title: Long-term outcome of patients with steroid-refractory acute severe UC treated with ciclosporin or infliximab.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  EudraCT: 2006-005299-42; ClinicalTrials.gouv number: NCT00542152; post-results.
authors.affiliation: CHU de Bordeaux, Hôpital Haut-Lévêque, Service d'Hépato-gastroentérologie et oncologie digestive-Université de Bordeaux, Bordeaux, France.
authors.forename: D
authors.initials: D
authors.lastname: Laharie
authors.affiliation: CHU de Nantes, Hôtel-Dieu, Hépato-Gastroentérologie, Institut des Maladies de l'Appareil Digestif, Nantes, France.
authors.forename: A
authors.initials: A
authors.lastname: Bourreille
authors.affiliation: CHRU de Lille, Hôpital Claude Huriez, Service des maladies de l'appareil digestif-Endoscopie digestive, Lille, France.
authors.forename: J
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authors.lastname: Branche
authors.affiliation: Hôpital Saint-Louis, service d'Hépato-Gastroentérologie, APHP-Université Paris VII, Paris, France.
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authors.affiliation: Hôpital Beaujon, Gastroentérologie, MICI et Assistance Nutritive, APHP-Université Paris VII, Clichy, France.
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authors.affiliation: CHU de Nice, Hôpital de l'Archet 2, Service de Gastroentérologie et Nutrition Clinique, Nice, France.
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authors.affiliation: CHU de Bordeaux, Hôpital Haut-Lévêque, Service d'Hépato-gastroentérologie et oncologie digestive-Université de Bordeaux, Bordeaux, France.
authors.forename: F
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authors.affiliation: CHU de Rouen, Hôpital Charles Nicolle, service de Gastroentérologie, UMR 1073″, Normandie Université-Rouen, Rouen, France.
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authors.affiliation: CHU de Besançon, Hôpital Jean Minjoz, Service de Gastroentérologie, Besançon, France.
authors.forename: L
authors.initials: L
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authors.affiliation: CHU de Toulouse, Hôpital Rangueil, Service de Gastro-entérologie et Nutrition, Toulouse, France.
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authors.affiliation: Hôpital Henri Mondor, Service d'Hépato-gastroentérologie, APHP-Université Créteil, Créteil, France.
authors.forename: A
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authors.affiliation: Hôpital St-Antoine, service de Gastroentérologie, Paris, France.
authors.forename: J
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authors.lastname: Cosnes
authors.affiliation: Gastroenterology Department, Hospital. Clinic, IDIBAPS, CIBEREHD, Barcelona, Spain.
authors.forename: E
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authors.lastname: Ricart
authors.affiliation: UCL Saint Luc, Service d'Hépato-Gastroentérologie, Brussels, Belgium.
authors.forename: O
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authors.lastname: Dewit
authors.affiliation: Hospital Ramon y Cajal, Unidad de EII/IBD Unit, Servicio de Gastroenterología y Hepatología, Madrid, Spain.
authors.forename: A
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authors.affiliation: CHU Amiens, Hôpital Nord, service d'Hépato-Gastroentérologie, Amiens, France.
authors.forename: M
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authors.lastname: Fumery
authors.affiliation: Hôpital Bicêtre, service d'Hépato-Gastroentérologie, APHP-Université Paris Sud 11,Le Kremlin Bicêtre, France.
authors.forename: F
authors.initials: F
authors.lastname: Carbonnel
authors.affiliation: CHU Clermont-Ferrand, Service Hépatologie-Gastro-entérologie, Clermont-Ferrand, France.
authors.forename: G
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authors.lastname: Bommelaer
authors.affiliation: Hôpital Louis Mourier, service d'Hépato-Gastroentérologie, Pôle Maladie Appareil Digestif, APHP-Université Paris VII, Colombes, France.
authors.forename: B
authors.initials: B
authors.lastname: Coffin
authors.affiliation: CHU de Saint-Etienne, Hôpital Nord, Service de Gastro-entérologie et Hépatologie, Saint-Etienne, France.
authors.forename: X
authors.initials: X
authors.lastname: Roblin
authors.affiliation: Division of Gastroenterology, University Hospital of Leuven, Leuven, Belgium.
authors.forename: G
authors.initials: G
authors.lastname: van Assche
authors.affiliation: Department of Gastroenterology, Hospital Universitari Mútua de Terrassa, University of Barcelona, Terrassa. CIBEREHD, Catalonia, Spain.
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authors.lastname: Esteve
authors.affiliation: Helsinki University, and Helsinki University Central Hospital, Clinic of Gastroenterology, HUS, Finland.
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authors.lastname: Farkkila
authors.affiliation: Gastroenterology 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.
authors.forename: J P
authors.identifier: 0000-0003-2090-3445
authors.initials: JP
authors.lastname: Gisbert
authors.affiliation: Hôpital St-Antoine, service de Gastroentérologie, Paris, France.
authors.forename: P
authors.initials: P
authors.lastname: Marteau
authors.affiliation: CHI Le Raincy Montfermeil, Service d'Hépato-gastroentérologie, Montfermeil, France.
authors.forename: S
authors.initials: S
authors.lastname: Nahon
authors.affiliation: Ghent University Hospital, Gent, Belgium.
authors.forename: M
authors.initials: M
authors.lastname: de Vos
authors.affiliation: UMR-S- 1153 Inserm, Equipe ECSTRA, Denis Diderot-Paris 7 University, Hôpital Saint-Louis, Paris, France.
authors.forename: J
authors.initials: J
authors.lastname: Lambert
authors.affiliation: UMR-S- 1153 Inserm, Equipe ECSTRA, Denis Diderot-Paris 7 University, Hôpital Saint-Louis, Paris, France.
authors.forename: J Y
authors.initials: JY
authors.lastname: Mary
authors.affiliation: Department of Gastroenterology, University Hospital CHU of Liège, Liège, Belgium.
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authors.initials: E
authors.lastname: Louis
mesh_terms: D000328:Adult; D003082:Colectomy; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000601:surgery; D016572:Cyclosporine / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004351:Drug Resistance; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D000069285:Infliximab / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D013256:Steroids / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005765:Gastrointestinal Agents; D007166:Immunosuppressive Agents; D013256:Steroids; D016572:Cyclosporine; D000069285:Infliximab
keywords: COLORECTAL SURGERY; IBD; ULCERATIVE COLITIS