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
; 90(6): 1190-1199, 2024 Jun.
Article
in En
| MEDLINE
| ID: mdl-38296199
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.Key words
Full text:
1
Database:
MEDLINE
Main subject:
Quality of Life
/
Severity of Illness Index
/
Dermatitis, Atopic
/
Antibodies, Monoclonal, Humanized
/
Foot Dermatoses
/
Hand Dermatoses
Type of study:
Clinical_trials
/
Diagnostic_studies
Limits:
Adolescent
/
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Year:
2024
Type:
Article