Journal of neurology
Real-world safety and efficacy of lecanemab in the treatment of Alzheimer's disease: a systematic review and meta-analysis
By Wu Y, Zhu L, Chen J and 3 others.
Abstract
Background
Despite the approval of lecanemab for Alzheimer's disease (AD), evidence regarding its performance outside controlled trial settings remains scarce, leaving its real-world safety and clinical utility largely unknown.
Methods
We searched PubMed, Embase, and Web of Science (through October 1, 2026) for real-world studies of lecanemab in AD. Outcomes included ARIA, discontinuation, infusion-related reactions, serious adverse events, MMSE, MoCA, CDR-SB, and amyloid PET. Random-effects models with REML and Hartung-Knapp adjustment were used. Subgroup analyses were stratified by region, APOE ε4 genotype, baseline CDR score, microhemorrhage, and white matter hyperintensity. Sensitivity analyses included leave-one-out and Egger's test. Scenario-based sensitivity analyses were also performed for overlapping cohorts. This study was registered with PROSPERO (No. CRD420261333493).