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Original article
Long-term outcome of patients with steroid-refractory acute severe UC treated with ciclosporin or infliximab
  1. D Laharie1,
  2. A Bourreille2,
  3. J Branche3,
  4. M Allez4,
  5. Y Bouhnik5,
  6. J Filippi6,
  7. F Zerbib1,
  8. G Savoye7,
  9. L Vuitton8,
  10. J Moreau9,
  11. A Amiot10,
  12. J Cosnes11,
  13. E Ricart12,
  14. O Dewit13,
  15. A Lopez-Sanroman14,
  16. M Fumery15,
  17. F Carbonnel16,
  18. G Bommelaer17,
  19. B Coffin18,
  20. X Roblin19,
  21. G van Assche20,
  22. M Esteve21,
  23. M Farkkila22,
  24. JP Gisbert23,
  25. P Marteau11,
  26. S Nahon24,
  27. M de Vos25,
  28. J Lambert26,
  29. JY Mary26,
  30. E Louis27
  31. for the Groupe d'Etudes Thérapeutiques des Affections Inflammatoires Digestives
  1. 1CHU de Bordeaux, Hôpital Haut-Lévêque, Service d'Hépato-gastroentérologie et oncologie digestive—Université de Bordeaux, Bordeaux, France
  2. 2CHU de Nantes, Hôtel-Dieu, Hépato-Gastroentérologie, Institut des Maladies de l'Appareil Digestif, Nantes, France
  3. 3CHRU de Lille, Hôpital Claude Huriez, Service des maladies de l'appareil digestif—Endoscopie digestive, Lille, France
  4. 4Hôpital Saint-Louis, service d'Hépato-Gastroentérologie, APHP—Université Paris VII, Paris, France
  5. 5Hôpital Beaujon, Gastroentérologie, MICI et Assistance Nutritive, APHP—Université Paris VII, Clichy, France
  6. 6CHU de Nice, Hôpital de l'Archet 2, Service de Gastroentérologie et Nutrition Clinique, Nice, France
  7. 7CHU de Rouen, Hôpital Charles Nicolle, service de Gastroentérologie, UMR 1073″, Normandie Université-Rouen, Rouen, France
  8. 8CHU de Besançon, Hôpital Jean Minjoz, Service de Gastroentérologie, Besançon, France
  9. 9CHU de Toulouse, Hôpital Rangueil, Service de Gastro-entérologie et Nutrition, Toulouse, France
  10. 10Hôpital Henri Mondor, Service d'Hépato-gastroentérologie, APHP—Université Créteil, Créteil, France
  11. 11Hôpital St-Antoine, service de Gastroentérologie, Paris, France
  12. 12Gastroenterology Department, Hospital. Clinic, IDIBAPS, CIBEREHD, Barcelona, Spain
  13. 13UCL Saint Luc, Service d'Hépato-Gastroentérologie, Brussels, Belgium
  14. 14Hospital Ramon y Cajal, Unidad de EII/IBD Unit, Servicio de Gastroenterología y Hepatología, Madrid, Spain
  15. 15CHU Amiens, Hôpital Nord, service d'Hépato-Gastroentérologie, Amiens, France
  16. 16Hôpital Bicêtre, service d'Hépato-Gastroentérologie, APHP—Université Paris Sud 11,Le Kremlin Bicêtre, France
  17. 17CHU Clermont-Ferrand, Service Hépatologie-Gastro-entérologie, Clermont-Ferrand, France
  18. 18Hôpital Louis Mourier, service d'Hépato-Gastroentérologie, Pôle Maladie Appareil Digestif, APHP—Université Paris VII, Colombes, France
  19. 19CHU de Saint-Etienne, Hôpital Nord, Service de Gastro-entérologie et Hépatologie, Saint-Etienne, France
  20. 20Division of Gastroenterology, University Hospital of Leuven, Leuven, Belgium
  21. 21Department of Gastroenterology, Hospital Universitari Mútua de Terrassa, University of Barcelona, Terrassa. CIBEREHD, Catalonia, Spain
  22. 22Helsinki University, and Helsinki University Central Hospital, Clinic of Gastroenterology, HUS, Finland
  23. 23Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) y Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
  24. 24CHI Le Raincy Montfermeil, Service d'Hépato-gastroentérologie, Montfermeil, France
  25. 25Ghent University Hospital, Gent, Belgium
  26. 26UMR-S- 1153 Inserm, Equipe ECSTRA, Denis Diderot—Paris 7 University, Hôpital Saint-Louis, Paris, France
  27. 27Department of Gastroenterology, University Hospital CHU of Liège, Liège, Belgium
  1. Correspondence to Dr David Laharie, service d'Hépato-gastroentérologie, Hôpital Haut-Lévêque, CHU de Bordeaux, Pessac 33600, France; david.laharie{at}chu-bordeaux.fr

Abstract

Objective Ciclosporin and infliximab have demonstrated short-term similar efficacy as second-line therapies in patients with acute severe UC (ASUC) refractory to intravenous steroids. The aim of this study was to assess long-term outcome of patients included in a randomised trial comparing ciclosporin and infliximab.

Design Between 2007 and 2010, 115 patients with steroid-refractory ASUC were randomised in 29 European centres to receive ciclosporin or infliximab in association with azathioprine. Patients were followed until death or last news up to January 2015. Colectomy-free survival rates at 1 and 5 years and changes in therapy were estimated through Kaplan-Meier method and compared between initial treatment groups through log-rank test.

Results After a median follow-up of 5.4 years, colectomy-free survival rates (95% CI) at 1 and 5 years were, respectively, 70.9% (59.2% to 82.6%) and 61.5% (48.7% to 74.2%) in patients who received ciclosporin and 69.1% (56.9% to 81.3%) and 65.1% (52.4% to 77.8%) in those who received infliximab (p=0.97). Cumulative incidence of first infliximab use at 1 and 5 years in patients initially treated with ciclosporin was, respectively, 45.7% (32.6% to 57.9%) and 57.1% (43.0% to 69.0%). Only four patients from the infliximab group were subsequently switched to ciclosporin. Three patients died during the follow-up, none directly related to UC or its treatment.

Conclusions In this cohort of patients with steroid-refractory ASUC initially treated by ciclosporin or infliximab, long-term colectomy-free survival was independent from initial treatment. These long-term results further confirm a similar efficacy and good safety profiles of both drugs and do not favour one drug over the other.

Trial registration number EudraCT: 2006-005299-42; ClinicalTrials.gouv number: NCT00542152; post-results.

  • ULCERATIVE COLITIS
  • IBD
  • COLORECTAL SURGERY

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Footnotes

  • Contributors DL: study concept and design; acquisition of data; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content; statistical analysis; obtained funding; technical or material support; study supervision. JYM: study concept and design; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content; statistical analysis; technical or material support; study supervision. JL: statistical analysis. AB, JB, MA, YB, JF, FZ, GS, LV, JM, AA, JC, ER, OD, ALS, MF, FC, GB, BC, XR, GVA, ME, MF, JPG, PM, SN, MDV and EL: acquisition of data and critical revision of the manuscript.

  • Funding Association Francois Aupetit.

  • Competing interests DL: consulting and/or lecture fees from Abbvie, Ferring, Janssen, MSD, Pfizer, Takeda. AB: consulting and/or lecture fees from Abbvie, Ferring, MSD, Pfizer, Takeda. MA: consulting and/or lecture fees from Janssen, MSD, Takeda. YB: consulting and/or lecture fees from Abbvie, Ferring, Hospira, Janssen, MSD, Pfizer, Takeda. JF: consulting and/or lecture fees from Abbvie, Ferring, MSD, Takeda. FZ: lecture fees for Abbvie, Takeda. GS: lecture fees from Abbvie, Ferring, MSD, Takeda. LV: lecture fees from Abbvie, Ferring, MSD, Hospira and Takeda and consulting fees from Abbvie. JM: lecture fees from Abbvie, Ferring, MSD, Takeda. AA: consulting and/or lecture fees from Abbvie, Ferring, MSD, Takeda. JC: consulting fees from Abbvie, Vifor. ER: consulting and/or lecture fees from Abbvie, MSD. OD: lecture fees from MSD. AL-S: lecture fees from Abbvie, MSD. MF: lecture fees from Abbvie, MSD, Takeda. GB: lecture fees from Abbvie, MSD, Takeda. BC: lecture fees from Abbvie, MSD. XR: consulting and/or lecture fees from Abbvie, Ferring, Janssen, MSD, Pfizer, Takeda, Theradiag. GvA: consulting and/or lecture fees and research support from MSD, Novartis. ME: consulting and/or lecture fees for MSD, Abbott, Shire Pharmaceuticals. JPG: consulting and/or lecture fees Abbvie, Janssen, Hospira, MSD, Pfizer, Takeda. PM: consulting and/or lecture fees from Abbvie, Ferring, MSD, Pfizer, Takeda. SN: consulting and/or lecture fees from Abbvie, Ferring, MSD, Takeda. MdV: consulting and/or lecture fees from Abbott, Ferring, MSD. EL: research grants from AstraZeneca, Schering-Plough; consulting and/or lecture fees from Abbott, Abbvie, AstraZeneca, Ferring, Schering-Plough, MSD, Chiesi, Menarini, Millenium, Mitsubishi Pharma, Nycomed, Falk, Takeda, UCB.

  • Patient consent Obtained.

  • Ethics approval The institutional review board at each centre approved the protocol, and all patients provided written informed consent.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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