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

Pfizer announced top-line results from two Phase III induction trials of Xeljanz (tofacitinib) 10 mg twice daily (BID) tablets in the OCTAVE global clinical development program for the treatment of adults with moderate to severe ulcerative colitis: OCTAVE Induction 1 (A3921094) and OCTAVE Induction 2 (A3921095). Both studies met their primary endpoints as measured by the proportion of patients receiving tofacitinib in remission at Week 8 compared to patients receiving placebo.

A total of 598 patients in OCTAVE Induction 1 and 541 patients in OCTAVE Induction 2 were randomized to tofacitinib 10 mg BID or placebo treatment groups. No new or unexpected safety findings for tofacitinib were observed in the studies. Serious adverse events observed were similar to those seen in other clinical development programs for tofacitinib. Detailed analyses of OCTAVE Induction 1 and OCTAVE Induction 2, including additional efficacy and safety data, will be submitted for presentation at a future scientific meeting.

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.