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
{"title":"Experience with donanemab over a 1-year period: observations of side effects and compliance from a regional specialty medical center.","authors":"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","doi":"10.1002/dad2.70438","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>The anti-amyloid monoclonal antibody donanemab (Kisunla™) treats patients with mild cognitive impairment or mild Alzheimer's disease.</p><p><strong>Methods: </strong>This study highlights 51 patients who received at least one donanemab infusion at our memory center between October 4, 2024 and October 3, 2025.</p><p><strong>Results: </strong>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) (<i>p</i> = 0.033) and ARIA-H (<i>p</i> = 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).</p><p><strong>Discussion: </strong>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.</p>","PeriodicalId":53226,"journal":{"name":"Alzheimer''s and Dementia: Diagnosis, Assessment and Disease Monitoring","volume":"18 3","pages":"e70438"},"PeriodicalIF":4.4000,"publicationDate":"2026-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13482909/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Alzheimer''s and Dementia: Diagnosis, Assessment and Disease Monitoring","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1002/dad2.70438","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/7/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
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.
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.