英夫利昔单抗用于腹腔脓肿消退后初治的克罗恩病患者：GETAID的一项前瞻性研究

Adalimumab in Biologic-naïve Patients With Crohn's Disease After Resolution of an Intra-abdominal Abscess: A Prospective Study From the GETAID.

作者信息

Bouhnik Yoram, Pineton de Chambrun Guillaume, Lambert Jérôme, Nachury Maria, Seksik Philippe, Altwegg Romain, Vuitton Lucine, Stefanescu Carmen, Nancey Stéphane, Aubourg Alexandre, Serrero Mélanie, Filippi Jérôme, Desseaux Kristell, Viennot Stéphanie, Abitbol Vered, Boualit Madina, Bourreille Arnaud, Giletta Cyrielle, Buisson Anthony, Roblin Xavier, Dib Nina, Malamut Georgia, Amiot Aurélien, Fumery Mathurin, Louis Edouard, Elgharabawy Yasmine, Peyrin-Biroulet Laurent

机构信息

Paris IBD Center, Groupe Hospitalier Privé Ambroise Paré - Hartmann, Neuilly sur Seine, France.

Department of Gastroenterology, Saint-Eloi Hospital, Montpellier University, Montpellier, France.

出版信息

Clin Gastroenterol Hepatol. 2023 Dec;21(13):3365-3378.e5. doi: 10.1016/j.cgh.2023.01.013. Epub 2023 Jan 31.

DOI:10.1016/j.cgh.2023.01.013

PMID:36731588

Abstract

BACKGROUND & AIMS: The management of intra-abdominal abscesses complicating Crohn's disease (CD) is challenging, and surgery with delayed intestinal resection is often recommended. The aims of this study were to estimate the success rate of adalimumab (ADA) in patients with CD with an intra-abdominal abscess resolved without surgery, and to identify predictive factors for success.

METHODS

A multicenter, prospective study was conducted in biologic-naïve patients with CD with resolved intra-abdominal abscess treated with ADA with a 2-year follow-up. The primary endpoint was ADA failure at week (W) 24 defined as a need for steroids after W12, intestinal resection, abscess recurrence, and clinical relapse. Secondary post-hoc endpoint was the long-term success defined as the survival without abscess relapse or intestinal resection at W104. The factors associated with ADA failure at W24 and W104 were identified using a logistic and a Cox regression, respectively.

RESULTS

From April 2013 to December 2017, 190 patients from 27 GETAID centers were screened, and 117 were included in the analysis. Fifty-eight patients (50%) were male, and the median age at baseline was 28 years. At W24, 87 patients (74%; 95% confidence interval [CI], 65.5%-82.0%; n = 117) achieved ADA success. Among the 30 patients with ADA failure, 15 underwent surgery. At W104, the survival rate without abscess recurrence or surgery was 72.9% (95% CI, 62.1%-79.8%; n = 109). Abscess drainage was significantly associated with ADA failure at W24 (odds ratio, 4.18; 95% CI, 1.06-16.5; P =0 .043). Disease duration (hazard ratio [HR], 1.32; 95% CI, 1.09-1.59; P = .008), abscess drainage (HR, 5.59; 95% CI, 2.21-14.15; P = .001), and inflammatory changes in mesenteric fat (HR, 0.4; 95% CI, 0.17-0.94; P = .046) were significantly associated with ADA failure at W104.

CONCLUSION

Provided that the abscess was carefully managed before initiating medical treatment, this study showed the high efficacy of ADA in the short and long term in biologic-naïve patients with CD complicated by an intra-abdominal abscess.

CLINICALTRIALS

gov, Number: NCT02856763.

摘要

背景与目的

克罗恩病（CD）并发腹腔内脓肿的治疗具有挑战性，通常建议进行手术并延迟肠切除。本研究的目的是评估阿达木单抗（ADA）在腹腔内脓肿已消退且未接受手术的CD患者中的成功率，并确定成功的预测因素。

方法

对未使用过生物制剂的CD患者进行多中心前瞻性研究，这些患者的腹腔内脓肿已消退，接受ADA治疗并随访2年。主要终点是第24周（W24）时ADA治疗失败，定义为在第12周（W12）后需要使用类固醇、进行肠切除、脓肿复发或临床复发。次要事后终点是长期成功，定义为在第104周（W104）时无脓肿复发或肠切除的生存情况。分别使用逻辑回归和Cox回归确定与W24和W104时ADA治疗失败相关的因素。

结果

2013年4月至2017年12月，对来自27个GETAID中心的190例患者进行了筛查，117例纳入分析。58例患者（50%）为男性，基线时的中位年龄为28岁。在W24时，87例患者（74%；95%置信区间[CI]，65.5%-82.0%；n = 117）ADA治疗成功。在30例ADA治疗失败的患者中，15例接受了手术。在W104时，无脓肿复发或手术的生存率为72.9%（95%CI，62.1%-79.8%；n = 109）。脓肿引流与W24时ADA治疗失败显著相关（比值比，4.18；95%CI，1.06-16.5；P = 0.043）。病程（风险比[HR]，1.32；95%CI，1.09-1.59；P = 0.008）、脓肿引流（HR，5.59；95%CI，2.21-14.15；P = 0.001）和肠系膜脂肪的炎症改变（HR，0.4；95%CI，0.17-0.94；P = 0.046）与W104时ADA治疗失败显著相关。