Post-Marketing Pharmacovigilance of Canakinumab from the FDA Adverse Event Reporting System (FAERS).

ABSTRACT: Background: Canakinumab, a humanized anti-IL-1β monoclonal antibody, is known for its ability to suppress IL-1β-mediated inflammation. However, continuous monitoring of its safety remains essential. Thus, we comprehensively evaluated the safety signals of canakinumab by data mining from FAERS. Methods: We used a disproportionate analysis to quantify canakinumab-related adverse events (AEs) using four algorithms. Clinical prioritization of the detected signals was assessed with a semiquantitative score method. Serious and non-serious outcomes were compared by statistical methods. Additionally, a stratification analysis of serious infections was conducted at the system organ class (SOC) level. Results: A total of 28,496 canakinumab-related AEs were collected, and 71 susp

SUBMITTER: Zhang W 

PROVIDER: S-EPMC11768236 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature