Pfizer Inc. (PFE) announced Monday that JADE DARE (B7451050), a 26-week, randomized, double-blind, double-dummy, active-controlled, multi-center Phase 3 study, met its co-primary and key secondary efficacy endpoints.
The study showed that abrocitinib was statistically superior compared to dupilumab in each evaluated efficacy measure and had a safety profile consistent with previous studies.
The head-to-head study was designed to directly compare the efficacy of abrocitinib 200mg versus dupilumab 300mg, in adult participants on background topical therapy with moderate to severe atopic dermatitis (AD).
Abrocitinib 200mg was administered by once-daily oral tablet and dupilumab was administered by subcutaneous injection every other week following a 600mg induction dose.
The co-primary efficacy endpoints in JADE DARE were the proportion of patients achieving at least a 4-point improvement in the severity of Peak Pruritus Numerical Rating Scale (PP-NRS4) from baseline at Week 2 and the proportion of patients achieving Eczema Area and Severity Index (EASI)-90 at Week 4.
The key secondary endpoint was the proportion of patients achieving EASI-90 at Week 16. The study will allow assessment of any difference in efficacy that may persist at month 6 of treatment.
A larger percentage of patients treated with abrocitinib 200mg experienced adverse events compared to dupilumab 300mg.
The study is part of the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program for abrocitinib.
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