Sanofi has reported positive data from the Phase III clinical trial of Dupixent (dupilumab) in moderate-to-severe atopic hand and foot dermatitis in adults and adolescents.
The placebo-controlled, double-blind Phase III trial has been designed for assessing Dupixent’s safety and efficacy in 133 indicated adolescents and adults, who had an inadequate response or are not tolerant to topical corticosteroids.
The study participants received Dupixent (adults 300mg, adolescents 200mg or 300mg based on body weight) every two weeks or placebo (n=66) in the trial.
According to the findings, 40% of the participants treated with Dupixent achieved the primary endpoint of clear or almost clear skin on hands and feet compared to placebo at 16 weeks.
The Dupixent-treated group had 69% average reduction in hand and foot lesions signs from baseline and had 75% average improvement in hand eczema disease severity from baseline compared to placebo.
Sanofi stated that 52% of the patients treated with Dupixent have reported clinically meaningful reduction in itch on hands and feet, the trial’s key secondary endpoint.
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Additionally, Dupixent showed similar safety results in atopic dermatitis.
Oregon Health and Science University Medical Dermatology professor Frances Storrs said: “Atopic hand and foot dermatitis can extensively disrupt the lives of patients, given the intense itch and painful skin lesions it causes on essential body areas.
“In this trial, Dupixent significantly improved disease signs, symptoms, and quality of life measures for this particularly difficult-to-treat subset of atopic dermatitis patients, with itch improvement seen as early as one week after the first dose.
“While the efficacy and safety profile of Dupixent is well-established for atopic dermatitis more broadly, these positive results are the first demonstrating the impact on specific and heavily used areas of the body.”
Herpes viral infections, upper respiratory tract infection, nasopharyngitis, conjunctivitis, and increased blood creatine phosphokinase are the more common adverse events (AEs) observed with Dupixent.