A drug under late-stage development by Pfizer has shown positive results in atopic dermatitis among adolescents and adults, the drugmaker said.
The New York-based company said Friday that its JADE MONO-2 study of abrocitinib showed that after 12 weeks of treatment, the percentage of patients achieving the study’s primary endpoints and key secondary endpoints with both doses of the drug. The drugmaker hasn’t released full data from either JADE MONO-2 or the first Phase III study, JADE MONO-1 – results of which were announced in May – but has submitted them for presentations at medical meetings.
The primary endpoints for both studies were the proportion of patients who achieved clear or almost clear skin and an improvement of at least two points on an investigator global assessment score, as well as the proportion of patients who achieved at least a 75 percent change in their Eczema Area and Severity Index, or EASI, score. The key secondary endpoints were the portion of patients achieving at least a four-point reduction in itch severity measured with the pruritis numerical rating score and magnitude of decrease in the Pruritis and Symptoms Assessment for Atopic Dermatitis, or PSAAD. Abrocitinib was administered at 100mg or 200mg twice daily.
The company said safety results were “broadly consistent” between both trials, with the rate of serious adverse events being 1.3 percent and 3.2 percent for the 100mg and 200mg doses, respectively, compared with 1.3 percent for placebo. The discontinuation rate in the placebo arm was 12.8 percent, while those in the 100mg and 200mg arms were 3.8 percent and 3.2 percent.
Abrocitinib is a JAK1 inhibitor. It belongs to a class similar to that of an approved agent, Incyte’s JAK2 inhibitor Jakafi (ruxolitinib), which is used to treat blood disorders, namely myelofibrosis and polycythemia vera, as well as acute graft-versus-host disease, a complication of bone marrow transplants. Meanwhile, Gilead Sciences and Galapagos have said they will file this year for Food and Drug Administration approval of filgotinib, another JAK1 inhibitor, in rheumatoid arthritis.
A topical formulation of the same active ingredient used in Jakafi is also in development for atopic dermatitis among patients aged 12 and older, with two 600-patient Phase III trials – titled TRuE AD1 and TRuE AD2 – that have been ongoing since November and December of last year and are expected to reach completion in August of September of next year.
Photo: grThirteen, Getty Images
