在炎症性肠病维持治疗期间，维多珠单抗谷浓度水平与临床、生物学及内镜检查结果的相关性
Association of trough vedolizumab levels with clinical, biological and endoscopic outcomes during maintenance therapy in inflammatory bowel disease.
作者信息
Plevris Nikolas, Jenkinson Philip W, Chuah Cher S, Lyons Mathew, Merchant Lynne M, Pattenden Rebecca J, Arnott Ian D, Jones Gareth R, Lees Charlie W
机构信息
The Edinburgh IBD Unit, Western General Hospital, Edinburgh, UK.
Department of Biochemistry, Western General Hospital, Edinburgh, UK.
出版信息
Frontline Gastroenterol. 2019 Jul 3;11(2):117-123. doi: 10.1136/flgastro-2019-101197. eCollection 2020 Mar.
OBJECTIVE
To establish the relationship between trough vedolizumab levels and outcomes during maintenance therapy.
DESIGN
Cross-sectional service evaluation was performed on patients with inflammatory bowel disease (IBD) receiving maintenance vedolizumab therapy (minimum of 12 weeks following induction). Prior to infusion, data on clinical activity (Harvey-Bradshaw Index or partial Mayo score), trough C-reactive protein (CRP)/vedolizumab levels and faecal calprotectin were collected. Endoscopic data (±8 weeks from vedolizumab level testing) were obtained by review of medical records. Vedolizumab levels were processed using the Immundiagnostik monitor ELISA.
SETTING
The Edinburgh IBD Unit, Western General Hospital (tertiary IBD referral centre).
PATIENTS
Seventy-three patients (30 ulcerative colitis and 43 Crohn's disease) were identified who fulfilled inclusion criteria and had vedolizumab levels matched with clinical activity scores, CRP and faecal calprotectin. Of these, 40 patients also had matched endoscopic data.
MAIN OUTCOME MEASURES
The association of trough vedolizumab levels with clinical remission (Harvey-Bradshaw Index <5 or partial Mayo <2), biologic remission (faecal calprotectin <250 µg/g+CRP <5 mg/L) and endoscopic remission (Mayo score 0/no inflammation and ulceration on colonoscopy).
RESULTS
The median trough vedolizumab levels were similar between patients in and not in clinical remission (10.6 vs 9.9 µg/mL, p=0.54); biologic remission (10.6 vs 9.8 µg/mL, p=0.35) and endoscopic remission (8.1 vs 10.2 µg/mL, p=0.21). Quartile analysis revealed no significant increase in the proportion of patients in clinical remission, biologic remission or endoscopic remission with increasing trough vedolizumab levels (p<0.05).
CONCLUSIONS
In this cohort, trough vedolizumab levels were not associated with clinical, biological or endoscopic outcomes during maintenance therapy.
目的
建立维持治疗期间维多珠单抗谷浓度水平与治疗结果之间的关系。
设计
对接受维多珠单抗维持治疗（诱导治疗后至少12周）的炎症性肠病（IBD）患者进行横断面服务评估。在输注前，收集临床活动度（哈维-布拉德肖指数或梅奥部分评分）、谷浓度C反应蛋白（CRP）/维多珠单抗水平和粪便钙卫蛋白的数据。通过查阅病历获得内镜数据（维多珠单抗水平检测前后±8周）。使用Immundiagnostik监测ELISA法检测维多珠单抗水平。
地点
西总医院爱丁堡IBD科室（三级IBD转诊中心）。
患者
确定73例患者（30例溃疡性结肠炎和43例克罗恩病）符合纳入标准，且维多珠单抗水平与临床活动度评分、CRP和粪便钙卫蛋白相匹配。其中40例患者还有匹配的内镜数据。
主要观察指标
维多珠单抗谷浓度水平与临床缓解（哈维-布拉德肖指数<5或梅奥部分评分<2）、生物学缓解（粪便钙卫蛋白<250µg/g+CRP<5mg/L）和内镜缓解（梅奥评分0/结肠镜检查无炎症和溃疡）之间的关联。
结果
临床缓解组和未临床缓解组患者的维多珠单抗谷浓度中位数相似（10.6对9.9µg/mL，p=0.54）；生物学缓解组（10.6对9.8µg/mL，p=0.35）和内镜缓解组（8.1对10.2µg/mL，p=0.21）。四分位数分析显示，随着维多珠单抗谷浓度水平升高，临床缓解、生物学缓解或内镜缓解的患者比例无显著增加（p<0.05）。
结论
在该队列中，维持治疗期间维多珠单抗谷浓度水平与临床、生物学或内镜治疗结果无关。
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