Abrocitinib meets co-primary endpoints in phase 3 trial
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The phase 3 JADE COMPARE trial met its co-primary efficacy endpoints in adults with moderate to severe atopic dermatitis. Results from the trial, which compared the use of the JAK1 inhibitor abrocitinib with placebo, will be submitted for presentation at a future conference, according to a press release from Pfizer.
The study enrolled 837 patients on background topical therapy who were randomly assigned to one of five treatment groups:
- 100 mg abrocitinib plus dupilumab matching placebo via subcutaneous injection every other week from day 1 to week 16, followed by 100 mg abrocitinib until week 20;
- 200 mg abrocitinib plus dupilumab matching placebo via subcutaneous injection every other week from day 1 to week 16, followed by 200 mg abrocitinib until week 20;
- 300 mg dupilumab with a 600 mg loading dose at baseline every other week with abrocitinib matching orally administered placebo once daily from day 1 to week 16, followed by abrocitinib matching orally administered placebo once daily until week 20;
- abrocitinib matching orally administered placebo once daily with dupilumab matching subcutaneously injected placebo administered every other week from day 1 to week 16, followed by 100 mg abrocitinib until week 20; or
- abrocitinib matching orally administered placebo once daily with dupilumab matching subcutaneously injected placebo administered every other week from day 1 to week 16, followed by 200 mg abrocitinib until week 20.
The proportion of patients who achieved an Investigator’s Global Assessment rating of clear (0) or almost clear (1) and a two-point or greater reduction from baseline to week 12, and the proportion of patients with a 75% or greater change from baseline in the Eczema Area and Severity Index score at week 12 served as the co-primary endpoints. The proportion of patients who achieved the IGA and EASI measures at 16 weeks and the proportion of patients who achieved a four-point or greater reduction in itch at 2 weeks per the Peak Pruritis Numerical Rating Scale were secondary endpoints. At week 2, relative pruritus relief achieved by abrocitinib was formally compared with dupilumab, according to the release.
“It was helpful to study abrocitinib in combination with topical therapies to provide data relevant to the real-world setting,” Michael Corbo, PhD, chief development officer, inflammation and immunology, Pfizer global product development, said in the release. “The addition of an active control was also important to better understand the significance of this potential new medicine, and we’re encouraged by the positive data from this trial.”
Trial results yielded a higher percentage of patients achieving each efficacy endpoint at week 12 with doses of abrocitinib than with placebo and a clinically significant itch reduction by week 2.
The safety profile was consistent with previous trials, and the JADE COMPARE trial results, along with the pivotal MONO-1 and MONO-2 trial results, will support filings with regulatory bodies, including the FDA, this year.