Immune checkpoint inhibitor-associated aseptic meningitis: a pharmacovigilance study using the FDA adverse event reporting system (2011-2024).
1/5 보강
[OBJECTIVE] Immune checkpoint inhibitors (ICIs) are pivotal in oncology but carry risks of immune-related adverse events (irAEs).
- 95% CI 4.71-6.91
APA
Guo H, Pang Y, et al. (2025). Immune checkpoint inhibitor-associated aseptic meningitis: a pharmacovigilance study using the FDA adverse event reporting system (2011-2024).. Frontiers in immunology, 16, 1654301. https://doi.org/10.3389/fimmu.2025.1654301
MLA
Guo H, et al.. "Immune checkpoint inhibitor-associated aseptic meningitis: a pharmacovigilance study using the FDA adverse event reporting system (2011-2024).." Frontiers in immunology, vol. 16, 2025, pp. 1654301.
PMID
41112302 ↗
Abstract 한글 요약
[OBJECTIVE] Immune checkpoint inhibitors (ICIs) are pivotal in oncology but carry risks of immune-related adverse events (irAEs). Aseptic meningitis (AM) represents a serious neurological irAE, yet real-world evidence on regimen-specific risk variations remains limited. This study aimed to characterize AM reporting patterns and safety signals across ICI regimens using FDA Adverse Event Reporting System (FAERS) data.
[METHODS] We analyzed FAERS reports (January 2011-December 2024) for ICIs-associated AM. Descriptive statistics summarized demographics, clinical profiles, and temporal trends. Disproportionality analyses employed four algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).
[RESULTS] Among 498 ICIs-associated AM reports, monotherapy predominated (78.7%) with pembrolizumab (34.9%), ipilimumab/nivolumab (21.3%), nivolumab (17.1%), and atezolizumab (15.9%) as leading agents. Patients had a median age of 64 years; 98% met serious adverse event criteria. Hospitalization (45.8%) was the most common outcome. Symptom onset was rapid (median: 34 days). Disproportionality analysis revealed pronounced signals for ipilimumab/nivolumab (ROR 5.71, 95% CI 4.71-6.91) and ipilimumab monotherapy (ROR 4.21, 95% CI 3.05-5.82). Anti-PD-1 agents collectively showed moderate association (ROR 2.55, 95% CI 2.25-2.88).
[CONCLUSIONS] ICIs-associated AM presents a clinically significant safety concern, particularly with ipilimumab-containing regimens. Rapid symptom onset underscores the need for vigilant neurological monitoring during early treatment phases. These findings warrant integration into clinical risk-assessment protocols and warrant further mechanistic investigation.
[METHODS] We analyzed FAERS reports (January 2011-December 2024) for ICIs-associated AM. Descriptive statistics summarized demographics, clinical profiles, and temporal trends. Disproportionality analyses employed four algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).
[RESULTS] Among 498 ICIs-associated AM reports, monotherapy predominated (78.7%) with pembrolizumab (34.9%), ipilimumab/nivolumab (21.3%), nivolumab (17.1%), and atezolizumab (15.9%) as leading agents. Patients had a median age of 64 years; 98% met serious adverse event criteria. Hospitalization (45.8%) was the most common outcome. Symptom onset was rapid (median: 34 days). Disproportionality analysis revealed pronounced signals for ipilimumab/nivolumab (ROR 5.71, 95% CI 4.71-6.91) and ipilimumab monotherapy (ROR 4.21, 95% CI 3.05-5.82). Anti-PD-1 agents collectively showed moderate association (ROR 2.55, 95% CI 2.25-2.88).
[CONCLUSIONS] ICIs-associated AM presents a clinically significant safety concern, particularly with ipilimumab-containing regimens. Rapid symptom onset underscores the need for vigilant neurological monitoring during early treatment phases. These findings warrant integration into clinical risk-assessment protocols and warrant further mechanistic investigation.
🏷️ 키워드 / MeSH 📖 같은 키워드 OA만
- Humans
- Meningitis
- Aseptic
- Immune Checkpoint Inhibitors
- United States
- Pharmacovigilance
- Female
- Male
- Middle Aged
- Adverse Drug Reaction Reporting Systems
- United States Food and Drug Administration
- Aged
- Adult
- 80 and over
- Young Adult
- Food and Drug Administration’s Adverse Event Reporting System
- aseptic meningitis
- data mining
- immune checkpoint inhibitors
- pharmacovigilance
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