Pfizer Inc. shared positive top-line results from a second Phase 3 pivotal study evaluating the efficacy and safety of its investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib, in patients aged 12 and older with moderate to severe atopic dermatitis (AD). This is the second monotherapy trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program (B7451013, or JADE MONO-2). Complete results from JADE MONO-1 will be presented as a late-breaking abstract at a major upcoming European scientific meeting in Madrid in October 2019.
JADE MONO-2 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.
Consistent with JADE MONO-1, 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, a statistically significant number of patients achieved a reduction in pruritus by week two, as measured by a four-point or larger reduction in itch severity measured with the pruritus numerical rating scale (NRS).
“These findings add to a growing body of evidence supporting the potential of abrocitinib to improve the lives of people living with moderate to severe atopic dermatitis,” said Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “We look forward to continued findings from the JADE program, with results from the next abrocitinib efficacy study, using an active control, becoming available in spring 2020. This will further our understanding of abrocitinib as a potential medicine for patients who suffer from this chronic condition.”
The co-primary study endpoints in JADE MONO-2 were the proportion of patients who achieved an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin and two-point or greater improvement; and the proportion of patients who achieved at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) score. The key secondary endpoints were the proportion of patients achieving a four-point or larger reduction in itch severity measured with the pruritus NRS and the magnitude of decrease in the Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD).
Safety results showed that both doses of abrocitinib were well-tolerated and were broadly consistent with JADE MONO-1. The frequency of treatment-emergent adverse events were 54%, 63%, and 66% for placebo, 100mg, and 200mg, respectively. The frequency of Serious Adverse Events were 1.3%, 3.2%, and 1.3% for placebo, 100mg, and 200mg, respectively. One patient with co-existing cardiovascular risk factors died from unknown etiology three weeks after completing treatment with abrocitinib 100mg once daily, which was deemed unrelated to the study drug by the investigator. The discontinuation rates due to an adverse event were low in each treatment arm (3.8% and 3.2% in 100mg and 200mg, respectively) compared to placebo (12.8%).
Full results from JADE MONO-2 will be submitted for presentation at a future scientific meeting and publication in a medical journal.