Maintenance Adalimumab Concentrations Are Associated with Biochemical, Endoscopic, and Histologic Remission in Inflammatory Bowel Disease
Maintenance Adalimumab Concentrations Are Associated with Biochemical, Endoscopic, and Histologic Remission in Inflammatory Bowel Disease
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DOI：
10.1007/s10620-018-5202-5
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发表时间：
2018-11-01
影响因子：
3.1
通讯作者：
Cheifetz, Adam S.
中科院分区：
文献类型：
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作者：
Juncadella, Anna;Papamichael, Konstantinos;Cheifetz, Adam S.
研究背景一种靶向治疗方法正在成为治疗炎症性肠病（IBD）、克罗恩病（CD）和溃疡性结肠炎（UC）的新标准。方法这项回顾性多中心研究包括连续接受阿达木单抗维持治疗的IBD患者，2013年7月至2016年12月治疗药物监测1周内C反应蛋白（CRP）和/或12周内内镜评价。生化缓解定义为CRP正常（5 mg/L）。内镜下缓解定义为无任何溃疡/糜烂，或CD患者回结肠切除术后Rutgeillary评分为1，UC患者马约内镜下评分为1。组织学缓解定义为无任何活动性炎症体征。阿达木单抗浓度测定使用均匀迁移率变化assay.Results91 CRP水平和72结肠镜检查从98 IBD患者[CD：n=72（73%）]进行了评价。基于受试者操作特征分析，我们确定CD患者阿达木单抗浓度阈值为11.8、12和12.2 g/mL，UC患者阿达木单抗浓度阈值为10.5、16.2和16.2 g/mL，分别对有或无生化、内镜或组织学缓解的患者进行分层。阿达木单抗浓度12 μ g/mL（OR 8; 95%CI 2-31.9; p=0.003）和12.2 μ g/mL（OR 9.6; 95%CI 1.7-56.1; p=0.012）分别与CD的内镜和组织学缓解独立相关，分别为.ConclusionsThis study demonstrates，higher maintenance adalimumab concentrations are associated with objective therapeutic outcomes in IBD.
BackgroundA treat-to-target therapeutic approach is emerging as the new standard of care for treating inflammatory bowel disease (IBD), Crohn's disease (CD), and ulcerative colitis (UC).AimsWe aimed to investigate the association of serum adalimumab concentrations during maintenance therapy with biochemical, endoscopic, and histologic remission in IBD.MethodsThis retrospective multicenter study included consecutive IBD patients on adalimumab maintenance therapy who had a C-reactive protein (CRP) within 1week and/or endoscopic evaluation within 12weeks of therapeutic drug monitoring between July 2013 and December 2016. Biochemical remission was defined as a normal CRP (5mg/L). Endoscopic remission was defined as the absence of any ulceration/erosion or a Rutgeerts score ofi1 for patients with an ileocolonic resection for CD and a Mayo endoscopic score of1 for UC. Histologic remission was defined as the absence of any sign of active inflammation. Adalimumab concentrations were measured using the homogeneous mobility shift assay.ResultsNinety-one CRP levels and 72 colonoscopies from 98 IBD patients [CD: n=72 (73%)] were evaluated. Based on receiver operating characteristic analyses, we identified an adalimumab concentration threshold of 11.8, 12, and 12.2g/mL in CD and 10.5, 16.2, and 16.2g/mL in UC to stratify patients with or without biochemical, endoscopic, or histologic remission, respectively. Adalimumab concentrations12g/mL (OR 8; 95% CI 2-31.9; p=0.003) and12.2g/mL (OR 9.6; 95% CI 1.7-56.1; p=0.012) were independently associated with endoscopic and histologic remission in CD, respectively.ConclusionsThis study demonstrates that higher maintenance adalimumab concentrations are associated with objective therapeutic outcomes in IBD.