Post-marketing safety of lecanemab: a real-world study based on FAERS database, multicenter cohort and network pharmacology - Summary - MDSpire

Post-marketing safety of lecanemab: a real-world study based on FAERS database, multicenter cohort and network pharmacology

  • By

  • Xiaoxuan Xing

  • Ke Wang

  • Yingnan Feng

  • Chao Wu

  • Lihua Jia

  • Huiying Li

  • Zhiyong Wen

  • Yinan Tang

  • Zhizhou Wang

  • Xiaotong Zhang

  • Xiaoxi Li

  • Yiming Hua

  • Lan Zhang

  • Xianzhe Dong

  • June 22, 2026

  • 0 min

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Objective:

To analyze lecanemab-related adverse events (AEs) using the FDA Adverse Event Reporting System (FAERS) database and a multicenter cohort, and to explore mechanisms via network pharmacology.

Approach:
    Key Findings:
    • In the FAERS analysis of 2,764 AEs from 1,389 lecanemab users, 12 of 41 positive SDRs were prioritized, with 75% (9/12) being nervous system disorders, primarily amyloid-related imaging abnormalities (ARIA).
    • In the cohort study, 29.05% (43/148) of patients experienced AEs, with infusion-related reactions being most common.
    • Age was identified as a risk factor for AE occurrence [OR (95% CI): 1.109 (1.011–1.215), P = 0.028], while pre-treatment significantly reduced AE incidence.
    Interpretation:

    Limitations:
    • The study may not capture all AEs due to the voluntary nature of FAERS reporting.
    • The cohort study's retrospective design may introduce biases.
    Conclusion:

Original Source(s)

Post-marketing safety of lecanemab: a real-world study based on FAERS database, multicenter cohort and network pharmacology

  • by Xiaoxuan Xing, Ke Wang, Yingnan Feng, Chao Wu, Lihua Jia, Huiying Li, Zhiyong Wen, Yinan Tang, Zhizhou Wang, Xiaotong Zhang, Xiaoxi Li, Yiming Hua, Lan Zhang, Xianzhe Dong

  • June 22, 2026

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