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Comparison of safety of lecanemab and aducanumab: a real-world disproportionality analysis using the FDA adverse event reporting system
Kong L, Yang X, Xu J.. Frontiers in pharmacology, 2025-05-30
Topic: Drug trials: efficacy and safety
Objective Studies on anti-Aβ drugs for the treatment of Alzheimer's disease (AD) have garnered significant attention; however, their safety still requires further research and monitoring. Although recent studies have analyzed the adverse drug events (ADEs) of lecanemab and aducanumab separately, there is a lack of comparison between these two drugs, and no exploration of gender differences. This study aims to compare the adverse reaction signals of lecanemab and aducanumab, also exploring the differences between genders. Research design and methods We analyzed ADEs reported by patients using lecanemab and aducanumab, using the FDA adverse event reporting system (FAERS). The data was classified using the preferred terms (PTs) and systemic organ categories (SOCs). Four positive signal detection algorithms were used, namely, the Ratio-to-Ratio (ROR), proportional reporting ratio (PRR), multi item gamma poisson shrinker (MGPS), and bayesian belief propagation neural network (BCPNN). Additionally, the time-to-onset of ADEs was also compared between the two drugs and between male and female patients. Results A total of 1,409 ADE reports in which an anti-Aβ antibody drug was primarily suspected were included in the study, comprising 892 cases (63.31%) of lecanemab and 517 cases (36.69%) of aducanumab. For both lecanemab and aducanumab, only the SOC 'nervous system disorders' met the criteria for positive signal for all four algorithms. The number of positive PT signals related to lecanemab and aducanumab was 40 and 33, respectively. Among them, "cerebral microbleeds," "amyloid protein related imaging abnormalities (ARIA)," and "central nervous system superficial squamous cell hyperplasia" all exhibited strong signals, regardless of drug or sex of the patient. Additionally, there were some differences in PT signals between male and female patients, and some new PT signals that were not included in the drug labels were identified. The median time-to-onset of lecanemab was shorter than that of aducanumab (33 days vs. 146 days). Conclusion Four signal calculation methods were used to assess potential adverse reaction signals of lecanemab and aducanumab. This study identified some new PT signals and some PT signals showed gender differences. The median time-to-onset of ADEs due to lecanemab is shorter than that due to aducanumab.
Key findings
- Objective Studies on anti-Aβ drugs for the treatment of Alzheimer's disease (AD) have garnered significant attention; however, their safety still requires further research and monitoring.
- Results A total of 1,409 ADE reports in which an anti-Aβ antibody drug was primarily suspected were included in the study, comprising 892 cases (63.31%) of lecanemab and 517 cases (36.69%) of aducanumab.
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Study details
- Participants1,409
- Effect size63.31%; 36.69%
- Evidence strengthLow
How this study scored 59/100
Published in a peer-reviewed journal. Scored zero for study design 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 34 of the 58 points we could judge it on, which is 59 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 | No study design recorded — scores zero, not guessed (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 | 3 / 4 | 1,409 participants |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| 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 40520157) |
| Free to read | 2 / 2 | Free to read |
| Points | 34 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 34 of the 58 points we could judge it on is 59 out of 100. |
| Total | 59 / 100 | — |
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APA 7th
Kong, L., Yang, X., & Xu, J. (2025). Comparison of safety of lecanemab and aducanumab: a real-world disproportionality analysis using the FDA adverse event reporting system. Frontiers in pharmacology. https://doi.org/10.3389/fphar.2025.1593989
Vancouver
Kong L, Yang X, Xu J. Comparison of safety of lecanemab and aducanumab: a real-world disproportionality analysis using the FDA adverse event reporting system. Frontiers in pharmacology. 2025. doi:10.3389/fphar.2025.1593989. PMID: 40520157.
BibTeX
@article{kong2025-40520157,
author = {Kong, L. and Yang, X. and Xu, J.},
title = {{Comparison of safety of lecanemab and aducanumab: a real-world disproportionality analysis using the FDA adverse event reporting system}},
journal = {Frontiers in pharmacology},
year = {2025},
doi = {10.3389/fphar.2025.1593989},
pmid = {40520157},
url = {https://doi.org/10.3389/fphar.2025.1593989}
}
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