Tofacitinib for induction of remission in ulcerative colitis: systematic review and meta-analysis

Paschalis Paschos; Anastasia Katsoula; Olga Giouleme; Maria Sarigianni; Aris Liakos; Eleni Athanasiadou; Eleni Bekiari; Apostolos Tsapas

doi:10.20524/aog.2018.0276

Tofacitinib for induction of remission in ulcerative colitis: systematic review and meta-analysis

Ann Gastroenterol. 2018 Sep-Oct;31(5):572-582. doi: 10.20524/aog.2018.0276. Epub 2018 May 10.

Authors

Paschalis Paschos^{1

2}, Anastasia Katsoula^{1

3}, Olga Giouleme³, Maria Sarigianni¹, Aris Liakos¹, Eleni Athanasiadou¹, Eleni Bekiari¹, Apostolos Tsapas^{1

4}

Affiliations

¹ Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University of Thessaloniki, Thessaloniki, Greece (Paschalis Paschos, Anastasia Katsoula, Maria Sarigianni, Aris Liakos, Eleni Athanasiadou, Eleni Bekiari, Apostolos Tsapas).
² First Department of Internal Medicine, "Papageorgiou" Hospital, Thessaloniki, Greece (Paschalis Paschos).
³ Second Propaedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece (Olga Giouleme, Anastasia Katsoula).
⁴ Harris Manchester College, University of Oxford, Oxford, UK (Apostolos Tsapas).

Abstract

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) approach.

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, I^2: 41%, GRADE: moderate), clinical response (OR 2.95, 95%CI 2.21-3.95, I^2: 0%, GRADE: high), mucosal healing (OR 2.70, 95%CI 1.81-4.03, I^2: 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, I^2: 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; meta-analysis; ulcerative colitis.