Mining and analysis of adverse events associated with aducanumab: a real-world study using FDA Adverse Event Reporting System database

BACKGROUND: Aducanumab, a monoclonal antibody, received approval for the treatment of Alzheimer's disease in 2021. However, it remains controversial over the security of this drug. In this study, aducanumab-related adverse events (AEs) were evaluated through data mining based on the FDA Adverse Event Reporting System (FAERS) database. RESEARCH DESIGN AND METHODS: The AE reports induced by aducanumab as the primary suspected drug were extracted from the FAERS database. The clinical characteristics of aducanumab-associated reports were analyzed. The potential new AE signals of aducanumab were explored using four disproportionality analysis methods. Furthermore, the difference in aducanumab-associated AE signals was investigated concerning sex, age, weight, dose, onset time, and continent. RESULTS: In total, 328 reports and 793 AEs associated with aducanumab were identified. Six new AEs were identified. No significant sex and weight difference in aducanumab-related signals was found. Notably, nervous system disorders, especially 'amyloid related imaging abnormality-edema/effusion' and 'amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits,' were more frequently to be reported within 121-240 days, particularly in Europe. CONCLUSIONS: This study contributes real-world evidence regarding the safety of aducanumab.