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接受加速批准的 aducanumab 治疗后出现淀粉样蛋白相关影像学异常的初步经验。

Initial Experiences with Amyloid-Related Imaging Abnormalities in Patients Receiving Aducanumab Following Accelerated Approval.

机构信息

Dr. Matthew Howe, Butler Hospital Memory and Aging Program, 345 Blackstone Boulevard, Providence, RI 02906, USA, Phone: 401-455-6403, Fax: 401-455-6405, Email:

出版信息

J Prev Alzheimers Dis. 2023;10(4):765-770. doi: 10.14283/jpad.2023.96.

DOI:10.14283/jpad.2023.96
PMID:37874098
Abstract

Aducanumab is the first FDA-approved amyloid-lowering immunotherapy for Alzheimer's disease. There is little real-world data to guide management of amyloid-related imaging abnormalities (ARIA), a potentially serious side-effect which requires surveillance with magnetic resonance imaging. We report our experiences in managing ARIA in patients receiving aducanumab at the Butler Hospital Memory and Aging Program during the year following FDA approval. We followed the Appropriate Use Recommendations for aducanumab to guide patient selection, detection, and management of ARIA (1). ARIA-E occurred in 6 out of 24 participants treated; all APOE-ε4 carriers. Treatment was discontinued in 4 cases of moderate-severe ARIA-E, temporarily held in 1 moderate case, and dosed through in 1 mild case (mean duration = 3 months, range, 1-6 months). No participants required hospitalization or high dose corticosteroids. Participants on anticoagulation were excluded and no macrohemorrhages occurred. These data support the measured approaches to treatment outlined in the Appropriate Use Recommendations.

摘要

阿杜卡努单抗是首款获得美国食品药品监督管理局批准的用于治疗阿尔茨海默病的淀粉样蛋白降低免疫疗法。目前几乎没有真实世界的数据可以指导淀粉样蛋白相关成像异常(ARIA)的管理,这是一种潜在的严重副作用,需要通过磁共振成像进行监测。我们报告了在 FDA 批准后的一年中,巴特勒医院记忆和老龄化项目中接受阿杜卡努单抗治疗的患者的 ARIA 管理经验。我们遵循了阿杜卡努单抗的适当使用建议,以指导 ARIA 的患者选择、检测和管理(1)。在 24 名接受治疗的参与者中,有 6 名发生了 ARIA-E;所有的 APOE-ε4 携带者。在 4 例中停止了中度至重度 ARIA-E 的治疗,1 例中度 ARIA-E 暂时停止治疗,1 例轻度 ARIA-E 继续治疗(平均持续时间=3 个月,范围为 1-6 个月)。没有参与者需要住院治疗或使用大剂量皮质类固醇。接受抗凝治疗的参与者被排除在外,没有发生大出血。这些数据支持了适当使用建议中概述的有针对性的治疗方法。

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