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. 2023 May 5;25(6):298.
doi: 10.3892/etm.2023.11997. eCollection 2023 Jun.

Efficacy and safety of vedolizumab in the treatment of patients with inflammatory bowel disease: A systematic review and meta‑analysis of randomized controlled trials

Hui-Jun Tang  1 , Cai-Qun Bie  1 , Li-Liangzi Guo  2 , Li-Xian Zhong  2 , Shao-Hui Tang  2
Affiliations

Efficacy and safety of vedolizumab in the treatment of patients with inflammatory bowel disease: A systematic review and meta‑analysis of randomized controlled trials

Hui-Jun Tang et al. Exp Ther Med. .

Abstract

Few studies have thoroughly assessed the efficacy and safety of vedolizumab (VDZ) in the treatment of inflammatory bowel disease (IBD). Therefore, this systematic review and meta-analysis was performed to further evaluate this association. PubMed, Embase, and the Cochrane databases were searched until April 2022. Randomized controlled trials (RCTs) evaluating the efficacy and safety of VDZ in the treatment of IBD were included. The risk ratio (RR) and 95% confidence intervals (CI) were estimated for each outcome using a random effects model. A total of 12 RCTs, including 4,865 patients, met the inclusion criteria. In the induction phase, VDZ was more effective than placebo for patients with ulcerative colitis and Crohn's disease (CD) in clinical remission (RR=2.09; 95% CI=1.66-2.62) and clinical response (RR=1.54; 95% CI=1.34-1.78). In the maintenance therapy group, VDZ reached higher clinical remission (RR=1.98; 95% CI=1.58-2.49) and clinical response (RR=1.78; 95% CI=1.40-2.26) rates compared with the placebo group. VDZ particularly improved clinical remission (RR=2.07; 95% CI=1.48-2.89) and clinical response (RR=1.84; 95% CI=1.54-2.21) in patients with TNF antagonist failure. In terms of corticosteroid-free remission, VDZ was also more effective than placebo in patients with IBD (RR=1.98; 95% CI=1.51-2.59). In Crohn's patients, VDZ was more effective than placebo in terms of mucosal healing (RR=1.78; 95% CI=1.27-2.51). With respect to adverse events, VDZ significantly reduced the risk of IBD exacerbation compared with the placebo (RR=0.60; 95% CI=0.39-0.93; P=0.023). However, when compared with the placebo, VDZ increased the risk of nasopharyngitis in patients with CD (RR=1.77; 95% CI=1.01-3.10; P=0.045). No significant differences in other adverse events were observed. Although there might be underlying risk, such as selection bias, in the present study it can be safely concluded that VDZ is a safe and effective biological agent for IBD, particularly for patients with TNF antagonist failure.

Keywords: inflammatory bowel disease; meta-analysis; randomized controlled trials; vedolizumab.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Figure 1
Figure 1
Flow diagram of the assessment of studies identified by the literature search for inclusion.
Figure 2
Figure 2
Randomized effects meta-analysis of the efficacy of vedolizumab treatment in the induction phase. (A) Clinical remission and (B) clinical response. UC, ulcerative colitis; CD, Crohn's disease; RR, risk ratio; CI, confidence interval.
Figure 3
Figure 3
Randomized effects meta-analysis of the efficacy of vedolizumab treatment in the maintenance phase. (A) Clinical remission and (B) clinical response. UC, ulcerative colitis; CD, Crohn's disease; RR, risk ratio; CI, confidence interval.
Figure 4
Figure 4
Random-effect meta-analysis of VDZ in IBD patients with a history of TNF antagonist failure. (A) Clinical remission and (B) clinical response. VDZ, vedolizumab; IBD, irritable bowel disease; RR, risk ratio; CI, confidence interval.
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