Bouhnik Yoram, Carbonnel Franck, Laharie David, Stefanescu Carmen, Hébuterne Xavier, Abitbol Vered, Nachury Maria, Brixi Hedia, Bourreille Arnaud, Picon Laurence, Bourrier Anne, Allez Matthieu, Peyrin-Biroulet Laurent, Moreau Jacques, Savoye Guillaume, Fumery Mathurin, Nancey Stephane, Roblin Xavier, Altwegg Romain, Bouguen Guillaume, Bommelaer Gilles, Danese Silvio, Louis Edouard, Zappa Magaly, Mary Jean-Yves
Gastroentérologie, MICI et Assistance Nutritive, Hôpital Beaujon, Clichy, France.
Gastro-entérologie, Hôpital Bicêtre, Le Kremlin Bicêtre, France.
Gut. 2018 Jan;67(1):53-60. doi: 10.1136/gutjnl-2016-312581. Epub 2017 Jan 24.
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.
抗肿瘤坏死因子（抗TNF）药物在克罗恩病（CD）合并症状性小肠狭窄（SSBS）患者中的疗效存在争议。本研究旨在评估阿达木单抗在这些患者中的疗效，并确定预测治疗成功的因素。
我们对CD合并SSBS患者进行了一项多中心、前瞻性观察队列研究。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周时的治疗成功，定义为继续使用阿达木单抗且未接受禁用治疗（入组后8周后使用皮质类固醇、其他抗TNF药物）、未进行内镜扩张或肠切除。使用逻辑回归模型确定与治疗成功独立相关的基线因素，得出一个简单的预后评分。次要终点是第24周后持续成功（仍使用阿达木单抗，未进行扩张或手术）以及整个队列中至肠切除的时间。
2010年1月至2011年12月，共筛查105例患者，97例纳入研究。第24周时，62/97（64%）例患者治疗成功。预后评分将患者分为预后良好组（43/49例成功）、预后中等组（17/28例成功）和预后不良组（1/16例成功）。中位随访时间3.8年，第24周时治疗成功的患者（即占整个队列的29%）中有45.7%±6.6%（比例±标准误）在4年时仍持续成功。在整个队列中，50.7%±5.3%的患者在入组4年后未接受肠切除。
约三分之二的CD合并SSBS患者对阿达木单抗治疗反应成功，其中近一半患者直至随访结束仍持续有效。超过一半的患者在开始治疗4年后未接受手术。
NCT01183403；结果
