Disproportionality analysis of satralizumab in FDA adverse event reporting system and Japanese adverse drug event report: a pharmacovigilance study.

ABSTRACT:

Background

To date, no post-marketing safety studies of satralizumab have been conducted. This study aims to evaluate the post-marketing safety profile of satralizumab using data from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) databases.

Methods

We extracted all adverse event (AE) reports related to satralizumab from the FAERS database covering the period from Q1-2023 to Q4 2024. Disproportionality analyses were conducted for AEs with at least four reports listing satralizumab as the primary suspect (PS), using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS), along with thei

SUBMITTER: Zhang L 

PROVIDER: S-EPMC12846964 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature