Abstract：
The pharmacokinetics and pharmacodynamics of biosimilar infliximab (IFX-BioS) in pediatric inflammatory bowel disease (IBD) are poorly investigated. The aim of this study was to investigate factors predicting IFX-BioS trough levels (TLs).
IBD children with an indication to start IFX-BioS were included in this prospective observational study (January 2021-June 2022). TLs were measured at the 4th and 6th infusions and correlated with several covariates.
A total of 110 TLs in 55 children were included. The multivariate linear regression model at the 4th infusion found a positive correlation between TLs and age at diagnosis (B:1.950, 95% CI: [0.019, 3.882], p = 0.048) and IFX-BioS dose/kg (B:1.962, 95% CI: [0.238, 3.687], p = 0.029), and a negative correlation with clinical scores (B:-0.401, 95% CI: [-0.738, -0.064], p = 0.023). At the 6th infusion, female gender (B:6.887, 95% CI: [0.861, 12.913], p = 0.029), hemoglobin (B:1.853, 95% CI: [0.501, 3.204], p = 0.011), and IFX-BioS dose/kg (B:1.792, 95% CI: [0.979, 2.605], p < 0.001) were found to be positively correlated to TLs. No association between combined clinical and biochemical remission and TLs was found.
This study discovered some predictors for IFX-BioS TLs in IBD children. Knowledge of predictive factors could help physicians choose the best dosing regimen.
IBD children with an indication to start IFX-BioS were included in this prospective observational study (January 2021-June 2022). TLs were measured at the 4th and 6th infusions and correlated with several covariates.
A total of 110 TLs in 55 children were included. The multivariate linear regression model at the 4th infusion found a positive correlation between TLs and age at diagnosis (B:1.950, 95% CI: [0.019, 3.882], p = 0.048) and IFX-BioS dose/kg (B:1.962, 95% CI: [0.238, 3.687], p = 0.029), and a negative correlation with clinical scores (B:-0.401, 95% CI: [-0.738, -0.064], p = 0.023). At the 6th infusion, female gender (B:6.887, 95% CI: [0.861, 12.913], p = 0.029), hemoglobin (B:1.853, 95% CI: [0.501, 3.204], p = 0.011), and IFX-BioS dose/kg (B:1.792, 95% CI: [0.979, 2.605], p < 0.001) were found to be positively correlated to TLs. No association between combined clinical and biochemical remission and TLs was found.
This study discovered some predictors for IFX-BioS TLs in IBD children. Knowledge of predictive factors could help physicians choose the best dosing regimen.
摘要：
在小儿炎症性肠病(IBD)中生物仿制药英夫利昔单抗(IFX-BioS)的药代动力学和药效学研究甚少。这项研究的目的是调查预测IFX-BioS谷水平（TLs）的因素。
■有开始IFX-BioS指征的IBD儿童被纳入这项前瞻性观察研究（2021年1月至2022年6月）。在第4次和第6次输注时测量TLs，并与几个协变量相关。
■共纳入55名儿童的110个TLs。第4次输注时的多元线性回归模型发现TLs与诊断时的年龄呈正相关(B:1.950,95%CI:[0.019,3.882],p=0.048）和IFX-BioS剂量/kg（B：1.962，95％CI：[0.238，3.687]，p=0.029),与临床评分呈负相关(B：-0.401，95%CI：[-0.738，-0.064]，p=0.023)。在第6次输液时,女性（B：6.887，95%CI：[0.861，12.913]，p=0.029),血红蛋白（B：1.853，95%CI：[0.501，3.204]，p=0.011),和IFX-BioS剂量/kg（B：1.792，95%CI：[0.979，2.605]，p<0.001)与TLs呈正相关。没有发现联合临床和生化缓解与TLs之间的关联。
■这项研究发现了IBD儿童IFX-BioSTLs的一些预测因子。预测因素的知识可以帮助医生选择最佳的给药方案。
■有开始IFX-BioS指征的IBD儿童被纳入这项前瞻性观察研究（2021年1月至2022年6月）。在第4次和第6次输注时测量TLs，并与几个协变量相关。
■共纳入55名儿童的110个TLs。第4次输注时的多元线性回归模型发现TLs与诊断时的年龄呈正相关(B:1.950,95%CI:[0.019,3.882],p=0.048）和IFX-BioS剂量/kg（B：1.962，95％CI：[0.238，3.687]，p=0.029),与临床评分呈负相关(B：-0.401，95%CI：[-0.738，-0.064]，p=0.023)。在第6次输液时,女性（B：6.887，95%CI：[0.861，12.913]，p=0.029),血红蛋白（B：1.853，95%CI：[0.501，3.204]，p=0.011),和IFX-BioS剂量/kg（B：1.792，95%CI：[0.979，2.605]，p<0.001)与TLs呈正相关。没有发现联合临床和生化缓解与TLs之间的关联。
■这项研究发现了IBD儿童IFX-BioSTLs的一些预测因子。预测因素的知识可以帮助医生选择最佳的给药方案。
