治疗早期阿尔茨海默病的新药仑卡奈单抗(lecanemab)

A New Drug for Early Alzheimer's Disease:Lecanemab

仑卡奈单抗(lecanemab)是一种人源化单克隆抗体,美国食品药品监督管理局于2023年1月6日批准其上市,用于治疗伴有轻度认知功能障碍或轻度痴呆的早期阿尔茨海默病(AD)。目前,该药在我国也处于申请上市状态。仑卡奈单抗对致病性β淀粉样蛋白(Aβ)原纤维具有高度亲和力,与之结合后可通过小胶质细胞途径清除脑内Aβ,从而发挥治疗作用。验证性Ⅲ期临床试验Clarity AD结果提示,仑卡奈单抗的临床疗效达到了主要临床终点和所有关键次要临床终点。仑卡奈单抗在AD受试者中具有良好的耐受性,输注相关反应为仑卡奈单抗最常见的不良事件,但在临床应用过程中仍需对淀粉样蛋白相关成像异常(ARIA)所引起的不良反应予以关注。此外,还开展了多项仑卡奈单抗的开放标签的长期临床试验,可为其临床合理应用带来更多的数据支持。

Lecanemab is a humanized monoclonal antibody approved by the US Food and Drug Administration(FDA)on January 6,2023 for treating early Alzheimer's disease(AD)with mild cognitive impairment or mild dementia.The drug is currently in the application stage for marketing in China.Lecanemab has a high affinity for pathogenic amyloidβprotein(Aβ)fibrils and induces a therapeutic effect by clearing Aβfrom the brain through the microglial pathway after binding.In the confirmatory phaseⅢclinical trial Clarity AD,lecanemab successfully achieved the primary endpoint and all key secondary endpoints.Lecanemab was well tolerated in AD patients,and infusion-related adverse events were the most common adverse events with lecanemab.However,adverse reactions due to amyloid-related imaging abnormalities(ARIA)should be of interest in clinic.In addition,multiple open-label long-term clinical trials have been conducted,which will provide additional data support for rational clinical applications.