P0293Vedolizumab persistence in Crohn’s Disease. Survival analysis: a single centre observational retrospective study. Is the Clinical Decision Support Tool (VDZ-CDST) associated to persistence?

Abstract Background Vedolizumab (VDZ) is a monoclonal antibody effective in Crohn’s disease (CD) refractory to conventional or anti-TNF therapy. The VDZ Clinical Decision Support Tool (VDZ-CDST) predicts the likelihood of response to VDZ, enabling treatment individualisation and reducing the use of ineffective strategies. This study evaluated VDZ persistence in patients with CD. Our aim was to assess factors associated with persistence, particularly the VDZ-CDST score at baseline. Methods We conducted an observational, retrospective, single-centre study including all CD patients treated with VDZ. The primary endpoint was to assess factors associated with persistence. Variables were analysed until the last recorded follow-up or VDZ discontinuation. Kaplan–Meier survival analysis was performed to estimate persistence over time. Differences in persistence according to VDZ-CDST categories were assessed using the log-rank test. Cox proportional hazards regression models were applied to examine factors associated with persistence, including both univariate and multivariate analyses. Results A total of 64 patients were included. Baseline characteristics are summarised in Table 1. Twenty-one patients (32.81%) discontinued VDZ during follow-up: 5 (23.81%) due to primary non-response, 12 (57.14%) due to loss of response, and 4 (19.05%) due to adverse effects. Mean treatment duration was 2.85 years (SD 2.2) (Figure 1A). Clinical remission, defined as a Harvey–Bradshaw Index (HBI) ≤ 4 and no VDZ discontinuation, was achieved in 82.81% at week 26 and 86.87% at week 52. No differences in persistence were observed according to VDZ-CDST categories at baseline (≤13: low probability of VDZ response; 14–19: medium probability; 19: high probability), log-rank p = 0.6164 (Figure 1B). Univariate analysis identified statistically significant associations between certain baseline characteristics and discontinuation (Figure 1C). VDZ-CDST was not statistically associated with discontinuation: Hazard Ratio HR 0.98 (95% CI 0.88–1.09; p = 0.6696). Conclusion Baseline VDZ-CDST has not been shown to be associated with VDZ treatment persistence in patients with CD. References: 1. Armuzzi A, Vermeire S, Chaparro M, et al. Effectiveness and Treatment Persistence of Vedolizumab Compared to Anti-Tumour Necrosis Factor-α in Patients With Crohn’s Disease: A Systematic Literature Review and Meta-Analysis. United European Gastroenterol J. 2025;13(4):552-565. doi:10.1002/ueg2.12705 2. Bressler B, Yarur A, Silverberg MS, et al. Vedolizumab and Anti-Tumour Necrosis Factor α Real-World Outcomes in Biologic-Naïve Inflammatory Bowel Disease Patients: Results from the EVOLVE Study. J Crohns Colitis. 2021;15(10):1694-1706. doi:10.1093/ecco-jcc/jjab058 3. Danese S, Subramaniam K, Van Zyl J, et al. Vedolizumab treatment persistence and safety in a 2-year data analysis of an extended access programme. Aliment Pharmacol Ther. 2021;53(2):265-272. doi:10.1111/apt.16160 4. Dotti AZ, Magro DO, Vilela EG, et al. Vedolizumab in Mild-to-Moderate Crohn’s Disease Patients Naïve to Biological Therapy: A Multicentric Observational Study. Crohns Colitis 360. 2023;5(4):otad053. Published 2023 Sep 22. doi:10.1093/crocol/otad053 Conflict of interest: Mr. Moralejo Lozano, Óscar: I have received educational funding from Abbvie, Johnson & Johnson, Takeda, Kern Pharma, Alfasigma, Pfizer, Lilly, Sandoz, Dr. Falk Pharma, Ferring, and Tillotts. I have also served as a speaker for Abbvie, Takeda, Alfasigma, and Lilly. Flores, Alberto: No conflict of interest Abanades Tercero, María: No conflict of interest Carrillo Ramos, Maria Jesus: María Jesús Carrillo Ramos has served as a speaker for Takeda and Alfasigma. Gigante González De La Aleja, Gema: No conflicts Ruano Díaz, Lucía: No conflict of interest Salmoral Luque, Rosario: Alfasigma, Janssen Gómez Rodriguez, Rafael Ángel: No conflict of interest