Af Björkesten C-G, Jussila A, Kemppainen H, Hallinen T, Soini E, Mankinen P, Valgarðsson S, Veckman V, Nissinen R, Naessens D, Molander P
Gastroenterology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital, Tampere, Finland.
Scand J Gastroenterol. 2019 Oct;54(10):1226-1232. doi: 10.1080/00365521.2019.1667426. Epub 2019 Sep 18.
A retrospective non-interventional, multi-centre patient chart review study was conducted to investigate the association of faecal calprotectin (FC) 1 year (±2 months) after biological therapy initiation with composite event-free survival (CEFS) consisting of surgical procedures, corticosteroid initiation, treatment failure or dose increase in patients with Crohn's disease (CD). In addition, the correlations of FC and other tests of disease activity were assessed. Data on Finnish CD patients initiating a biological therapy between 2010 and 2016, were collected. The association of FC and CEFS was analysed with Kaplan-Meier and Cox proportional hazard modelling. The correlations were tested with Pearson's test. Biological therapy was initiated in 186 patients, of which 87 (46.8%) had FC results available at 1 year and 80 had follow-up exceeding 14 months. The characteristics of patients with and without FC results were similar. Patients with elevated FC (>250 µg/g) had a significantly increased risk of experiencing composite event (HR 3.4, 95% CI: 1.3-8.9; = .013) when compared to patients with normal FC (FC ≤ 100). No such risk was observed in patients with intermediately increased FC level (100 µg/g < FC ≤ 250 µg/g) (HR 2.2 (95% CI: 0.8-6.2; = .120). FC value had significant positive correlation with CRP, HBI and leukocyte values when measured at similar timepoints. Elevated level of FC approximately 1 year after the initiation of biological therapy was associated with an increased risk of either surgical procedures, corticosteroid initiation, treatment failure or dose increase (i.e. composite outcome) in patients with CD.
开展了一项回顾性非干预性多中心患者病历审查研究，以调查生物治疗开始1年（±2个月）后粪便钙卫蛋白（FC）与克罗恩病（CD）患者的复合无事件生存期（CEFS）之间的关联，CEFS包括外科手术、开始使用皮质类固醇、治疗失败或剂量增加。此外，还评估了FC与其他疾病活动检测指标之间的相关性。收集了2010年至2016年间开始生物治疗的芬兰CD患者的数据。采用Kaplan-Meier法和Cox比例风险模型分析FC与CEFS之间的关联。相关性通过Pearson检验进行检测。186例患者开始了生物治疗，其中87例（46.8%）在1年时有FC检测结果，80例随访时间超过14个月。有和没有FC检测结果的患者特征相似。与FC正常（FC≤100）的患者相比，FC升高（>250µg/g）的患者发生复合事件的风险显著增加（风险比3.4，95%置信区间：1.3 - 8.9；P = 0.013）。FC水平中度升高（100µg/g < FC≤250µg/g）的患者未观察到此类风险（风险比2.2（95%置信区间：0.8 - 6.2；P = 0.120）。在相似时间点测量时，FC值与CRP、HBI和白细胞值呈显著正相关。生物治疗开始约1年后FC水平升高与CD患者进行外科手术、开始使用皮质类固醇、治疗失败或剂量增加（即复合结局）的风险增加相关。
