Dupilumab revealed superior efficacy compared with placebo in the phase 3 LIBERTY-AD-HAFT trial for the treatment of atopic dermatitis (AD) of the hands and feet. A total of 40.3% of patients achieved an Investigator’s Global Assessment (IGA) of clear or almost clear.
The results of the trial, presented by Eric Simpson, MD, MCR, at the 2023 American Academy of Dermatology annual meeting, consisted of 133 patients with hand and/or foot AD.1 Patients were randomized with dupilumab or placebo to 16 weeks of therapy and 12 additional weeks of follow-up.
All participants were at least 12 (with a mean age of 35.8 and 33.4) and presented with moderate-to-severe AD on hands and feet. A baseline hand and foot IGA of 3 was present in just over 70% of patients, and at least 70% also presented with moderate-to-severe AD on other body locations. The mean length of hand and/or foot AD was around 15.5 years.
The study result at week 16 were positive, with a statistically significant higher fraction of patients in the dupilumab arm meeting the primary endpoint of a hand and foot IGA 0-1, compared with 16.7% on placebo (P<0.01).
Also at week 16, the key secondary endpoint of achieving a 4-point or greater improvement in the Peak Pruritus Numerical Rating Scale was met, with 52.2% versus 13.6% favoring dupilumab (P<0.0001).
Furthermore, in the dupilumab group versus placebo, the modified total lesion symptom score for hand and foot, the Hand Eczema Severity Index, and QOL were notably improved.
Regarding safety, results coincided with dupilumab’s previously observed profile. In comparing dupilumab with the placebo arm, at least 5% of patients reported nasopharyngitis (16.4% vs 10.6%) as the most common treatment-related adverse event.
“Hopefully, we will get access to a drug like this soon, this will greatly improve the QOL of our patients,” Dr. Simpson said.
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