Short- and Long-Term Effectiveness and Safety of Vedolizumab in Crohn's Disease: A Multicenter Retrospective Study from the Hokkaido Phoenix Cohort.

Abstract

Introduction: Real-world data on the long-term effectiveness of vedolizumab (VDZ) in East Asian patients with Crohn's disease (CD) remain limited. This study aimed to assess treatment persistence, clinical and endoscopic effectiveness, safety, and predictors of VDZ discontinuation in a multicenter Japanese cohort.

Methods: A retrospective study was conducted across seven hospitals between June 2019 and October 2025, including patients with CD who initiated VDZ. Outcomes included VDZ continuation, factors associated with discontinuation, longitudinal changes in clinical and endoscopic indices, and adverse events.

Results: Seventy-three patients were included. VDZ continuation was 62.3% and 37.8% at 1 and 3 years, respectively. In a multivariable Cox analysis, higher baseline C-reactive protein (CRP), higher body mass index (BMI), and female sex were independently associated with increased risk of VDZ discontinuation, with a trend toward better persistence among patients with ileal disease. In the 1-year analysis, female sex and prior biologic exposure predicted early discontinuation. CD activity index and its subscores improved during early treatment, and albumin levels increased gradually over time. Simple endoscopic score for CD improved at 1 and 2 years. Among patients with active disease, >40% achieved remission from week 6 onward. Adverse events occurred in 16.4%, with two (2.7%) patients discontinuing VDZ due to infusion reactions or psoriasiform rashes.

Conclusion: VDZ demonstrated acceptable long-term durability, clinically meaningful and endoscopic improvement, and a favorable safety profile in Japanese real-world practice. Baseline CRP, BMI, and sex were important predictors of treatment persistence.