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OCTAVE: UC patients achieve sustained remission with Xeljanz
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Xeljanz maintained remission through 52 weeks in patients with moderately to severely active ulcerative colitis who previously achieved clinical response in the OCTAVE Induction trials, Pfizer announced.
Xeljanz (tofacitinib citrate, Pfizer) is an oral, small molecule Janus kinase inhibitor under investigation for inflammatory bowel disease. It is currently approved in many countries as a second-line treatment for moderate-to-severe rheumatoid arthritis.
OCTAVE Sustain is the third phase 3 trial in the OCTAVE clinical development program, in which researchers randomly assigned 593 patients to twice daily 5 mg or 10 mg tofacitinib or placebo. The study achieved its primary endpoint, with a greater proportion of patients in either tofacitinib dose group in remission (defined as a total Mayo score 2, no subscore >1 and a rectal bleeding subscore of 0) at week 52. There were also no new unexpected safety findings.
The company plans to present detailed analysis of this trial at a future scientific meeting, including additional safety and efficacy data.
“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,” Michael Corbo, PhD, chief development officer, Inflammation & Immunology, Pfizer Inc., said in a press release.
Previously the OCTAVE Induction 1 and 2 trials showed twice daily 10 mg tofacitinib rapidly induced remission in patients with moderate to severe ulcerative colitis who previously failed treatment with corticosteroids, thiopurines or anti-TNFs.
A long-term open-label extension trial, OCTAVE Open is currently ongoing, and aims to evaluate safety and tolerability of 5 mg and 10 mg tofacitinib twice daily in patients who have completed or had treatment failure in OCTAVE Sustain, or who were nonresponders in the OCTAVE Induction trials. The company expects these four studies will be included in the submission package for approval of an ulcerative colitis indication.
Disclosures: Corbo is employed by Pfizer.