeneron Pharmaceuticals Inc., Theravance, Incyte, Dermavant, AnaptysBio, and Asana BioSciences. Alan Irvine is an investigator, speaker, and/or advisory board member for and/or received honoraria or research grants from Sanofi and Regeneron Pharmaceuticals Inc., AbbVie Inc., Pfizer, and Genentech. Amy Paller is a consultant with honorarium from AntibioTx A/S, Asana BioSciences, LLC, Boehringer Ingelheim International GMBH, Dermavant Sciences, Dermira Pharmaceuticals, Eli Lilly, Forte Biosciences, Inc., Galderma, Incyte Pharmaceuticals, Leo Pharma AS, Menlo Therapeutics, MorphoSys AG, Novartis Pharma AG, Pfizer, Regeneron Pharmaceuticals, Inc, Sanofi/Genzyme, SATO Pharmaceuticals, Sienna Biopharmaceuticals, Inc., Sonoma Pharmaceuticals, Inc., Theravance Biopharma and Valeant Pharmaceuticals. Investigator without personal compensation for Eli Lilly, Galderma, Incyte and Regeneron. Michael J. Cork is an investigator and/or for Abbvie, Amlar, Astellas, Boots, Dermavant, Galapagos, Galderma, Hyphens, Johnson & Johnson, Leo, L{\textquoteright}Oreal, Menlo, Novartis, Oxagen, Pfizer, Procter & Gamble, Reckitt Benckiser, Regeneron, Sanofi Genzyme. Emma Guttman-Yassky is an investigator, and/or consultant for and/or received honoraria, grants or research funding from Celgene, Dermira, Janssen Biotech Inc., Novartis Pharmaceuticals, Leo Pharma, AbbVie, Sanofi, Regeneron Pharmaceuticals Inc., AbbVie Inc., Galderma, Glenmark, Pfizer, Eli Lilly and Co., Allergan, Escalier Biosciences, Mitsubishi Tanabe, Asana BioSciences, Kyowa Kirin, DS Biopharma, Concert, DBV, Innovaderm, Amgen, Ralexar, Novan, EMD Serono, Flx Bio, Union Therapeutics, and Dermavant Sciences. Publisher Copyright: {\textcopyright} 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.",
year = "2019",
month = may,
doi = "10.1111/jdv.15480",
language = "English",
volume = "33",
pages = "807--815",
journal = "Journal of the European Academy of Dermatology and Venereology",
issn = "0926-9959",
publisher = "Wiley-Blackwell",
number = "5",
}