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12. Ciclosporin versus infliximab in acute severe ulcerative colitis refractory to intravenous steroids: A randomized study

D. Laharie1, A. Bourreille2, J. Branche3, M. Allez4, Y. Bouhnik5, J. Filippi6, F. Zerbib7, M. Nachury8, G. Savoye9, J. Moreau10, J. Delchier11, E. Ricart12, J. Cosnes13, A. López-Sanromán14, O. Dewit15, F. Carbonnel16, G. Bommelaer17, B. Coffin18, G. Van Assche19, M. Esteve20, M. Faarkila21, A. Perez22, J. Mary23, J. Colombel3, M. Lémann4

1Hôpital Haut-Lévèque, Pessac, France; 2CHU Nantes, Nantes, France; 3Hôpital Claude-Huriez, Lille, France; 4Hôpital Saint-Louis, Paris, France; 5Hôpital Beaujon, Clichy, France; 6Hôpital de l'Archet, Nice, France; 7Hôpital Saint-André, Bordeaux, France; 8CHU Besançon, Besançon, France; 9CHU Rouen, Rouen, France; 10Hôpital Rangueil, Toulouse, France; 11Hôpital Henri-Mondor, Creteil, France; 12Hospital Clinic, CIBER-EHD, Barcelona, Spain; 13Hôpital Saint-Antoine, Paris, France; 14University Hospital Ramón y Cajal, Madrid, Spain; 15St. Luc University Hospital, Bruxelles, Belgium; 16Kremlin-Bicêtre, Paris, France; 17CHU, Clermont-Ferrand, France; 18Hôpital Louis-Mourier, Colombes, France; 19University Hospital Gasthuisberg, Leuven, Belgium; 20Hospital Universitari Mutua de Terrassa, Barcelona, Spain; 21Helsinki University Central Hospital, Helsinki, Finland; 22University Hospital, Madrid, Spain; 23Université Jussieu, Paris, France

Intravenous (i.v.) corticosteroids remain the mainstay of conventional therapy for acute severe ulcerative colitis (ASUC). Cyclosporin (Cys) and Infliximab (IFX) are effective rescue therapy for i.v. steroid-resistant ASUC. We here report the first randomized controlled study comparing Cys to IFX in i.v. steroid-resistant ASUC.

Methods: Patients with ASUC were included between June 2007 to August 2010 in 23 GETAID and 6 ECCO centres. They were randomised to i.v. Cys (2 mg/kg/d for one week, then switched orally during 98 days) or IFX (5 mg/kg at weeks 0–2–6) if they fulfilled the criteria for i.v. steroid failure: Lichtiger score >10 after at least 5 days of i.v. methyl-prednisolone ≥0.8 mg/kg/d. In patients with clinical response at day 7 (D7), as defined by a Lichtiger score <10 with a decrease of at least 3 points compared with baseline, azathioprine was started at a dose of 2.5 mg/kg/d and steroids were decreased according to a fixed regimen. The primary end-point was the rate of treatment failure defined by: (i) absence of clinical response at D7; (ii) absence of remission (Mayo score ≤2 without any subscore >1) without steroids at D98; (iii) relapse between D7 and D98 (sustained increase of the Lichtiger score leading to a new treatment); (iv) severe adverse event (SAE) leading to treatment interruption; (v) colectomy; (vi) fatality. It was assumed that 30% in the Cys group and 60% in the IFX would fail. Fifty patients in each group would provide a 80% power with type-I error of 5% (two-sided test). An interim analysis was planned after 30 patients have been treated by IFX.

Results: The interim analysis led to increase from 100 to 116 the number of patients planned to enter the study. At the same time no recommendation of study cessation SAE-related was made by the independent DSMB. The latest included patient should reach D98 in November 2010. Results of the study will be available for the ECCO congress.

The study received grants from Association François Aupetit, SNFGE & IOIBD.