Profiling of Potential Postmarket Risk Tracking and Pharmacovigilance Data for Avacopan.

Area of Science:

• Pharmacovigilance
• Clinical Safety
• Real-world Evidence

Background:

• Avacopan is a key treatment for antineutrophil cytoplasmic antibody-associated vasculitis (ANCA-vasculitis).
• Limited large-scale, real-world safety data exists for post-commercialization avacopan use.
• Understanding avacopan's safety profile in diverse patient populations is crucial.

Purpose of the Study:

• To assess the post-marketing safety of avacopan.
• To identify potential adverse events associated with avacopan treatment.
• To provide evidence for informed clinical application and risk management.

Main Methods:

• Utilized the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.
• Employed Bayesian confidence propagation neural network and reporting odds ratio (ROR) for signal mining.
• Analyzed adverse event reports from Q3 2021 to Q4 2024.

Main Results:

• 7141 adverse events reported for 3135 patients treated with avacopan.
• Higher incidence of adverse events observed in female patients.
• 225 deaths reported, with increased mortality in patients aged 65+ and males.
• Identified 136 adverse event signals, including increased ANCA and kidney biopsy.
• New safety signals included alopecia, sepsis, pulmonary hemorrhage, hypertransaminasemia, deafness, and insomnia.

Conclusions:

• Avacopan use is associated with potential risks, varying significantly by gender and age.
• Further prospective studies are required to validate findings.
• Refinement of risk warnings, monitoring strategies, and preventative measures is recommended for specific populations.