Disproportionality Analysis of Adverse Events Associated with IL-1 Inhibitors in the FDA Adverse Event Reporting...

Area of Science:

• Pharmacovigilance and drug safety research.
• Immunology and inflammatory disease treatment.
• Real-world evidence generation.

Background:

• Interleukin-1 (IL-1) inhibitors are used for inflammatory diseases but require large-scale safety assessments.
• Real-world studies on IL-1 inhibitor safety are limited.
• This study utilizes the FDA Adverse Event Reporting System (FAERS) for pharmacovigilance.

Purpose of the Study:

• To conduct a large-scale, real-world safety assessment of IL-1 inhibitors.
• To identify and characterize adverse events (AEs) associated with IL-1 inhibitor use.
• To provide insights for optimizing clinical use and minimizing AEs.

Main Methods:

• Analysis of AE reports in the FAERS database (Q1 2004 - Q3 2024).
• Disproportionality analysis using ROR, PRR, BCPNN, and MGPS algorithms to detect risk signals.
• Identification of significant system organ classes (SOCs) and preferred terms (PTs) for AEs.

Main Results:

• 17,670 AE reports involving IL-1 inhibitors were analyzed.
• Significant signals included infections/infestations and congenital disorders.
• Notable AE signals at PT level: pyrexia, nasopharyngitis, injection site erythema.
• Identified rare AEs: cardiac disorders (e.g., POTS with anakinra) and endocrine disorders (e.g., secondary adrenocortical insufficiency with canakinumab).
• 36.33% of cases occurred after >360 days of treatment.

Conclusions:

• This study provides crucial real-world safety data for IL-1 inhibitors.
• Identified safety signals can inform clinical practice and risk management.
• Findings contribute to enhancing the safe and effective use of IL-1 inhibitors.