The safety profiles of avacopan on microscopic polyangiitis and granulomatosis with polyangiitis: a real-world pharmacovigilance analysis.

ABSTRACT:

Background

Avacopan is an oral selective C5a receptor inhibitor. It received FDA approval in October 2021 for use with standard glucocorticoid therapy to treat antineutrophil cytoplasmic antibody-associated vasculitis. However, there are limitations to understanding adverse events (AEs) in clinical practice. In this study, we analyzed AEs related to avacopan by mining the FDA Adverse Event Reporting System (FAERS).

Methods

Adverse event reports associated with avacopan were retrieved from the FAERS database covering Q1-2022 to Q4 2024. After data standardization, reports exclusively involving avacopan were retained. Two disproportionality analysis methods, namely the reporting odds ratio and Bayesian confidence propagation neural network, were utilized to detect safety signa

SUBMITTER: Li Y 

PROVIDER: S-EPMC12540178 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature