Real-world pharmacovigilance of ofatumumab in multiple sclerosis: a comprehensive FAERS data analysis.

ABSTRACT:

Background

Ofatumumab, a fully human monoclonal antibody targeting CD20, is approved for the treatment of relapsing multiple sclerosis. Comprehensive real-world safety data are crucial for informing clinical practice.

Methods

The FDA Adverse Event Reporting System database was utilized to perform a disproportionality analysis, covering reports from Q3 2020 to Q2 2024, in which ofatumumab was identified as the primary suspected drug. Statistical approaches used included the Reporting Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, and Multi-item Gamma Poisson Shrinker. The timing of adverse events was assessed using the Weibull distribution model to highlight temporal risk patterns.

Results

Known adverse reactions, such as inje

SUBMITTER: Chen H 

PROVIDER: S-EPMC11799251 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature