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
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