What the study found
The study found that casimersen reports in the FDA Adverse Event Reporting System were associated with a broad set of reported event categories, with a median time to onset of 253 days. The authors identified 30 preferred terms that met all four disproportionality criteria.
Why the authors say this matters
The authors conclude that these findings provide a descriptive overview of real-world reporting patterns after casimersen use. The study suggests the results may inform post-marketing pharmacovigilance activities and support hypothesis generation in future studies.
What the researchers tested
The researchers analyzed FDA Adverse Event Reporting System reports from 2004 to 2024 that involved casimersen, then removed duplicates and coded reports using the Medical Dictionary for Regulatory Activities. They used four disproportionality methods: Reporting Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, and Empirical Bayesian Geometric Mean, and also examined time to onset plus age and sex subgroups.
What worked and what didn't
Among 21,964,449 reports, 598 listed casimersen as the primary suspect, mostly in males and in patients younger than 18 years. Twenty-one system organ classes were implicated, including injury, poisoning, and procedural complications, vascular disorders, product issues, and social circumstances; 30 preferred terms were significant across all four methods, including product dose omission, poor venous access, proteinuria, hematuria, chromaturia, underdose, illness, and infusion-site extravasation.
What to keep in mind
This was a pharmacovigilance study based on spontaneous adverse event reports, so it describes reporting patterns rather than proving causation. The abstract does not describe other limitations.
Key points
- Casimersen was analyzed in FDA adverse event reports from 2004 to 2024.
- 598 reports listed casimersen as the primary suspect, most often in males and patients under 18.
- The median reported time to adverse event onset was 253 days.
- Twenty-one system organ classes were implicated in the reports.
- Thirty preferred terms met all four disproportionality criteria.
Disclosure
- Research title:
- Casimersen reporting patterns show delayed adverse event onset
- Authors:
- Zhenghua Hao, Ke Jiang, Junfeng Zhang, Linmei Zhao
- Institutions:
- Second Hospital of Shanxi Medical University, Shanxi Medical University, Shanxi Medical University, Shanxi Medical University, Shanxi Medical University
- Publication date:
- 2026-02-26
- OpenAlex record:
- View
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