Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Department of Pediatrics, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.
Gut Liver. 2019 Sep 15;13(5):541-548. doi: 10.5009/gnl18129.
BACKGROUND/AIMS: Infliximab (IFX) often loses its therapeutic effect in initial responders with inflammatory bowel disease (IBD) over time. Low serum IFX trough levels (TLs) are linked to poor clinical response and outcomes. Maintenance of optimal therapeutic IFX concentrations is important for sustaining response and achieving good clinical outcomes. Measurement of serum IFX TLs is helpful for determining a further proper therapeutic plan. However, adequate therapeutic IFX TLs in pediatric IBD is uncertain. We aimed to identify the cutoff values for IFX TLs associated with laboratory response to IFX maintenance therapy.
Patients with pediatric IBD who had received IFX infusions between December 2008 and March 2015 at Samsung Medical Center were retrospectively investigated. We analyzed 239 blood samples that were collected from 103 pediatric patients. We measured IFX TLs at induction (6 and 14 weeks) and during maintenance therapy (>22 weeks, 8 weeks interval) by fluid-phase radioimmunoassays.
A significant association was found between the erythrocyte sedimentation rate (ESR) and IFX TLs during maintenance (correlation coefficient, -0.11; p=0.0005). A cutoff value of 18 mm/hr for ESR was used to define higher levels. Receiver operating characteristic analysis identified optimal cutoff values: IFX TL >1.58 µg/mL (sensitivity 82% and specificity 73%).
Cutoff values are considered a prerequisite for further investigating the clinical usefulness of measurements of IFX in patients maintained with IFX treatment.
背景/目的：英夫利昔单抗（IFX）在炎症性肠病（IBD）患者中，随着时间的推移，初始应答者的治疗效果往往会丧失。血清 IFX 谷浓度（TL）低与临床应答不良和结局不佳有关。维持最佳治疗性 IFX 浓度对于维持应答和获得良好的临床结局很重要。检测血清 IFX TL 有助于确定进一步的适当治疗方案。然而，儿童 IBD 中合适的治疗性 IFX TL 尚不确定。我们旨在确定与 IFX 维持治疗的实验室应答相关的 IFX TL 截断值。
回顾性调查了 2008 年 12 月至 2015 年 3 月在三星医疗中心接受 IFX 输注的患有儿童 IBD 的患者。我们分析了来自 103 名儿科患者的 239 份血样。我们通过液相传感免疫测定法在诱导（6 周和 14 周）和维持治疗期间（>22 周，间隔 8 周）测量 IFX TL。
在维持治疗期间，红细胞沉降率（ESR）与 IFX TL 之间存在显著相关性（相关系数，-0.11；p=0.0005）。使用 ESR 18mm/hr 的截断值来定义较高水平。接受者操作特征分析确定了最佳截断值：IFX TL>1.58µg/mL（敏感性 82%，特异性 73%）。
截断值被认为是进一步研究 IFX 测量在接受 IFX 治疗的患者中的临床有用性的前提。
