P384 Postoperative Endoscopic Recurrence In Patients With Crohn’s Disease After “Curative” Ileocecal Resection on Prophylaxis Treatment With Either Anti-TNFs, Vedolizumab or Ustekinumab: A Real-World Multicentre European Study
Yanai, H.(1,2);Amir Barak , H.(1,2);Kagramanova, A.(3);Knyazev , O.(3);Sabino, J.(4);Haenen, S.(4);Mantzaris , G.J.(5);Mountaki, K.(5);Pugliese, D.(6);Armuzzi, A.(6,7);Furfaro, F.(8);Fiorino, G.(8);Drobne, D.(9,10);Kurent, T.(10);Yassin, S.(2,11);Maharshak, N.(2,11);Castiglione, F.(12);Nardone, O.M.(12);de Sire, R.(12);Farkas, K.(13);Molnar, T.(13);Krznaric, Z.(14);Brinar, M.(14);Chashkova, E.(15);Margolin, M.L.(2,16);Kopylov, U.(2,16);Bezzio, C.(17);Bar-Gil Shitrit, A.(18);Lukas , M.(19,20);Chaparro, M.(21);Truyens, M.(22,23);Nancey, S.(24);Revés, J.(25);Avni-Biron, I.(1,2);Ollech, J.E.(1,2);Dotan, I.(1,2);Aharoni Golan, M.(1,2);
(1)Rabin Medical Center, Division of Gastroenterology, Petah Tikva, Israel;(2)Tel Aviv University, Sackler Faculty of Medicine, Tel Aviv, Israel;(3)Moscow Clinical Scientific Centre n.a. A.S. Loginov, IBD department, Moscow, Russian Federation;(4)University Hospitals Leuven, Department of Gastroenterology, Leuven, Belgium;(5)GHA 'Eveggelismos-Polykliniki', Department of Gastroenterology, Athens, Greece;(6)Fondazione Policlinico Universitario "A. Gemelli" IRCCS, CEMAD- Inflammatory Bowel Disease Unit- Unità Operativa Complessa di Medicina Interna e Gastroenterologia- Dipartimento di Scienze Mediche e Chirurgiche, Rome, Italy;(7)Università Cattolica del Sacro Cuore, Dipartimento Universitario di Medicina e Chirurgia Traslazionale, Rome, Italy;(8)Humanitas Clinical and Research Center – IRCCS, IBD Unit- Rozzano, Milan, Italy;(9)University Medical Centre Ljubljana, Department of Gastroenterology, Ljubljana, Slovenia;(10)University of Ljubljana, Medical Faculty, Ljubljana, Slovenia;(11)Tel Aviv Medical Center, Department of Gastroenterology and Liver Diseases, Tel Aviv, Israel;(12)University of Naples Federico II, Department of Clinical Medicine and Surgery, Naples, Italy;(13)University of Szeged, Department of Medicine, Szeged, Hungary;(14)University Hospital Centre, Department of Gastroenterology- Hepatology and Nutrition, Zagreb, Croatia;(15)Irkutsk Scientific Center of Surgery and Traumatology, Department of Reconstructive Surgery, Irkutsk, Russian Federation;(16)Sheba medical center, Gastroenterology department, Tel Hashomer, Israel;(17)Rho Hospital, Gastroenterology Unit- Asst Rhodense, Milano, Italy;(18)Shaare Zedek Medical Center, Digestive Diseases Institute, Jerusalem, Israel;(19)ISCARE Clinical Centre, Clinical and Research Centre for Inflammatory Bowel Disease, Prague, Czech Republic;(20)General University Hospital and First Faculty of Medicine- Charles University, Institute of Medical Biochemistry and Laboratory Medicine, Prague, Czech Republic;(21)Hospital Universitario de La Princesa- Instituto de Investigación Sanitaria Princesa IIS-IP- Universidad Autónoma de Madrid and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas CIBERehd, Gastroenterology Department, Madrid, Spain;(22)University Hospital Ghent, IBD unit-Department of Gastroenterology, Ghent, Belgium;(23)Ghent University, Department of Internal Medicine and Pediatrics, Ghent, Belgium;(24)Lyon-Sud hospital- Hospices Civils de Lyon, Department of Gastroenterology, Lyon, France;(25)Hospital Beatriz Ângelo- Loures, Gastroenterology Division, Lisbon, Portugal;
Endoscopic post-operative recurrence (ePOR) is common following ileocecal resection (ICR) in patients with Crohn's disease (CD), reaching up to 70% at 1-year. In clinical trials, prophylaxis with anti-TNF therapies demonstrated a decrease in ePOR to around 20% at 1-year. Here we aimed to compare the effectiveness of vedolizumab (VDZ) and ustekinumab (UST) to anti-TNFs for preventing ePOR after curative ICR in adults with CD in a real-world setting.
This was a retrospective multicenter study, assessing patients with CD >17years who underwent ICR between 2015-2019, started prophylaxis within six months of surgery, and underwent an ileocolonoscopy ≥ four months after prophylaxis. ePOR (Rutgeerts score ≥ i2 or colonic-segmental-SES-CD≥6) was assessed at 12, 24, 36-months periods post-surgery. Multivariate logistic regression was used to assess risk factors for ePOR, and IPTW was performed to compare the effectiveness between agents.
Included 297 patients [53.9% males, age-at-diagnosis 24(19-32) years (median;IQR), age-at-ICR 34(26-43)years (median;IQR), 18.5% current-smokers]. Of these, 17.2% had previous-ICR, 8.1% were biologic naïve, 65.7% anti-TNF experienced, and 28.6% exposed to 2 biologics. Overall, 224, 39 and 34 patients received respectively anti-TNFs, VDZ or UST for prevention of POR. Patients on VDZ and UST were more likely to be biologic experienced or post previous-ICR. ePOR rates for the entire cohort, anti-TNF, VDZ and UST were: 41.8%, 40.2%, 33%, and 61.8% at 12-months, 49.0%, 46.5%, 44.4%, and 72.4% at 24- months, and 48.6%, 47.9%, 44.0% and 62.5% at 36-months, respectively. Risk factors for ePOR: past infliximab (Adj.OR =1.73 [95% CI: 1.01-2.97], p=0.045) or adalimumab (Adj.OR = 2.32 [95% CI: 1.35-4.01], p=0.002), and technical aspects of anastomosis. After controlling for the disparities between groups by the IPTW method risk of ePOR at 12-months was comparable between patients on anti-TNFs vs VDZ or anti-TNFs vs UST. However, comparison between VDZ vs UST groups revealed that patients on UST were at a higher risk for ePOR at 12-months (OR=3.75 [95% CI: 1.33-10.6]), p=0.012.
Prevention of ePOR was successful in ~60% of patients at 12-months period. Patients on prophylaxis VDZ or UST consisted of a distinct, more refractory group with higher rates of ePOR. Post-operative treatment with UST or VDZ resulted in a similar risk of ePOR when compared to post-operative prophylaxis with anti-TNF after controlling for disease severity.