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治疗复发缓解型多发性硬化症的高效达利珠单抗生产工艺

Daclizumab high-yield process in the treatment of relapsing-remitting multiple sclerosis.

作者信息

Preiningerova Jana Lizrova, Vachova Marta

机构信息

Department of Neurology and Center of Clinical Neuroscience, Charles University in Prague, 1st Faculty of Medicine and General University Hospital in Prague, Praha 2, Praha, 121 08, Czech Republic.

Department of Neurology and Center of Clinical Neuroscience, Charles University in Prague, Faculty of Medicine and General University Hospital in Prague, Praha, Czech Republic.

出版信息

Ther Adv Neurol Disord. 2017 Jan;10(1):67-75. doi: 10.1177/1756285616671887. Epub 2016 Oct 19.

DOI:10.1177/1756285616671887
PMID:28450896
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5400154/
Abstract

Daclizumab is a humanized monoclonal antibody that binds to the α subunit (CD25) of the interleukin-2 receptor and favorably modulates the immune environment in multiple sclerosis (MS). Blockage of CD25, among other effects, causes expansion and enhanced function of regulatory CD56 natural killer cells, which seems to be the leading mechanism of action in MS. Phase II and III clinical trials have demonstrated that monthly subcutaneous injections of daclizumab high yield process (DAC HYP) 150 mg in patients with relapsing MS led to a significant reduction of annualized relapse rate and decreased number of contrast-enhanced lesions on brain magnetic resonance imaging. Treatment with DAC HYP had efficacy superior to treatment with weekly injections of interferon β1a. This review summarizes the development of and clinical experience with daclizumab in MS.

摘要

达克珠单抗是一种人源化单克隆抗体,可与白细胞介素-2受体的α亚基(CD25)结合,从而对多发性硬化症(MS)的免疫环境产生有利调节作用。阻断CD25等作用可导致调节性CD56自然杀伤细胞的扩增和功能增强,这似乎是MS的主要作用机制。II期和III期临床试验表明,复发型MS患者每月皮下注射150 mg的达克珠单抗高产率工艺(DAC HYP)可显著降低年化复发率,并减少脑磁共振成像上对比增强病灶的数量。DAC HYP治疗的疗效优于每周注射干扰素β1a的治疗。本综述总结了达克珠单抗在MS中的研发情况和临床经验。

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本文引用的文献

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Safety and efficacy of daclizumab in relapsing-remitting multiple sclerosis: 3-year results from the SELECTED open-label extension study.达克珠单抗治疗复发缓解型多发性硬化症的安全性与疗效:SELECTED开放标签扩展研究的3年结果
BMC Neurol. 2016 Jul 26;16:117. doi: 10.1186/s12883-016-0635-y.
2
Cutaneous Adverse Events in the Randomized, Double-Blind, Active-Comparator DECIDE Study of Daclizumab High-Yield Process Versus Intramuscular Interferon Beta-1a in Relapsing-Remitting Multiple Sclerosis.在复发缓解型多发性硬化症中,达克珠单抗高产工艺与肌肉注射干扰素β-1a的随机、双盲、活性对照DECIDE研究中的皮肤不良事件。
Adv Ther. 2016 Jul;33(7):1231-45. doi: 10.1007/s12325-016-0353-2. Epub 2016 Jun 1.
3
Pharmacokinetics of daclizumab high-yield process with repeated administration of the clinical subcutaneous regimen in patients with relapsing-remitting multiple sclerosis.复发缓解型多发性硬化症患者中采用临床皮下给药方案重复给药的高效生产过程的达利珠单抗的药代动力学。
Clin Pharmacol. 2016 Feb 11;8:9-13. doi: 10.2147/CPAA.S98221. eCollection 2016.
4
Population Pharmacokinetics of Daclizumab High-Yield Process in Healthy Volunteers and Subjects with Multiple Sclerosis: Analysis of Phase I-III Clinical Trials.健康志愿者和多发性硬化症患者中达克珠单抗高产工艺的群体药代动力学:I-III期临床试验分析
Clin Pharmacokinet. 2016 Aug;55(8):943-55. doi: 10.1007/s40262-016-0366-7.
5
Cutaneous adverse events in multiple sclerosis patients treated with daclizumab.使用达克珠单抗治疗的多发性硬化症患者的皮肤不良事件。
Neurology. 2016 Mar 1;86(9):847-55. doi: 10.1212/WNL.0000000000002417. Epub 2016 Feb 3.
6
Daclizumab high-yield process reduced the evolution of new gadolinium-enhancing lesions to T1 black holes in patients with relapsing-remitting multiple sclerosis.在复发缓解型多发性硬化症患者中,达克珠单抗高产率工艺减少了新的钆增强病灶演变为T1低信号空洞的情况。
Eur J Neurol. 2016 Feb;23(2):412-5. doi: 10.1111/ene.12922.
7
Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis.达利珠单抗 HYP 与干扰素β-1a 治疗复发型多发性硬化症的比较。
N Engl J Med. 2015 Oct 8;373(15):1418-28. doi: 10.1056/NEJMoa1501481.
8
Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECTION): a multicentre, randomised, double-blind extension trial.达利珠单抗高产工艺治疗复发缓解型多发性硬化症(SELECTION):一项多中心、随机、双盲扩展试验。
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Daclizumab-induced adverse events in multiple organ systems in multiple sclerosis.在多发性硬化症中,达利珠单抗引起的多器官系统不良事件。
Neurology. 2014 Mar 18;82(11):984-8. doi: 10.1212/WNL.0000000000000222. Epub 2014 Feb 14.
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