Robert Herpen, MA , 2025-05-14 16:42:00
Key takeaways:
- The Infusion-related reactions occurred in roughly one-third of study participants were mild to moderate in nature.
- Although 23 enrollees withdrew, no macrohemorrhages or deaths were recorded.
Treatment with lecanemab infusion was safe and generally well-tolerated within an outpatient memory clinic setting, with few infusion-related reactions and a low number of withdrawals due to adverse events.
“As anti-amyloid immunotherapies become increasingly available outside of clinical trials, there is an urgent need to understand how to use them safely and efficiently in real-world settings,” Madeline Paczynski, PA-C, MCMSc, of the Memory Diagnostic Center in the department of neurology at Washington University School of Medicine, told Healio regarding the study published in JAMA Neurology. “Our study addresses this gap by examining early safety considerations and logistical requirements in routine clinical practice.”
Data were derived from Paczynski M, et al. JAMA Neurol. 2025;doi:10.1001/jamaneurol.2025.1232.
An FDA-approved anti-amyloid infusion therapy, lecanemab (Leqembi, Eisai) is prescribed for those in the early stages of symptomatic Alzheimer’s disease. However, the treatment is associated with significant adverse events such as infusion-related reactions and amyloid-related imaging abnormalities (ARIA) with edema/effusion (ARIA-E) and/or hemorrhage/hemosiderin deposition (ARIA-H), Paczynski and colleagues wrote.
They sought to determine safety and efficacy of lecanemab infusion in a cohort of individuals within an outpatient specialty memory clinic.
Their retrospective analysis included 234 older adults (mean age, 74.4 years; 50% women) given lecanemab between August 2023 and October 2024 at Washington University’s Memory Diagnostic Center.
Participants were administered 10mg/kg IV lecanemab every 2 weeks, with monitoring ahead of the fifth, seventh and 14th infusions. They also underwent blood-based biomarker testing to confirm amyloid as well as amyloid PET scans and further testing for presence of apolipoprotein E (APOE) e4 alleles, along with baseline and follow-up MRI to detect ARIA-related abnormalities.
The study’s primary outcome was incidence of infusion-related reactions, ARIA and withdrawal from treatment.
According to results, infusion-related reactions occurred in 87 patients (37%), with reactions predominantly mild in nature. Five patients developed a serious reaction within 24 hours of administration, with three suffering a fall that required hospitalization after the first infustion.
From 194 patients at risk for ARIA, 44 (23%) had at least one confirmed microhemorrhage and/or superficial siderosis before lecanemab treatment
During an average of 6.5 months of treatment, at least one ARIA finding emerged in 42 patients (22%). Also, 29 individuals (15%) developed ARIA-E with or without ARIA-H, 13 others (6.7%) developed isolated ARIA-H and 11 (5.7%) developed symptomatic ARIA. Two of those presented with clinically severe symptoms.
A total of 23 (9.8%) enrollees withdrew from the study, 10 of those due to ARIA; however, no deaths were recorded, and participants did not develop macrohemorrhage.
“Our findings provide practical insight for clinicians implementing anti-amyloid immunotherapies, including patient selection, management of side effects and support for shared decision making,” Paczynski said. “This work helps to bridge the gap between research settings and real-world care delivery.”
For more information:
Madeline Paczynski, PA-C, MCMSc, can be reached at: mpaczynski@wustl.edu.
