PURPOSE: Autoimmune diseases such as systemic lupus erythematosus (SLE), Sjögren's syndrome (SS), and rheumatoid arthritis (RA) are strongly associated with dry eye disease (DED), often driven by ocular surface inflammation. Lifitegrast ophthalmic solution 5% (Xiidra®), a lymphocyte function-associated antigen-1 (LFA-1) antagonist, targets T-cell–mediated inflammation, a key mechanism in autoimmune-related DED. This analysis describes real-world characteristics in autoimmune patients initiating lifitegrast.

METHODS: A retrospective cohort study using the American Academy of Ophthalmology IRIS® Registry linked to pharmacy claims identified adults with DED who initiated lifitegrast between January 1, 2017, and December 31, 2024. Subgroups included patients with comorbid SLE, SS, or RA diagnosed at or within 12 months prior to lifitegrast initiation. Demographics, comorbidities, and treatment patterns were assessed.

RESULTS: Among 143,005 patients with DED initiating lifitegrast, 2,720 (2%) had SLE, 8,651 (6%) had SS, and 8,249 (6%) had RA. Mean ages were 57, 59, and 62 years, respectively; >90% were female across cohorts. Aqueous tear deficiency predominated (>90% across cohorts). Ocular comorbidities included cataract (37–45%) and glaucoma (6–9%). Nonocular comorbidities were common, including hypertension (44–57%) and other autoimmune conditions (eg, SS in SLE cohort: 38%; RA in SS cohort: 23%). Prior DED therapy included topical cyclosporine (14–19%) and punctal plugs (10–11%). Mean lifitegrast treatment duration ranged from 140 to 150 days.

CONCLUSIONS: Autoimmune patients with DED initiating lifitegrast in routine practice exhibited high inflammatory burden and frequent ocular comorbidities. These findings support lifitegrast as a targeted therapy for autoimmune-related DED in real-world settings.