Pfizer reports positive phase 3 data in atopic dermatitis
pharmafile | October 7, 2019 | News story | Sales and Marketing |
Pfizer has announced top-line results from a second Phase 3 study evaluating the efficacy and safety of its oral JAK1 inhibitor, abrocitinib, in patients aged 12 or over with moderate to severe atopic dermatitis.
The study, called JADE MONO-2, used 391 subjects and was designed to evaluate the efficacy and safety of two doses (100mg and 200mg once daily) of abrocitinib monotherapy over the course of 12 weeks.
The results were consistent with Pfizer’s JADE MONO-1 with results showing that by week 12 the percentage of patients achieving primary and second endpoints and the rate being much higher than placebo.
Michael Corbo, Chief Development Officer of Inflammation & Immunology at Pfizer, said: “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.
“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 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.
Full results from JADE MONO-2 will be submitted for presentation at a future scientific meeting and publication in a medical journal.
Nik Kiran
