A real-world pharmacovigilance study of mepolizumab in the FDA adverse event reporting system (FAERS) database

Area of Science:

• Pharmacovigilance
• Clinical Pharmacology
• Real-world Evidence

Background:

• Mepolizumab treats severe asthma, eosinophilic granulomatosis with polyangiitis, eosinophilia syndromes, and chronic rhinitis with nasal polyps.
• Existing adverse drug reaction (ADR) data primarily comes from clinical trials, lacking extensive real-world sample sizes.
• Real-world safety data is crucial for comprehensive understanding of mepolizumab's ADR profile.

Purpose of the Study:

• To evaluate mepolizumab-associated adverse events using a large real-world database.
• To identify significant adverse events (AEs) and compare them with product labeling.
• To analyze the time to onset and gender-specific patterns of mepolizumab-induced AEs.

Main Methods:

• Analysis of the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) database.
• Inclusion of 18,040 reports of mepolizumab-associated adverse events.
• Application of multiple disproportionality analysis algorithms to assess AE significance.

Main Results:

• Identification of 198 mepolizumab-induced AEs, including novel findings not listed in product labeling.
• Median time to onset for adverse reactions was 109 days, with most occurring within the first month.
• Gender-specific differences in AEs were observed, with females experiencing more digestive/neurological effects and males facing higher risks of hospitalization/death.

Conclusions:

• The study provides valuable real-world insights into mepolizumab's safety profile.
• Findings can optimize mepolizumab's clinical use and improve patient outcomes by minimizing side effects.
• This pharmacovigilance data supports enhanced clinical implementation and patient safety strategies for mepolizumab.