Afonso Joana, de Sousa Helena Tavares, Rosa Isadora, Carvalho João, Dias Cláudia Camila, Magro Fernando
Department of Biomedicine, Unit of Pharmacology and Therapeutics, Faculty of Medicine, University of Porto, Porto, Portugal.
Gastroenterology Department, Algarve Hospital Centre, Portugal.
Therap Adv Gastroenterol. 2017 Sep;10(9):661-671. doi: 10.1177/1756283X17722915. Epub 2017 Aug 11.
The commercialization of CT-P13, an infliximab (IFX) biosimilar, has the potential to decrease health-related costs and enhance access to biological therapies. This study aimed to address the accuracy and inter-assay agreement of the CT-P13 quantification using four different assays initially developed to assess IFX.
The four different methods, one in-house method and three commercially available kits, were used to quantify exogenously-spiked samples and the sera from 185 inflammatory bowel disease (IBD) patients on CT-P13 therapy.
The quantification of the spiked samples unveiled a consistent and accurate behaviour of three of the tested methods, with average percentage recoveries of 90%, 102% and 109%. Results from the clinical samples demonstrated that these three assays were also highly correlated, both concerning Spearman's rank coefficients (range 0.890-0.947) and intraclass correlation coefficients (range 0.907-0.935). There were a few systematic deviations among them, but their impact in the clinical stratification of the patients using different cut-offs was minimal, particularly when these cut-offs were in the 3-4 µg/ml range, for which the strength of agreement (as assessed by the Kappa statistics that ranged from 0.732 to 0.902) was substantial to almost perfect.
Our results indicate that three of the tested IFX quantification methods can be used to accurately quantify CT-P13 without any adjustments.
英夫利昔单抗（IFX）生物类似药CT-P13的商业化有降低健康相关成本及增加生物疗法可及性的潜力。本研究旨在探讨使用最初为评估IFX而开发的四种不同检测方法对CT-P13进行定量的准确性和检测间一致性。
使用四种不同方法（一种内部方法和三种市售试剂盒）对外源性加标的样本以及185例接受CT-P13治疗的炎症性肠病（IBD）患者的血清进行定量。
对加标样本的定量显示，三种检测方法表现出一致且准确的结果，平均回收率分别为90%、102%和109%。临床样本的结果表明，这三种检测方法在斯皮尔曼等级系数（范围为0.890 - 0.947）和组内相关系数（范围为0.907 - 0.935）方面也高度相关。它们之间存在一些系统偏差，但在使用不同临界值对患者进行临床分层时，其影响极小，特别是当这些临界值在3 - 4 µg/ml范围内时，一致性强度（通过Kappa统计评估，范围为0.732至0.9
