Pfizer's tofacitinib meets primary endpoint in Phase III studies on ulcerative colitis

US pharma giant Pfizer (NYSE: PFE) has announced results from two Phase III trials of tofacitinib, showing it met the primary endpoints in ulcerative colitis.

The primary endpoints were measured by the proportion of adults with moderate-to-severe ulcerative colitis receiving the JAK inhibitor in remission at week eight compared to placebo. Tofacitinib is already marketed as Xeljanz to treat moderate-to-severe rheumatoid arthritis as a second-line therapy.

The studies, called OCTAVE Induction 1 and OCTAVE Induction 2, enrolled 598 patients and 541 patients respectively. The adults, who have moderate-to-severe ulcerative colitis, were randomized to treatment with either tofacitinib or placebo for eight weeks.