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阿仑单抗:复发缓解型多发性硬化症治疗中的疗效与风险综述

Alemtuzumab: a review of efficacy and risks in the treatment of relapsing remitting multiple sclerosis.

作者信息

Guarnera Cristina, Bramanti Placido, Mazzon Emanuela

机构信息

Experimental Neurology Laboratory, IRCCS Centro Neurolesi "Bonino-Pulejo", Via Provinciale Palermo, Contrada Casazza, Messina, Italy.

出版信息

Ther Clin Risk Manag. 2017 Jul 14;13:871-879. doi: 10.2147/TCRM.S134398. eCollection 2017.

Abstract

Alemtuzumab is a selective humanized monoclonal antibody directed against the CD52 antigen, and has been found to be a powerful treatment for relapsing remitting multiple sclerosis. Alemtuzumab demonstrated high efficacy in several clinical studies. The risk of relapse and sustained accumulation of disability showed significant reduction in the Phase II CAMMS223 and the Phase III clinical trials CARE MS I and CARE MS II. The data presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis confirmed these results. After completion of a 1-year treatment cycle, alemtuzumab showed a sustained effect. Although the efficacy of alemtuzumab has been widely proven, several severe adverse effects have been reported with its use. Infusion-associated reactions, increased risk of infections, and secondary autoimmunity have been associated with alemtuzumab. Autoimmune disease - mainly of the thyroid - has been reported. Immune thrombocytopenic purpura and autoimmune nephropathies have been observed less frequently. These adverse effects, given the short period of alemtuzumab marketing for relapsing remitting multiple sclerosis, require strict monitoring.

摘要

阿仑单抗是一种针对CD52抗原的选择性人源化单克隆抗体,已被发现是复发缓解型多发性硬化症的一种有效治疗方法。阿仑单抗在多项临床研究中显示出高效性。在II期CAMMS223试验以及III期临床试验CARE MS I和CARE MS II中,复发风险和残疾的持续累积均显著降低。在第32届欧洲多发性硬化症治疗与研究委员会大会上公布的数据证实了这些结果。在完成1年的治疗周期后,阿仑单抗显示出持续的疗效。尽管阿仑单抗的疗效已得到广泛证实,但其使用也报告了一些严重的不良反应。输注相关反应、感染风险增加以及继发性自身免疫都与阿仑单抗有关。已报告了自身免疫性疾病——主要是甲状腺疾病。免疫性血小板减少性紫癜和自身免疫性肾病的观察频率较低。鉴于阿仑单抗用于复发缓解型多发性硬化症的上市时间较短,这些不良反应需要严格监测。

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