Oral atopic dermatitis therapy shows positive phase 3 results
Pfizer announced phase 3 study results from its investigational oral JAK1 inhibitor, abrocitinib, for treating patients aged at least 12 years with moderate to severe atopic dermatitis.
The randomized, double-blind, placebo-controlled, parallel-group study evaluated two doses of abrocitinib, 100 mg and 200 mg once daily, over 12 weeks in 387 patients.
The study endpoints included the proportion of patients who achieved an Investigator Global Assessment score of clear (0) or almost clear (1) skin and at least 2-point improvement.
Additionally, investigators studied the proportion of patients who achieved at least a 75% change from baseline in Eczema Area and Severity Index score.
Secondary endpoints were the proportion of patients achieving a 4-point or larger reduction in itch severity measured with the pruritic numerical rating scale and the magnitude of decrease in the Pruritis and Symptoms Assessment for Atopic Dermatitis.
By week 12, the percentage of patients achieving each coprimary endpoint and each secondary endpoint with either dose was statistically significantly higher than placebo, according to the company press release.
After the first dose, the results demonstrated response to treatment for a statistically significant number of patients during the first 2 to 4 weeks.
Both doses were well-tolerated, and researchers found no unexpected safety events.
According to the company, this is the first trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program, and additional data from another study will be available later in the year.