Top-line results were announced from a phase 3 study evaluating the safety and efficacy of abrocitinib, an oral Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis in patients ≥12 years old.
The placebo-controlled study (B7451012) included 387 patients and evaluated 2 doses of abrocitinib (100mg and 200mg once daily) over 12 weeks. The co-primary endpoints of the trial were response based on: Investigator’s Global Assessment (IGA) score of clear (0) or almost clear (1) and a reduction from baseline of ≥2 points and 75% improvement from baseline on Eczema Area and Severity Index (EASI), both at Week 12.
Results showed that compared with placebo, the percentage of patients who achieved each co-primary endpoint was statistically significantly higher with either dose of abrocitinib. Findings from the study also showed a response to abrocitinib treatment during the first 2-4 weeks following the first dose in a statistically significant number of patients.
In addition, key secondary endpoints of the study, which included the proportion of patients achieving a 4 point or larger reduction in itch severity measured with the pruritus numerical rating scale (NRS) and the magnitude of decrease in the Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD), were also achieved.
“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,” said Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development.
B7451012 is the first trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program. In February 2018, abrocitinib received Breakthrough Therapy designation from the Food and Drug Administration for the treatment of patients with moderate to severe atopic dermatitis.
According to Pfizer, additional efficacy and safety data are expected to be available following study publication and presentation at a future scientific meeting.
For more information visit pfizer.com.