Post-marketing safety of lecanemab: a real-world study based on FAERS database, multicenter cohort and network pharmacology
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By
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Xiaoxuan Xing
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Ke Wang
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Yingnan Feng
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Chao Wu
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Lihua Jia
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Huiying Li
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Zhiyong Wen
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Yinan Tang
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Zhizhou Wang
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Xiaotong Zhang
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Xiaoxi Li
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Yiming Hua
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Lan Zhang
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Xianzhe Dong
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June 22, 2026
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Clinical Scorecard: Real-World Safety Evaluation of Lecanemab: Insights from FAERS Database, Multicenter Cohort, and Network Pharmacology Analysis
At a Glance
| Category | Detail |
|---|
| Condition | Alzheimer’s Disease (AD) |
| Key Mechanisms | Monoclonal antibody targeting amyloid-beta (Aβ) |
| Target Population | Patients with mild cognitive impairment or mild dementia due to AD |
| Care Setting | Real-world clinical practice |
Key Highlights
- Lecanemab associated with 29.05% adverse events in a multicenter cohort study.
- Common AEs include infusion-related reactions and amyloid-related imaging abnormalities (ARIA).
- Age identified as a risk factor for adverse event occurrence.
- Disproportionality analysis revealed 12 significant SDRs, primarily nervous system disorders.
- Continuous monitoring of safety profile is essential.
Guideline-Based Recommendations
Diagnosis
- Monitor for cognitive decline and assess for mild cognitive impairment or mild dementia.
Management
- Consider lecanemab for eligible patients with mild cognitive impairment or mild dementia due to AD.
Monitoring & Follow-up
- Regularly assess for adverse events, particularly ARIA and infusion-related reactions.
Risks
- Significant safety risks associated with ARIA, including cerebral microhaemorrhages and cerebral macrohemorrhages.
Patient & Prescribing Data
Patients with mild cognitive impairment or mild dementia due to AD.
Pre-treatment significantly reduces the incidence of adverse events.
Clinical Best Practices
- Implement continuous safety monitoring for patients receiving lecanemab.
- Educate patients on potential adverse events, especially ARIA.
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