Koga Akihiro, Matsui Toshiyuki, Takatsu Noritaka, Takada Yasumichi, Kishi Masahiro, Yano Yutaka, Beppu Takahiro, Ono Yoichiro, Ninomiya Kazeo, Hirai Fumihito, Nagahama Takashi, Hisabe Takashi, Takaki Yasuhiro, Yao Kenshi, Imaeda Hirotsugu, Andoh Akira
Department of Gastroenterology, Fukuoka University Chikushi Hospital, Chikushino, Japan.
Department of Medicine, Shiga University of Medical Science, Otsu, Japan.
Intest Res. 2018 Apr;16(2):223-232. doi: 10.5217/ir.2018.16.2.223. Epub 2018 Apr 30.
BACKGROUND/AIMS: Decreased trough levels of infliximab (TLI) and antibodies to infliximab (ATI) are associated with loss of response (LOR) in Crohn's disease. Two prospective studies were conducted to determine whether TLI or ATI better correlates with LOR (Study 1), and whether TLI could become a predictor of mucosal healing (MH) (Study 2).
Study 1 was conducted in 108 patients, including those with LOR and remission to compare ATI and TLI in discriminating the 2 conditions based on receiver operating characteristic (ROC) curve analyses. Study 2 involved 35 patients who were evaluated endoscopically.
In Study 1, there were no differences between the 2 assays in ROC curve analyses; the TLI cutoff value for LOR was 2.6 µg/mL (sensitivity, 70.9%; specificity, 79.2%), and the ATI cutoff value was 4.9 µg/mL (sensitivity, 65.5%; specificity, 67.9%). The AUROC (area under the ROC curve) of TLI was greater than that of ATI. AUROC was useful for discriminating between the 2 conditions. In Study 2, the TLI was significantly higher in the colonic MH group than in the non-MH group (2.7 µg/mL vs. 0.5 µg/mL, =0.032).
TLI is better than ATI for clinically diagnosing LOR, and a correlation was observed between TLI and colonic MH.
背景/目的：英夫利昔单抗谷浓度（TLI）降低及英夫利昔单抗抗体（ATI）与克罗恩病反应丧失（LOR）相关。进行了两项前瞻性研究，以确定TLI或ATI与LOR的相关性更强（研究1），以及TLI是否可成为黏膜愈合（MH）的预测指标（研究2）。
研究1纳入108例患者，包括发生LOR和处于缓解期的患者，基于受试者工作特征（ROC）曲线分析比较ATI和TLI对这两种情况的区分能力。研究2纳入35例接受内镜评估的患者。
在研究1中，两种检测方法在ROC曲线分析中无差异；LOR的TLI临界值为2.6μg/mL（灵敏度70.9%；特异性79.2%），ATI临界值为4.9μg/mL（灵敏度65.5%；特异性67.9%）。TLI的ROC曲线下面积（AUROC）大于ATI。AUROC有助于区分这两种情况。在研究2中，结肠MH组的TLI显著高于非MH组（2.7μg/mL对0.5μg/mL，P = 0.032）。
在临床诊断LOR方面，TLI优于ATI，且观察到TLI与结肠MH之间存在相关性。
