Dupilumab improves hand, foot atopic dermatitis in phase 3 study
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Key takeaways:
- A total of 40.3% of patients treated with dupilumab achieved IGA 0 or 1 compared with 16.7% of placebo-treated patients.
- Dupilumab significantly decreased itch in 52.2% of patients.
NEW ORLEANS — Patients with hand and foot atopic dermatitis experienced significant improvement with dupilumab, which sustained an acceptable safety profile, according to phase 3 study results presented here.
“These results are the first to highlight how Dupixent can improve signs and symptoms of atopic hand and foot dermatitis, which is very difficult to treat,” Eric Simpson, MD, MCR, Frances J. Storrs Medical Dermatology Professor at Oregon Health & Science University, told Healio concerning his presentation at the American Academy of Dermatology Annual Meeting. “In this trial, significantly more patients treated with Dupixent experienced clear or almost clear skin and reduced itch, and also had improvements in broader impacts of the disease such as skin pain, sleep and hand eczema-related quality of life, compared to placebo.”
Simpson presented data from the randomized, double-blind LIBERTY-AD-HAFT phase 3 trial of dupilumab (Dupixent, Sanofi/Regeneron) in 133 patients aged 12 years and older with moderate to severe hand and foot atopic dermatitis.
Patients were randomly assigned to receive dupilumab monotherapy (n = 67) or placebo (n = 66) for 16 weeks. Adults were administered 300 mg every 2 weeks, whereas adolescents were administered 200 mg/300 mg at the same frequency.
Results showed that the study met the primary endpoint and all secondary endpoints. Significantly more dupilumab-treated patients achieved the primary endpoint of IGA 0 or 1 compared with placebo-treated patients (40.3% vs. 16.7%; P = .003).
Of the dupilumab group, 52.2% achieved the key secondary endpoint of a 4 point or greater improvement in the Hand and Foot Pruritus Numerical Rating Scale compared with 13.6% in the placebo group (P < .0001).
The percent change from baseline was significantly higher in the dupilumab group compared with the placebo group in modified Total Lesion Sign Score (LS mean, 69.4; standard error [SE], 5.8 vs. LS mean, 31; SE, 5.9; P < .0001) and Hand Eczema Severity Index (LS mean, 74.8; SE, 6.3 vs. LS mean, 39.9; SE, 6.2; P < .0001).
The study reported an acceptable safety profile with the most common treatment emergent adverse events in dupilumab and placebo groups including nasophyngitis (16% vs. 11%, respectively) and atopic dermatitis (5% vs. 18%).
“Given the strong safety and efficacy profile Dupixent has already shown from infancy to adulthood in people with moderate to severe atopic dermatitis, we were hopeful to see positive results in those with atopic dermatitis concentrated on the hands and feet,” Simpson said. “We are pleased to see such strong results in patients that experience intense itch and painful skin lesions on such critical areas of the body.”