Long-term outcome of patients with steroid-refractory acute severe UC treated with ciclosporin or infliximab.
Gut
; 67(2): 237-243, 2018 02.
Article
em En
| MEDLINE
| ID: mdl-28053054
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 5â 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 5.4â years, colectomy-free survival rates (95% CI) at 1 and 5â 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 5â 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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Fármacos Gastrointestinais
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Colite Ulcerativa
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Ciclosporina
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Infliximab
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Imunossupressores
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Gut
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
França