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

Document Type

Journal Article

Publication Date

1-29-2024

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 (HF-IGA) score 0 or 1 at week 16. Secondary pre-specified endpoints assessed the severity and extent of signs, symptom intensity (itch, pain), quality of life, and sleep. RESULTS: 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 HF-IGA score 0 or 1 (40.3% vs 16.7%; P=.003). All other pre-specified 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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