ArticleScientific reports2025
A real-world safety analysis of infection-related adverse events associated with belimumab, rituximab, and TNF inhibitors using the FAERS database.
Article in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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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
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Infectious Risks Associated with Biologic Therapies in Autoimmune, Rheumatologic and Dermatologic Diseases: A Narrative Review.Microorganisms · 2026Review
- Adverse event reporting patterns of rituximab and obinutuzumab in B-cell non-Hodgkin lymphoma: a FAERS pharmacovigilance study.Frontiers in immunology · 2026Article
- Adverse Event Profiles of Monoclonal Antibodies: A Descriptive Analysis of FAERS Data.Health services insights · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
Objective The study aims to evaluate infection-related safety profiles of belimumab, rituximab, and TNF inhibitors using the FDA Adverse Event Reporting System (FAERS) database. Methods A disproportionality analysis combining Reporting Odds Ratios (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) was conducted on FAERS data from Q1 2014 to Q2 2024. Results Belimumab and rituximab are more likely to cause progressive multifocal leukoencephalopathy (PML), while infliximab show a greater variety tuberculosis (TB)-related AEs than other biological agents. Rituximab exhibited a risk association with hepatitis B virus reactivation and sepsis-related AEs. Most of these infection AEs are listed in drug packaging labels, our study also identified some rare and potential AEs such as cutaneous leishmaniasis, gallbladder empyema, leprosy, chikungunya virus infection and dengue fever. Conclusion Belimumab, rituximab, and TNF inhibitors exhibit distinct infection risks. Clinicians should prioritize monitoring for severe events like PML, TB, and hepatitis B viral reactivation. However, epidemiological investigations and further causality assessments are required.
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Registered trials
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