Long-term efficacy and safety of vedolizumab compared with infliximab in biologic-naive ulcerative colitis: a systematic review and meta-analysis

Background/Aims: Vedolizumab and infliximab are widely used biologic agents for ulcerative colitis (UC), yet their comparative long-term effectiveness and safety in biologic-naive patients remain uncertain. This meta-analysis evaluated long-term efficacy and safety outcomes of vedolizumab versus infliximab in this population. Methods: A systematic search of MEDLINE, Scopus, the Cochrane Library, and ClinicalTrials.gov was conducted. Studies enrolling biologic-naive UC patients with a minimum follow-up of 12 months and reporting comparative outcomes between vedolizumab and infliximab were included. Random-effects meta-analyses were performed to pool odds ratios with 95% confidence intervals. Results: Twenty-five studies met the inclusion criteria. Vedolizumab was associated with significantly greater treatment persistence than infliximab at 12, 24, 36, and 48 months, while no significant difference was observed at 60 months. Patients receiving vedolizumab were more likely to achieve clinical remission and endoscopic remission at 12 months. Rates of steroid-free remission at 12 months were comparable between groups. Vedolizumab was linked to lower hospitalization rates at 12 and 36 months, with no difference at 24 months, and showed similar risks of inflammatory bowel disease-related surgery. The need for dose optimization was lower with vedolizumab at 12 months. Regarding safety, vedolizumab was associated with a lower incidence of serious adverse events compared with infliximab. Conclusions: In biologic-naive UC patients with long-term follow-up, vedolizumab demonstrates favorable treatment persistence, remission, and safety profiles compared with infliximab. Given the predominance of observational evidence, these findings should be interpreted cautiously and warrant confirmation in prospective comparative studies.