OP14 Prevention of postoperative recurrence of Crohn's disease with vedolizumab: First results of the prospective placebo-controlled randomised trial REPREVIO

D'Haens, G.(1)*;Taxonera, C.(2);Lopez-Sanroman, A.(3);Nos Mateu, P.(4);Danese, S.(5);Armuzzi, A.(6);Roblin, X.(7);Peyrin-Biroulet, L.(8);West, R.(9);Witteman, B.(10);Duijvestein, M.(11);Gecse, K.(1);Hulshoff, M.(1);Mostafavi, N.(1);Clasquin, E.(1);Bouhnik, Y.(12);Laharie, D.(13);

(1)Amsterdam University Medical Centres, Gastroenterology, Amsterdam, The Netherlands;(2)Hospital Clinico San Carlos, Gastroenterology, Madrid, Spain;(3)Hospital Ramon Y Cajal, Gastroenterology, Madrid, Spain;(4)Hospital Universitario y Politecnico La Fe de Valencia, Gastroenterology, Valencia, Spain;(5)Instituto Clinico Humanitas, Gastroenterology, Rozzano, Italy;(6)IRCCS Humanitas Research Hospital, IBD Center, Rozzano- Milan, Italy;(7)CHU Saint-Etienne, Gastroenterology, Saint Priest, France;(8)CHRU de Nancy, Gastroenterology, Brabois, France;(9)Franciscus Gasthuis & Vlietland, Gastroenterology, Rotterdam, The Netherlands;(10)Ziekenhuis Gelderse Vallei, Gastroenterology, Ede, The Netherlands;(11)RadboudUMC, Gastroenterology, Nijmegen, The Netherlands;(12)Hopital Beaujon, Gastroenterology, Clichy, France;(13)Hopital du Haut-Leveque, Gastroenterology, Pessac, France;


Crohn’s disease (CD) is a chronic, immune-mediated inflammatory condition of the intestine, for which the majority of patients still needs to undergo surgical resection. Following the most common intervention ileocolonic resection, the vast majority of patients suffers from recurrence of CD in the neoterminal ileum. Endoscopic lesions usually precede symptoms in the first months after resection and predict the severity of the further disease course. No treatments have been approved for recurrence-prevention of CD. REPREVIO is a prospective placebo-controlled randomized trial investigating the preventive effect of vedolizumab, an anti-integrin antibody, on recurrence of CD.


Following ileocolonic resection, patients were treated with vedolizumab (300 mg IV at week 0,8,16 and 24) or PLC (1:1) at 12 sites in the Netherlands, France, Italy and Spain. Treatment was initiated within 4 weeks following ileocolonic resection with anastomosis. Six months following surgery, patients underwent ileocolonoscopy for assessment of recurrent lesions. Video recordings were centrally scored using the modified Rutgeerts’ score by 2 readers with adjudication in case of disagreement. The primary endpoint was endoscopic recurrence (ER) of CD (non-parametric); secondary endpoints were the proportion of patients with ER >i2a and clinical recurrence. Adverse events were recorded.


95 pts were screened and 80 randomized. All patients have reached month 6 and the videos are being analysed. We will receive the results of all statistical analysis in December, 2022.


The efficacy of vedolizumab postoperative recurrence-prevention treatment was studied in the REPREVIO study.