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Vedolizumab in the Prevention of Postoperative Recurrence of Crohn’s Disease – REPREVIO Trial
D'Haens G, Taxonera C, Lopez-Sanroman A, Nos P, Danese S, Armuzzi A, Roblin X, Peyrin-Biroulet L, West R, Mares WGN, Duijvestein M, Gecse KB, Feagan BG, Zou G, Hulshoff MS, Mookhoek A, Oldenburg L, Clasquin E, Bouhnik Y, Laharie D.
Lancet Gastroenterol Hepatol. 2025 Jan;10(1):26-33. doi: 10.1016/S2468-1253(24)00317-0. Epub 2024 Nov 18. PMID: 39571587.
Highlights

Despite recent advances in the treatment of Crohn’s disease (CD) and an increasing focus on the early introduction of advanced therapies, approximately half of patients still require ileocolonic resection. Among these, 50% will experience endoscopic recurrence within one year. Furthermore, the optimal strategy to prevent postoperative recurrence of CD remains unclear. This study aimed to evaluate the efficacy and safety of vedolizumab in preventing this recurrence. espaço.png

The REPREVIO study was a double-blind, randomized, placebo-controlled clinical trial conducted across 13 hospitals in France, Italy, the Netherlands, and Spain. Participants had undergone ileocolonic resection and had one or more risk factors for recurrence. Patients were randomly assigned to receive either intravenous vedolizumab or placebo within four weeks after surgery. A total of 43 patients were included in the vedolizumab group, and 37 in the placebo group. espaço.png

At week 26, severe endoscopic recurrence was observed in 10 (23.3%) of the 43 patients treated with vedolizumab compared to 23 (62.2%) of the 37 patients in the placebo group (p=0.0004). Serious adverse events occurred in three (7.0%) of the patients who received vedolizumab and in two (5.4%) of the 37 patients who received placebo. Thus, it was demonstrated that treatment with vedolizumab initiated within four weeks after ileocolonic resection was superior to placebo in preventing endoscopic recurrence of CD, making it an attractive option for postoperative management in patients with risk factors for recurrence.