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即时检验可能有助于在使用阿达木单抗的积极策略中对炎症性肠病患者进行治疗药物监测。

Point-of-Care Assays Could Be Useful for Therapeutic Drug Monitoring of IBD Patients in a Proactive Strategy with Adalimumab.

作者信息

Cherry Mohamad, Dutzer Dominique, Nasser Yara, Berger Anne-Emmanuelle, Roblin Xavier, Paul Stephane

机构信息

Department of Immunology, CIC1408, GIMAP EA3064, University Hospital of Saint Etienne, 42055 Saint Etienne, France.

Department of Gastroenterology, University Hospital of Saint Etienne, 42055 Saint Etienne, France.

出版信息

J Clin Med. 2020 Aug 25;9(9):2739. doi: 10.3390/jcm9092739.

Abstract

The objective of the study was to evaluate whether Point-of-Care (POC) assays are equivalent to ELISAs for measuring residual trough levels of adalimumab (ADA) in a cohort of Inflammatory Bowel Disease (IBD) patients. ADA trough levels obtained by POC assays were used to optimize patients in daily clinical practice. Different assays (three ELISAs (Enzyme-Linked ImmunoSorbent Assay) from two different suppliers and two POC assays) were compared to measure ADA trough levels in a first cohort of 31 IBD patients. All assays revealed a high correlation within the assays, ranging from 0.86 to 0.99. Cut-off values were always higher with ELISAs than with POC assays. Then, a small prospective clinical study with a second cohort of 37 IBD patients was performed to compare POC assays and ELISAs for their ability to optimize patients on the basis of the measured ADA trough levels. The use of a POC assay to monitor ADA trough levels did not improve the follow-up of patients with loss of response, as they were always optimized whatever their ADA residual rate. For patients in clinical remission, a POC assay can be useful in some clinical situations to maintain or de-escalate ADA doses according to the measured trough levels. In conclusion, different assays for ADA monitoring are quite equivalent. A POC assay could be only useful for a proactive strategy for asymptomatic patients with a sub-therapeutic dose of ADA, but new therapeutic thresholds need to be identified.

摘要

本研究的目的是评估即时检验(POC)检测在测量一组炎症性肠病(IBD)患者中阿达木单抗(ADA)的残留谷浓度时是否等同于酶联免疫吸附测定(ELISA)。在日常临床实践中,通过POC检测获得的ADA谷浓度用于优化患者治疗。比较了不同的检测方法(来自两家不同供应商的三种ELISA(酶联免疫吸附测定)和两种POC检测),以测量31例IBD患者的第一个队列中的ADA谷浓度。所有检测方法在各检测之间均显示出高度相关性,范围为0.86至0.99。ELISA的临界值总是高于POC检测。然后,对37例IBD患者的第二个队列进行了一项小型前瞻性临床研究,以比较POC检测和ELISA根据测得的ADA谷浓度优化患者的能力。使用POC检测监测ADA谷浓度并不能改善对反应丧失患者的随访,因为无论他们的ADA残留率如何,他们总是得到优化。对于临床缓解的患者,POC检测在某些临床情况下可能有助于根据测得的谷浓度维持或降低ADA剂量。总之,用于ADA监测的不同检测方法相当等效。POC检测仅对ADA剂量低于治疗剂量的无症状患者的积极策略有用,但需要确定新的治疗阈值。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/614a/7565289/86ce7b754367/jcm-09-02739-g001.jpg

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