Intravitreal versus Subcutaneous Adalimumab in Active Non-Infectious Uveitis: A Randomized Non-Inferiority Trial.

Abstract

Purpose: To compare the clinical effectiveness and safety of subcutaneous adalimumab (SCA) versus intravitreal adalimumab (IVA) in treating active non-infectious uveitis (NIU).Methods: This single-center, phase 2 non-inferiority randomized controlled trial included patients with active NIU assigned to receive either SCA (80 mg loading dose, then 40 mg every 2 weeks) or IVA (1.5 mg at baseline, then every 4 weeks). Follow-ups occurred weekly for the first 2 weeks, then every 4 weeks until 26 weeks. Primary outcomes were changes in anterior chamber cell (AC) and vitreous haze (VH) grades at 26 weeks (non-inferiority margin: 0.5). Secondary outcomes included best-corrected visual acuity (BCVA), central retinal thickness (CRT), fluorescein angiography (FA) score, and oral prednisone dose.Results: A total of 23 patients (43 eyes) were randomized into the SCA (n = 12) or IVA (n = 11) treatment group. IVA was found to be non-inferior to SCA. The upper limit of the 90% confidence interval (CI) for the difference in AC grade change (-0.33 [-0.79 to 0.38], p = 0.440) and VH grade change (-0.34 [-1.15 to 0.47], p = 0.490) remained below the noninferiority margin of + 0.5 grade. No significant differences were found between the two treatment groups for secondary outcomes, including changes in BCVA (p = 0.594), CRT (p = 0.607), FA score (p = 0.318), and oral prednisone dose (p = 0.881). No serious systemic or ocular adverse events (AE) were observed. SCA resulted in a higher number of non-serious systemic AE (21) compared to IVA (5).Conclusions: IVA was non-inferior to SCA in treating active NIU and resulted in fewer systemic adverse events.