Summary

This study provides a comprehensive real-world assessment of the safety profile of avacopan, using data from the FDA Adverse Event Reporting System. Various statistical methods were applied to evaluate the frequency, significance, and timing of adverse events (AEs), as well as differences by age and gender.

A total of 3,150 AE reports were identified, including several significant signals and 34 previously unrecognized events, though none were classified as high clinical priority. The median time to onset was 48 days, with many events occurring early in treatment. Older patients (≥65 years) showed a higher risk of AEs. Hepatobiliary events were the most common, particularly among female and elderly patients.

Overall, avacopan demonstrated a favorable safety profile in real-world use. However, the findings highlight the importance of targeted monitoring, especially in older patients and for liver-related events in order to support individualized treatment strategies

Impact on Patient Treatment and Future Perspectives

By presenting the full spectrum of potential side effects, this study helps to individualize treatment. The previously unrecognized events have no general impact, however they might influence prescription at the individual level.

Hepatopathies and older age (>65years) remain the most important risk factors

References:

Chen S-F, et al. Real-world safety assessment of avacopan in patients with antineutrophil cytoplasmic antibody-associated vasculitis. RMD Open 2026;12:e006439. doi:10.1136/rmdopen-2025-006439

Composed by

Prof. Dr. med. Peter Villiger, Ordinarius of Rheumatology and Clinical Immunology em, University Hospital and University of Bern