A real-world pharmacovigilance study of efgartigimod alfa in the FDA adverse event reporting system database.

ABSTRACT:

Objective

Efgartigimod alfa, approved for treating generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive, has uncertain long-term safety in large populations This study analyzed adverse events (AEs) linked to efgartigimod alfa using data from the FDA Adverse Event Reporting System (FAERS).

Methods

We collected and analyzed efgartigimod alfa-related reports from the FAERS database from the first quarter of 2022 through the second quarter of 2024. Disproportionality analysis was used in data mining to quantify efgartigimod alfa-related AE signals.

Results

A total of 3,040 reports with efgartigimod alfa as the primary suspect and 12,487 AEs were retrieved from FAERS. The most frequently reported serious outcome

SUBMITTER: Yang Y 

PROVIDER: S-EPMC12041031 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature