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阿仑单抗:用于治疗复发型多发性硬化症的综述。

Alemtuzumab: a review of its use in patients with relapsing multiple sclerosis.

机构信息

Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand,

出版信息

Drugs. 2014 Mar;74(4):489-504. doi: 10.1007/s40265-014-0195-7.

Abstract

Alemtuzumab (Lemtrada™) is a humanized therapeutic monoclonal antibody, which has been approved for use in patients with B-cell chronic lymphocytic leukaemia for several years, and has recently become approved in the EU and several other countries for use in adult patients with active relapsing-remitting multiple sclerosis. This article reviews the available pharmacological properties of intravenous infusions of alemtuzumab and its clinical efficacy and tolerability in adult patients with relapsing-remitting multiple sclerosis. Alemtuzumab is an effective treatment for patients with relapsing-remitting multiple sclerosis, and has a generally acceptable tolerability profile. In phase III trials, it was shown to be more effective than a current first-line treatment, subcutaneous interferon beta-1a, in decreasing relapse rate in treatment-naïve and previously treated patients and in decreasing disability progression in previously treated patients. Of note, these results appear to have extended into the long-term follow-up, despite no further treatment. There was an increased risk of autoimmunity and infection associated with alemtuzumab in these trials; while these adverse events were generally mild to moderate, some were severe. Alemtuzumab is a highly convenient treatment, requiring hospital attendance for an intravenous infusion for a handful of days on two consecutive years, with no treatment required in between; however, this convenience is counterbalanced by the need for regular monitoring for the increased risk of autoimmunity. More investigation is required before final conclusions can be drawn on the correct placement of alemtuzumab in multiple sclerosis treatment; however, it is of a certainty a welcome addition to the treatment options for these patients.

摘要

阿仑单抗(Lemtrada™)是一种人源化的治疗性单克隆抗体,已获准用于治疗 B 细胞慢性淋巴细胞白血病患者多年,最近在欧盟和其他几个国家获准用于治疗活跃的复发缓解型多发性硬化症成年患者。本文综述了静脉输注阿仑单抗的现有药理学特性及其在复发缓解型多发性硬化症成年患者中的临床疗效和耐受性。阿仑单抗是治疗复发缓解型多发性硬化症患者的有效药物,具有一般可接受的耐受性特征。在 III 期临床试验中,与当前的一线治疗药物皮下注射干扰素 β-1a 相比,它在降低治疗初治和既往治疗患者的复发率以及降低既往治疗患者的残疾进展方面更有效。值得注意的是,尽管没有进一步治疗,但这些结果似乎已经扩展到长期随访中。在这些试验中,阿仑单抗与自身免疫和感染风险增加相关;虽然这些不良事件通常为轻度至中度,但有些为重度。阿仑单抗是一种非常方便的治疗方法,需要在连续两年的两天内住院进行静脉输注治疗,两次治疗之间无需治疗;然而,这种便利性被需要定期监测以增加自身免疫风险所抵消。在对阿仑单抗在多发性硬化症治疗中的正确定位得出最终结论之前,还需要进一步研究;然而,它无疑是这些患者治疗选择的一个可喜补充。

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