Real-world safety profile of anifrolumab: An observational disproportionality analysis of the FAERS database - PubMed
7 hours ago
- #FAERS-database
- #pharmacovigilance
- #disproportionality-analysis
- Anifrolumab's real-world safety was assessed using FDA Adverse Event Reporting System (FAERS) data from Q3 2021 to Q1 2025, identifying 97 positive safety signals.
- Analysis included 1,293 reports with 3,542 adverse events, using disproportionality methods (reporting odds ratio and Bayesian confidence propagation neural network) to detect signals.
- Signals encompassed labeled events like infusion-related reactions and infections, plus unexpected renal, cardiovascular, and neurological adverse events.
- Multivariable logistic regression showed that factors like concomitant immunosuppressants, comorbidities, and disease severity did not significantly predict key adverse events, supporting signal robustness.
- The study is hypothesis-generating and limited by FAERS database constraints (e.g., underreporting, no causality establishment), requiring confirmation in further research.