Vedolizumab for the prevention and treatment of postoperative recurrence in Crohn’s disease: A real- world latium net study

BACKGROUND: Vedolizumab has demonstrated efficacy in randomized trials on postoperative Crohn's disease; however, real-world data on both prophylaxis and treatment of recurrence are limited. METHODS: In this retrospective multicenter study, patients with Crohn's disease treated with vedolizumab after ileocolonic resection (2018-2024) were included. Patients were stratified into a prophylaxis cohort and a recurrence-treatment cohort. Severe endoscopic recurrence (Rutgeerts ≥i3) at 6-12 months was the primary endpoint in the prophylaxis cohort. Endoscopic response (≥1-point Rutgeerts reduction) at a follow-up colonoscopy within 2 years, was evaluated in the treatment cohort. Treatment failure was defined as discontinuation of vedolizumab due to any reason. Treatment persistence was analyzed using Kaplan-Meier and multivariable Cox regression models. RESULTS: A total of 108 patients were included; 50 received vedolizumab as postoperative prophylaxis. Severe endoscopic recurrence occurred in 22% of prophylaxis patients. Prior intestinal resection (OR 5.24, 95% CI 1.03-26.61; p = 0.046) and younger age at surgery (OR 0.93, 95% CI 0.87-0.99; p = 0.042) were independently associated with severe recurrence. In the recurrence cohort (n = 58), endoscopic response was 44.8%. Overall VDZ failure occurred in 31.5%. Prophylactic use was independently associated with reduced failure (HR 0.17, 95% CI 0.05-0.53; p = 0.002). CONCLUSIONS: Vedolizumab showed sustained effectiveness for postoperative prophylaxis and more modest effectiveness in established recurrence.