Dupixent Receives Expanded FDA Approval for Atopic Dermatitis with Moderate to Severe Hand and Foot Involvement

The US Food and Drug Administration (FDA) has approved an update to the label for Dupixent (dupilumab) for atopic dermatitis (AD), incorporating new efficacy and safety data specifically for patients ages 12 years and older with AD and uncontrolled moderate to severe involvement of the hands and/or feet.¹

Dupilumab is indicated for patients ages 12 years and older with moderate to severe AD involving hands and feet who had an inadequate response or intolerance to topical corticosteroids. Patients with hand and foot disease predominantly driven by allergic or irritant contact dermatitis were excluded from the trial.

The label revision is based on findings from the Phase 3 LIBERTY-AD-HAFT trial, which evaluated the efficacy and safety of dupilumab in 133 adult and adolescent patients (aged 12 to 17 years) with AD featuring moderate to severe involvement of the hands and/or feet. The patients were treated with dupilumab (n = 67) every 2 weeks (adults 300 mg, adolescents 200 mg or 300 mg based on body weight) or placebo (n = 66). The trial met its primary and key secondary endpoints. After 16 weeks of treatment, 40% of patients on dupilumab had clear or almost clear skin on their hands and feet, achieving an Investigator's Global Assessment score of 0 (“clear”) or 1 (“almost clear”) compared to 17% who received placebo. Additionally, after 16 weeks of treatment, 52% of patients on dupilumab experienced a clinically meaningful reduction in itch on their hands and feet, indicated by a ≥4-point reduction in the Peak-Pruritus Numerical Rating Scale  score compared to 14% who received placebo.

The safety results from the LIBERTY-AD-HAFT trial were generally consistent with the established safety profile of dupilumab for AD. Common adverse events  (≥1%) include injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia.

Reference

1. Media update: Dupixent (dupilumab) U.S. label updated with data further supporting use in atopic dermatitis with moderate-to-severe hand and foot involvement. Press Release. Sanofi. January 16, 2024. Accessed January 19, 2024. https://www.sanofi.com/en/media-room/press-releases/2024/2024-01-16-12-00-00-2809681