Pfizer Inc. recently announced that its third Phase III study of XELJANZ (tofacitinib citrate), Oral Clinical Trials for tofacitinib in ulcerative colitis (OCTAVE) Sustain, has turned in positive results.
The study was conducted on patients with moderate-to-severe active ulcerative colitis (UC).
In the 52-week OCTAVE Sustain study, adult patients were given oral tofacitinib in doses of 5 mg or 10 mg twice daily for the maintenance treatment of moderate-to-severe UC that was active. The requirements for the patients was the completion of either the OCTAVE Induction 1 or OCTAVE Induction 2 studies.
“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,” Pfizer’s Chief Development Officer, Inflammation & Immunology Michael Corbo said. “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.”
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