Article (Scientific journals)
Long-term outcome of patients with steroid-refractory acute severe UC treated with ciclosporin or infliximab.
Laharie, D.; Bourreille, A.; Branche, J. et al.
2018In Gut
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Keywords :
COLORECTAL SURGERY; IBD; ULCERATIVE COLITIS
Abstract :
[en] 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.
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Laharie, D.
Bourreille, A.
Branche, J.
Allez, M.
Bouhnik, Y.
Filippi, J.
Zerbib, F.
Savoye, G.
Vuitton, L.
Moureau, J
Amiot, A.
Cosnes, J.
Ricart, E.
Dewit, O.
Lopez-Sanroman, A.
Fumery, M.
Carbonnel, F.
Bommelaer, G.
Coffin, B.
Roblin, X.
van Assche, G.
Esteve, M.
Farkkila, M.
Gisbert, J. P.
Marteau, P.
Nahon, S.
de Vos, M.
Lambert, J
Mary, J. Y.
Louis, Edouard  ;  Université de Liège - ULiège > Département des sciences cliniques > Hépato-gastroentérologie
More authors (20 more) Less
Language :
English
Title :
Long-term outcome of patients with steroid-refractory acute severe UC treated with ciclosporin or infliximab.
Publication date :
2018
Journal title :
Gut
ISSN :
0017-5749
eISSN :
1468-3288
Publisher :
BMJ Publishing Group, United Kingdom
Peer reviewed :
Peer Reviewed verified by ORBi
Commentary :
Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Available on ORBi :
since 23 March 2018

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