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J Crohns Colitis. 2019 Feb 6. doi: 10.1093/ecco-jcc/jjz032. [Epub ahead of print]

Ciclosporin therapy after infliximab failure in hospitalized patients with acute severe colitis is effective and safe.

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University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL, USA.


Background & Aims:

Options for medical management of patients with acute severe colitis (ASC) failing IV steroids are limited and include rescue therapy with either infliximab or ciclosporin. In patients failing infliximab, second-line rescue therapy with ciclosporin is an alternative. The aim of this study was to investigate the efficacy and safety of ciclosporin in patients with steroid-refractory ASC failing first-line rescue therapy with infliximab.


This is a retrospective, tertiary center study from 2010-2017. Included were patients hospitalized for ASC and treated with IV ciclosporin after failing IV steroids and infliximab within the previous 2 months. Time to colectomy, clinical response and occurrence of adverse events were analyzed.


Forty patients with steroid-resistant ASC were included. Patients were followed for a median of 13 months (IQR 5-32). Colectomy-free survival was 65%, 59.4%, and 41.8% at one month, three months and one year, respectively. Sixty percent of patients (24/40) achieved clinical remission at a median of 2 weeks (IQR 1-3 weeks). Infliximab levels before ciclosporin infusion were available for 26 patients (median level 17.5 mg/ml, IQR 8-34 mg/ml) and were not associated with adverse events. Sixteen patients (40%) experienced adverse events after ciclosporin treatment, none resulted in drug discontinuation.


In patients with IV steroid-refractory ASC who failed infliximab therapy, second-line rescue therapy with ciclosporin is effective and safe. This is the largest patient cohort to receive ciclosporin as second-line rescue therapy for ASC. We believe that ciclosporin may be offered to selected patients prior to referral for colectomy.


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