Cheli Stefania, Savino Diego, Penagini Francesca, Zuccotti Gianvincenzo, Zuin Giovanna, Clementi Emilio, Cattaneo Dario
Unit of Clinical Pharmacology, ASST Fatebenefratelli Sacco, University Hospital, 20157 Milano, Italy.
Pediatric Department, "Vittore Buzzi" Children's Hospital, University of Milan, 20154 Milan, Italy.
Pharmaceutics. 2023 Jun 27;15(7):1834. doi: 10.3390/pharmaceutics15071834.
Therapeutic drug monitoring (TDM) is a useful tool for optimising the use of anti-TNFα inhibitors in patients with inflammatory bowel diseases (IBDs). Recently, point-of-care methods for the quantification of drug levels and anti-drug antibodies (ADAs) have been developed to overcome the limitations of conventional enzyme-linked immunoabsorbent assays (ELISAs). Here, we evaluated the performance, interchangeability, and agreement between an automated ELISA-based immunoassay (CHORUS Promonitor) and the lateral flow assay (RIDAQUICK) for the quantification of infliximab (IFX, = 65) and adalimumab (ADM, = 58) plasma levels in IBD patients. Thirty-two samples for IFX and twenty-three samples for ADM that tested positively for the presence of ADAs were also used. Overall, data analysis showed a good agreement of ADM trough concentrations (R = 0.75) between the two assays as well as for ADA measurement (K > 0.8). However, IFX levels highlighted a weak correlation (R = 0.58) between the two kits, with the RIDAQUICK assay overestimating IFX plasma values by 30% when compared to the CHORUS Promonitor kit. Results from this study show that the two assays are not quantitatively and qualitatively interchangeable due to substantial discrepancies in some results. Accordingly, the same assay should be used for the longitudinal follow-up of IBD patients.
治疗药物监测（TDM）是优化炎症性肠病（IBD）患者抗TNFα抑制剂使用的有用工具。最近，为克服传统酶联免疫吸附测定（ELISA）的局限性，已开发出用于定量药物水平和抗药物抗体（ADA）的即时检测方法。在此，我们评估了基于自动化ELISA的免疫测定（CHORUS Promonitor）和侧向流动测定（RIDAQUICK）在定量IBD患者英夫利昔单抗（IFX，n = 65）和阿达木单抗（ADM，n = 58）血浆水平方面的性能、互换性和一致性。还使用了32份IFX样本和23份ADM样本，这些样本检测出ADA呈阳性。总体而言，数据分析表明两种测定方法在ADM谷浓度（R = 0.75）以及ADA测量方面（K>0.8）具有良好的一致性。然而，IFX水平突出显示两种试剂盒之间的相关性较弱（R = 0.58），与CHORUS Promonitor试剂盒相比，RIDAQUICK测定高估了IFX血浆值30%。这项研究的结果表明，由于某些结果存在重大差异，这两种测定方法在定量和定性方面不可互换。因此，IBD患者的纵向随访应使用相同的测定方法。
