Colon to Rectum
Aliment Pharmacol Ther. 2023;58(4):429–42
Real-world effectiveness of vedolizumab compared to anti-TNF agents in biologic-naive patients with ulcerative colitis: A 2-year propensity-score-adjusted analysis from the prospective, observational VEDOIBD study
Background: This observational real-world evidence (RWE) study is based on prospectively collected data from the VEDOIBD registry study.
Aim: To compare the effectiveness of vedolizumab and anti-tumor necrosis factor (TNF) agents in biologic-naive patients with ulcerative colitis (UC) at the end of induction and during maintenance treatment.
Methods: Between 2017 and 2020, the authors enrolled 512 patients with UC starting therapy with vedolizumab or an anti-TNF agent in 45 inflammatory bowel disease (IBD) centers across Germany. They excluded biologic-experienced patients and those with missing partial Mayo (pMayo) outcomes; this resulted in a final sample of 314 (182 on vedolizumab and 132 on an anti-TNF agent). The primary outcome was clinical remission measured using pMayo score; any switch to a different biologic agent was considered an outcome failure (modified intention-to-treat analysis). Propensity score adjustment with inverse probability of treatment weighting was used to correct for confounding.
Results: During induction therapy, clinical remission was relatively low and similar in vedolizumab- and anti-TNF-treated patients (23% vs. 30.4%, p = 0.204). However, clinical remission rates after 2 years were significantly higher for vedolizumab-treated patients than for those treated with an anti-TNF agent (43.2% vs. 25.8%, p < 0.011). Among patients treated with vedolizumab, 29% switched to other biologics versus 54% who had received an anti-TNF agent.
Conclusion: After 2 years of treatment, vedolizumab resulted in higher remission rates than anti-tumor necrosis factor agents.
DOI: 10.1111/apt.17616