Safety evaluation of ILaris: a real-world analysis of adverse events based on the FAERS database.

Abstract

Background: There is a lack of real-world studies on the safety of Ilaris in large populations. The purpose of this study was to investigate adverse events (AEs) associated with Ilaris using data from the FDA Adverse Event Reporting System (FAERS) database to guide clinical use.

Methods: We evaluated retrospectively extracted reports of AEs from the FAERS database between the first quarter of 2009 and the second quarter of 2024. The presence of a significant association between Ilaris and AEs was assessed by using disproportionality analyses including ROR,PRR,BCPNN,MGPS.

Results: After evaluating 14,691,170 data, 7968 ILaris-associated AEs were obtained after removing duplicates and unspecified sex items. A number of AEs were finalized through the study, including Common Pyrexia, Condition Aggravated, Influenza, and unexpected signals not listed in the drug insert, such as Pulmonary Thrombosis, Hepatomegaly, Blood Lactate Dehydrogenase Increased, Splenomegaly, Appendicitis. Ilaris induced AEs involving 27 system organ classes (SOCs). There were gender differences in AEs signaling associated with Ilaris.

Conclusions: It is critical for healthcare professionals to closely monitor patients for symptoms (such as pulmonary thrombosis, Hepatomegaly, Blood Lactate Dehydrogenase Increased, Splenomegaly, Appendicitis) and other adverse events during treatment.