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Phase III JADE DARE trial of PF 04965842 meets primary endpoint in atopic dermatitis and shows superiority over dupilumab.- Pfizer

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Published:2nd Sep 2021
Pfizer announced that JADE DARE (B7451050), a 26-week, randomized, double-blind, double-dummy, active-controlled, multi-center Phase III study, met its co-primary and key secondary efficacy endpoints. The study showed that PF 04965842 (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 least 90% improvement from baseline) 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 proportion of patients experiencing serious adverse events, severe adverse events, and adverse events leading to study discontinuation were similar in both treatment arms. Two deaths occurred in patients treated with abrocitinib 200mg, which were characterized by the investigator as unrelated to the study drug. One death was attributed to COVID-19 and the second was attributed to intracranial hemorrhage and cardiorespiratory arrest, and classified as a major adverse cardiovascular event (MACE). There were no cases of malignancies or venous thromboembolism (VTE) events confirmed through adjudication. The safety profile seen with abrocitinib was consistent with previous studies in the JADE program. Pfizer intends to share these data with the U.S. FDA and other regulatory agencies around the world reviewing submissions for abrocitinib.

Condition: Atopic Dermatitis (Eczema)
Type: drug

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