Real-World Disproportionality Analysis of the Food and Drug Administration Adverse Event Reporting System Database...

Area of Science:

• Pharmacovigilance
• Oncology
• Drug Safety

Background:

• Asciminib treats Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).
• Its long-term safety in diverse patient groups requires further investigation.
• Real-world data is crucial for understanding drug safety profiles.

Purpose of the Study:

• To evaluate adverse events (AEs) associated with asciminib using real-world data.
• To identify potential safety concerns and unexpected reactions.
• To provide insights for clinical drug safety management.

Main Methods:

• Analysis of the FDA Adverse Event Reporting System (FAERS) database from October 2021 to December 2023.
• Utilized statistical metrics like reporting odds ratio and proportional reporting ratio.
• Employed four analytical algorithms to detect disproportional event frequencies.

Main Results:

• Identified 966 adverse events linked to asciminib out of over 3.9 million total reports.
• Detected 663 significant preferred terms with disproportional frequencies.
• Uncovered 26 significant AEs associated with off-label asciminib use, including hepatotoxicity and pancreatitis.

Conclusions:

• Asciminib use may be associated with additional potential adverse events.
• Further research is needed to confirm these observed safety signals.
• Real-world pharmacovigilance data enhances understanding of asciminib's safety profile.