来卡耐单抗在专业记忆诊所的应用。

IF 20.4 1区 医学 Q1 CLINICAL NEUROLOGY
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
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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. 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引用次数: 0

摘要

两种靶向淀粉样斑块的单克隆抗体lecanemab和donanemab已获得美国食品和药物管理局(FDA)的传统批准,用于治疗早期症状性阿尔茨海默病(AD)。与这些治疗相关的最显著不良事件是输注相关反应和淀粉样蛋白相关成像异常(ARIA),伴有水肿/积液(ARIA- e)和/或出血/含铁血黄素沉积(ARIA- h)。在临床实践中提供这些治疗的可行性和安全性尚不清楚。目的探讨来卡耐单抗治疗专业记忆门诊患者的可行性和安全性。设计、环境和参与者本研究回顾性分析了2023年8月1日至2024年10月1日在华盛顿大学记忆诊断中心(一家门诊专业记忆诊所)连续开始使用莱卡耐单抗的患者。在234例早期症状性阿尔茨海默病患者中开始使用莱卡耐单抗。资格基于FDA标签和适当的使用建议,偶尔有例外。患者接受来卡耐单抗治疗,10mg /kg,每2周静脉注射一次。主要结果和测量:评估输液相关反应、ARIA和退出治疗。结果234例lecanemab患者平均年龄74.4 (SD, 6.7)岁,其中女性117例(50%),男性117例。(50%) 87例患者(37%)发生了输液相关反应,通常是轻微的。在研究期间有ARIA风险的194例患者中,44例在开始使用莱卡耐单抗之前至少有1次微出血和/或表面性铁沉着(23%)。在平均6.5个月的治疗期间,共有42名患者(22%)发生ARIA;29例发生ARIA-E合并或不合并ARIA-H(15%), 13例发生分离ARIA-H(6.7%)。11例(5.7%)出现症状性ARIA,其中2例(1.0%)临床症状严重。没有患者发生大出血或死亡。轻度痴呆患者出现症状性ARIA的比例为27%;那些患有轻度认知障碍或非常轻度痴呆症的人有1.8%的比例。总的来说,234例患者中有23例(9.8%)因各种原因退出治疗,10例为ARIA(4.3%)。结论与相关性:一家单一专科记忆诊所在14个月内对234例患者进行了莱卡耐单抗治疗。包括ARIA在内的重大不良事件的发生频率是可控的。这些结果可以为讨论抗淀粉样蛋白治疗的风险提供信息。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Lecanemab Treatment in a Specialty Memory Clinic.
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.
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来源期刊
JAMA neurology
JAMA neurology CLINICAL NEUROLOGY-
CiteScore
41.90
自引率
1.70%
发文量
250
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.
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