The U.S. Food and Drug Administration (FDA) has updated the label for dupilumab (Dupixent, Regeneron Pharmaceuticals, Inc. and Sanofi), adding efficacy and safety data for people aged 12 years and older with atopic dermatitis (AD) and uncontrolled moderate-to-severe hand and/or foot involvement.
More than twice as many atopic dermatitis patients with uncontrolled moderate-to-severe hand and/or foot involvement who were treated with Dupixent achieved clear or almost clear skin and nearly four times as many had improvement in itch, compared with placebo, according to new Phase 3 data.
“Chronic hand eczema is very debilitating,” Emma Guttman-Yassky, MD, PhD, the Waldman Professor of Dermatology and Immunology and Health System Chair of The Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City, tells TDD. “It is important to have systemic treatments approved for CHE, both with and without atopic dermatitis. This is particularly important as these patients often do not meet the criteria for a biologic as hands and feet combined are only 9% and if only hands it is 4.5% or less,” says Dr. Guttman-Yassky, the Director of the Occupational Dermatitis Clinic and Director of the Laboratory for Inflammatory Skin Diseases.
Peter A. Lio, MD, a Clinical Assistant Professor of Dermatology and Pediatrics at Northwestern University Feinberg School of Medicine and a partner at Medical Dermatology Associates of Chicago, agrees. “Hands and feet are excellent examples of how a relatively small body surface area can have an outsized effect on quality of life. While this is not surprising and comports with my clinical experience, it is really exciting to see specific body sites studied and to know that there is measurable efficacy there,” he tells TDD.
The Phase 3 data are from the first and only trial evaluating a biologic specifically for this difficult-to-treat population and have also been added to the Dupixent label in the European Union, with regulatory submissions underway in additional countries, Regeneron Pharmaceuticals, Inc. and Sanofi report.
“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,” says George D. Yancopoulos, MD, PhD, Board Co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent, in a news 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.”
The label update is based on data from the Phase 3 LIBERTY-AD-HAFT trial. In the trial, patients received Dupixent (n=67) every two weeks (adults 300 mg, adolescents 200 mg or 300 mg based on body weight) or placebo (n=66). At 16 weeks, patients treated with Dupixent experienced the following:
- 40% achieved clear or almost clear skin on hands and feet compared to 17% with placebo, the primary endpoint
- 52% saw a clinically meaningful reduction in itch on hands and feet compared to 14% with placebo, the key secondary endpoint
The safety results were generally consistent with the known safety profile of Dupixent in atopic dermatitis. Most common adverse events (AEs) observed with Dupixent (≥1%) in atopic dermatitis include:
- Injection site reactions
- Conjunctivitis
- Blepharitis
- Oral herpes
- Keratitis
- Eye pruritus
- Other herpes simplex virus infection
- Dry eye
- 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,” adds Naimish Patel, MD, Head of Global Development, Immunology and Inflammation at Sanofi. “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.”
