Esophagus to Small Intestine

Inflamm Bowel Dis. 2024;30(5):746–56

Bokemeyer B, Plachta-Danielzik S, di Giuseppe R, Efken P, Mohl W, Hoffstadt M, Krause T, Schweitzer A, Schnoy E, Atreya R, Teich N, Trentmann L, Ehehalt R, Hartmann P, Schreiber S

Real-world effectiveness of vedolizumab vs. anti-TNF in biologic-naive Crohn’s disease patients: A 2-year propensity-score-adjusted analysis from the VEDOIBD-study

Background: The aim of this observational, real-world evidence, modified intention-to-treat (mITT) study based on prospectively collected data from the VEDOIBD registry was to compare the effectiveness of vedolizumab (VEDO) versus anti-tumor necrosis factor (anti-TNF) in biologic-naive Crohn’s disease (CD) patients.
Methods: Between 2017 and 2020, 557 CD patients starting therapy with VEDO or anti-TNF were consecutively enrolled in 45 inflammatory bowel disease (IBD) centers across Germany. Per study protocol, the analysis excluded biologic-experienced patients and those with a missing Harvey-Bradshaw Index score, resulting in a final sample of 327 biologic-naive CD patients. Clinical remission was measured using the Harvey-Bradshaw Index at the end of induction therapy and after 1 and 2 years. Switching to a different therapy was considered an outcome failure. Propensity score adjustment with inverse probability of treatment weighting was used to correct for confounding.
Results: The effectiveness of both VEDO (n = 86) and anti-TNF (n = 241) was remarkably high for induction treatment, but VEDO performed significantly less well than anti-TNF (clinical remission: 56.3% vs. 73.9%, p < 0.05). In contrast, clinical remission after 2 years was significantly better for VEDO compared with anti-TNF (74.2% vs. 44.7%; p < 0.05; odds ratio = 0.45; 95% confidence interval: 0.22–0.94). Remarkably, only 17% of patients switched from VEDO to another biologic versus 44% who received anti-TNF.

Conclusions: The results of this prospective, 2-year, real-world evidence study suggest that the choice of vedolizumab (VEDO) led to higher remission rates after 2 years compared with anti-tumor necrosis factor. This could support the role of VEDO as a first-line biologic therapy in Crohn’s disease.

DOI: 10.1093/ibd/izad138