Positive Results for Oral Tofacitinib in Ulcerative Colitis Presented
Pfizer announced detailed results from the first 2 pivotal Phase 3 trials of the OCTAVE program evaluating oral tofacitinib 10mg twice daily in inducing remission in adults with moderately to severely active ulcerative colitis (UC). Findings were orally presented at the 11th Congress of ECCO Scientific Session.
The OCTAVE (Oral Clinical Trials for tofAcitinib in ulceratiVE colitis) global clinical program for oral tofacitinib includes three Phase 3 studies and a long-term extension study. OCTAVE Induction 1 and OCTAVE Induction 2 are identical, placebo-controlled Phase 3 trials evaluating induction of remission by tofacitinib in adults with moderately to severely active UC. Remission was defined as a Mayo score of ≤2 points, with no individual subscore exceeding 1 point, and a rectal bleeding subscore of 0.
Results from the 2 studies demonstrated that oral tofacitinib 10mg twice daily induced remission in a significantly greater proportion of patients compared to placebo, meeting the studies' primary endpoint. In OCTAVE Induction 1, 18.5% of patients treated with tofacitinib achieved remission vs. 8.2% in the placebo group (95% CI: 4.3, 16.3) at Week 8. Results were consistent in OCTAVE Induction 2, with 16.6% of tofacitinib-treated patients achieving remission vs. 3.6% for placebo (95% CI: 8.1, 17.9) at Week 8. In addition, a significantly greater number of patients treated with tofacitinib achieved mucosal healing compared to placebo at Week 8, the studies' secondary endpoint (Induction 1: 31.3% vs. 15.6%, respectively; Induction 2: 28.4% vs. 11.6%, respectively).
Additional studies for the OCTAVE clinical program are ongoing, including another placebo-controlled Phase 3 study, OCTAVE Sustain, and an open-label extension study, OCTAVE Open. Results for OCTAVE Sustain are anticipated by the end of 2016. Pfizer expects to use the results from these 4 studies to support the application for a potential UC indication.
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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