Abstract

Abstract Background Long-term vedolizumab (VDZ) outcomes in real-world cohorts have been largely limited to 1-year follow-up, with few bio-naïve patients or objective markers of inflammation assessed. We aimed to assess factors affecting VDZ persistence including clinical, biochemical and faecal biomarker remission at 1, 3 and 5 years. Methods We performed a retrospective, observational, cohort study. All adult IBD patients who had received VDZ induction for UC/IBDU were included. Baseline phenotype and follow-up data were collected via review of electronic medical records. Results We included 290 patients (UC n=271 [93.4%], IBDU n=19 [6.6%]) with a median time on VDZ of 27.6 months (IQR 14.4-43.2). At the end of follow-up, a total of 157/290 (54.1%) patients remained on VDZ. Median time to discontinuation was 14.1 months (7.0-23.3). Previous exposure to ≥1 advanced therapy, steroid use at baseline; and disease extension were independent predictors for VDZ persistence (Table 1). Clinical remission (partial Mayo <2) was 75.7% (171/226), 72.4% (157/217) and 70.2% (127/181) at year 1,3 and 5 respectively. Steroid use during maintenance VDZ therapy occurred in 31.7% (92/290), hospitalization in 15.5% (45/290) and surgery in 3.4% (10/291). The rate of serious adverse events was 1.2 per 100 patient-years of follow-up. Conclusion VDZ persistence is influenced by previous exposure to biologics/small molecules, disease distribution and steroid use at baseline. VDZ effectiveness is enduring with favourable long-term safety profile.

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