Pfizer presents Phase 3 data for Abrocitinib in moderate to severe AD
Pfizer announced complete results from a Phase 3, 12-week, pivotal study in patients aged 12 and older with moderate to severe atopic dermatitis. Abrocitinib, an investigational oral Janus kinase 1 inhibitor, met all the co-primary and key secondary endpoints, which were related to skin clearance and itch relief compared to placebo. Safety data showed that both evaluated doses of abrocitinib were well tolerated and were consistent with a companion study from the JAK1 Atopic Dermatitis Efficacy and Safety global development program. The co-primary study endpoints in JADE MONO-1 were the proportion of patients who achieved an Investigator Global Assessment score of clear or almost clear skin and two-point or greater improvement relative to baseline; and the proportion of patients who achieved at least a 75% or greater change from baseline in their Eczema Area and Severity Index score. The key secondary endpoints were the proportion of patients achieving a four-point or larger reduction in itch severity measured with the pruritus numerical rating scale, and the magnitude of decrease in the Pruritus and Symptoms Assessment for Atopic Dermatitis, a patient-reported measurement scale developed by Pfizer. Other secondary endpoints included the proportion of patients who achieved a 90% or greater change in EASI score, and the percentage change from baseline in their SCORing Atopic Dermatitis response at all scheduled time points. Both doses of abrocitinib significantly improved the IGA and EASI-75 dose response outcomes compared to placebo. The percentage changes in SCORAD were significantly greater at all time points in the 200mg and 100mg treatment arms compared to placebo.