Adverse event profile of ocular injury associated with JAK inhibitors in patients with rheumatoid arthritis: a disproportionality analysis.

Abstract

Background: Janus kinase inhibitors (JAKIs) have been approved for the treatment of rheumatoid arthritis (RA) for several years. A recent real-world study has shown the possibility of a relationship between the occurrence of ocular adverse events (OEs) and the use of JAKIs but failed to rule out whether those OEs are related to RA.

Research design and methods: A retrospective, pharmacovigilance study using the FDA Adverse Event Reporting System to evaluate OE reports following treatment with JAK inhibitors in patients with RA from Q1 2004 to Q1 2024.

Results: We identified 3226 cases associated with JAKIs and 24,158 cases associated with TNFIs. Most of the OEs are serious cases, the age distribution was similar but the sex distribution was not balanced. The OEs with top 10 ROR values in TNFIs had no detectable signal in JAKIs, and the time of onset of OEs also shows difference. Besides, far fewer OE were reported for baricitinib than for the other JAKIs.

Conclusions: Different types of JAKIs are associated with special types of OEs and differ in time of onset compared with TNF inhibitors. More rigorous trials should be conducted to better understand the risk factors in JAKIs-related OEs.