High Rates of Remission, Mucosal Healing With Tofacitinib in Patients With Ulcerative Colitis: Presented at ECCO-IBD

By Shazia Qureshi

AMSTERDAM, the Netherlands -- March 22, 2016 -- In patients with moderate-to-severe active ulcerative colitis, 8 weeks of treatment with tofacitinib resulted in higher rates of remission and mucosal healing compared with placebo, according to a study presented here at the 11th Congress of the European Crohn’s and Colitis Organisation, Inflammatory Bowel Diseases (ECCO-IBD).

Geert D’Haens, MD, University of Amsterdam, Amsterdam, the Netherlands, and colleagues analysed data from 2 randomised, double-blind placebo-controlled trials. The studies included adult patients with moderate-to-severe active ulcerative colitis.

In the OCTAVE Induction 1 study, 476 patients received tofacitinib 10 mg BID and 122 received placebo for 8 weeks. In the OCTAVE Induction 2 study, 429 patients received tofacitinib 10 mg BID and 112 received placebo for 8 weeks.

The primary endpoint in both studies was remission at week 8, defined as a total maximum Mayo score of 2, no subscore that was higher than 1, and zero on the rectal bleeding subscore.

Results in both trials showed higher rates of reaching the primary endpoint with tofacitinib compared with placebo. In OCTAVE Induction 1, remission occurred in 18.5% of tofacitinib-treated patients compared with 8.2% for placebo (P = .007). In OCTAVE Induction 2, the rates were 16.6% versus 3.6% respectively (P = .0005).

One of the main secondary endpoints was mucosal healing at week 8, which the investigators defined as a Mayo endoscopic subscore of ≤1. This was also found to be significantly different between groups in favour of active treatment in both trials. Mucosal healing was reported for 31.3% of tofacitinib-treated patients compared with 15.6% of placebo-treated patients (P =.0005) in the 1st induction trial, and 28.4% versus 11.6%, respectively, for the 2nd trial (P = .0002).

Adverse event (AE) rates were similar across groups, and rates of serious AEs were not higher with tofacitinib versus placebo. Tofacitinib treatment did seem to lead to some cases of elevated serum lipids and creatine kinase. One death occurred across both trials; this was a patient in the tofacitinib group, who died of dissecting aortic aneurysm.

Responders from both trials were invited to enter a 1-year maintenance study (NCT01458574), and re-randomised to tofacitinib 10 mg BID, 5 mg BID or placebo. The trial is ongoing.

Funding for this study was provided by Pfizer.

[Presentation title: Efficacy and Safety of Oral Tofacitinib as Induction Therapy in Patients With Moderate-to-Severe Ulcerative Colitis: Results From 2 Phase 3 Randomised Controlled Trials. Abstract OP019]

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