加速批准后接受Aducanumab的患者淀粉样蛋白相关影像学异常的初步经验

IF 8.5 3区 医学 Q1 CLINICAL NEUROLOGY Jpad-Journal of Prevention of Alzheimers Disease Pub Date : 2023-08-07 DOI:10.14283/jpad.2023.96
Matthew D. Howe, K. J. Britton, H. E. Joyce, G. J. Pappas, M. A. Faust, B. C. Dawson, M. C. Riddle, S. P. Salloway
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引用次数: 0

摘要

Aducanumab是fda批准的首个用于阿尔茨海默病的降低淀粉样蛋白免疫疗法。淀粉样蛋白相关成像异常(ARIA)是一种潜在的严重副作用,需要进行磁共振成像监测,目前很少有实际数据来指导治疗。我们报告在FDA批准后的一年中,我们在Butler医院记忆和衰老项目中接受aducanumab的患者中管理ARIA的经验。我们遵循aducanumab的适当使用建议来指导患者对ARIA的选择、检测和管理(1)。在接受治疗的24名参与者中,有6名出现ARIA- e;所有APOE-ε4携带者。4例中重度ARIA-E患者停止治疗,1例中度患者暂时停止治疗,1例轻度患者停止治疗(平均持续时间为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。接受抗凝治疗的受试者被排除在外,未发生大出血。这些数据支持《适当使用建议》中概述的可衡量的治疗方法。
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Initial Experiences with Amyloid-Related Imaging Abnormalities in Patients Receiving Aducanumab Following Accelerated Approval
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.
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来源期刊
自引率
7.80%
发文量
85
期刊介绍: The JPAD « Journal of Prevention of Alzheimer’Disease » will publish reviews, original research articles and short reports to improve our knowledge in the field of Alzheimer prevention including : neurosciences, biomarkers, imaging, epidemiology, public health, physical cognitive exercise, nutrition, risk and protective factors, drug development, trials design, and heath economic outcomes. JPAD will publish also the meeting abstracts from Clinical Trial on Alzheimer Disease (CTAD) and will be distributed both in paper and online version worldwide.
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