Pfizer Inc. (PFE) announced Wednesday positive top-line results from a Phase 3 pivotal study (B7451012) evaluating the efficacy and safety of its investigational oral Janus kinase (JAK1) inhibitor, abrocitinib (PF-04965842), in patients aged 12 and older with moderate to severe atopic dermatitis (AD). The study also achieved all co-primary and secondary endpoints.
The study was a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of two doses (100mg and 200mg once daily) of abrocitinib monotherapy over 12 weeks.
Top-line results showed that by week 12 the percentage of patients achieving each co-primary efficacy endpoint and each key secondary endpoint with either dose of abrocitinib was statistically significantly higher than placebo.
In addition, the results demonstrate response to treatment for a statistically significant number of patients during the first two to four weeks following first dose.
These top-line findings are encouraging and provide evidence that abrocitinib, if approved, could be an effective new oral once-daily treatment option for patients.
Abrocitinib received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with moderate to severe AD in February 2018.
If a drug is designated as a Breakthrough Therapy, the FDA will expedite the development and review of such drug.
AD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects. AD is one of the most common, chronic, relapsing childhood dermatoses, affecting 1% to 3% of adults and 15% to 20% of children worldwide.
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