Phase III JADE MONO-1 study of PF 04965842 meets endpoints in atopic dermatitis.- Pfizer

Pfizer Inc. announced complete results from a Phase III, 12-week, pivotal study (JADE MONO-1) of PF 04965842 (abrocitinib) in patients aged 12 and older with moderate to severe atopic dermatitis (AD). Abrocitinib, an investigational oral Janus kinase 1 (JAK1) 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 (200mg and 100mg) were well tolerated and were consistent with a companion study (JADE MONO-2) from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program.

The co-primary study endpoints in JADE MONO-1 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 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 (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 numerical rating scale (NRS), and the magnitude of decrease in the Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD), 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 (SCORAD) response at all scheduled time points. Both doses of abrocitinib significantly improved the IGA and EASI-75 dose response outcomes compared to placebo.

The most frequently reported treatment-emergent adverse events in abrocitinib-treated patients (200mg, 100mg) were short-lasting nausea (20.1%, 9.0%), headache (9.7%, 7.7%), and nasopharyngitis (11.7%, 14.7%), while for placebo, it was dermatitis (16.9%). The results were shared as a Late-Breaking presentation at the 28th Congress of the European Academy of Dermatology and Venereology.