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Clinical Trial Evaluation

Dupilumab for the treatment of atopic dermatitis: A clinical trial review

, PharmD, , BA & , MD PhD
 

Abstract

Introduction: Current treatment options for moderate-to-severe atopic dermatitis (AD) are limited and have potentially dangerous side effects. Dupilumab is a novel monoclonal antibody that was recently studied in adult patients with moderate-to-severe AD. Dupilumab inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling and was previously found to be effective in asthma. Considering that both AD and asthma are Th2 cell-mediated inflammatory processes, it is reasonable to suspect that dupilumab would be beneficial in AD.`

Areas covered: This article is a review of the one major clinical trial that assessed the efficacy of dupilumab in patients with AD. Its goal is to provide a comparison to the current modalities for the treatment of AD and expert insight regarding future studies.

Expert opinion: The results of this study are a significant therapeutic advancement. Dupilumab was shown to provide a mean percent change in Eczema Area and Severity Index score of −74% ± 3.6, in addition to, statistically and clinically significant reductions the severity, symptomatology, and morbidity associated with AD. However, the small sample size makes it difficult to assess the magnitude of this effect. As a result, dupilumab will likely be reserved for cases of severe AD unresponsive to traditional modalities.

Declaration of interest

The Center for Dermatology Research is supported by an unrestricted educational grant from Galderma Laboratories, L.P. Dr. Feldman is a speaker for Janssen and Taro. He is a consultant and speaker for Galderma, Stiefel/GlaxoSmithKline, Abbott Labs, Leo Pharma Inc. Dr. Feldman has received grants from Galderma, Janssen, Abbott Labs, Amgen, Stiefel/GlaxoSmithKline, Celgene and Anacor. He is a consultant for Amgen, Baxter, Caremark, Gerson Lehrman Group, Guidepoint Global, Hanall Pharmaceutical Co Ltd, Kikaku, Lilly, Merck & Co Inc, Merz Pharmaceuticals, Mylan, Novartis Pharmaceuticals, Pfizer Inc, Qurient, Suncare Research and Xenoport. He is on an advisory board for Pfizer Inc. Dr. Feldman is the founder and holds stock in Causa Research and holds stock and is majority owner in Medical Quality Enhancement Corporation. He receives Royalties from UpToDate and Xlibris. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

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