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A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for lecanemab
Yan L, Zhang L, Xu Z, Luo Z.. Frontiers in pharmacology, 2025-04-02
Topic: Drug trials: efficacy and safety
Recent Phase 3 clinical trials have demonstrated its ability to reduce brain amyloid-β (Aβ) load and slow cognitive decline in patients with early Alzheimer's disease (AD). However, since its approval, reports on adverse effects (AEs) associated with lecanemab have been limited. Results A total of 811 AEs reports related to lecanemab used in AD patients and 506 AEs in Non-AD patients were included. Among these, ARIA-E, ARIA-H, brain oedema and status epilepticus were associated with Important Medical Events (IMEs) for AD patients, and brain oedema, cerebral haemorrhage, cerebral microhaemorrhage, subdural haematoma, ischaemic stroke, cerebral infarction were associated with IMEs for Non-AD patients.
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APA 7th
Yan, L., Zhang, L., Xu, Z., & Luo, Z. (2025). A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for lecanemab. Frontiers in pharmacology. https://doi.org/10.3389/fphar.2025.1559447
Vancouver
Yan L, Zhang L, Xu Z, Luo Z. A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for lecanemab. Frontiers in pharmacology. 2025. doi:10.3389/fphar.2025.1559447. PMID: 40242445.
BibTeX
@article{yan2025-40242445,
author = {Yan, L. and Zhang, L. and Xu, Z. and Luo, Z.},
title = {{A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for lecanemab}},
journal = {Frontiers in pharmacology},
year = {2025},
doi = {10.3389/fphar.2025.1559447},
pmid = {40242445},
url = {https://doi.org/10.3389/fphar.2025.1559447}
}
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Key findings
- Recent Phase 3 clinical trials have demonstrated its ability to reduce brain amyloid-β (Aβ) load and slow cognitive decline in patients with early Alzheimer's disease (AD).
- However, since its approval, reports on adverse effects (AEs) associated with lecanemab have been limited.
- Results A total of 811 AEs reports related to lecanemab used in AD patients and 506 AEs in Non-AD patients were included.
- Among these, ARIA-E, ARIA-H, brain oedema and status epilepticus were associated with Important Medical Events (IMEs) for AD patients, and brain oedema, cerebral haemorrhage, cerebral microhaemorrhage, subdural haematoma, ischaemic stroke, cerebral infarction were associated with IMEs for Non-AD patients.
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Study details
- Study designclinical trial
- Participants811
- Evidence strengthLow
How this study scored 53/100
Published in a peer-reviewed journal. Scored zero for study design, effect reported and randomised / 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 multi-centre collaboration, so those were left out: it earned 31 of the 58 points we could judge it on, which is 53 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Frontiers in pharmacology) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | Design recorded as “clinical trial”, which our rubric does not rank (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 4 / 5 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 2 / 4 | 811 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 0 / 2 | No randomisation 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 |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 40242445) |
| Free to read | 2 / 2 | Free to read |
| Points | 31 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 31 of the 58 points we could judge it on is 53 out of 100. |
| Total | 53 / 100 | — |
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