Madeline Paczynski,Anna Hofmann,Zachary Posey,Maren Gregersen,Michelle Rudman,Dawn Ellington,Melissa Aldinger,Erik S Musiek,David M Holtzman,Randall J Bateman,Justin M Long,Nupur Ghoshal,David B Carr,Alan Dow,Sheyda Namazie-Kummer,Nayid Jana,Chengjie Xiong,John C Morris,Tammie L S Benzinger,Suzanne E Schindler,B Joy Snider
{"title":"来卡耐单抗在专业记忆诊所的应用。","authors":"Madeline Paczynski,Anna Hofmann,Zachary Posey,Maren Gregersen,Michelle Rudman,Dawn Ellington,Melissa Aldinger,Erik S Musiek,David M Holtzman,Randall J Bateman,Justin M Long,Nupur Ghoshal,David B Carr,Alan Dow,Sheyda Namazie-Kummer,Nayid Jana,Chengjie Xiong,John C Morris,Tammie L S Benzinger,Suzanne E Schindler,B Joy Snider","doi":"10.1001/jamaneurol.2025.1232","DOIUrl":null,"url":null,"abstract":"Importance\r\nTwo monoclonal antibodies targeting amyloid plaques, lecanemab and donanemab, have received traditional US Food and Drug Administration (FDA) approval for the treatment of early symptomatic Alzheimer disease (AD). The most significant adverse events associated with these therapies are infusion-related reactions and amyloid-related imaging abnormalities (ARIA) with edema/effusion (ARIA-E) and/or hemorrhage/hemosiderin deposition (ARIA-H). The feasibility and safety of providing these treatments in clinical practice is unclear.\r\n\r\nObjective\r\nTo examine the feasibility and safety of treating patients in specialty memory clinics with lecanemab.\r\n\r\nDesign, Setting, and Participants\r\nThis retrospective analysis of consecutive patients in whom lecanemab was initiated between August 1, 2023, and October 1, 2024, at Washington University Memory Diagnostic Center, an outpatient specialty memory clinic. Lecanemab was initiated in 234 patients with early symptomatic AD. Eligibility was based on the FDA label and appropriate use recommendations with occasional exceptions.\r\n\r\nExposure\r\nPatients were treated with lecanemab, 10 mg/kg, intravenously every 2 weeks.\r\n\r\nMain Outcomes and Measures\r\nInfusion-related reactions, ARIA, and withdrawal from treatment were assessed.\r\n\r\nResults\r\nThe 234 patients treated with lecanemab had a mean age of 74.4 (SD, 6.7) years, 117 were female (50%), and 117 were male. (50%) Infusion-related reactions occurred in 87 patients (37%) and were typically mild. Of the 194 patients at risk for ARIA during the study period, 44 had at least 1 microhemorrhage and/or superficial siderosis before initiation of lecanemab (23%). Over an average treatment period of 6.5 months, 42 total patients (22%) developed ARIA; 29 developed ARIA-E with or without ARIA-H (15%) and 13 developed isolated ARIA-H (6.7%). Eleven patients (5.7%) developed symptomatic ARIA, 2 of those patients (1.0%) with clinically severe symptoms. No patients developed a macrohemorrhage or died. Patients with mild dementia had a 27% rate of symptomatic ARIA; those with mild cognitive impairment or very mild dementia had a 1.8% rate. Overall, 23 of 234 patients (9.8%) withdrew from treatment for various reasons, 10 for ARIA (4.3%).\r\n\r\nConclusions and Relevance\r\nA single-specialty memory clinic initiated lecanemab treatment in 234 patients over 14 months. The frequency of significant adverse events, including ARIA, was manageable. These results may inform discussions about the risks of anti-amyloid treatments.","PeriodicalId":14677,"journal":{"name":"JAMA neurology","volume":"13 1","pages":""},"PeriodicalIF":20.4000,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Lecanemab Treatment in a Specialty Memory Clinic.\",\"authors\":\"Madeline Paczynski,Anna Hofmann,Zachary Posey,Maren Gregersen,Michelle Rudman,Dawn Ellington,Melissa Aldinger,Erik S Musiek,David M Holtzman,Randall J Bateman,Justin M Long,Nupur Ghoshal,David B Carr,Alan Dow,Sheyda Namazie-Kummer,Nayid Jana,Chengjie Xiong,John C Morris,Tammie L S Benzinger,Suzanne E Schindler,B Joy Snider\",\"doi\":\"10.1001/jamaneurol.2025.1232\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Importance\\r\\nTwo monoclonal antibodies targeting amyloid plaques, lecanemab and donanemab, have received traditional US Food and Drug Administration (FDA) approval for the treatment of early symptomatic Alzheimer disease (AD). The most significant adverse events associated with these therapies are infusion-related reactions and amyloid-related imaging abnormalities (ARIA) with edema/effusion (ARIA-E) and/or hemorrhage/hemosiderin deposition (ARIA-H). The feasibility and safety of providing these treatments in clinical practice is unclear.\\r\\n\\r\\nObjective\\r\\nTo examine the feasibility and safety of treating patients in specialty memory clinics with lecanemab.\\r\\n\\r\\nDesign, Setting, and Participants\\r\\nThis retrospective analysis of consecutive patients in whom lecanemab was initiated between August 1, 2023, and October 1, 2024, at Washington University Memory Diagnostic Center, an outpatient specialty memory clinic. Lecanemab was initiated in 234 patients with early symptomatic AD. Eligibility was based on the FDA label and appropriate use recommendations with occasional exceptions.\\r\\n\\r\\nExposure\\r\\nPatients were treated with lecanemab, 10 mg/kg, intravenously every 2 weeks.\\r\\n\\r\\nMain Outcomes and Measures\\r\\nInfusion-related reactions, ARIA, and withdrawal from treatment were assessed.\\r\\n\\r\\nResults\\r\\nThe 234 patients treated with lecanemab had a mean age of 74.4 (SD, 6.7) years, 117 were female (50%), and 117 were male. (50%) Infusion-related reactions occurred in 87 patients (37%) and were typically mild. Of the 194 patients at risk for ARIA during the study period, 44 had at least 1 microhemorrhage and/or superficial siderosis before initiation of lecanemab (23%). Over an average treatment period of 6.5 months, 42 total patients (22%) developed ARIA; 29 developed ARIA-E with or without ARIA-H (15%) and 13 developed isolated ARIA-H (6.7%). Eleven patients (5.7%) developed symptomatic ARIA, 2 of those patients (1.0%) with clinically severe symptoms. No patients developed a macrohemorrhage or died. Patients with mild dementia had a 27% rate of symptomatic ARIA; those with mild cognitive impairment or very mild dementia had a 1.8% rate. Overall, 23 of 234 patients (9.8%) withdrew from treatment for various reasons, 10 for ARIA (4.3%).\\r\\n\\r\\nConclusions and Relevance\\r\\nA single-specialty memory clinic initiated lecanemab treatment in 234 patients over 14 months. The frequency of significant adverse events, including ARIA, was manageable. These results may inform discussions about the risks of anti-amyloid treatments.\",\"PeriodicalId\":14677,\"journal\":{\"name\":\"JAMA neurology\",\"volume\":\"13 1\",\"pages\":\"\"},\"PeriodicalIF\":20.4000,\"publicationDate\":\"2025-05-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JAMA neurology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1001/jamaneurol.2025.1232\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JAMA neurology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1001/jamaneurol.2025.1232","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Importance
Two monoclonal antibodies targeting amyloid plaques, lecanemab and donanemab, have received traditional US Food and Drug Administration (FDA) approval for the treatment of early symptomatic Alzheimer disease (AD). The most significant adverse events associated with these therapies are infusion-related reactions and amyloid-related imaging abnormalities (ARIA) with edema/effusion (ARIA-E) and/or hemorrhage/hemosiderin deposition (ARIA-H). The feasibility and safety of providing these treatments in clinical practice is unclear.
Objective
To examine the feasibility and safety of treating patients in specialty memory clinics with lecanemab.
Design, Setting, and Participants
This retrospective analysis of consecutive patients in whom lecanemab was initiated between August 1, 2023, and October 1, 2024, at Washington University Memory Diagnostic Center, an outpatient specialty memory clinic. Lecanemab was initiated in 234 patients with early symptomatic AD. Eligibility was based on the FDA label and appropriate use recommendations with occasional exceptions.
Exposure
Patients were treated with lecanemab, 10 mg/kg, intravenously every 2 weeks.
Main Outcomes and Measures
Infusion-related reactions, ARIA, and withdrawal from treatment were assessed.
Results
The 234 patients treated with lecanemab had a mean age of 74.4 (SD, 6.7) years, 117 were female (50%), and 117 were male. (50%) Infusion-related reactions occurred in 87 patients (37%) and were typically mild. Of the 194 patients at risk for ARIA during the study period, 44 had at least 1 microhemorrhage and/or superficial siderosis before initiation of lecanemab (23%). Over an average treatment period of 6.5 months, 42 total patients (22%) developed ARIA; 29 developed ARIA-E with or without ARIA-H (15%) and 13 developed isolated ARIA-H (6.7%). Eleven patients (5.7%) developed symptomatic ARIA, 2 of those patients (1.0%) with clinically severe symptoms. No patients developed a macrohemorrhage or died. Patients with mild dementia had a 27% rate of symptomatic ARIA; those with mild cognitive impairment or very mild dementia had a 1.8% rate. Overall, 23 of 234 patients (9.8%) withdrew from treatment for various reasons, 10 for ARIA (4.3%).
Conclusions and Relevance
A single-specialty memory clinic initiated lecanemab treatment in 234 patients over 14 months. The frequency of significant adverse events, including ARIA, was manageable. These results may inform discussions about the risks of anti-amyloid treatments.
期刊介绍:
JAMA Neurology is an international peer-reviewed journal for physicians caring for people with neurologic disorders and those interested in the structure and function of the normal and diseased nervous system. The Archives of Neurology & Psychiatry began publication in 1919 and, in 1959, became 2 separate journals: Archives of Neurology and Archives of General Psychiatry. In 2013, their names changed to JAMA Neurology and JAMA Psychiatry, respectively. JAMA Neurology is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications.