Pfizer announces results from studies of tofacitinib in ulcerative colitis

Pfizer has announced detailed results from the first two pivotal Phase III studies from the OCTAVE programme.

Results from OCTAVE Induction 1 and OCTAVE Induction 2, evaluating the efficacy and safety of oral tofacitinib 10 mg twice daily (BID) in inducing remission in adult patients with moderately to severely active ulcerative colitis (UC), were presented at ECCO.

Both OCTAVE Induction 1 and OCTAVE Induction 2 met their primary endpoint. At Week 8, a significantly greater proportion of patients receiving tofacitinib 10 mg BID were in remission as compared to placebo, 18.5% versus 8.2%, respectively in OCTAVE Induction 1. The results from OCTAVE Induction 2 were consistent, with a significantly greater proportion of patients receiving tofacitinib 10 mg BID in remission as compared to placebo, 16.6% versus 3.6%, respectively at Week 8. Remission was defined as a Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and a rectal bleeding subscore of 0.

In addition, a significantly greater number of patients receiving tofacitinib 10 mg BID achieved mucosal healing at Week 8 as compared to placebo, the key secondary endpoint in both studies. In OCTAVE Induction 1, 31.3% of patients receiving tofacitinib 10 mg BID achieved mucosal healing as compared to 15.6% of patients treated with placebo at Week 8. Similar results were seen in OCTAVE Induction 2 with 28.4% of patients receiving tofacitinib 10 mg BID achieving mucosal healing as compared to 11.6% of patients treated with placebo at Week 8. Mucosal healing is defined by Mayo endoscopic subscore of 0 or 1.

Safety findings similar to other tofacitinib trials

Safety findings for tofacitinib in OCTAVE Induction 1 and Induction 2 were similar to those observed in other tofacitinib investigational clinical trials.

Commenting on the results, Geert D’Haens, MD, PhD, Professor of Gastroenterology at The Academic Medical Center (AMC), University of Amsterdam, and study investigator, said: “Ulcerative colitis can be a difficult disease to manage, as many patients fail or become intolerant to conventional therapies. We are encouraged by the results from the OCTAVE Induction studies, as they showed that in these trials oral tofacitinib reduced the symptoms of moderate to severe ulcerative colitis and induced remission of the disease. What’s more, these results were seen in patients who were previously treated with tumour necrosis factor inhibitors (TNFis) as well as those who had not received treatment with TNFis. And, improvements in symptoms were observed as early as week 2, the first time point it was measured.”