使用三种不同技术在 RA 应答患者队列中检测抗阿达木单抗抗体。

Detection of anti-adalimumab antibodies in a RA responsive cohort of patients using three different techniques.

机构信息

Laboratory of Peptide and Protein Chemistry and Biology, PeptLab, Italy; Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmaceutical Sciences and Nutraceutics, University of Florence, Via Ugo Schiff 6, I-50019, Sesto Fiorentino, Italy. Electronic address: https://www.peptlab.eu.

Experimental Laboratory of Immunorheumatologic Researches, IRCCS Istituto Auxologico Italiano, Milan, Italy.

出版信息

Anal Biochem. 2019 Feb 1;566:133-138. doi: 10.1016/j.ab.2018.11.018. Epub 2018 Nov 22.

DOI:10.1016/j.ab.2018.11.018

PMID:30471243

Abstract

Reliable monitoring of clinical relevant anti-drug antibodies is fundamental in the follow-up of patients under adalimumab treatment. The aim of this study is to compare anti-adalimumab antibodies by using three methods based on different technologies. A cross-sectional study was performed in 50 patients with rheumatoid arthritis (RA) treated with adalimumab. Anti-adalimumab antibodies were detected in patients' sera by different techniques: bridging ELISA, reporter gene assay (RGA), and surface plasmon resonance (SPR). Results showed that all methods recognized anti-adalimumab antibodies and the percentage of positives fluctuated among the assays. Five (10%) of the 50 patients were positive in ELISA, 4 (8%) in RGA, and 6 (12%) in SPR. Among positive patients, 4 were positive in the three assays, one patient uniquely in ELISA, and two in SPR. Spearman correlation between ELISA and RGA showed good agreement (Spearman r = 0.800). No correlation between RGA and SPR was observed (Spearman r = 0.108). Similar results were obtained between ELISA and SPR (Spearman r = - 0.241). Summarizing, ELISA, RGA and SPR recognized anti-adalimumab antibodies in few RA patients, showing good agreement among the methodology employed. On the other hand, differences observed between SPR and ELISA or RGA highlight the relevance of the employed technologies in anti-drug antibody identification.

摘要

可靠地监测针对阿达木单抗的临床相关抗体，是接受阿达木单抗治疗的患者随访中的基础。本研究旨在比较三种基于不同技术的方法检测抗阿达木单抗抗体的结果。本研究为横断面研究，共纳入 50 例接受阿达木单抗治疗的类风湿关节炎患者。采用不同技术：桥接酶联免疫吸附测定法（ELISA）、报告基因分析（RGA）和表面等离子体共振（SPR），检测患者血清中的抗阿达木单抗抗体。结果显示，所有方法均能识别抗阿达木单抗抗体，且各检测方法的阳性率有所波动。在 50 例患者中，ELISA 阳性 5 例（10%），RGA 阳性 4 例（8%），SPR 阳性 6 例（12%）。在阳性患者中，有 4 例在三种检测方法中均呈阳性，1 例仅在 ELISA 中呈阳性，2 例仅在 SPR 中呈阳性。ELISA 与 RGA 之间的 Spearman 相关性显示出良好的一致性（Spearman r=0.800）。然而，RGA 与 SPR 之间无相关性（Spearman r=0.108）。ELISA 与 SPR 之间也得到了相似的结果（Spearman r=-0.241）。总结来说，ELISA、RGA 和 SPR 在少数 RA 患者中识别出了抗阿达木单抗抗体，所采用的方法之间具有良好的一致性。另一方面，SPR 与 ELISA 或 RGA 之间的差异突出了所采用技术在抗药物抗体鉴定中的相关性。