Pfizer’s oral JAK inhibitor cleared patients’ skin and improved atopic dermatitis, or eczema, symptoms in a phase 3 study, echoing results from another phase 3 trial presented earlier this year.
Both studies enrolled nearly 400 patients aged 12 and older with moderate to severe atopic dermatitis and tested two doses of Pfizer’s abrocitinib: 100 mg and 200 mg. Data from the latest study, JADE MONO-2, showed that after 12 weeks of treatment, the treatment bested placebo at improving eczema symptoms, such as itch and skin inflammation, by at least 75%, as measured by the Eczema Area and Severity Index (EASI). More patients taking abrocitinib ended up with “clear” or “almost clear” skin by the end of the study period compared to placebo. Abrocitinib also delivered on its secondary endpoints, both of which were scores to measure pruritus, or skin itch.
The drug’s safety profile looks on par with that shown in the earlier phase 3 study, JADE MONO-1. A higher proportion of abrocitinab patients experienced side effects than placebo—63% and 64% for the 100 mg and 200 mg doses, respectively, versus 54% for placebo—but fewer patients on abrocitinib quit the trial compared to placebo. The dropout rate for abrocitinib was between 3% and 4% for both doses, versus nearly 13% for placebo.
“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, Ph.D., chief development officer of Pfizer’s inflammation and immunology unit, in a statement. “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.”
Abrocitinib is a daily pill, which could be regarded as bad news for treatment adherence, but it could still be more attractive to patients than Sanofi and Regeneron’s Dupixent, which must be injected twice a month.
Although the drug must be taken daily, unlike twice-monthly Dupixent, it may still be more appealing to patients than either Dupixent or lebrikizumab, which are both injected.
Abrocitinib isn’t the only eczema treatment chasing Dupixent—Dermira posted phase 2b data in March showing its anti-IL-13 antibody lebrikizumab outshone placebo at improving symptoms, as measured by the EASI. Of course, comparing results across trials is difficult, but lebrikuzumab could one-up Dupixent if it can come through with a more attractive dosing schedule. It tested a once-monthly injection in its phase 2b study, which worked, but did not have a clear efficacy edge over Dupixent.
That said, there should be plenty of room for both lebrikizumab and abrocitinib to challenge Dupixent, as they have different mechanisms of action, wrote Cantor Fitzgerald analysts in a note Friday morning.