Lupus & antiphospholipid syndrome
Postmarketing safety evaluation of belimumab: a pharmacovigilance analysis
Authors' conclusion
The current study provides a valuable evaluation of the postmarketing safety of belimumab.
Study context
- Population
- Adverse Event (AE) reports in the FDA Adverse Event Reporting System (FAERS), January 2021 to December 2023belimumab-related AE reports
- Participants
- 9,782 reports
- Outcome
- Positive safety signals of belimumab (reporting OR)
Methodological detailsdisproportionality analysis of the FAERS database, reporting OR
- Disproportionality analysis of the FAERS database
- Reporting OR
Main finding
As reported in the abstract
Positive safety signals related to belimumab
Positive safety signals identified
485
Observational data: associations, not effects.
Further findings
| Outcome | Values |
|---|---|
| Onset time of belimumab-related AEs | Belimumab median 75 days |
AEs by age
- Frequently reported in paediatric patients: SLE; in adult patients: injection site pain
AEs by region
- Drug ineffective commonly reported in North America, Asia and Europe; inappropriate schedule of product administration high incidence in South America
Original publication
Postmarketing safety evaluation of belimumab: a pharmacovigilance analysis. Lupus Sci Med. Published 9 January 2025. doi:10.
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