ArticleLupus science & medicine2025
Postmarketing safety evaluation of belimumab: a pharmacovigilance analysis.
Article in Lupus science & medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
3 citing papers in PubMed.
- Belimumab prevention against organ damage over 8 years and safety up to 13 years: three pooled open-label, long-term extension SLE studies.Lupus science & medicine · 2026Article
- Cardiovascular Involvement in Systemic Lupus Erythematosus: Focus on Arrhythmias.Diagnostics (Basel, Switzerland) · 2026Review
- Telitacicept versus belimumab in proliferative lupus nephritis.Frontiers in immunology · 2025Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe present study aimed to provide a comprehensive evaluation of the postmarketing safety of belimumab based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
methodsAdverse event (AE) reports in the FAERS database from January 2021 to December 2023 were extracted to perform the disproportionality analysis by calculating the reporting OR. The clinical characteristics and onset times of AEs were investigated. The differences across ages and regions in belimumab-related AEs were also explored.
resultsA total of 4 974 201 AE reports were retrieved from the FAERS database, among which 9782 reports were related to belimumab. 485 positive safety signals related to belimumab were identified. In addition to the labelled AEs, such as depression and infections, new unexpected AEs, including product dose omission issue and inappropriate schedule of product administration, were identified. The median onset time of belimumab-related AEs was 75 days. Moreover, our analysis revealed frequently reported AEs in paediatric patients, such as systemic lupus erythematosus, and in adult patients, such as injection site pain. Additionally, AEs such as drug ineffective were commonly reported in patients of North America, Asia and Europe, while AEs, including an inappropriate schedule of product administration, had a high incidence in patients of South America.
conclusionThe current study provides a valuable evaluation of the postmarketing safety of belimumab. Further studies are required to validate and confirm these findings. Clinicians should be vigilant regarding these potential AEs and pay more attention to the proper dosage regimen of belimumab in clinical practice.
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