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; Cai-Qun Bie; Li-Liangzi Guo; Li-Xian Zhong; Shao-Hui Tang

doi:10.3892/etm.2023.11997

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

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

Authors

Hui-Jun Tang¹, Cai-Qun Bie¹, Li-Liangzi Guo², Li-Xian Zhong², Shao-Hui Tang²

Affiliations

¹ Department of Gastroenterology, Shenzhen Integrated Traditional Chinese and Western Medicine Hospital, Shenzhen, Guangdong 518104, P.R. China.
² Department of Gastroenterology, The First Affiliated Hospital, Jinan University, Guangzhou, Guangdong 510632, P.R. China.

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.

Grants and funding

Funding: No funding was received.