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OCTAVE trials: Xeljanz induces remission in moderate-to-severe UC

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Two phase 3 induction trials of Xeljanz in patients with moderate-to-severe ulcerative colitis met their primary endpoints, the manufacturer announced today.

Xeljanz (tofacitinib, Pfizer) is a Janus kinase inhibitor currently approved as a second-line therapy for moderate-to-severe rheumatoid arthritis, according to the press release. OCTAVE Induction 1 (n = 598) and 2 (n = 541) are identical phase 3 placebo-controlled trials that evaluated the safety and efficacy of twice daily 10-mg oral tofacitinib for induction of remission in adult patients with moderate-to-severe UC. In both trials, a greater proportion of patients who received tofacitinib were in remission at week 8 compared with placebo. No new or unexpected safety issues were observed, and serious adverse events were comparable to those observed in previous studies.

“We are encouraged by the results of the OCTAVE induction studies as UC is a chronic, and at times debilitating, disease that can be difficult to treat,” Rory O’Connor, MD, senior vice president and head of global medical affairs, global innovative pharmaceuticals business, Pfizer Inc., said in a press release. “Pfizer remains committed to advancing the science of Janus kinase inhibition and enhancing understanding of tofacitinib, the first in this new class of medications being investigated for [UC]. We look forward to sharing the results of our ongoing phase 3 maintenance study OCTAVE Sustain, when available, which will provide further information on tofacitinib in [UC].”

Detailed safety and efficacy data for both trials will be submitted for presentation at a future scientific meeting, according to the press release. The OCTAVE Sustain trial results are expected by the end of 2016, and the OCTAVE global clinical development program, which “will form the potential submission package to regulatory authorities for a potential UC indication,” also includes a long-term extension trial, OCTAVE Open.

Disclosures: O’Connor reports he is an employee of Pfizer.