Positive topline results were announced from a phase 3 trial evaluating abrocitinib, an oral Janus Kinase 1 inhibitor, in patients 12 years and older with moderate to severe atopic dermatitis following response to induction treatment with abrocitinib 200mg.
The JADE REGIMEN trial (N=1233) was a responder-enriched, double-blind, placebo-controlled withdrawal study that included a 12-week open-label run-in period to determine response to an initial induction treatment with abrocitinib 200mg. Patients who had a positive clinical response to induction treatment (n=798) then entered a 40-week, double-blind, maintenance treatment period in which they were randomized to receive abrocitinib 100mg, abrocitinib 200mg, or placebo once daily.
The primary end point of the trial was flare requiring rescue treatment, defined as a loss of at least 50% of the Eczema Area and Severity Index response at week 12 and an Investigator’s Global Assessment (IGA) score of 2 or higher.
Results showed that through week 52, the probability of not experiencing a flare was significantly higher among patients who continued on abrocitinib 200mg, or switched to the 100mg dose, compared with those who received placebo (81.1%, 57.4%, and 19.1%, respectively). Moreover, patients who continued on the 200mg dose were significantly less likely to have a flare vs those in the lower dose group (P <.0001). Compared with the placebo group, patients in both abrocitinib dose groups were also significantly more likely to maintain IGA score of 0 (clear) or 1 (almost clear) (P <.0001).
As for safety, 63.2% and 54% of patients treated with abrocitinib 200mg and 100mg experienced an adverse event compared with 45.3% for placebo. Serious adverse events were reported in 4.9% of patients treated with the 200mg dose, 1.5% of patients treated with the 100mg dose, and 0.7% of patients given placebo.
“These latest results from our phase 3 clinical trial program shed light on the potential abrocitinib, if approved, could have to prevent troublesome flares in patients,” said Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development.
The Food and Drug Administration recently granted Priority Review to abrocitinib for the treatment of moderate to severe atopic dermatitis. The Agency is expected to make a decision on the application in April 2021.
For more information visit pfizer.com.
Pfizer announces positive results from fifth phase 3 trial of abrocitinib, evaluating safety
and efficacy across different dosing regimens. [press release]. New York, NY: Pfizer, Inc;
November 11, 2020.