D Laharie1, A Bourreille2, J Branche3, M Allez4, Y Bouhnik5, J Filippi6, F Zerbib1, G Savoye7, L Vuitton8, J Moreau9, A Amiot10, J Cosnes11, E Ricart12, O Dewit13, A Lopez-Sanroman14, M Fumery15, F Carbonnel16, G Bommelaer17, B Coffin18, X Roblin19, G van Assche20, M Esteve21, M Farkkila22, J P Gisbert23, P Marteau11, S Nahon24, M de Vos25, J Lambert26, J Y Mary26, E Louis27. 1. CHU de Bordeaux, Hôpital Haut-Lévêque, Service d'Hépato-gastroentérologie et oncologie digestive-Université de Bordeaux, Bordeaux, France. 2. CHU de Nantes, Hôtel-Dieu, Hépato-Gastroentérologie, Institut des Maladies de l'Appareil Digestif, Nantes, France. 3. CHRU de Lille, Hôpital Claude Huriez, Service des maladies de l'appareil digestif-Endoscopie digestive, Lille, France. 4. Hôpital Saint-Louis, service d'Hépato-Gastroentérologie, APHP-Université Paris VII, Paris, France. 5. Hôpital Beaujon, Gastroentérologie, MICI et Assistance Nutritive, APHP-Université Paris VII, Clichy, France. 6. CHU de Nice, Hôpital de l'Archet 2, Service de Gastroentérologie et Nutrition Clinique, Nice, France. 7. CHU de Rouen, Hôpital Charles Nicolle, service de Gastroentérologie, UMR 1073″, Normandie Université-Rouen, Rouen, France. 8. CHU de Besançon, Hôpital Jean Minjoz, Service de Gastroentérologie, Besançon, France. 9. CHU de Toulouse, Hôpital Rangueil, Service de Gastro-entérologie et Nutrition, Toulouse, France. 10. Hôpital Henri Mondor, Service d'Hépato-gastroentérologie, APHP-Université Créteil, Créteil, France. 11. Hôpital St-Antoine, service de Gastroentérologie, Paris, France. 12. Gastroenterology Department, Hospital. Clinic, IDIBAPS, CIBEREHD, Barcelona, Spain. 13. UCL Saint Luc, Service d'Hépato-Gastroentérologie, Brussels, Belgium. 14. Hospital Ramon y Cajal, Unidad de EII/IBD Unit, Servicio de Gastroenterología y Hepatología, Madrid, Spain. 15. CHU Amiens, Hôpital Nord, service d'Hépato-Gastroentérologie, Amiens, France. 16. Hôpital Bicêtre, service d'Hépato-Gastroentérologie, APHP-Université Paris Sud 11,Le Kremlin Bicêtre, France. 17. CHU Clermont-Ferrand, Service Hépatologie-Gastro-entérologie, Clermont-Ferrand, France. 18. Hôpital Louis Mourier, service d'Hépato-Gastroentérologie, Pôle Maladie Appareil Digestif, APHP-Université Paris VII, Colombes, France. 19. CHU de Saint-Etienne, Hôpital Nord, Service de Gastro-entérologie et Hépatologie, Saint-Etienne, France. 20. Division of Gastroenterology, University Hospital of Leuven, Leuven, Belgium. 21. Department of Gastroenterology, Hospital Universitari Mútua de Terrassa, University of Barcelona, Terrassa. CIBEREHD, Catalonia, Spain. 22. Helsinki University, and Helsinki University Central Hospital, Clinic of Gastroenterology, HUS, Finland. 23. 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. 24. CHI Le Raincy Montfermeil, Service d'Hépato-gastroentérologie, Montfermeil, France. 25. Ghent University Hospital, Gent, Belgium. 26. UMR-S- 1153 Inserm, Equipe ECSTRA, Denis Diderot-Paris 7 University, Hôpital Saint-Louis, Paris, France. 27. Department of Gastroenterology, University Hospital CHU of Liège, Liège, Belgium.
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. 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/.
RCT Entities:
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. 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/.
Authors: Christopher Andrew Lamb; Nicholas A Kennedy; Tim Raine; Philip Anthony Hendy; Philip J Smith; Jimmy K Limdi; Bu'Hussain Hayee; Miranda C E Lomer; Gareth C Parkes; Christian Selinger; Kevin J Barrett; R Justin Davies; Cathy Bennett; Stuart Gittens; Malcolm G Dunlop; Omar Faiz; Aileen Fraser; Vikki Garrick; Paul D Johnston; Miles Parkes; Jeremy Sanderson; Helen Terry; Daniel R Gaya; Tariq H Iqbal; Stuart A Taylor; Melissa Smith; Matthew Brookes; Richard Hansen; A Barney Hawthorne Journal: Gut Date: 2019-09-27 Impact factor: 23.059
Authors: Matthew C Choy; Dean Seah; David M Faleck; Shailja C Shah; Che-Yung Chao; Yoon-Kyo An; Graham Radford-Smith; Talat Bessissow; Marla C Dubinsky; Alexander C Ford; Leonid Churilov; Neville D Yeomans; Peter P De Cruz Journal: Inflamm Bowel Dis Date: 2019-06-18 Impact factor: 5.325
Authors: I Ordás; E Domènech; M Mañosa; V García-Sánchez; E Iglesias-Flores; M Peñalva; A Cañas-Ventura; O Merino; F Fernández-Bañares; F Gomollón; M Vera; A Gutiérrez; E Garcia-Planella; M Chaparro; M Aguas; E Gento; F Muñoz; M Aguirresarobe; C Muñoz; L Fernández; X Calvet; C E Jiménez; M A Montoro; A Mir; M L De Castro; M F García-Sepulcre; F Bermejo; J Panés; M Esteve Journal: Am J Gastroenterol Date: 2017-07-04 Impact factor: 10.864