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Post-marketing safety of lecanemab: a real-world study based on FAERS database, multicenter cohort and network pharmacology
Xing X, Wang K, Feng Y, Wu C, Jia L, Li H, Wen Z, Tang Y et al.. Frontiers in psychiatry, 2026-06-22
Topic: Risk, prevention and care in population studies
Plain-language summary
Introduction Lecanemab is a monoclonal antibody targeting amyloid-beta (Aβ) approved for treating Alzheimer's disease (AD) with mild cognitive impairment or mild dementia. Continuous monitoring of its real-world safety profile remains essential. This study aimed to analyze lecanemab-related adverse events (AEs) using the FDA Adverse Event Reporting System (FAERS) database and a multicenter cohort, and explored mechanisms via network pharmacology. Methods We conducted an updated disproportionality analysis of FAERS data from 2023 to 2024 to identify disproportionate reporting signals (SDRs). A multicenter retrospective cohort study was performed, including lecanemab users from June 2024 to February 2025. Data were collected from electronic medical records of five tertiary hospitals. AEs were identified and influencing factors of AE occurrence were analyzed. Additionally, a drug-gene interaction network was constructed to explore potential mechanisms. Results 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. Gene enrichment analysis suggested potential links between lecanemab-related genes and AEs. Discussion This study provides real-world evidence on the risk profile of lecanemab, highlighting the importance of continued safety monitoring. These findings may inform discussions about the risks associated with anti-amyloid treatments and warrant further confirmation in large-scale prospective studies.
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APA 7th
Xing, X., Wang, K., Feng, Y., Wu, C., Jia, L., Li, H., et al. (2026). Post-marketing safety of lecanemab: a real-world study based on FAERS database, multicenter cohort and network pharmacology. Frontiers in psychiatry. https://doi.org/10.3389/fpsyt.2026.1822543
Vancouver
Xing X, Wang K, Feng Y, Wu C, Jia L, Li H, et al. Post-marketing safety of lecanemab: a real-world study based on FAERS database, multicenter cohort and network pharmacology. Frontiers in psychiatry. 2026. doi:10.3389/fpsyt.2026.1822543. PMID: 42440762.
BibTeX
@article{xing2026-42440762,
author = {Xing, X. and Wang, K. and Feng, Y. and Wu, C. and Jia, L. and Li, H. and Wen, Z. and Tang, Y. and others},
title = {{Post-marketing safety of lecanemab: a real-world study based on FAERS database, multicenter cohort and network pharmacology}},
journal = {Frontiers in psychiatry},
year = {2026},
doi = {10.3389/fpsyt.2026.1822543},
pmid = {42440762},
url = {https://doi.org/10.3389/fpsyt.2026.1822543}
}
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Key findings
- Results 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).
- 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.
- These findings may inform discussions about the risks associated with anti-amyloid treatments and warrant further confirmation in large-scale prospective studies.
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Study details
- Study designcohort study
- Effect size29.05%
- Evidence strengthModerate
How this study scored 66/100
Published in a peer-reviewed journal, and it is a cohort study following people over time. Scored zero for sample size, studied in people and randomized / blinded because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record and multicenter collaboration, so those were left out: it earned 38 of the 58 points we could judge it on, which is 66 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Frontiers in psychiatry) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 7 / 12 | A cohort study following people over time |
| Strength of evidence | 3 / 5 | Rated “moderate” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 5 / 5 | 2026 — within 1 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomized / blinded | 0 / 2 | No randomization or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multicenter collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 42440762) |
| Free to read | 2 / 2 | Free to read |
| Points | 38 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 38 of the 58 points we could judge it on is 66 out of 100. |
| Total | 66 / 100 | — |
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