Al-Bawardy Badr, Ramos Guilherme Piovezani, Willrich Maria Alice V, Jenkins Sarah M, Park Sang Hyoung, Aniwan Satimai, Schoenoff Shayla A, Bruining David H, Papadakis Konstantinos A, Raffals Laura, Tremaine William J, Loftus Edward V
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA.
Inflamm Bowel Dis. 2019 Feb 21;25(3):580-586. doi: 10.1093/ibd/izy272.
BACKGROUND/AIMS: The clinical utility of vedolizumab (VDZ) trough levels (VTLs) in inflammatory bowel disease (IBD) is not well defined. The aims of this study are to determine the median VTLs and frequency of detected antibodies, the correlation of VTLs with C-reactive protein (CRP) and mucosal healing (MH), and the change in clinical management based on VTLs.
A cross-sectional study of IBD patients treated with VDZ with VTLs checked between July 1, 2016, and March 1, 2017, was conducted. Mucosal healing was defined as absence of mucosal ulcers in Crohn's disease (CD) and Mayo endoscopic score ≤1 for ulcerative colitis (UC). Normal CRP was defined as ≤8 mg/L.
A total of 171 patients (62% CD, 31% UC, 7% indeterminate colitis) were included. Median VTLs was 15.3 ug/mL (range, 0-60), and 1 patient had detectable antibodies to VDZ. Patients with a normal CRP had a median VTLs of 17.3 ug/mL vs 10.7 ug/mL in high CRP patients (P = 0.046). This was noted in CD (20.3 vs 10.4 ug/mL; P = 0.005) but not in UC patients (14.4 vs 20.8; P = 0.72). Mucosal healing was achieved in 35% of patients (37 of 105); among these, median VTLs was 13.7 ug/mL vs 16.1 ug/mL in patients who did not achieve MH (P = 0.64). Vedolizumab trough levels resulted in a change in clinical management in 73%.
Our cohort showed a low rate of immunogenicity to VDZ and an association between VTLs and CRP in CD but not in UC patients. No relationship between VTLs and MH was detected. Vedolizumab trough level measurements altered management in approximately three fourths of patients.
背景/目的：维多珠单抗（VDZ）谷浓度（VTL）在炎症性肠病（IBD）中的临床应用尚未明确。本研究的目的是确定VTL的中位数和检测到抗体的频率，VTL与C反应蛋白（CRP）和黏膜愈合（MH）的相关性，以及基于VTL的临床管理变化。
对2016年7月1日至2017年3月1日期间接受VDZ治疗并检测VTL的IBD患者进行了一项横断面研究。黏膜愈合定义为克罗恩病（CD）无黏膜溃疡，溃疡性结肠炎（UC）的梅奥内镜评分≤1。正常CRP定义为≤8mg/L。
共纳入171例患者（62%为CD，31%为UC，7%为不确定性结肠炎）。VTL的中位数为15.3μg/mL（范围为0 - 60），1例患者检测到抗VDZ抗体。CRP正常的患者VTL中位数为17.3μg/mL，而CRP高的患者为10.7μg/mL（P = 0.046）。在CD患者中观察到这种情况（20.3 vs 10.4μg/mL；P = 0.005），但在UC患者中未观察到（14.4 vs 20.8；P = 0.72）。35%的患者（共105例中的37例）实现了黏膜愈合；在这些患者中，未实现MH的患者VTL中位数为13.7μg/mL，而实现了MH的患者为16.1μg/mL（P = 0.64）。73%的患者因VDZ谷浓度导致临床管理发生变化。
我们的队列显示对VDZ的免疫原性率较低，且在CD患者中VTL与CRP相关，而在UC患者中无此相关性。未检测到VTL与MH之间的关系。VDZ谷浓度测量改变了约四分之三患者的管理。
