Real-world safety and efficacy of lecanemab in the treatment of Alzheimer's disease: a systematic review and meta-analysis.
Yunfeng Wu, Liuhui Zhu, Jianzhun Chen et al.
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In 30 seconds
This systematic review and meta-analysis pooled real-world studies of lecanemab treatment in people with Alzheimer’s disease, including 37 studies. The pooled incidence of any amyloid-related imaging abnormality (ARIA) was 15.1%, while symptomatic ARIA occurred in 1.3%. ARIA rates were higher among APOE ε4 homozygotes and in patients with baseline microhemorrhage. Cognitive outcomes generally showed no statistically significant changes; amyloid PET measures decreased at 6 and 12 months. Because cognitive outcomes lacked control data, the review could not establish clinical efficacy.
Key findings
- Pooled incidence was 15.1% for any ARIA and 1.3% for symptomatic ARIA.
- Any ARIA occurred in 34.1% of APOE ε4 homozygotes, compared with 14.5% of heterozygotes and 11.0% of non-carriers.
- Baseline microhemorrhage was associated with higher any ARIA (23.4% vs 11.5%) and ARIA-H (19.3% vs 4.2%).
- Cognitive outcomes generally showed no statistically significant changes; amyloid PET decreased at 6 and 12 months.
Why it matters
Real-world pooled estimates provide context for lecanemab safety beyond controlled trials, including variation in ARIA rates by APOE ε4 status and baseline microhemorrhage. The findings also distinguish changes in amyloid PET from demonstrated cognitive benefit: without control data, the observed cognitive results cannot confirm efficacy. This supports cautious interpretation of both safety estimates and clinical outcomes.
What to keep in mind
Cognitive outcomes lacked control data, preventing confirmation of efficacy. The review also notes that longer-term, cross-regional controlled studies are needed.