A Real-World Disproportionality Analysis of Avacopan in Anti-Neutrophil Cytoplasmic Antibodies Associated Vasculitis: Insights From FDA Adverse Event Reporting System

This study analyzed 3,529 reports from the FDA Adverse Event Reporting System to assess the real-world safety of Avacopan, a treatment for ANCA-associated vasculitis. Known adverse events such as hepatobiliary disorders and serious infections were confirmed, while unexpected signals like venous thromboembolism, cholestatic jaundice, and alopecia were identified. Most adverse events occurred within the first 30 days of treatment, with variations by age and sex. The findings highlight the importance of early-treatment monitoring and personalized strategies, and suggest further research to confirm and understand these emerging safety signals.