Dupilumab treatment improves signs, symptoms, quality of life, and work productivity in patients with atopic hand and foot dermatitis: Results from a phase 3, randomized, double-blind, placebo-controlled trial

Eric L. Simpson, Department of Dermatology, Oregon Health & Science University, Portland, Oregon.
Jonathan I. Silverberg, The George Washington University School of Medicine and Health Sciences, Washington, District of Columbia.
Margitta Worm, Division of Allergy and Immunology, Department Dermatology, Venerology and Allergology, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Golara Honari, Department of Dermatology, Stanford University School of Medicine, Stanford, California.
Koji Masuda, Department of Dermatology, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Kyoto, Japan.
Ewa Syguła, Department of Dermatology, Andrzej Mielȩcki Memorial Independent Public Clinical Hospital, Katowice, Poland.
Marie L. Schuttelaar, Department of Dermatology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Eric Mortensen, Regeneron Pharmaceuticals Inc, Tarrytown, New York.
Elizabeth Laws, Sanofi, Bridgewater, New Jersey.
Bolanle Akinlade, Regeneron Pharmaceuticals Inc, Tarrytown, New York.
Naimish Patel, Sanofi, Cambridge, Massachusetts.
Jennifer Maloney, Regeneron Pharmaceuticals Inc, Tarrytown, New York.
Heather Paleczny, Regeneron Pharmaceuticals Inc, Tarrytown, New York.
Dimittri Delevry, Regeneron Pharmaceuticals Inc, Tarrytown, New York.
Jing Xiao, Regeneron Pharmaceuticals Inc, Tarrytown, New York.
Ariane Dubost-Brama, Sanofi, Chilly-Mazarin, France.
Ashish Bansal, Regeneron Pharmaceuticals Inc, Tarrytown, New York. Electronic address: ashish.bansal@regeneron.com.

Document Type

Journal Article

Publication Date

2-1-2024

Journal

Journal of the American Academy of Dermatology

DOI

10.1016/j.jaad.2023.12.066

Keywords

atopic hand and foot dermatitis; dupilumab; hand eczema; interleukin-13; interleukin-4; pruritus, type 2 inflammation

Abstract

BACKGROUND: Despite high disease burden, systemic treatment options for patients with atopic hand and/or foot dermatitis (H/F AD) are limited. OBJECTIVES: To evaluate efficacy and safety of dupilumab in H/F AD using specific instruments for assessing disease severity on hands and feet. METHODS: In this multicenter phase 3 trial, adults and adolescents with moderate-to-severe H/F AD were randomized to dupilumab monotherapy (regimen approved for generalized AD), or matched placebo. The primary endpoint was proportion of patients achieving Hand and Foot Investigator's Global Assessment score 0 or 1 at week 16. Secondary prespecified endpoints assessed the severity and extent of signs, symptom intensity (itch, pain), quality of life, and sleep. RESULTS: A total of 133 patients (adults = 106, adolescents = 27) were randomized to dupilumab (n = 67) or placebo (n = 66). At week 16, significantly more patients receiving dupilumab (n = 27) than placebo (n = 11) achieved Hand and Foot Investigator's Global Assessment score 0 or 1 (40.3% vs 16.7%; P = .003). All other prespecified endpoints were met. Safety was consistent with the known AD dupilumab profile. LIMITATIONS: Short-term, 16-week treatment period. CONCLUSION: Dupilumab monotherapy resulted in significant improvements across different domains of H/F AD with acceptable safety, supporting dupilumab as a systemic treatment approach for this often difficult to treat condition.

Department

Dermatology

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