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多发性硬化症的新型注射治疗方法。

Emerging injectable therapies for multiple sclerosis.

机构信息

Department of Neurology, Johns Hopkins University, Baltimore, MD, USA.

出版信息

Lancet Neurol. 2013 Nov;12(11):1115-26. doi: 10.1016/S1474-4422(13)70192-3. Epub 2013 Oct 1.

DOI:10.1016/S1474-4422(13)70192-3
PMID:24090587
Abstract

Available treatment options for relapsing-remitting multiple sclerosis (MS) have expanded in recent years, and several injectable therapies are under development. In this Rapid Review, we summarise emerging injectable therapies for relapsing-remitting MS, and discuss pharmacological mechanisms, clinical trials, adverse events, and use in clinical practice. Many new potential treatments for MS are at an intermediate to advanced stage of development. Alemtuzumab is a monoclonal antibody that has shown efficacy in phase 3 trials but, because of serious adverse events associated with this drug, clinical monitoring is essential. Pegylated interferon beta-1a has shown efficacy in a phase 3 trial. Daclizumab and ocrelizumab are monoclonal antibodies that have shown efficacy and acceptable safety profiles in phase 2 trials; both are under investigation in ongoing phase 3 trials. Ofatumumab is a monoclonal antibody that has shown efficacy in a small phase 2 trial. Animal models suggest that anti-LINGO1 antibody has remyelinating potential, and phase 2 trials of the antibody are underway. Further clarification of purported mechanisms of action and continued surveillance will be essential to establish the safety and clinical efficacy of these drugs in patients with relapsing-remitting MS.

摘要

近年来,复发缓解型多发性硬化症(MS)的治疗选择有所增加,并且有几种注射疗法正在开发中。在本次快速综述中,我们总结了新兴的用于复发缓解型 MS 的注射疗法,并讨论了其药理机制、临床试验、不良反应以及在临床实践中的应用。许多针对 MS 的新潜在治疗方法处于中间到后期开发阶段。阿仑单抗是一种单克隆抗体,在 3 期临床试验中显示出疗效,但由于该药物存在严重的不良反应,因此临床监测至关重要。聚乙二醇干扰素 beta-1a 在 3 期临床试验中显示出疗效。达利珠单抗和奥瑞珠单抗是在 2 期临床试验中显示出疗效和可接受安全性特征的单克隆抗体;两者都在正在进行的 3 期临床试验中进行研究。奥法妥木单抗是一种在小型 2 期试验中显示出疗效的单克隆抗体。动物模型表明,抗 LINGO1 抗体具有髓鞘再生潜力,该抗体的 2 期临床试验正在进行中。为了在复发缓解型 MS 患者中确定这些药物的安全性和临床疗效,需要进一步阐明所谓的作用机制并持续监测。

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Emerging injectable therapies for multiple sclerosis.多发性硬化症的新型注射治疗方法。
Lancet Neurol. 2013 Nov;12(11):1115-26. doi: 10.1016/S1474-4422(13)70192-3. Epub 2013 Oct 1.
2
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Daclizumab in active relapsing multiple sclerosis (CHOICE study): a phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon beta.达利珠单抗治疗活跃期复发型多发性硬化症(CHOICE 研究):一项干扰素 β 附加治疗的 2 期、随机、双盲、安慰剂对照的研究
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