Year 2017 / Volume 109 / Number 8
Original
Medium to long-term efficacy and safety of oral tacrolimus in moderate to severe steroid refractory ulcerative colitis

559-565

DOI: 10.17235/reed.2017.4899/2017

Raúl Vicente Olmedo Martín, Víctor Amo Trillo, Rocío González Grande, Miguel Jiménez Pérez,

Abstract
Background and objective: Oral tacrolimus is an effective drug that induces clinical remission in patients with moderate to severe ulcerative colitis refractory to steroids. However, there is little data with regard to its medium to long-term efficacy and safety. The aim of this study was to assess the medium to long-term efficacy and safety of oral tacrolimus in this challenging clinical situation. Methods: This was a retrospective observational review of the clinical charts of 34 patients with moderate to severe ulcerative colitis refractory to steroids treated with oral tacrolimus at our hospital (July 2001-July 2016). Remission was defined as a Lichtiger index score < 3 and response was defined as a score < 10 with a reduction of at least three points compared to the baseline score. Results and conclusions: Seven patients (20.58%) required colectomy during the follow-up period (mean 65 months). Nine patients required rescue with infliximab (four patients during the first six months of follow-up and the other five after the first six months). The short to medium clinical efficacy combining both remission and clinical response was 82% at six months. Kaplan-Meier analysis showed that the percentage of patients free from colectomy and additional sequential rescue therapy was 75% at 54 months (median follow-up). The early introduction of thiopurines (< 2 months from start of tacrolimus) showed no significant improvement in prognosis (p = 0.72). Fifty-three per cent of patients experienced adverse effects, none of whom required treatment withdrawal. No severe infections were noted during the follow-up.
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Olmedo Martín R, Amo Trillo V, González Grande R, Jiménez Pérez M. Medium to long-term efficacy and safety of oral tacrolimus in moderate to severe steroid refractory ulcerative colitis. 4899/2017


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Publication history

Received: 12/02/2017

Accepted: 21/03/2017

Online First: 15/06/2017

Published: 31/07/2017

Article revision time: 36 days

Article Online First time: 123 days

Article editing time: 169 days


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