Analysis and mining of brodalumab adverse events based on FAERS database

The aim of this study is to evaluate the real-world safety of brodalumab by analyzing adverse events (AEs) associated with the drug. The AE reports related to brodalumab from the FAERS database from 2017 Q1 to 2023 Q4 were collected. Subsequently, we employed four disproportionality analysis methods to identify positive signals among AEs associated with brodalumab, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS). In 1480 AE reports with brodalumab as the primary suspected drug, 168 preferred terms (PTs) exhibiting positive signals were identified. This study confirmed several known positive AEs, such as injection site vesicles and injection site hemorrhage. In addition, the study identified several positive AEs not listed in the drug product information, including palmoplantar pustulosis and extranodal marginal zone b-cell lymphoma (malt type). This study evaluated the real-world safety profile of brodalumab and identified several unexpected AEs, such as palmoplantar pustulosis and extranodal marginal zone b-cell lymphoma (malt type). These findings provide new safety insights for clinicians and may contribute to the safer and more rational use of brodalumab in clinical practice.