影响儿童炎症性肠病人群中英夫利昔单抗生物类似药谷浓度的因素。

Factors that influence infliximab biosimilar trough levels in the pediatric inflammatory bowel disease population.

机构信息

Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood "G. Barresi", University of Messina, Messina, Italy.

Statistical and Mathematical Sciences Unit, Department of Economics, University of Messina, Messina, Italy.

出版信息

Expert Rev Clin Immunol. 2024 Feb;20(2):237-244. doi: 10.1080/1744666X.2023.2284226. Epub 2024 Jan 21.

DOI:10.1080/1744666X.2023.2284226

PMID:37962991

Abstract

BACKGROUND

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).

RESEARCH DESIGN AND METHODS

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 4 and 6 infusions and correlated with several covariates.

RESULTS

A total of 110 TLs in 55 children were included. The multivariate linear regression model at the 4 infusion found a positive correlation between TLs and age at diagnosis (B:1.950, 95% CI: [0.019, 3.882], = 0.048) and IFX-BioS dose/kg (B:1.962, 95% CI: [0.238, 3.687], = 0.029), and a negative correlation with clinical scores (B:-0.401, 95% CI: [-0.738, -0.064], = 0.023). At the 6 infusion, female gender (B:6.887, 95% CI: [0.861, 12.913], = 0.029), hemoglobin (B:1.853, 95% CI: [0.501, 3.204], = 0.011), and IFX-BioS dose/kg (B:1.792, 95% CI: [0.979, 2.605], < 0.001) were found to be positively correlated to TLs. No association between combined clinical and biochemical remission and TLs was found.

CONCLUSIONS

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

背景

生物类似物英夫利昔单抗（IFX-BioS）在儿科炎症性肠病（IBD）中的药代动力学和药效动力学研究甚少。本研究旨在探讨预测 IFX-BioS 谷浓度（TLs）的因素。

研究设计与方法

本前瞻性观察研究纳入了 2021 年 1 月至 2022 年 6 月有指征开始使用 IFX-BioS 的 IBD 患儿。在第 4 和第 6 次输注时测量 TLs，并与多个协变量相关联。

结果

共纳入 55 例患儿的 110 个 TLs。第 4 次输注的多元线性回归模型发现，TLs 与诊断时年龄（B：1.950，95%CI：[0.019，3.882]，=0.048）和 IFX-BioS 剂量/kg（B：1.962，95%CI：[0.238，3.687]，=0.029）呈正相关，与临床评分（B：-0.401，95%CI：[-0.738，-0.064]，=0.023）呈负相关。第 6 次输注时，女性（B：6.887，95%CI：[0.861，12.913]，=0.029）、血红蛋白（B：1.853，95%CI：[0.501，3.204]，=0.011）和 IFX-BioS 剂量/kg（B：1.792，95%CI：[0.979，2.605]，<0.001）与 TLs 呈正相关。未发现联合临床和生化缓解与 TLs 之间存在关联。