Ocular Inflammation as a Risk Factor for Anti-Adalimumab Antibodies in Patients with Autoimmune Diseases Treated with Adalimumab.

Abstract

To investigate the potential impact of ocular inflammation on development of anti-adalimumab antibodies (AAA) in patients with systemic autoimmune diseases treated with adalimumab. Retrospective, Case-control study. Patients who were treated with adalimumab for various autoimmune conditions for at least six months and tested for adalimumab level and/or AAA from June 2005 to May 2024. Stanford Research Repository (STARR) database, a clinical data warehouse that aggregates electronic health records from Stanford Health Care, Stanford Children's Health, and affiliated clinics, was used to identify eligible participants. Demographic data, systemic diagnoses, ocular involvement, prior and concurrent treatment were also collected. Subsequently, univariate and multivariable logistic regression analyses were conducted to identify factors associated with AAA development. The correlation of AAA with ocular inflammation and the proportion of AAA-positive patients in the study cohort. Among 704 patients, 151 (21.5%) developed AAA and were predominantly females compared to the AAA-negative group (60.9% vs. 47.0%; adjusted OR [aOR], 1.75; 95% CI, 1.07-2.85; P = 0.024). On multivariable analysis, ocular inflammation (aOR, 2.19; 95% CI, 1.19-4.02; P = 0.011), female sex (aOR, 1.75; 95% CI, 1.08-2.85; P = 0.024), and adalimumab interruption (aOR, 1.74; 95% CI, 1.03-2.94; P = 0.038) remained independent risk factors for AAA formation. Prior biologic therapy other than TNF- α inhibitors was protective (aOR, 0.27; 95% CI, 0.08-0.98; P = 0.046), while prior TNF-α inhibitor exposure remained a risk factor (aOR, 2.11; 95% CI, 1.25-3.55; P = 0.005). Ocular inflammation in patients with autoimmune disorders is associated with an increased risk of AAA formation, suggesting a potential role for therapeutic drug monitoring in optimizing adalimumab therapy. Notably, more than one-fifth of patients receiving adalimumab in this cohort developed anti-adalimumab antibodies.