Interim analysis of all-case post-marketing surveillance study in Japan: lecanemab in patients with early Alzheimer's disease - PubMed
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- #Alzheimer's disease
- #Post-marketing surveillance
- #Lecanemab
- Interim analysis of a post-marketing surveillance study in Japan for lecanemab in early Alzheimer's disease patients.
- Lecanemab is a monoclonal antibody targeting amyloid-beta protofibrils for mild cognitive impairment and mild dementia due to Alzheimer's.
- Study focuses on amyloid-related imaging abnormalities (ARIAs) and infusion-related reactions within 28 weeks of treatment initiation.
- Data from 2672 patients showed a median age of 76.0 years, with 62.6% diagnosed with MCI.
- At Week 28, 7.3% discontinued treatment; ARIA observed in 7.1%, ARIA-E in 3.0%, and ARIA-H in 5.2% of patients.
- Infusion-related reactions occurred in 17.0% of patients, with 0.7% being serious cases.
- Highest ARIA incidence was in patients with APOE ε4 homozygotes.
- Findings align with clinical trial trends regarding ARIA distributions and infusion-related reactions.