Abstract Background Vedolizumab (VDZ) is an α4β7 anti-integrin monoclonal antibody effective in Crohn’s disease (CD) 1. While its short- and mid-term efficacy is well established, real-world data on outcomes beyond 3 years are scarce. Recent studies suggest a progressive decline in persistence rates after 3 years, with very limited data beyond this period 2. The primary objective was to evaluate the 5-year persistence of VDZ. Secondary objectives were to describe clinical, biological and endoscopic responses at 2 years among patients remaining on treatment, and to identify predictors of long-term persistence, including the Clinical Decision Support Tool (CDST) score. Methods This is a retrospective study included 60 adult patients with CD treated with VDZ.Collected variables included age, sex, BMI, smoking status, disease duration and location and CDST score. Treatment persistence was evaluated at 5 years. Clinical, biological, and endoscopic responses were assessed at 2 years. A global response was then defined as the achievement of a clinical improvement, normalization or marked reduction of inflammatory biomarkers, and endoscopic improvement. Predictors of persistence were analyzed. Results The mean age was 45.4 years, mean disease duration was 12.7 years, and mean CDST score was calculated at 20.6. At 5 years, 56.1% remained on VDZ. Persistence was significantly associated with male sex (65.2% vs 27.8%, p = 0.017), longer disease duration (215 vs 106 months, p = 0.001), absence of rheumatologic manifestations (13.0% vs 44.4%, p = 0.024), and clinico-biological response at 12 months (65.2% vs 30.8%, p = 0.047). At 24 months, a global response was observed in all patients persisting at 5 years compared to 22.2% of those who discontinued (p 0.001). At 2 years, 76.5% remained on VDZ. Persistence was associated with similar factors, in addition to the absence of isolated colonic disease. A global response at 2 years was achieved by 89.7% of persistent patients compared with none of the non-persistent group (p 0.001). The CDST, uniformly elevated in this cohort, did not discriminate between persistent and non-persistent patients, but reflected appropriate initial patient selection. Conclusion This real-world study documents 5-year outcome data on VDZ persistence in CD, a duration infrequently studied, with 56% of patients maintaining treatment. Early response at 12 and 24 months emerged as a key determinant of long-term persistence, highlighting the value of assessing 2-year outcomes to identify durable responders. Although not discriminatory, the CDST score emphasizes the potential role of predictive tools in guiding personalized therapeutic strategies. These results contribute to defining the long-term role of VDZ in the management of CD. References: 1-Fiorino G, Correale C, Fries W, Repici A, Malesci A, Danese S. Leukocyte traffic control: a novel therapeutic strategy for inflammatory bowel disease. Expert Rev Clin Immunol. 2010;6(4):567–72 2-Giuffrida, P., et al. (2021). Long-term Effectiveness of Vedolizumab in Crohn’s Disease: A Five-Year Follow-up Study. Alimentary Pharmacology & Therapeutics, 54(6), 569-578. Conflict of interest: Dr. Harb, Marc: No conflict of interest Muls, Vinciane: No conflict of interest Hoyois, Alice: No conflict of interest Aoun, Jennifer: No conflict of interest
Harb et al. (Thu,) studied this question.