Two phase III trials of Xeljanz (tofacitinib) in ulcerative colitis meet primary endpoints- Pfizer

Pfizer announced the oral presentation of detailed results from the first two pivotal Phase III studies from the OCTAVE program of Xeljanz (tofacitinib) in ulcerative colitis, at the 11th Congress of ECCO. Results from OCTAVE Induction 1 and OCTAVE Induction 2, evaluating the efficacy and safety of oral tofacitinib 10 mg twice daily (BID) in inducing remission in adult patients with moderately to severely active ulcerative colitis (UC), were presented during the Scientific Session 7: ECCO Fellowships & Grants. Both OCTAVE Induction 1 and OCTAVE Induction 2 met their primary endpoint. At Week 8, a significantly greater proportion of patients receiving tofacitinib 10 mg BID were in remission as compared to placebo, 18.5% (n=88) versus 8.2% (n=10), respectively in OCTAVE Induction 1. The results from OCTAVE Induction 2 were consistent, with a significantly greater proportion of patients receiving tofacitinib 10 mg BID in remission as compared to placebo, 16.6% (n=71) versus 3.6% (n=4), respectively at Week 8. Remission was defined as a Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and a rectal bleeding subscore of 0.

In addition, a significantly greater number of patients receiving tofacitinib 10 mg BID achieved mucosal healing at Week 8 as compared to placebo, the key secondary endpoint in both studies. In OCTAVE Induction 1, 31.3% (n=149) of patients receiving tofacitinib 10 mg BID achieved mucosal healing as compared to 15.6% (n=19) of patients treated with placebo at Week 8. Similar results were seen in OCTAVE Induction 2 with 28.4% (n=122) of patients receiving tofacitinib 10 mg BID achieving mucosal healing as compared to 11.6% (n=13) of patients treated with placebo at Week 8. Mucosal healing is defined by Mayo endoscopic subscore of 0 or 1. Safety findings for tofacitinib in OCTAVE Induction 1 and Induction 2 were similar to those observed in other tofacitinib investigational clinical trials.

Comment: The OCTAVE global clinical development program includes three Phase III studies, OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain (A3921096), as well as a long-term extension trial, OCTAVE Open (A3921139). Results for OCTAVE Sustain are anticipated by the end of 2016. These four studies will form the potential submission package to regulatory authorities for a potential UC indication.