Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL, USA.
J Crohns Colitis. 2019 Sep 19;13(9):1105-1110. doi: 10.1093/ecco-jcc/jjz032.
Options for medical management of patients with acute severe colitis [ASC] failing intravenous (i.v.) 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 centre study undertaken from 2010 to 2017. Included were patients hospitalized for ASC and treated with i.v. ciclosporin after failing i.v. steroids and infliximab within the previous 2 months. Time to colectomy, clinical response, and occurrence of adverse events were analysed.
Forty patients with steroid-resistant ASC were included. Patients were followed for a median of 13 months (interquartile range [IQR] 5-32 months). Colectomy-free survival was 65%, 59.4%, and 41.8% at 1 month, 3 months and 1 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, but none resulted in drug discontinuation.
In patients with i.v. steroid-refractory ASC who failed infliximab therapy, second-line rescue therapy with ciclosporin was shown to be 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.
静脉（IV）类固醇治疗失败的急性重度结肠炎（ASC）患者的医学治疗选择有限，包括英夫利昔单抗或环孢素的补救治疗。在英夫利昔单抗治疗失败的患者中，环孢素二线补救治疗是一种替代方法。本研究旨在调查环孢素在静脉类固醇治疗失败且在过去 2 个月内接受过英夫利昔单抗一线补救治疗的 ASC 患者中的疗效和安全性。
这是一项回顾性的三级中心研究，于 2010 年至 2017 年进行。纳入标准为因 ASC 住院且在过去 2 个月内接受过 IV 环孢素和 IV 类固醇治疗但仍对类固醇耐药的患者。分析手术时间、临床反应和不良事件的发生情况。
共纳入 40 例 ASC 患者。患者中位随访时间为 13 个月（IQR 5-32 个月）。1 个月、3 个月和 1 年的无结肠切除术生存率分别为 65%、59.4%和 41.8%。60%的患者[40/40]在中位时间为 2 周（IQR 1-3 周）时达到临床缓解。26 例患者[26/40]可获得环孢素输注前英夫利昔单抗水平（中位水平为 17.5mg/mL，IQR 8-34mg/mL），但与不良事件无关。16 例患者[40%]在环孢素治疗后出现不良事件，但均未导致药物停药。
在静脉类固醇治疗失败的 ASC 患者中，二线补救治疗采用环孢素是有效且安全的。这是接受环孢素二线补救治疗的 ASC 患者中最大的患者队列。我们认为，在转介行结肠切除术之前，可向部分患者提供环孢素。
