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Glenn J Jaffe, Jennifer E Thorne, david scales, Pablo Franco, Samir R Tari, Anne Camez, Alexandra P. Song, Martina Kron, Talin Barisani-Asenbauer, Andrew D Dick; Adalimumab in Patients With Active, Non-infectious Uveitis Requiring High-dose Corticosteroids: the VISUAL-1 Trial. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):3115.
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To assess adalimumab (ADA) efficacy and safety in patients with active, non-infectious uveitis requiring high-dose corticosteroid therapy.
This multinational, double-masked trial included patients aged ≥18 years with active, non-infectious intermediate, posterior, or panuveitis despite ≥2 weeks of prednisone (≥10 mg/d to ≤60 mg/d). Patients with active uveitis had ≥1 of the following: active, inflammatory chorioretinal or retinal vascular lesion; anterior chamber (AC) cell grade ≥2+; or vitreous haze (VH) grade ≥2+. Patients were randomized 1:1 to receive placebo or ADA subcutaneously. The ADA group received an 80 mg baseline loading dose and 40 mg every other week for up to 80 weeks; all patients received prednisone 60 mg/day that was tapered to 0 mg by week 15. The primary endpoint was time to treatment failure (TF) in ≥1 eye. TF was defined as ≥1 of the following: new, active, inflammatory vascular lesions; worsening of best-corrected visual acuity (BCVA) by ≥15 letters at or after week 6; inability to achieve ≤0.5+ AC cell grade or ≤0.5+ VH grade (at week 6); or 2-step increase in AC cell grade or VH grade (after week 6). Ranked secondary endpoints included change in AC cell grade, VH grade, and BCVA from the best state achieved before week 6 to the final visit. Adverse events were monitored.
217 patients were enrolled (female, 57%; mean age, 42.7 y; mean duration of uveitis, 46 months); 22% had intermediate, 33% had posterior, and 45% had panuveitis. Patients who received ADA were less likely to have TF (hazard ratio=0.5; 95% CI, 0.36-0.70; P<0.001). Median time to TF was 13 weeks for placebo and 24 weeks for ADA (Figure). Patients who received ADA had fewer causes of failure. Worsening of AC cell grade, VH grade, and BCVA from best state achieved was reduced with ADA compared with placebo (Table). The rates of adverse events were similar in ADA and placebo groups (1046 vs 952 events/100 patient y, respectively).
In patients with active, non-infectious intermediate, pan, or posterior uveitis (ie, uveitis involving the posterior segment) uncontrolled on prednisone ≥10 mg daily, ADA significantly lowered the risk for uveitic flare or BCVA loss. The safety profile was consistent with the known safety profile across the approved ADA indications.
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