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Comparison of the Risk of Acute Anterior Uveitis Flare Between Adalimumab and Subcutaneous Infliximab in Patients
Oh Chan Kwon1, Soo Min Ahn2, Seokchan Hong2
1Division of Rheumatology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.
Background:
Acute anterior uveitis (AAU) is the most common extra-musculoskeletal manifestation of radiographic axial spondyloarthritis (r-axSpA) and is an important consideration when selecting biological therapy. Although adalimumab (ADA) and infliximab are commonly used in patients with r-axSpA and AAU, direct comparative evidence, particularly between ADA and subcutaneous infliximab (IFX-SC), remains limited.
Objective:
The objective of this study was to compare the risk of AAU flare between ADA and IFX-SC in patients with r-axSpA and a history of AAU.
Methods:
This multicenter, head-to-head, randomized, open-label trial enrolled patients with r-axSpA and a documented AAU event within the preceding 2 years. Participants were randomly assigned (1:1) to receive ADA (40 mg every 2 weeks) or IFX-SC (intravenous 5 mg/kg induction followed by subcutaneous 120 mg every 2 weeks) and were followed for 48 weeks. The primary endpoint was AAU flare occurrence. Hazard ratios (HRs) were estimated using Cox proportional hazards models. Secondary endpoints included changes in best-corrected visual acuity (BCVA), r-axSpA disease activity and functional indices, and safety outcomes.
Results:
Fifty-six patients were randomized (ADA, n = 28; IFX-SC, n = 28). During follow-up, one AAU flare episode occurred in each group. The adjusted HR of IFX-SC (vs ADA) for an AAU flare was 0.496 (95% confidence interval 0.025-9.768, p = 0.645). No significant differences in secondary endpoints were observed between groups (right BCVA, p = 0.622; left BCVA, p = 0.306; Axial Spondyloarthritis Disease Activity Score, p = 0.293; Bath Ankylosing Spondylitis Disease Activity Index, p = 0.262; Bath Ankylosing Spondylitis Functional Index, p = 0.307). Adverse events were similar in frequency and severity, with no new safety signals identified.
Conclusions:
No statistically significant differences in AAU flare risk or secondary ocular and rheumatologic outcomes were observed between ADA and IFX-SC over 48 weeks in patients with r-axSpA and prior AAU. These findings suggest that IFX-SC may represent a potential alternative to ADA for AAU flare prevention as well as disease activity control in this population.
Clinical Trial Registration Number:
Clinical Research Information Service (CRIS), Republic of Korea; KCT0007239.
