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; Jonathan I Silverberg; Margitta Worm; Golara Honari; Koji Masuda; Ewa Syguła; Marie L A Schuttelaar; Eric Mortensen; Elizabeth Laws; Bolanle Akinlade; Naimish Patel; Jennifer Maloney; Heather Paleczny; Dimittri Delevry; Jing Xiao; Ariane Dubost-Brama; Ashish Bansal

doi:10.1016/j.jaad.2023.12.066

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

J Am Acad Dermatol. 2024 Feb 1:S0190-9622(24)00146-4. doi: 10.1016/j.jaad.2023.12.066. Online ahead of print.

Authors

Eric L Simpson¹, Jonathan I Silverberg², Margitta Worm³, Golara Honari⁴, Koji Masuda⁵, Ewa Syguła⁶, Marie L A Schuttelaar⁷, Eric Mortensen⁸, Elizabeth Laws⁹, Bolanle Akinlade⁸, Naimish Patel¹⁰, Jennifer Maloney⁸, Heather Paleczny⁸, Dimittri Delevry⁸, Jing Xiao⁸, Ariane Dubost-Brama¹¹, Ashish Bansal¹²

Affiliations

¹ Department of Dermatology, Oregon Health & Science University, Portland, Oregon.
² The George Washington University School of Medicine and Health Sciences, Washington, District of Columbia.
³ Division of Allergy and Immunology, Department Dermatology, Venerology and Allergology, Charité-Universitätsmedizin Berlin, Berlin, Germany.
⁴ Department of Dermatology, Stanford University School of Medicine, Stanford, California.
⁵ Department of Dermatology, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Kyoto, Japan.
⁶ Department of Dermatology, Andrzej Mielȩcki Memorial Independent Public Clinical Hospital, Katowice, Poland.
⁷ Department of Dermatology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
⁸ Regeneron Pharmaceuticals Inc, Tarrytown, New York.
⁹ Sanofi, Bridgewater, New Jersey.
¹⁰ Sanofi, Cambridge, Massachusetts.
¹¹ Sanofi, Chilly-Mazarin, France.
¹² Regeneron Pharmaceuticals Inc, Tarrytown, New York. Electronic address: ashish.bansal@regeneron.com.

PMID: 38296199
DOI: 10.1016/j.jaad.2023.12.066

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.

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