克罗恩病患儿英夫利西单抗维持治疗前血药浓度与疾病转归的关系

Association between drug trough concentration and disease outcome before infliximab maintenance treatment in children with Crohn's disease

摘要:

目的 探讨维持治疗前英夫利西单抗血药浓度（infliximab trough level，IFX-TL）与克罗恩病（Crohn's disease，CD）患儿疾病转归之间的关系。 方法 回顾性选取2018年8月—2021年11月首次规律接受英夫利西单抗（infliximab，IFX）诱导治疗并于维持治疗前测定IFX-TL的35例CD患儿为研究对象，收集基线及维持治疗前的临床资料及实验室指标，分析不同转归与IFX-TL之间的关系。 结果 临床缓解组、内镜缓解组和联合缓解组IFX-TL均高于相应未缓解组，差异有统计学意义（P<0.05），生物学缓解组与未缓解组IFX-TL比较差异无统计学意义（P>0.05）。受试者工作特征曲线结果显示，IFX-TL预测临床缓解的最佳截断值为2.3 μg/mL，曲线下面积为0.959（95%CI：0.894~1，P<0.001），灵敏度为90%，特异度为100%。 结论 在接受IFX治疗的CD患儿中，维持治疗前得到临床和内镜缓解的患儿有更高的IFX-TL，IFX-TL对临床缓解有预测价值。

Abstract:

Objective To study the association between infliximab trough level (IFX-TL) prior to maintenance treatment and disease outcome in children with Crohn's disease (CD). Methods A retrospective analysis was performed on 35 children with CD who received induction therapy with infliximab (IFX) and the measurement of IFX-TL before maintenance treatment from August 2018 to November 2021. Clinical data and laboratory markers at baseline and before maintenance treatment were collected, and the association between outcome and IFX-TL was analyzed. Results The clinical remission group, endoscopic remission group, and combined remission group had a significantly higher IFX-TL level than the corresponding non-remission groups (P<0.05), and there was no significant difference in the IFX-TL level between the biological remission and non-biological remission groups (P>0.05). The receiver operating characteristic (ROC) curve showed that IFX-TL had an area under the ROC curve of 0.959 (95%CI: 0.894-1) in predicting clinical remission, with a sensitivity of 90% and a specificity of 100% at the optimal cutoff value of 2.3 μg/mL (P<0.001). Conclusions Among children with CD receiving infliximab induction therapy, the children achieving clinical and endoscopic remission before maintenance treatment tend to have a higher level of IFX-TL. IFX-TL has a certain predictive value for clinical remission.