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Pfizer Inc. announced top-line results from Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) Sustain, the third phase 3 study of Xeljanz (tofacitinib citrate) being investigated in patients with moderately to severely active ulcerative colitis (UC). OCTAVE Sustain is a 52 week study that evaluated oral tofacitinib 5 mg and 10 mg twice daily (BID) as a maintenance treatment in adult patients with moderately to severely active UC who previously completed and achieved clinical response in either the OCTAVE Induction 1 or OCTAVE Induction 2 studies.
Top-line results from the OCTAVE Sustain study showed that the proportion of patients in remission at week 52, the primary efficacy endpoint, was significantly greater in both the tofacitinib 5 and 10 mg BID groups compared to placebo. In OCTAVE Sustain, remission was defined as total Mayo scorea =2, no subscore >1, and rectal bleeding subscore of 0. No new or unexpected safety findings for tofacitinib were observed in the study.
OCTAVE Sustain is a phase 3, randomized, double-blind, placebo-controlled, parallel group, multi-center study.A total of 593 patients were randomized to tofacitinib 5 mg BID, tofacitinib 10 mg BID and placebo BID. Detailed analyses of OCTAVE Sustain, including additional efficacy and safety data, will be submitted for presentation at a future scientific meeting.
The OCTAVE global clinical development program includes three phase 3 studies, OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain, as well as a long-term extension trial, OCTAVE Open. We expect that these four studies will form the submission package to regulatory authorities for a potential UC indication.
OCTAVE Induction 1 and OCTAVE Induction 2 are two replicate Phase 3 placebo-controlled studies that evaluated induction of remission by oral tofacitinib 10 mg BID in adult patients with moderately to severely active UC. Subjects needed to have failed or been intolerant to UC treatments including corticosteroids, thiopurines or tumor necrosis factor inhibitors (TNFi).
OCTAVE Sustain is a phase 3 placebo-controlled study evaluating oral tofacitinib 5 mg and 10 mg BID as maintenance therapy in adult patients with moderately to severely active UC.
OCTAVE Open is an ongoing open-label extension study designed to assess the safety and tolerability of tofacitinib 5 mg and 10 mg BID in patients who have completed or who have had treatment failure in OCTAVE Sustain or who were non-responders upon completing OCTAVE Induction 1 or 2.
Xeljanz/Xeljanz XR (tofacitinib citrate) is a prescription medicine called a Janus kinase (JAK) inhibitor. In the United States, Xeljanz XR 11 mg QD is the first and only once-daily oral JAK inhibitor approved for the treatment of moderate to severe rheumatoid arthritis (RA). Xeljanz is approved in more than 45 countries around the world for the treatment of moderate to severe RA as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs (DMARDs).
