Sanofi and Regeneron announced new findings from the Phase 3 CAFÉ study that evaluated Dupixent (dupilumab) in adults with moderate-to-severe atopic dermatitis (AD) who have inadequate control or are intolerant to cyclosporine A or when this treatment is medically inadvisable.
In CAFÉ (n=325), patients were randomized into 3 treatment groups to receive either Dupixent 300mg weekly with topical corticosteroids, Dupixent 300mg every 2 weeks with topical corticosteroids or placebo with topical corticosteroids.
The primary endpoint was the proportion of patients that had a ≥75% improvement in the Eczema Area and Severity Index (EASI-75) score at 16 weeks from baseline. The data indicated 59% of patients given Dupixent weekly with topical corticosteroids and 63% of patients given Dupixent every 2 weeks with topical corticosteroids achieved EASI-75 vs. 30% of patients given placebo with topical corticosteroids (P<0.0001).
A secondary endpoint of mean percent change in EASI from baseline at 16 weeks was 78% in the Dupixent weekly group and 80% in the Dupixent every 2 weeks group vs. 47% in the placebo group (P<0.0001). Also, the mean percent improvement from baseline in the intensity of patient-reported itch was 52%, 54%, and 25% for the Dupixent weekly, Dupixent every other week, and placebo groups, respectively (P<0.0001).
Overall, treatment with Dupixent and topical corticosteroids significantly improved measures of overall disease severity, skin clearing, itching, and patient-reported quality of life measures. Regarding safety, the outcomes were consistent the 3 previous Phase 3 studies of Dupixent in moderate-to-severe atopic dermatitis.
Dupixent, a human monoclonal antibody, works by simultaneously inhibiting overactive signaling of IL-4 and IL-13 cytokines. It was approved in March 2017 to treat adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
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