Promising Phase 3 Trial Results for Ulcerative Colitis Therapy Xeljanz Announced by Pfizer

Promising Phase 3 Trial Results for Ulcerative Colitis Therapy Xeljanz Announced by Pfizer

Pfizer has just announced top-line results from OCTAVE Sustain, the third Phase 3 study investigating Xeljanz (tofacitinib citrate) in patients with moderate-to-severe active ulcerative colitis (UC).

The OCTAVE Clinical Development Program includes three studies – OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain, in addition to a long-term extension trial, OCTAVE Open.

Phase 3 OCTAVE Sustain (oral clinical trials for Xeljanz in ulcerative colitis) is a randomized, double-blind, placebo-controlled, parallel group, multi-center, 52-week trial assessing two daily doses of oral Xeljanz (5 mg and 10 mg) as a maintenance treatment in 593 adult patients who have previously completed and achieved clinical response in either OCTAVE Induction 1 or OCTAVE Induction 2 studies.

Xeljanz is a Janus kinase inhibitor (JAK). Xeljanz XR 11 mg is the first once-daily oral JAK inhibitor approved in the U.S. for the treatment of moderate-to-severe rheumatoid arthritis. The efficacy and safety profile of Xeljanz has been studied in over 6,200 patients over more than 19,400 patient-years of drug exposure in the global clinical development program.

The results announced by Pfizer show that a significant greater proportion of patients achieved remission of ulcerative colitis at week 52, the study’s primary efficacy point, in both dosage groups compared to a placebo.

In OCTAVE Sustain, remission was defined as total Mayo score less than or equal to 2, no sub-score greater than 1, and rectal bleeding sub-score of 0. There are no reports of unexpected safety findings.

“Ulcerative colitis is a chronic, often debilitating inflammatory condition that can be difficult to treat. There are a limited number of therapies available and patients need additional treatment options,” Michael Corbo, PhD, Pfizer’s chief development officer of Inflammation & Immunology, said in a press release.

“These findings, along with the previously released positive induction data from the OCTAVE studies, are encouraging and provide evidence that tofacitinib, if approved, has the potential to be an effective new oral treatment option that both induces and maintains remission,” Corbo said, adding that Pfizer is proud to advance its clinical development program for Xeljanz “to bring a potential new treatment option to patients living with ulcerative colitis.”

Click here for full prescribing information for Xeljanz and Xeljanz XR, including the therapy’s box warning and medication guide.