C Difficile Cases are Infrequent in Ulcerative Colitis Patients Treated With Tofacitinib

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The majority of cases were mild to moderate in severity.

Patients with ulcerative colitis who are treated with tofacitinib are not at an increased risk of clostridium difficile infections (CDI), according to new research.

A team, Edward V Loftus Jr, MD, Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, evaluated CDI incidence in patients with ulcerative colitis treated with tofacitinib.

The Drug

Tofacitinib is an oral, small molecule Januse kinase inhibitor used to treat patients with ulcerative colitis. Patients with IBD often vulnerable to C difficile infections.

In the study, the investigators identified events from 4 phase 2 or 3 randomized, placebo-controlled induction studies, as well as an open-label, long-term extension study and a phase 3 maintenance study.

The trials were analyzed as either an induction, maintenance, or overall patients with participants receiving tofacitinib 5 or 10 mg twice daily.

The team also evaluated the proportions and incidence rates of CDI as unique patients with events per 100 patient-years of exposure.

The Study

The study included 1157 patients who received at least 1 dose of tofacitinib 5 mg or 10 mg twice daily, with a total of 2814.4 patient-years of tofacitinib exposure and up to 7.8 years of treatment. Of this group, 82.6% of patients received predominantly tofacitinib 10 mg twice daily.

In the induction studies 3 patients had CDI, 2 of which were treated with tofacitinib and the remaining participant was in the placebo group.

For the maintenance portion, 3 patients had CDI, all of which were in the placebo arm.

Finally in the overall cohorts, 9 patients had CDI. The overall cohort CDI incidence rate was 0.31 (95% CI, 0.14-0.59), but all cases were mild or moderate in severity and resolved with treatment in 8 patients.

In addition, 66% (n = 6) of patients continued tofacitinib treatment without interruptions, while 2 patients reported as serious due to hospitalization. Also, a pair of patients were receiving corticosteroids when the C difficile infection occurred.

“CDIs among patients with UC receiving tofacitinib were infrequent, cases were mild–moderate in severity, and most resolved with treatment,” the authors wrote.


Last year, investigators found fecal microbiota transplantation (FMT) is effective at curing patients with CDI and underlying IBD.

The overall pooled cure rate with single and multiple transplantations was 26.8% (95% CI, 22.5-31.6%; I2 = 9%).

For IBD flares, the pooled rate after FMT was 26.8% (95% CI, 22.5-31.6%; I2 = 9%). For colectomy, the pooled rate following FMT was 7.3% (95% CI, 4.7-10.5%; I2 = 56%).

The investigators also analyzed 141 pediatric patients, 106 of which had CDI resolution after the first FMT. The pooled cure rate of this patient subgroup was 78% (95% CI, 58-93%; I2 = 59%) with an overall pooled cure rate with single and multiple FMT of 77% (95% CI, 50%-96%; I2 = 63%).

The pooled cure rate of an IBD flare after FMT was 10.8% (95% CI, 5.7%-18.5% I2 = 43%), while the pooled cure rate of colectomy after FMT was 10.3% (95% CI, 2.1%-30.2% I2 = 23%).

The study, “Clostridium difficile Infection in Patients with Ulcerative Colitis Treated with Tofacitinib in the Ulcerative Colitis Program,” was published online in inflammatory bowel disease.