Tofacitinib Effective for Moderate-to-Severe Ulcerative Colitis

HealthDay News — Patients with moderate-to-severe ulcerative colitis who haven’t done well on other treatments may have success with tofacitinib (Xeljanz), according to a study published in the May 4 issue of the New England Journal of Medicine.

The researchers randomly assigned 1,732 patients with ulcerative colitis to one of three phase 3 trials. The first two trials looked at 1,139 patients with moderate-to-severe ulcerative colitis who had failed with conventional treatment or treatment with a tumor necrosis factor antagonist such as infliximab. They received tofacitinib or a placebo twice a day for 8 weeks. In the third trial, 593 patients who responded to tofacitinib were assigned to a maintenance dose (1 group with 5 mg and another group with 10 mg) of the drug, or placebo for a year. 

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In the first trial, 18.5% of the patients taking tofacitinib experienced a remission of their condition in 8 weeks. That compared to just 8.2% of patients receiving placebo. In the second trial, 16.6% of those taking tofacitinib had a remission, compared with 3.6% of those taking placebo, the researchers found. In the third trial, 34.3 percent of patients taking 5mg of tofacitinib had disease remission after one year, while 40.6% of those taking a 10-mg dose of the drug had remission at a year. Only 11.1% of patients on placebo saw a remission.

“The rate of serious infection was similar across the 3 treatment groups, and the rates of overall infection and herpes zoster infection were higher with tofacitinib than with placebo,” the authors write. “Across all three trials, adjudicated nonmelanoma skin cancer occurred in five patients who received tofacitinib and in one who received placebo, and adjudicated cardiovascular events occurred in five who received tofacitinib and in none who received placebo; as compared with placebo, tofacitinib was associated with increased lipid levels.”

The study was funded by Pfizer, the manufacturer of tofacitinib. One author disclosed receiving research grants from and serving as a consultant for Pfizer.

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