Abrocitinib vs placebo or dupilumab for atopic dermatitis
New England Journal of Medicine Mar 31, 2021
Bieber T, Simpson EL, Silverberg JI, et al. - This phase 3, double-blind trial was conducted to test abrocitinib (oral Janus kinase 1 inhibitor) vs placebo or dupilumab for the treatment of atopic dermatitis. Patients suffering from atopic dermatitis that was unresponsive to topical agents or that warranted systemic therapy were included. Participants were randomized in a 2:2:2:1 ratio to receive 200 mg or 100 mg of abrocitinib orally once daily, 300 mg of dupilumab subcutaneously every other week (following a loading dose of 600 mg), or placebo. All participants were also given topical therapy. There were 838 patients who were randomized, with 226 patients in the 200-mg abrocitinib group, 238 in the 100-mg abrocitinib group, 243 in the dupilumab group, and 131 in the placebo group. At weeks 12 and 16, significantly greater decreases in signs and symptoms of moderate-to-severe atopic dermatitis were conferred by abrocitinib at a dose of either 200 mg or 100 mg once daily vs placebo. Regarding itch response at week 2, superiority of 200 mg dose, but not the 100 mg dose, of abrocitinib over dupilumab was evident. Experts noted that in terms of most other key secondary endpoint comparisons at week 16 (Investigator’s Global Assessment and Eczema Area and Severity Index–75 responses), neither abrocitinib dose differed significantly from dupilumab.
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