Real-world safety of ixekizumab: a disproportionality analysis using the FDA adverse event reporting system and the VigiAccess databases.

ABSTRACT:

Introduction

Ixekizumab is a biologic agent primarily indicated for the treatment of moderate to-severe plaque psoriasis. This study aimed to evaluate the post-marketing safety profile of ixekizumab by analyzing adverse event (AE) reports retrieved from the Food and Drug Administration Adverse Event Reporting System (FAERS) database and VigiAccess databases.

Methods

Four disproportionality analysis methods were employed in this study to detect positive signals associated with ixekizumab, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). Sensitivity analyses were conducted to ensure the robustness of the findings. Additionally, the time to onset of AEs

SUBMITTER: Zhao K 

PROVIDER: S-EPMC12554608 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature