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Pfizer announced positive topline results from the phase 3 JADE MONO-2 trial of abrocitinib, an oral Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD).
The multicenter, double-blind, placebo-controlled trial evaluated the efficacy and safety of abrocitinib in 391 patients aged ≥12 years with a minimum body weight of 40kg who have moderate to severe AD. Patients were randomized to receive abrocitinib 100mg, 200mg, or placebo once daily for 12 weeks. The co-primary end points were based on the 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). Key secondary endpoints included a 4-point or greater improvement in itch severity measured by the pruritus numerical rating scale (NRS); and the magnitude of decrease in the Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD).
Results demonstrated that both doses of abrocitinib were associated with statistically significant improvements in the co-primary and key secondary end points compared with placebo. Additionally, patients showed a statistically significant reduction in pruritus with at least a 4-point improvement by week 2, as measured by pruritus NRS.
With regard to safety, abrocitinib was well-tolerated and consistent with that observed in the JADE MONO-1 trial. The frequency of treatment-emergent adverse reactions for abrocitinib 100mg, 200mg, and placebo were 63%, 66%, and 54%, respectively, and the frequency of serious adverse reactions were 3.2%, 1.3%, and 1.3%, respectively; discontinuation rates due to an adverse event were 3.8%, 3.2%, and 12.8%, respectively.
Full detailed data from the trial will be submitted for presentation at a future scientific meeting and publication in a medical journal.
“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.”
The FDA previously granted Breakthrough Therapy designation to abrocitinib for moderate to severe AD in February 2018.
For more information visit pfizer.com.
