Pfizer (NYSE:PFE) announces positive results from a second Phase 3 clinical trial, JADE Mono-2, evaluating JAK1 inhibitor abrocitinib in patients at least 12 years old with moderate-to-severe atopic dermatitis.
The study met the co-primary endpoints of statistically valid proportions of patients in the treatment groups achieving clear or almost clear skin and at least a two-point improvement in IGA score from baseline at week 12 and/or at least a 75% improvement in EASI score from baseline at week 12, compared to placebo. Key secondary endpoints were also met.
On the safety front, the frequencies of treatment-emergent adverse events for the 100 mg and 200 mg doses were 63% and 66%, respectively, compared to 54% for control. The frequencies of serious adverse events were 3.2%, 1.3% and 1.3%, respectively. One patient with cardiovascular risk factors died from unknown causes three weeks after treatment, deemed unrelated to abrocitinib. The discontinuation rates were 3.8%, 3.2% and 12.8%, respectively.
Complete results will be submitted for presentation at a future medical conference and publication.
In May, the company announced successful results from the first study, JADE Mono-1.
Data from other studies in the JADE program will be available in Q4 and 2020.
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