December 7, 2021
Can tofacitinib reduce colectomy rates for acute severe ulcerative colitis?
These findings need to be confirmed in a randomized trial with long-term follow-up, but do support the use of high-dose tofacitinib as an alternative to anti-TNF therapy for patients hospitalized with acute severe ulcerative colitis.
Berinstein JA, Sheehan JL, Dias M, et al. Tofacitinib for Biologic-Experienced Hospitalized Patients With Acute Severe Ulcerative Colitis: A Retrospective Case-Control Study. Clin Gastroenterol Hepatol. 2021;19(10):2112–20.e1; https://doi.org/10.1016/j.cgh.2021.05.038
Roughly 25% of ulcerative colitis patients require hospitalization for acute severe ulcerative colitis (ASUC), and an estimated 30% of these individuals require colectomy. In this study, researchers retrospectively examined outcomes from 40 inpatients with ASUC administered tofacitinib induction treatment during hospitalization, along with intravenous corticosteroids. A matched control group of 113 similar patients who did not receive tofacitinib was also included in the analysis.
The patients, most of whom had extensive colitis, were an average of 34 and 38 years of age in the tofacitinib and control groups, respectively, and had a mean disease duration of 10 and 8 years, respectively. All tofacitinib recipients and 41% of controls had previously received a biologic agent. Tofacitinib was administered either twice or thrice daily for total doses of 20 mg or 30 mg, respectively.
Results showed that those receiving tofacitinib were 72% less likely to undergo colectomy within 90 days than the matched controls (Hazard Ratio [HR]: 0.28; 95% Confidence Interval [CI], 0.10–0.81; p=0.018). More specifically, the 30 mg daily group experienced a significant reduction in colectomy rates (HR: 0.11; 95% CI, 0.02–0.56; p=0.008), while the effect was not significant in the 20 mg daily group (HR: 0.66; 95% CI, 0.21–2.09; p=0.5).
There were no significant differences in rates of venous thromboembolic and cardiovascular events between the tofacitinib and control groups, and no differences in rates of infection, including bacterial infections, opportunistic infections, herpes zoster and COVID-19. Of those patients who underwent colectomy within 90 days of treatment, 39% in the control group experienced a postoperative infection, compared to none of those in the tofacitinib group. Half of tofacitinib recipients were still receiving corticosteroids at 90 days, compared to 31% of those in the control group.
Study Design: Retrospective case-control
Allocation: Not applicable
Level of Evidence: 3b