TY - JOUR
T1 - Dupilumab treatment improves signs, symptoms, quality of life, and work productivity in patients with atopic hand and foot dermatitis
T2 - Results from a phase 3, randomized, double-blind, placebo-controlled trial
AU - Simpson, Eric L.
AU - Silverberg, Jonathan I.
AU - Worm, Margitta
AU - Honari, Golara
AU - Masuda, Koji
AU - Syguła, Ewa
AU - Schuttelaar, Marie L.A.
AU - Mortensen, Eric
AU - Laws, Elizabeth
AU - Akinlade, Bolanle
AU - Patel, Naimish
AU - Maloney, Jennifer
AU - Paleczny, Heather
AU - Delevry, Dimittri
AU - Xiao, Jing
AU - Dubost-Brama, Ariane
AU - Bansal, Ashish
N1 - Publisher Copyright:
© 2024 American Academy of Dermatology, Inc.
PY - 2024
Y1 - 2024
N2 - 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.
AB - 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.
KW - atopic hand and foot dermatitis
KW - dupilumab
KW - hand eczema
KW - interleukin-13
KW - interleukin-4
KW - pruritus, type 2 inflammation
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U2 - 10.1016/j.jaad.2023.12.066
DO - 10.1016/j.jaad.2023.12.066
M3 - Article
C2 - 38296199
AN - SCOPUS:85186255055
SN - 0190-9622
JO - Journal of the American Academy of Dermatology
JF - Journal of the American Academy of Dermatology
ER -