Xeljanz Demonstrates Efficacy in Third Phase 3 Ulcerative Colitis Study
Pfizer announced top-line results from OCTAVE Sustain, the third Phase 3 study of Xeljanz (tofacitinib citrate) for the potential treatment of patients with moderately to severely active ulcerative colitis (UC).
OCTAVE (Oral Clinical Trials for tofAcitinib in ulceratiVE colitis) Sustain is a 52-week, multicenter, randomized, double-blind, placebo-controlled, parallel group Phase 3 trial evaluating oral tofacitinib 5mg and 10mg twice daily vs. placebo as a maintenance treatment in 593 adults with moderately to severely active UC who previously completed and achieved clinical response in either the OCTAVE Induction 1 or OCTAVE Induction 2 studies. The primary efficacy endpoint was the proportion of patients in remission at Week 52, defined as total Mayo score ≤2, no subscore >1, and rectal bleeding subscore of 0.
The study met the primary endpoint, demonstrating that a significantly greater proportion of patients in both the tofacitinib 5mg and 10mg arms achieved remission at Week 52 compared to the placebo arm. No new or unexpected safety findings for tofacitinib were observed in the study. Detailed trial data for OCTAVE Sustain will be analyzed and presented at a future scientific meeting.
Tofacitinib is a Janus Kinase (JAK) inhibitor. It is currently marketed as Xeljanz and Xeljanz XR for the treatment of moderate to severe rheumatoid arthritis (RA) as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs (DMARDs).
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