Department of Medicine, University of British Columbia, Vancouver, BC, Canada.
Djavad Mowafaghian Centre for Brain Health, Vancouver, BC, Canada.
J Neurol. 2018 Nov;265(11):2494-2505. doi: 10.1007/s00415-018-8822-y. Epub 2018 Mar 10.
Alemtuzumab is a humanized anti-CD52 monoclonal antibody approved in more than 65 countries for the treatment of relapsing-remitting multiple sclerosis (RRMS). Compared with subcutaneous interferon-beta-1a, alemtuzumab significantly reduced clinical disease activity and the rate of brain volume loss, and improved disability outcomes in patients with active RRMS who were either treatment naive (CARE-MS I study) or who had an inadequate response (≥ 1 relapse after ≥ 6 months of treatment) to prior therapy (CARE-MS II study). Adverse events (AEs) associated with alemtuzumab include infusion-associated reactions, infections, and autoimmunity. The most commonly reported autoimmune AEs observed with alemtuzumab involve the thyroid gland, followed by immune thrombocytopenia and nephropathies. A monitoring program was designed and implemented to facilitate the early detection of autoimmune events to ensure timely and adequate management. The aim of this article is to provide physicians (including neurologists, general practitioners, endocrinologists, hematologists, and nephrologists who may be less familiar with the symptoms and treatment of autoimmune events), with practical real-world recommendations for the monitoring and management of autoimmunity associated with alemtuzumab treatment.
阿仑单抗是一种人源化抗 CD52 单克隆抗体,已在 65 多个国家获得批准,用于治疗复发缓解型多发性硬化症(RRMS)。与皮下注射干扰素-β-1a 相比,阿仑单抗可显著降低活跃 RRMS 患者的临床疾病活动度和脑容量损失率,并改善治疗初治(CARE-MS I 研究)或先前治疗应答不足(≥1 次复发,治疗≥6 个月后)患者的残疾结局(CARE-MS II 研究)。与阿仑单抗相关的不良反应(AE)包括输注相关反应、感染和自身免疫。阿仑单抗最常报告的自身免疫性 AE 涉及甲状腺,其次是免疫性血小板减少症和肾脏病。设计并实施了一项监测计划,以促进自身免疫事件的早期发现,确保及时和充分的管理。本文旨在为(包括可能不太熟悉自身免疫事件的症状和治疗的神经科医生、全科医生、内分泌科医生、血液科医生和肾科医生)医生提供有关阿仑单抗治疗相关自身免疫监测和管理的实用真实世界建议。