Positive top-line results have been announced from Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) Sustain, the third phase 3 study of Xeljanz (tofacitinib citrate, Pfizer) in patients with moderately to severely active ulcerative colitis (UC). OCTAVE Sustain was a 52-week study that evaluated oral tofacitinib 5 mg and 10 mg twice daily 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.
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-mg and 10-mg twice-daily groups compared with placebo. Remission was defined as a total Mayo score of 2 or lower, no subscore higher than 1, and a rectal bleeding subscore of 0. No new or unexpected safety findings for tofacitinib were observed in the study.
“Ulcerative colitis is a chronic, often debilitating inflammatory condition that can be difficult to treat. There are a limited number of therapies available, and patients need additional treatment options,” says Michael Corbo, PhD, Chief Development Officer of Inflammation and Immunology at Pfizer. “These findings, along with the previously released positive induction data from the OCTAVE studies, are encouraging and provide evidence that tofacitinib, if approved, has the potential to be an effective new oral treatment option that both induces and maintains remission.”
OCTAVE Sustain was a phase 3, randomized, double-blind, placebo-controlled, parallel group, multicenter study. A total of 593 patients were randomized to tofacitinib 5 mg twice daily, tofacitinib 10 mg twice daily, or placebo twice daily. 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. Pfizer expects that these four studies will form the submission package to regulatory authorities for a potential UC indication.
Source: Pfizer; July 28, 2016.