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C. M. Samson, C. S. Foster, R. Kim, N. Falk, D. S. Chu, D. Callanan, Q. Nguyen, T. P. Dryja; An Open-Label Proof-Of Concept Study to Assess the Efficacy of AIN457 in Patients With Noninfectious Uveitis. Invest. Ophthalmol. Vis. Sci. 2010;51(13):2917.
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Animal studies suggest that inhibition of the cytokine IL-17 may reduce inflammation in uveitis. This open-label phase II study was designed to evaluate AIN457, an IL-17A inhibitor, for the treatment of patients with noninfectious uveitis.
Sixteen patients with noninfectious uveitis were enrolled in this study, including 11 patients with posterior segment uveitis (intermediate uveitis, posterior uveitis, or panuveitis) and 5 patients with anterior uveitis. AIN457 at a dose of 10 mg/kg was administered intravenously once at baseline and once 3 weeks later; evaluation of the patients was conducted over a period of approximately 9 months. The key efficacy variable was proportion of responders at week 8, including assessments of visual acuity, vitreous haze, anterior chamber inflammation, and reduction of corticosteroid treatment.
The proportion of patients responding to treatment with AIN457 was comparable to the proportion seen historically with infliximab. Eight of 11 patients (73%) with posterior segment uveitis and 3 of 5 patients (60%) with anterior uveitis met the response criteria in this study. One patient with severe anterior uveitis had no apparent response and was rescued with prednisone. In most cases, achievement of response was apparent within 3 weeks after the first dose of AIN457. At week 8, the average gain in visual acuity was approximately 11.5 letters for patients with posterior segment uveitis, representing an improvement in Snellen acuity from approximately 20/120 to 20/65. In anterior patients, the average gain in visual acuity was approximately 4.8 letters.
AIN457 appears to be efficacious in patients with chronic noninfectious uveitis requiring systemic immunosuppression, warranting further study in phase III clinical trials.
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