Endoscopic Postoperative Recurrence in Crohn’s Disease After Curative Ileocecal Resection with Early Prophylaxis by Anti-TNF, Vedolizumab or Ustekinumab: A Real-World Multicentre European Study

Author:

Yanai Henit12,Kagramanova Anna3,Knyazev Oleg345,Sabino João6,Haenen Shana6,Mantzaris Gerassimos J7,Mountaki Katerina7,Armuzzi Alessandro8,Pugliese Daniela9,Furfaro Federica10,Fiorino Gionata11ORCID,Drobne David1213ORCID,Kurent Tina13,Yassin Sharif214,Maharshak Nitsan214,Castiglione Fabiana15,de Sire Roberto15ORCID,Nardone Olga Maria16,Farkas Klaudia17,Molnar Tamas17ORCID,Krznaric Zeljko18,Brinar Marko18,Chashkova Elena19,Livne Margolin Moran220,Kopylov Uri220,Bezzio Cristina21,Bar-Gil Shitrit Ariella2223,Lukas Milan2425,Chaparro María2627ORCID,Truyens Marie2829,Nancey Stéphane30,Lobaton Triana2829,Gisbert Javier P2627,Saibeni Simone21ORCID,Bacsúr Péter17,Bossuyt Peter31ORCID,Schulberg Julien323334,Hoentjen Frank35,Viganò Chiara3637,Palermo Andrea3637,Torres Joana3839ORCID,Revés Joana39,Karmiris Konstantinos40,Velegraki Magdalini40ORCID,Savarino Edoardo41,Markopoulos Panagiotis42,Tsironi Eftychia42,Ellul Pierre43,Calviño Suárez Cristina44,Weisshof Roni4546,Ben-Hur Dana4546,Naftali Timna472,Eriksson Carl48ORCID,Koutroubakis Ioannis E49,Foteinogiannopoulou Kalliopi49ORCID,Limdi Jimmy K50,Liu Eleanor50,Surís Gerard51,Calabrese Emma52,Zorzi Francesca52,Filip Rafał53,Ribaldone Davide Giuseppe54ORCID,Snir Yifat12,Goren Idan12ORCID,Banai-Eran Hagar12,Broytman Yelena12,Amir Barak Hadar12,Avni-Biron Irit12ORCID,Ollech Jacob E12,Dotan Iris12,Aharoni Golan Maya555657

Affiliation:

1. Division of Gastroenterology, Rabin Medical Center , Petah Tikva , Israel

2. Sackler Faculty of Medicine, Tel Aviv University , Israel

3. Moscow Clinical Scientific Centre named after. A.S. Loginov , Moscow , Russian Federation

4. State Scientific Centre of Coloproctology named after A.N. Ryzhyh , Moscow , Russian Federation

5. Research Institute of Health Organization and Medical Management , Moscow , Russian Federation

6. Department of Gastroenterology, University Hospitals of Leuven , Leuven , Belgium

7. Department of Gastroenterology, GHA ‘Evaggelismos-Ophthalmiatreion Athinon-Polykliniki’ , Athens , Greece

8. IBD Center, IRCCS Humanitas Research Hospital, Rozzano , Milan , Italy

9. CEMAD, IBD UNIT, Unità Operativa Complessa di Medicina Interna e Gastroenterologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario ‘A. Gemelli’ IRCCS , Rome , Italy

10. IBD Center, Humanitas Research Hospital-IRCCS , Milan , Italy

11. Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University , Milan , Italy

12. Department of Internal Medicine, Medical Faculty, University of Ljubljana , Ljubljana , Slovenia

13. Department of Gastroenterology, University Medical Centre Ljubljana , Ljubljana , Slovenia

14. Department of Gastroenterology and Liver Diseases, Tel Aviv Medical Center , Tel Aviv , Israel

15. Department of Clinical Medicine and Surgery, University of Naples Federico II , Naples , Italy

16. Department of Public Health, University of Naples Federico II , Naples , Italy

17. Department of Medicine, University of Szeged , Szeged , Hungary

18. Department of Gastroenterology, Hepatology and Nutrition, University Hospital Centre , Zagreb , Croatia

19. Irkutsk Scientific Center of Surgery and Traumatology , Russia

20. Department of Gastroenterology, Sheba Medical Center , Tel Hashomer , Israel

21. Gastroenterology Unit, Rho Hospital, ASST Rhodense , Rho (MI) , Italy

22. Digestive Diseases Institute, Shaare Zedek Medical Center , Jerusalem , Israel

23. Faculty of Medicine, Hebrew University , Jerusalem , Israel

24. Clinical and Research Centre for Inflammatory Bowel Disease, ISCARE Clinical Centre , Prague , Czech Republic

25. Institute of Medical Biochemistry and Laboratory Medicine, General University Hospital and First Faculty of Medicine, Charles University , Prague , Czech Republic

26. Department of Gastroenterology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS- Princesa), Universidad Autónoma de Madrid (UAM) , Spain

27. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd) , Madrid , Spain

28. IBD unit, Department of Gastroenterology, University Hospital Ghent , Ghent , Belgium

29. Department of Internal Medicine and Pediatrics, Ghent University , Ghent , Belgium

30. Department of Gastroenterology, Lyon-Sud hospital, Hospices Civils de Lyon, Lyon and INSERM U1111, CIRI , Lyon , France

31. Imelda GI clinical Research Center, Department of Gastroenterology, Imelda General Hospital , Bonheiden , Belgium

32. Department of Gastroenterology, St Vincent’s Hospital , Melbourne, VIC , Australia

33. Department of Medicine, University of Melbourne , Melbourne, VIC , Australia

34. Department of Gastroenterology, Austin Hospital , Melbourne, VIC , Australia

35. Inflammatory Bowel Disease Center, Department of Gastroenterology, Radboud University Medical Center, Nijmegen, The Netherlands and Division of Gastroenterology, Department of Medicine, University of Alberta , Edmonton , Canada

36. Division of Gastroenterology and Center for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca , Monza , Italy

37. European Reference Network on Hepatological Diseases (ERN RARE-LIVER), San Gerardo Hospital , Monza , Italy

38. Division of Gastroenterology, Hospital da Luz Lisboa , Portugal

39. Division of Gastroenterology, Hospital Beatriz Ângelo , Loures, Lisbon , Portugal

40. Department of Gastroenterology, Venizeleio General Hospital , Heraklion, Crete , Greece

41. Department of Surgical Oncological & Gastroenterological Sciences (DiSCOG), Gastroenterology Unit, Padua University , Padua , Italy

42. Department of Gastroenterology, Metaxa Memorial General Hospital , Piraeus , Greece

43. Division of Gastroenterology Mater Dei Hospital , Msida , Malta

44. Department of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela , Santiago de Compostela , Spain

45. Department of Gastroenterology, Rambam Health Care Campus , Haifa , Israel

46. Rappaport Faculty of Medicine, The Technion – Israel Institute of Technology , Haifa , Israel

47. Institute of Gastroenterology, Meir Hospital Sapir Medical Center , Kfar Saba , Israel

48. Department of Gastroenterology, Faculty of Medicine and Health, Örebro University , Örebro , Sweden

49. Gastroenterology Department, University Hospital of Heraklion , Crete , Greece

50. Department of Gastroenterology, The Northern Care Alliance NHS Foundation Trust, Manchester Academic Health Sciences, University of Manchester , Manchester , UK

51. Gastroenterology Department, Hospital de Bellvitge and IDIBELL, L’Hospitalet , Spain

52. Gastroenterology Unit, Department of Systems Medicine, University of Rome Tor Vergata , Italy

53. Department of Gastroenterology with IBD Unit , Clinical Hospital No. 2, Rzeszów , Poland

54. Department of Medical Sciences, University of Turin , Turin , Italy

55. Department of Gastroenterology and Hepatology, Kaplan Medical Center , Rehovot , Israel

56. Faculty of Medicine, Hebrew University of Jerusalem , Jerusalem , Israel

57. Concord Medical Center, Clalit Health Services , Bnei Brak , Israel

Abstract

Abstract Background Endoscopic-post-operative-recurrence [ePOR] in Crohn’s disease [CD] after ileocecal resection [ICR] is a major concern. We aimed to evaluate the effectiveness of early prophylaxis with biologics and to compare anti-tumour necrosis factor [anti-TNF] therapy to vedolizumab [VDZ] and ustekinumab [UST] in a real-world setting. Methods A retrospective multicentre study of CD-adults after curative ICR on early prophylaxis was undertaken. ePOR was defined as a Rutgeerts score [RS] ≥ i2 or colonic-segmental-SES-CD ≥ 6. Multivariable logistic regression was used to evaluate risk factors, and inverse probability treatment weighting [IPTW] was applied to compare the effectiveness between agents. Results The study included 297 patients (53.9% males, age at diagnosis 24 years [19–32], age at ICR 34 years [26–43], 18.5% smokers, 27.6% biologic-naïve, 65.7% anti-TNF experienced, 28.6% two or more biologics and 17.2% previous surgery). Overall, 224, 39 and 34 patients received anti-TNF, VDZ or UST, respectively. Patients treated with VDZ and UST were more biologic experienced with higher rates of previous surgery. ePOR rates within 1 year were 41.8%. ePOR rates by treatment groups were: anti-TNF 40.2%, VDZ 33% and UST 61.8%. Risk factors for ePOR at 1 year were: past-infliximab (adjusted odds ratio [adj.OR] = 1.73 [95% confidence interval, CI: 1.01–2.97]), past-adalimumab [adj.OR = 2.32 [95% CI: 1.35-4.01] and surgical aspects. After IPTW, the risk of ePOR within 1 year of VDZ vs anti-TNF or UST vs anti-TNF was comparable (OR = 0.55 [95% CI: 0.25–1.19], OR = 1.86 [95% CI: 0.79–4.38]), respectively. Conclusion Prevention of ePOR within 1 year after surgery was successful in ~60% of patients. Patients treated with VDZ or UST consisted of a more refractory group. After controlling for confounders, no differences in ePOR risk were seen between anti-TNF prophylaxis and other groups.

Publisher

Oxford University Press (OUP)

Subject

Gastroenterology,General Medicine

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