Pharmacovigilance Analysis of Lifitegrast-Associated Adverse Events Using the FDA Adverse Event Reporting System...

Area of Science:

• Pharmacovigilance
• Ophthalmology
• Drug Safety

Background:

• Lifitegrast is the first approved lymphocyte function-associated antigen-1 antagonist for dry eye disease.
• Real-world safety data for lifitegrast is limited.
• This study aimed to elucidate lifitegrast's safety profile through pharmacovigilance.

Purpose of the Study:

• To conduct a pharmacovigilance analysis of lifitegrast-associated adverse events (AEs).
• To identify potential safety signals using real-world data from the FDA's FAERS database.
• To compare identified AEs with those listed on the drug label.

Main Methods:

• Utilized data from the FDA Adverse Event Reporting System (FAERS) from July 2016 to March 2024.
• Extracted reports where lifitegrast was the primary suspect.
• Applied four algorithms to quantify AE signals, including reporting odds ratio and proportional reporting ratio.

Main Results:

• Analyzed over 12.9 million AE reports, with lifitegrast implicated in 12,390.
• Identified 179 preferred terms exhibiting significant disproportionality.
• Discovered novel AEs such as hypoacusis, instillation site infection, temporomandibular joint syndrome, and reduced blood folate levels.

Conclusions:

• Most lifitegrast AEs align with known side effects.
• Identified potential novel safety signals requiring further investigation.
• Prospective studies are recommended to confirm the relationship between these AEs and lifitegrast.