Schulze Hermann, Esters Philip, Hartmann Franz, Stein Juergen, Christ Christina, Zorn Michael, Dignass Axel
a Department of Medicine I , Agaplesion Markus Hospital , Frankfurt , Germany.
b Interdisziplinäres Crohn Colitis Centrum , Frankfurt , Germany.
Scand J Gastroenterol. 2018 Jun;53(6):670-676. doi: 10.1080/00365521.2018.1452974. Epub 2018 Mar 21.
Vedolizumab (VDZ) drug monitoring strategies in inflammatory bowel disease (IBD) patients have not been systematically investigated so far. We evaluated the correlation between VDZ trough levels (VTL) and the treatment response in IBD.
Fifty-one patients with active IBD on or starting a therapy with VDZ were enrolled in this prospective and observational single centre study. Disease activity indices, blood tests, and anthropometric parameters were assessed over a time period of 6 months. One hundred and fifty-five VDZ serum trough levels were measured directly before the next scheduled application using liquid chromatography mass spectrometry (LC-MS/MS).
VDZ treatment was found to be clinically effective (Harvey Bradshaw Index (HBI) dropping from 10 to 5.5 points (p < .0005) in Crohn's disease (CD) patients; partial Mayo score (pMS) from 4.4 to 2.1 points (p < .0005) in ulcerative colitis patients (UC). CRP levels tended to decrease and haemoglobin levels to increase under VDZ therapy. CD patients with a serum CRP level lower than 5 mg/l exhibited significantly higher VTL than those with elevated CRP levels (34.9 versus 21.7 µg/ml, p = .00153). UC patients with haemoglobin levels higher 12 g/dl at the time of VTL measurement had significantly higher VTL compared to patients with lower haemoglobin levels (35.4 versus 15.6 µg/ml, p < .0005).
Our data suggest a significant correlation between VTL and response to therapy in IBD patients (higher VTL associated with better response).
迄今为止，尚未对炎症性肠病（IBD）患者的维多珠单抗（VDZ）药物监测策略进行系统研究。我们评估了VDZ谷浓度（VTL）与IBD治疗反应之间的相关性。
51例正在接受或开始接受VDZ治疗的活动性IBD患者纳入了这项前瞻性单中心观察性研究。在6个月的时间内评估疾病活动指数、血液检查和人体测量参数。使用液相色谱质谱联用仪（LC-MS/MS）在下一次预定给药前直接测量155次VDZ血清谷浓度。
发现VDZ治疗具有临床疗效（克罗恩病（CD）患者的哈维·布拉德肖指数（HBI）从10分降至5.5分（p < .0005）；溃疡性结肠炎（UC）患者的部分梅奥评分（pMS）从4.4分降至2.1分（p < .0005））。在VDZ治疗下，CRP水平趋于下降，血红蛋白水平趋于上升。血清CRP水平低于5 mg/l的CD患者的VTL显著高于CRP水平升高的患者（34.9对21.7 µg/ml，p = .00153）。在VTL测量时血红蛋白水平高于12 g/dl的UC患者的VTL显著高于血红蛋白水平较低的患者（35.4对15.6 µg/ml，p < .0005）。
我们的数据表明IBD患者的VTL与治疗反应之间存在显著相关性（VTL越高，反应越好）。
