Sanofi and Regeneron’s Dupixent (dupilumab) was associated with significant improvements in moderate-to-severe atopic hand and foot dermatitis symptoms, according to phase 3 results presented at the American Academy of Dermatology 2023 annual meeting.
Typically referred to as eczema, atopic dermatitis is one of the most common inflammatory skin diseases, affecting over 26 million people in the US alone.
The disease causes itchy, red, swollen and cracked skin, usually affecting the folds of the arms, back of the knees, hands, feet, face and neck.
“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,” explained Eric Simpson, Frances J Storrs professor of medical dermatology at the Oregon Health and Science University and principal investigator of the trial.
The phase 3 trial evaluated Dupixent in 133 adolescents and adults with moderate-to-severe atopic hand and foot dermatitis who had an inadequate response or intolerance to topical corticosteroids.
The trial met its primary endpoint, with 40% of Dupixent-treated achieving clear or almost clear skin on their hands and feet at week 16 compared to 17% with placebo.
The key secondary endpoint of clinically meaningful reduction in itch on hands and feet was also met, and statistical significance was seen across average reduction in signs of hand and foot lesions, and average improvement in hand eczema disease severity from baseline.
Simpson said: “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.”
Dupixent has already received regulatory approvals for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis and prurigo nodularis.
As well as the currently approved indications, the partners are studying Dupixent across a broad range of diseases driven by type 2 inflammation or other allergic processes, including certain patients with urticaria, chronic pruritus and chronic obstructive pulmonary disease.