Post-Market Surveillance of Retinal Detachments and Janus Kinase Inhibitors

Authors

Amer Alsoudi, Corewell Health East
Arash Delavar
Karen Wai
Euna Koo
Prithvi Mruthyunjaya
Ehsan Rahimy

Document Type

Conference Proceeding

Publication Date

6-2025

Publication Title

Investigative Ophthalmology and Visual Science

Abstract

Purpose : Janus kinase (JAK) inhibitor agents include Food and Drug Administration (FDA) Black Box Warnings for retinal detachment (RD). The clinical implications of these findings warrant further evaluation of these potential risks in the clinical practive setting.

Methods : In this retrospective cohort study, we conduct post-market surveillance of posterior vitreous detachments (PVD), retinal breaks without detachment (RB), and RD associated with the use of JAK inhibitors using two multi-system databases. The study included 9802 patients in TriNetX initiated on a JAK inhibitor. Separately, a total of 40340, 54655, 4491, 60585, and 62411 adverse event (AE) data for select JAK inhibitors were obtained and analyzed using FDA’s Adverse Event Reporting System (FAERS). The intervention was the initiation of select JAK inhibitors. IRR of PVD, RB, RD, as well need for laser retinopexy and retinal detachment repair among patients initiated on a JAK inhibitor or not from 2012-2024 was calculated. Separately, reporting odds ratio (ROR) for retinal detachment AEs related to JAK inhibitors in FAERS was evaluated from 2012 to 2024.

Results : FAERS contained unique cases of retinal detachment AEs related to use of upadacitinib (reporting odds ratio [ROR]: 3.38, 95% CI, 2.63 – 4.35), ruxolitinib (ROR: 0.90, 95% CI, 0.59 – 1.36), baricitinib (ROR: 1.49, 95% CI, 0.48 – 4.61), tofacitinib (ROR: 0.84, 95% CI, 0.56 – 1.27), and tofacitinib XR (ROR: 0.43, 95% CI, 0.24 – 0.75), respectively, reported between 2012-2024. Those initiated on a JAK inhibitor between 2012-2024 had a modestly increased incidence of PVD than those not initiated on a JAK inhibitor (IRR: 1.19; 95% CI: 1.00-1.41), but rarely developed RB (IRR: 0.91; 95% CI: 0.53-1.57) or RD (IRR: 0.86; 95% CI: 0.54-1.57) in the TriNetX database.

Conclusions : In this multi-database, post-market surveillance study, patients using JAK inhibitors rarely developed RD or RB though may have had an increased incidence of PVD. Future AE reporting trends and comparison studies are needed to further investigate the association between vitreoretinal pathology and use of JAK inhibitors.

Volume

66

Issue

8

First Page

6303

Comments

Association for Research in Vision and Ophthalmology ARVO Annual Meeting, May 4-8, 2025, Salt Lake City, UT

Last Page

6303

Recommended Citation

Alsoudi A, Delavar A, Wai K, Koo E, Mruthyunjaya P, Rahimy E. Post-market surveillance of retinal detachments and Janus kinase inhibitors. Invest Ophthal Vis Sci. 2025 Jun;66(8):6303.