A real-world pharmacovigilance study of nusinersen based on the FAERS database

Abstract

Objective: This study aimed to evaluate and analyse nusinersen adverse events (AEs) in the FDA Adverse Event Reporting System (FAERS) to provide comprehensive safety data on nusinersen in real-world. Methods: Reports on nusinersen were extracted from the FAERS database spanning from January 2017 to December 2023. Disproportionality analysis were performed using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN) and multi-item gamma Poisson shrinker (MGPS), to find out the AEs for nusinersen. Additionally, we described the time-to-onset (TTO) of AEs. Results: The study retained the 227 preferred terms (PTs) identified by all four algorithms. Important AEs such as traumatic lumbar puncture, neuromuscular scoliosis, cerebrospinal fluid (CSF) pressure increased, neurological procedural complication, mechanical ventilation complication, cerebrospinal fluid leakage, CSF protein increased, procedural anxiety, arachnoid cyst, chronic respiratory failure and sudden infant death syndrome. The median TTO for nusinersen AEs was 119.5 days (interquartile range [IQR] 14–492 days). More than 32.01% of AEs occurred after one year. Conclusion: Our signal detection of nusinersen reportedsome potential signals of uncommon AEs, which could aid in risk identification and clinical monitoring.