Abstract
BACKGROUND: To evaluate the real-world long-term efficacy and safety of adalimumab (ADA) in refractory non-infectious uveitis (NIU), analyzing clinical outcomes, treatment adjustments, and the potential role of ADA trough levels (ADA TL) in therapeutic response. By identifying factors influencing response, our study aims to contribute to a more personalized approach. METHODS: A multicenter, cross-sectional, observational study was conducted in NIU patients receiving ADA for ≥ 6 months. Disease activity was defined using the Standardization of Uveitis Nomenclature (SUN) criteria, and patients were categorized as responders (R) or non-responders (NR). The study assessed corticosteroid (CS) and immunosuppressive therapy adjustments, relapse rates, adverse events (AEs), patient-reported outcomes (PROMs), and the relationship between serum ADA TL, anti-drug antibodies (AAA), and clinical response. RESULTS: A total of 52 patients (91 eyes) with a median disease duration of 6.5 years (IQR 3.0–11.5) were included. Anterior uveitis was the most frequent subtype (34.6%), followed by panuveitis (26.9%), posterior (25%) and intermediate uveitis (13.5%). ADA therapy resulted in a significant reduction in systemic CS and c-DMADs. At the study visit, 65.4% of patients achieved complete inflammatory quiescence, with anterior (OR = 0.06, P = 0.009) and posterior uveitis (OR = 0.11, P = 0.04), being associated with a higher likelihood of response. ADA TL and AAA did not correlate with clinical response (median [IQR]: R = 8.5 [3.9–14.8] µg/mL vs. NR = 10.3 [7.9–14.5] µg/mL). AEs were reported by 32.7% of patients, predominantly mild-to-moderate infections, fatigue, and headaches. No significant differences in efficacy, safety, or relapse rates were observed between original ADA and biosimilars. CONCLUSIONS: Original ADA and biosimilars demonstrate long-term effectiveness and safety in NIU, reducing the need for systemic therapy, with comparable effectiveness and safety. PROMs further revealed that improvements in vision-related QoL were primarily driven by general vision perception, underscoring the subjective impact of treatment beyond objective inflammation control. While serum ADA levels were influenced by some clinical variables, they did not correlate with response to treatment.