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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.

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. Journal of the American Academy of Dermatology Simpson, E. L., Silverberg, J. I., Worm, M., Honari, G., Masuda, K., Sygula, E., Schuttelaar, M. L., Mortensen, E., Laws, E., Akinlade, B., Patel, N., Maloney, J., Paleczny, H., Delevry, D., Xiao, J., Dubost-Brama, A., Bansal, A. 2024

Abstract

Despite high disease burden, systemic treatment options for patients with atopic hand and/or foot dermatitis (H/F AD) are limited.To evaluate efficacy and safety of dupilumab in H/F AD using specific instruments for assessing disease severity on hands and feet.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.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.Short-term, 16-week treatment period.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.

View details for DOI 10.1016/j.jaad.2023.12.066

View details for PubMedID 38296199