Pfizer announced top-line results Monday from two Phase III trials of tofacitinib, showing that it met their primary endpoints as measured by the proportion of adults with moderate-to-severe ulcerative colitis receiving the drug in remission at week eight, compared to patients receiving placebo. The company already markets the JAK inhibitor under the name Xeljanz for the treatment of moderate-to-severe rheumatoid arthritis as a second-line therapy after failure of at least one disease-modifying antirheumatic drug.
In the OCTAVE Induction 1 and OCTAVE Induction 2 studies, which enrolled 598 patients and 541 patients, respectively, adults with moderate-to-severe ulcerative colitis were randomised to treatment with tofacitinib or placebo for eight weeks. Pfizer said no new or unexpected safety findings were observed in either trial, while serious adverse events were similar to those recorded in other clinical development programmes for the drug. The company added that detailed analyses of the trials, including additional efficacy and safety data, will be submitted for presentation at a future research conference.
"We are encouraged by the results of the OCTAVE induction studies as ulcerative colitis is a chronic, and at times debilitating, disease that can be difficult to treat," remarked Rory O'Connor, head of global medical affairs at Pfizer's global innovative pharmaceuticals business. The company indicated that data from the ongoing OCTAVE Sustain maintenance study are anticipated by the end of 2016, while results from all three trials, as well as a fourth long-term extension study dubbed OCTAVE Open, will comprise the potential submission package to regulatory authorities for clearance of tofacitinib in a possible ulcerative colitis indication.
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