Tofacitinib for induction of remission in ulcerative colitis: systematic review and meta-analysis
Background The aim of the study was to assess the efficacy and safety of tofacitinib and its impact
on quality of life in patients with moderate-to-severe ulcerative colitis.
Methods We conducted a systematic review and meta-analysis of randomized controlled
trials comparing tofacitinib with placebo or any active comparator. We searched Medline,
Embase, the Cochrane Library and gray literature for articles published up to May 2017.
We synthesized data using a fixed-effect model. We conducted subgroup analysis based on
prior exposure to anti-tumor necrosis factor (TNF). We summarized the strength of evidence
using the Grading of Recommendations Assessment, Development and Evaluation (GRADE)
Results We included three trials with 1220 participants. Compared with placebo, tofacitinib was
effective in inducing clinical remission (odds ratio [OR] 3.84, 95% confidence interval [CI] 2.29-
6.44, I2: 41%, GRADE: moderate), clinical response (OR 2.95, 95%CI 2.21-3.95, I2: 0%, GRADE:
high), mucosal healing (OR 2.70, 95%CI 1.81-4.03, I2: 0%, GRADE: high). Tofacitinib was effective
in both anti-TNF-naïve and -experienced patients. Tofacitinib had a favorable effect on quality
of life. There were no significant differences in the safety profile in terms of the incidence of any
or serious adverse events compared to placebo. The risk for infections was increased (OR 1.51,
95%CI 1.05-2.19, I2: 0%, GRADE: moderate), but the incidence of serious infections did not differ
between tofacitinib and placebo.
Conclusion In patients with moderate-to-severe ulcerative colitis, short-term treatment with
tofacitinib is effective for induction of remission and improvement of quality of life.
Keywords Tofacitinib, ulcerative colitis, meta-analysis
Ann Gastroenterol 2018; 31 (5): 572-582