Adverse Event Profiles of Adalimumab in Children: A Disproportionality Analysis.

ABSTRACT:

Background

Adalimumab has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult rheumatoid arthritis (RA), and subsequently approved for pediatric treatment of various autoimmune diseases in children of different ages. Due to genetic differences between children and adults in terms of physiology and immunity, there is a need to explore the safety of adalimumab in children in the real world. The aim of this study is to identify potential adverse event (AE) signals associated with the use of adalimumab in pediatric patients (<18 years old) using data from the FDA Adverse Event Reporting System (FAERS).

Methods

AEs associated with adalimumab in pediatric patients reported in the FAERS database from the first quarter (Q1) of 2017 to the third qu

SUBMITTER: Zhang W 

PROVIDER: S-EPMC11357133 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature