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TNF 抑制剂治疗术后克罗恩病患者的药物水平与内镜复发的相关性。

The Association Between Drug Levels and Endoscopic Recurrence in Postoperative Patients with Crohn's Disease Treated with Tumor Necrosis Factor Inhibitors.

机构信息

*Department of Gastroenterology, Sheba Medical Center, Ramat Gan, Israel, and Sackler Medical School, Tel Aviv University, Tel Aviv, Israel; and †Service de Gastrologie-Entérologie-Hépatologie, CHU de Saint-Etienne, Saint-Etienne, France.

出版信息

Inflamm Bowel Dis. 2017 Nov;23(11):1924-1929. doi: 10.1097/MIB.0000000000001220.

DOI:10.1097/MIB.0000000000001220
PMID:28837524
Abstract

BACKGROUND

Endoscopic recurrence is associated with a risk of clinical recurrence in patients with Crohn's disease after ileocecal or small bowel resection. Drug levels and presence of antidrug antibodies are associated with important clinical and endoscopic outcomes in patients with Crohn's disease treated with tumor necrosis factor inhibitors, such association was not evaluated for endoscopic postsurgical recurrence.

METHODS

Consecutive patients with Crohn's disease treated with anti-tumor necrosis factors after surgery were identified in the databases of the participating centers. Anti-tumor necrosis factor levels and antidrug antibodies were correlated with Rutgeerts score on colonoscopy performed ≥6 months postoperatively. Significant endoscopic recurrence (SER) was defined as Rutgeerts score >2.

RESULTS

Seventy-three consecutive patients (32-infliximab, 41-adalimumab) were included in the study. The colonoscopies were performed after a median of 15 (7-43) months after surgery and 8 (6-15) months from treatment onset. SER was demonstrated in 26/73 (35.6%) of the patients. The need for dose optimization, as well as trough infliximab levels (2.4 μg/mL [0.45-4.1] versus 1.1 (0-0.6), P = 0.008) and presence of antidrug antibodies (1/18 [5.6%] versus 10/14 [71.4%], P = 0.0001) were significantly associated with a risk of SER. The optimal cutoff infliximab level for prediction of SER was 1.8 μg/mL. No association between adalimumab levels and antiadalimumab antibodies was demonstrated.

摘要

背景

在接受回肠或小肠切除术的克罗恩病患者中,内镜复发与临床复发的风险相关。在接受肿瘤坏死因子抑制剂治疗的克罗恩病患者中,药物水平和抗药物抗体与重要的临床和内镜结局相关,这种关联尚未在接受内镜手术后的复发患者中进行评估。

方法

在参与中心的数据库中确定了接受抗肿瘤坏死因子治疗的手术后克罗恩病患者。在手术后≥6 个月进行结肠镜检查时,将抗肿瘤坏死因子水平和抗药物抗体与 Rutgeerts 评分相关联。显著内镜复发(SER)定义为 Rutgeerts 评分>2。

结果

本研究纳入了 73 例连续患者(32 例使用英夫利昔单抗,41 例使用阿达木单抗)。结肠检查在手术后中位数 15(7-43)个月和治疗开始后 8(6-15)个月进行。在 73 例患者中有 26/73(35.6%)例发生 SER。需要剂量优化,以及谷值英夫利昔单抗水平(2.4μg/mL [0.45-4.1] 与 1.1(0-0.6),P=0.008)和抗药物抗体的存在(1/18 [5.6%] 与 10/14 [71.4%],P=0.0001)与 SER 风险显著相关。预测 SER 的最佳英夫利昔单抗水平截断值为 1.8μg/mL。阿达木单抗水平与抗阿达木单抗抗体之间无关联。

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