Ocular Adverse Effects of TNF-α Inhibitors in the FDA Adverse Event Reporting System (FAERS)

Abstract

Autoimmune inflammatory diseases affect 7.6-9.4% of the global population, predominantly women. TNF-α inhibitors (TNFI) have revolutionized rheumatic disease treatment but are associated with serious ocular adverse events (AEs). We analyzed FAERS data for adalimumab, etanercept, and infliximab (1998-2024), documenting patient demographics and the top 10 ocular AEs for each TNFI. Of the 45,445 reported ocular AEs, 66.6% were in females and 50.3% were in adults aged 18-64. The most common AEs included visual impairment (7,093), cataract (5,730), and blurred vision (5,586). There were 2,271 reports of blindness. The distribution of AEs was similar across adult age groups but rare in pediatric patients and those over 85. A review by da Silva et al corroborates our findings, identifying uveitis, optic neuropathy, and retinal toxicity among others. FAERS data showed 1,927 uveitis cases linked to adalimumab, 1,054 to etanercept, and 1,076 to infliximab. These AEs may result from TNF-α binding in ocular tissues, paradoxically causing and treating uveitis. Our study highlights the severity of ocular AEs with TNFI use, suggesting a need for vigilance in monitoring patients, especially given the potential for irreversible blindness. The limitations include voluntary reporting and underreporting in FAERS, underscoring the need for further research to better understand these risks.