The FDA has added efficacy and safety data for patients ages 12 years and older with uncontrolled moderate-to-severe atopic dermatitis with hand and/or foot involvement.
Regeneron Pharmaceuticals, Inc. and Sanofi have announced today that the US Food and Drug Administration (FDA) has approved an update to the label for dupilumab (Dupixent) in atopic dermatitis (AD), specifically addressing patients aged 12 years and older with uncontrolled moderate-to-severe hand and/or foot involvement.
The label update is based on findings from the phase 3 LIBERTY-AD-HAFT trial, a double-blind, placebo-controlled study involving 133 adult and adolescent patients with AD and moderate-to-severe hand and/or foot involvement.
According to a press release, this study is the first and only trial to evaluate a biologic in this patient population. This data has also been added to the Dupixent label in the European Union. Regulatory submissions are also underway in additional countries.
“We rely heavily on our hands and feet throughout the day, making atopic dermatitis particularly disruptive for patients who experience constant itch and painful cracking and bleeding skin lesions on these critical areas of the body,” said George D. Yancopoulos, MD, PhD, board co-chair, president, and chief scientific officer at Regeneron, and a principal inventor of Dupixent, in a press release. “Dupixent has been used to treat hundreds of thousands of patients with moderate-to-severe atopic dermatitis around the world since its initial U.S. approval in 2017, and we are pleased that Dupixent is now the first biologic with data in the label supporting its use in this particularly challenging subset of the disease.”
Adult patients received 300 mg dupilumab and adolescent patients received either 200 mg or 300 mg dupilumab depending on body weight (n=67) or placebo (n=66) every 2 weeks for 16 weeks.
By week 16, 40% of patients treated with dupilumab achieved clear or almost clear skin on hands and feet, compared to 17% with placebo, meeting the study's primary endpoint.
Additionally, 52% of patients receiving dupilumab experienced a clinically meaningful reduction in itch on hands and feet, compared to 14% with placebo, meeting the study's key secondary endpoint.
Safety results were consistent with the known safety profile of dupilumab. Common adverse events occurred in less than or equal to 1% of patients and included injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia.
“Living with atopic dermatitis on your most essential body areas like the hands and feet can make daily activities including walking and writing incredibly burdensome even in the case where disease symptoms are mild elsewhere. Unfortunately, treating atopic dermatitis on the hands and feet has historically been difficult and there have been no Phase 3 trials evaluating a biologic in this population of patients,” said Naimish Patel, MD, head of Global Development, Immunology and Inflammation at Sanofi, in a press release. “Having these data added for this difficult-to-treat population is important for physicians looking for tools to treat these patients and reinforces the already well-established efficacy and safety of Dupixent in atopic dermatitis overall.”
Regeneron. Dupixent (dupilumab) U.S. label updated with data further supporting use in atopic dermatitis with moderate-to-severe hand and foot involvement. Globe Newswire. Published January 16, 2024. Accessed January 16, 2024. https://www.globenewswire.com/news-release/2024/01/16/2809695/0/en/Dupixent-dupilumab-U-S-Label-Updated-with-Data-Further-Supporting-Use-in-Atopic-Dermatitis-with-Moderate-to-Severe-Hand-and-Foot-Involvement.html