OBJECTIVES: The aim of this study was to assess the efficacy of vedolizumab, adalimumab, golimumab, infliximab, and tofacitinib for moderate-to-severe ulcerative colitis in anti-TNF-alpha-naïve, adult patients in randomized clinical trials.

METHODS: We performed a comprehensive search of PubMed to identify randomized clinical trials with results published up to November 2019 that assess the efficacy of at least one of infliximab, adalimumab, golimumab, vedolizumab, and tofacitinib comparing them to placebo or other treatments in the induction phase and/or maintenance phase of therapy for moderate to severe ulcerative colitis.

RESULTS: We found 180 articles and identified 17 randomized clinical trials for data use to assess clinical response and clinical remission in the induction phase and maintenance phase. Sustained clinical response and sustained clinical remission were also assessed. In the induction phase, fourteen studies showed that all treatments were significantly better than placebo in clinical response (treatments in interest versus placebo or conventional treatments, OR: 2.42, 95% CI: 2.09-2.79). For clinical remission in the maintenance phase, eleven studies assessed treatments other than tofacitinib and showed that they were significantly better than placebo (2.62, 2.10-3.27). Six studies assessed treatments other than tofacitinib for sustained clinical response and showed that they were significantly better than placebo (2.97, 2.34-3.77). A study compared adalimumab and vedolizumab head to head, and it showed that vedolizumab was significantly better than adalimumab in clinical response in induction phase (2.39, 1.71-3.33) and in clinical remission in maintenance phase (1.62, 1.14-2.31).

CONCLUSIONS: Infliximab, adalimumab, golimumab, vedolizumab, and tofacitinib were efficacious in clinical response in the induction phase, and the four treatments other than tofacitinib had data to support their efficacy in clinical remission in the maintenance phase and sustained clinical response. Since we reviewed 17 studies for five treatments, further research with more data is needed to establish solid evidence.