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多发性硬化症生物制剂药物治疗中的药效监测

Drug Efficacy Monitoring in Pharmacotherapy of Multiple Sclerosis With Biological Agents.

作者信息

Caldano Marzia, Raoul William, Rispens Theo, Bertolotto Antonio

机构信息

*Neuroscience Institute Cavalieri Ottolenghi (NICO) and Neurology Department-Centro Riferimento Regionale Sclerosi Multipla (CReSM), San Luigi University Hospital, Turin, Italy; †CNRS, GICC UMR 7292, Université François-Rabelais de Tours, Tours, France; and ‡Sanquin Research and Landsteiner Laboratory, Department of Immunopathology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.

出版信息

Ther Drug Monit. 2017 Aug;39(4):350-355. doi: 10.1097/FTD.0000000000000393.

DOI:10.1097/FTD.0000000000000393
PMID:28328761
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5538300/
Abstract

Multiple sclerosis is a heterogenous disease. Although several EMA-approved disease-modifying treatments including biopharmaceuticals are available, their efficacy is limited, and a certain percentage of patients are always nonresponsive. Drug efficacy monitoring is an important tool to identify these nonresponsive patients early on. Currently, detection of antidrug antibodies and quantification of biological activity are used as methods of efficacy monitoring for interferon beta and natalizumab therapies. For natalizumab and alemtuzumab treatments, drug level quantification could be an essential component of the overall disease management. Thus, utilization and development of strategies to determine treatment response are vital aspects of multiple sclerosis management given the tremendous clinical and economic promise of this tool.

摘要

多发性硬化症是一种异质性疾病。尽管有几种欧洲药品管理局(EMA)批准的疾病修饰疗法,包括生物制药,但它们的疗效有限,总有一定比例的患者无反应。药物疗效监测是早期识别这些无反应患者的重要工具。目前,抗药物抗体检测和生物活性定量被用作干扰素β和那他珠单抗疗法疗效监测的方法。对于那他珠单抗和阿仑单抗治疗,药物水平定量可能是整体疾病管理的重要组成部分。因此,鉴于该工具巨大的临床和经济前景,确定治疗反应的策略的应用和开发是多发性硬化症管理的重要方面。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4a64/5538300/627b9b4da814/tdm-39-350-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4a64/5538300/627b9b4da814/tdm-39-350-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4a64/5538300/627b9b4da814/tdm-39-350-g002.jpg

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本文引用的文献

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The Cost of Relapsing-Remitting Multiple Sclerosis Patients Who Develop Neutralizing Antibodies during Interferon Beta Therapy.在干扰素β治疗期间产生中和抗体的复发缓解型多发性硬化症患者的治疗成本
PLoS One. 2016 Jul 8;11(7):e0159214. doi: 10.1371/journal.pone.0159214. eCollection 2016.
2
New insights into the pharmacokinetics and pharmacodynamics of natalizumab treatment for patients with multiple sclerosis, obtained from clinical and in vitro studies.从临床和体外研究中获得的关于那他珠单抗治疗多发性硬化症患者的药代动力学和药效学的新见解。
J Neuroinflammation. 2016 Jun 27;13(1):164. doi: 10.1186/s12974-016-0635-2.
3
Pharmacogenomics strategies to optimize treatments for multiple sclerosis: Insights from clinical research.
优化多发性硬化症治疗的药物基因组学策略:来自临床研究的见解
Prog Neurobiol. 2017 May;152:114-130. doi: 10.1016/j.pneurobio.2016.02.001. Epub 2016 Mar 4.
4
A Randomized Trial Evaluating Various Administration Routes of Natalizumab in Multiple Sclerosis.一项评估那他珠单抗在多发性硬化症中多种给药途径的随机试验。
J Clin Pharmacol. 2016 Oct;56(10):1254-62. doi: 10.1002/jcph.707. Epub 2016 Mar 3.
5
Clinical Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies Approved to Treat Rheumatoid Arthritis.已批准用于治疗类风湿关节炎的单克隆抗体的临床药代动力学和药效学
Clin Pharmacokinet. 2015 Nov;54(11):1107-23. doi: 10.1007/s40262-015-0296-9.
6
Socio-economic aspects of the testing for antibodies in MS-patients under interferon therapy in Austria: a cost of illness study.奥地利接受干扰素治疗的多发性硬化症患者抗体检测的社会经济层面:一项疾病成本研究。
Mult Scler Relat Disord. 2014 Nov;3(6):670-7. doi: 10.1016/j.msard.2014.09.003. Epub 2014 Sep 16.
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New FDA-Approved Disease-Modifying Therapies for Multiple Sclerosis.美国食品药品监督管理局(FDA)新批准的用于治疗多发性硬化症的疾病修正疗法
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8
Evaluation of the impact of neutralizing antibodies on IFNβ response.评估中和抗体对 IFNβ 反应的影响。
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9
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Cytokine Growth Factor Rev. 2015 Apr;26(2):241-8. doi: 10.1016/j.cytogfr.2014.12.002. Epub 2014 Dec 24.
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Cytokine Growth Factor Rev. 2015 Apr;26(2):229-39. doi: 10.1016/j.cytogfr.2014.11.005. Epub 2014 Nov 22.