More positive Phase III results for Pfizer's oral Xeljanz in ulcerative colitis
US pharma giant Pfizer (NYSE: PFE) has announced positive top-line results from a third Phase III study of Xeljanz (tofacitinib citrate) in patients with ulcerative colitis (UC).
The results are from the Octave Sustain trial, a 52-week study that evaluated oral tofacitinib 5mg and 10mg twice daily (BID) as a maintenance treatment in adult patients with moderately to severely active UC, who previously completed and achieved clinical response in either the OCTAVE Induction 1 or OCTAVE Induction 2 studies.
Top-line results from this latest study, which involved 593 subjects, showed that the proportion of patients in remission at week 52, the primary efficacy endpoint, was significantly greater in both the tofacitinib 5 and 10mg BID groups compared to placebo. No new or unexpected safety findings for tofacitinib were observed in the trial.
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