Ulcerative colitis treatment Xeljanz records positive top-line results in Phase III trial
pharmafile | July 29, 2016 | News story | Medical Communications, Research and Development | Pfizer, Xeljanz, tofacitinib, ulcerative colitis
Pfizer has announced positive top-line results from oral clinical trials for tofacitinib in ulcerative colitis (Octave) sustain, the third Phase III of Xeljanz (tofacitinib citrate), a treatment for patients suffering from moderate to severely active ulcerative colitis (UC).
The multi-center trial comprised a total of 593 patients who were randomised to tofacitinib 5 mg BID, tofacitinib 10 mg BID and placebo BID treatment groups. Over 52 weeks it was determined that remission rates in UC sufferers taking oral tafacitinib 5 mg and 10mg twice daily (BID) and who had previously completed and achieved clinical response in either the Octave induction 1 or 2 studies were significantly greater compared to placebo.
“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,” said Michael Corbo, chief development officer, Inflammation & 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. We are proud to advance our clinical development program for tofacitinib as we work to bring a potential new treatment option to patients living with ulcerative colitis.”
Matt Fellows
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