Efficacy of adalimumab in patients with Crohn's disease and symptomatic small bowel stricture: a multicentre, prospective, observational cohort (CREOLE) study.
Efficacy of adalimumab in patients with Crohn's disease and symptomatic small bowel stricture: a multicentre, prospective, observational cohort (CREOLE) study.
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DOI：
10.1136/gutjnl-2016-312581
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发表时间：
2018-01
期刊：
影响因子：
24.5
通讯作者：
GETAID CREOLE Study Group
中科院分区：
文献类型：
--
作者：
Bouhnik Y;Carbonnel F;Laharie D;Stefanescu C;Hébuterne X;Abitbol V;Nachury M;Brixi H;Bourreille A;Picon L;Bourrier A;Allez M;Peyrin-Biroulet L;Moreau J;Savoye G;Fumery M;Nancey S;Roblin X;Altwegg R;Bouguen G;Bommelaer G;Danese S;Louis E;Zappa M;Mary JY;GETAID CREOLE Study Group
抗肿瘤坏死因子（抗TNF）在克罗恩病（CD）和症状性小肠狭窄（SSBS）患者中的疗效存在争议。本研究的目的是评估阿达木单抗在这些患者中的疗效，并确定预测成功的因素。我们在CD和SSBS患者中进行了一项多中心、前瞻性、观察性队列研究。纳入的患者在基线时接受磁共振小肠造影，随后接受阿达木单抗治疗。主要终点是第24周时的成功，定义为继续阿达木单抗治疗，未进行禁用治疗（入选后8周后使用皮质类固醇，其他抗TNF）、内镜扩张或肠切除术。使用逻辑回归模型确定与成功独立相关的基线因素，得到简单的预后评分。次要终点是第24周后的长期成功（仍使用阿达木单抗，未进行扩张或手术）和整个队列的肠切除时间。从2010年1月至2011年12月，筛选了105例患者，纳入97例。在第24周，62/97（64%）例患者获得成功。预后评分定义了43/49成功的良好预后组，17/28成功的中等预后组和1/16成功的不良预后组。中位随访时间为3.8年后，45.7%±6.6%（比例±SE）的第24周成功患者（即整个队列的29%）在4年时仍长期成功。 在整个队列中，50.7%±5.3%的患者在入选后4年未接受肠切除术。 在约三分之二的SSBS CD患者中观察到阿达木单抗的成功应答，其中近一半患者的应答延长至随访结束。超过一半的患者在治疗开始后4年没有手术。 NCT 01183403;结果。
The efficacy of anti-tumour necrosis factors (anti-TNFs) in patients with Crohn's disease (CD) and symptomatic small bowel stricture (SSBS) is controversial. The aim of this study was to estimate the efficacy of adalimumab in these patients and to identify the factors predicting success. We performed a multicentre, prospective, observational cohort study in patients with CD and SSBS. The included patients underwent magnetic resonance enterography at baseline and subsequently received adalimumab. The primary endpoint was success at week 24, defined as adalimumab continuation without prohibited treatment (corticosteroids after the eight week following inclusion, other anti-TNFs), endoscopic dilation or bowel resection. The baseline factors independently associated with success were identified using a logistic regression model, leading to a simple prognostic score. Secondary endpoints were prolonged success after week 24 (still on adalimumab, without dilation nor surgery) and time to bowel resection in the whole cohort. From January 2010 to December 2011, 105 patients were screened and 97 were included. At week 24, 62/97 (64%) patients had achieved success. The prognostic score defined a good prognosis group with 43/49 successes, an intermediate prognosis group with 17/28 successes and a poor prognosis group with 1/16 successes. After a median follow-up time of 3.8 years, 45.7%±6.6% (proportion±SE) of patients who were in success at week 24 (ie, 29% of the whole cohort) were still in prolonged success at 4 years. Among the whole cohort, 50.7%±5.3% of patients did not undergo bowel resection 4 years after inclusion. A successful response to adalimumab was observed in about two-thirds of CD patients with SSBS and was prolonged in nearly half of them till the end of follow-up. More than half of the patients were free of surgery 4 years after treatment initiation. NCT01183403; Results.
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