Experience with donanemab over a 1-year period: observations of side effects and compliance from a regional specialty medical center.

IF 4.4 Q1 CLINICAL NEUROLOGY
Lisa B E Shields, Hannah S Hust, Gregory E Cooper, Theresa Kluthe, Rachel N Hart, Andrew P Thaliath, Brandon C Dennis, Stephanie W Freeman, Jessica F Cain, Whoy Y Shang, Kendall M Wasz, Adam T Orr, Christopher B Shields, Shirish S Barve, Kenneth G Pugh
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引用次数: 0

Abstract

Introduction: The anti-amyloid monoclonal antibody donanemab (Kisunla™) treats patients with mild cognitive impairment or mild Alzheimer's disease.

Methods: This study highlights 51 patients who received at least one donanemab infusion at our memory center between October 4, 2024 and October 3, 2025.

Results: Of the 48 patients who underwent at least one surveillance brain MRI after starting donanemab, 10 (20.8%) had ARIA detected. ε4 carriers more frequently displayed amyloid-related imaging abnormalities (ARIA-cortical superficial hemosiderosis/microhemorrhages [ARIA-H] and/or ARIA-edema/effusion) (p = 0.033) and ARIA-H (p = 0.020) compared to ε4 non-carriers. No patients developed symptomatic ARIA. Seven (13.7%) patients experienced infusion-related side effects. Eight (15.7%) patients discontinued donanemab due to ARIA progression (5), severe infusion reactions (2), and need for anticoagulants (1).

Discussion: Donanemab may be safely used in a real-world setting with structured monitoring. ARIA was observed in 20.8% of patients in this implementation cohort. Larger-scale multicenter data are needed to benchmark rates.

donanemab在1年期间的使用经验:来自区域专业医疗中心的副作用和依从性观察。
抗淀粉样蛋白单克隆抗体donanemab (Kisunla™)用于治疗轻度认知障碍或轻度阿尔茨海默病患者。方法:本研究选取了51例在2024年10月4日至2025年10月3日期间在我们的记忆中心接受至少一次donanemab输注的患者。结果:48例患者在开始多纳单抗治疗后至少接受了一次脑MRI监测,其中10例(20.8%)检测到ARIA。与非ε4携带者相比,ε4携带者更容易出现淀粉样蛋白相关的影像学异常(aria -皮质浅表性含铁血黄素沉着/微出血[ARIA-H]和/或aria -水肿/积液)(p = 0.033)和ARIA-H (p = 0.020)。无患者出现症状性ARIA。7例(13.7%)患者出现输液相关副作用。8例(15.7%)患者因ARIA进展(5例)、严重输液反应(2例)和需要抗凝剂(1例)而停用donanemab。讨论:Donanemab可以安全地用于现实世界的结构化监测。在该实施队列中,有20.8%的患者出现ARIA。需要更大规模的多中心数据来基准费率。
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来源期刊
CiteScore
7.80
自引率
7.50%
发文量
101
审稿时长
8 weeks
期刊介绍: Alzheimer''s & Dementia: Diagnosis, Assessment & Disease Monitoring (DADM) is an open access, peer-reviewed, journal from the Alzheimer''s Association® that will publish new research that reports the discovery, development and validation of instruments, technologies, algorithms, and innovative processes. Papers will cover a range of topics interested in the early and accurate detection of individuals with memory complaints and/or among asymptomatic individuals at elevated risk for various forms of memory disorders. The expectation for published papers will be to translate fundamental knowledge about the neurobiology of the disease into practical reports that describe both the conceptual and methodological aspects of the submitted scientific inquiry. Published topics will explore the development of biomarkers, surrogate markers, and conceptual/methodological challenges. Publication priority will be given to papers that 1) describe putative surrogate markers that accurately track disease progression, 2) biomarkers that fulfill international regulatory requirements, 3) reports from large, well-characterized population-based cohorts that comprise the heterogeneity and diversity of asymptomatic individuals and 4) algorithmic development that considers multi-marker arrays (e.g., integrated-omics, genetics, biofluids, imaging, etc.) and advanced computational analytics and technologies.
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