Dupilumab showed strong results for uncontrolled moderate-to-severe hand and foot atopic dermatitis, meeting its primary and secondary endpoints in the trial.
In late-breaking data presented at the American Academy of Dermatology (AAD) 2023 Annual Meeting in New Orleans, dupilumab (Dupixent) was found to have positive results for uncontrolled moderate-to-severe hand and foot atopic dermatitis (AD).1
The data indicated that the trial met its major primary and secondary endpoints, causing the drug to become the first biologic to be evaluated for this hard-to-treat patient population.
“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,” stated Eric Simpson, MD, principal trial investigator and Frances J. Storrs Professor of Medical Dermatology at the Oregon Health and Science University.
During the course of the trial, the participants were given dupilumab every 2 weeks, with adult participants receiving 300 mg, adolescent participants receiving 200 mg or 300 mg—depending on their body weight—or the placebo.
The trial investigators determined their primary endpoint to be an evaluation of clear or almost clear skin for participants’ hand and feet AD. They assessed through a rating of 0 or 1 on the Investigator Global Assessment Scale.
The investigators determined the key secondary endpoint to be a measurement of the proportion of participants that showed hand and feet itch improvement from baseline. This was assessed through a reduction after 16 weeks of ≥4-points on the Peak-Pruritis Numeric Rating Scale.
“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,” Simpson explained.
After the participants in the study were given dupilumab or a placebo every 2 weeks, by 16 weeks those who had been treated with dupilumab experienced significant improvements.
The investigators reported that over 40% were able to achieve clear or almost clear skin on their hands and feet, compared to just 17% with the placebo group.
Additionally, they noted that nearly 4 times as many participants who were on dupilumab saw a clinically meaningful reduction of itch on hands and feet, seeing improvements as early as a single week.
The investigators also noted that there were also substantial improvements in measures of hand and foot skin pain, sleep, and hand eczema-related quality of life.
“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,” Simpson stated.