Vedolizumab vs. Anti-TNF Agents in Biologic-naive UC Patients
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Real-world Effectiveness of Vedolizumab Compared to Anti-TNF Agents in Biologic-naïve Patients With Ulcerative Colitis

A Two-year Propensity-score-adjusted Analysis From the Prospective, Observational VEDOibd-Study

Bernd Bokemeyer; Sandra Plachta-Danielzik; Romina di Giuseppe; Philipp Efken; Wolfgang Mohl; Thomas Krause; Martin Hoffstadt; Robert Ehehalt; Leo Trentmann; Axel Schweitzer; Petra Jessen; Petra Hartmann; Stefan Schreiber

Disclosures

Aliment Pharmacol Ther. 2023;58(4):429-442. 

In This Article

Abstract and Introduction

Abstract

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-TNF agents in biologic-naïve patients with ulcerative colitis (UC) at the end of induction and during maintenance treatment.

Methods: Between 2017 and 2020, we enrolled 512 patients with UC starting therapy with vedolizumab or an anti-TNF agent in 45 IBD centres across Germany. We 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 ITT analysis). We used propensity score adjustment with inverse probability of treatment weighting 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 two years were significantly higher for vedolizumab-treated patients than those treated with an anti-TNF agent (43.2% vs. 25.8%, p< 0.011). Among patients treated with vedolzumab, 29% switched to other biologics, versus 54% who had received an anti-TNF agent.

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