April 2010
Volume 51, Issue 13
ARVO Annual Meeting Abstract  |   April 2010
An Open-Label Proof-Of Concept Study to Assess the Efficacy of AIN457 in Patients With Noninfectious Uveitis
Author Affiliations & Notes
  • C. M. Samson
    New York Eye & Ear Infirmary, New York, New York
  • C. S. Foster
    Massachusetts Eye Research and Surgery Institution, Cambridge, Massachusetts
  • R. Kim
    Vitreoretinal Consultants, Houston, Texas
  • N. Falk
    Retina Consultants, Slingerlands, New York
  • D. S. Chu
    Cornea and Laser Eye Institute, Teaneck, New Jersey
  • D. Callanan
    Texas Retina Associates, Arlington, Texas
  • Q. Nguyen
    Wilmer Eye Institute, Baltimore, Maryland
  • T. P. Dryja
    Novartis Institutes for Biomedical Research, Cambridge, Massachusetts
  • Footnotes
    Commercial Relationships  C.M. Samson, None; C.S. Foster, Novartis, C; R. Kim, None; N. Falk, None; D.S. Chu, None; D. Callanan, None; Q. Nguyen, None; T.P. Dryja, Novartis, E.
  • Footnotes
    Support  None.
Investigative Ophthalmology & Visual Science April 2010, Vol.51, 2917. doi:
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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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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: : 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.

Methods: : 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.

Results: : 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.

Conclusions: : AIN457 appears to be efficacious in patients with chronic noninfectious uveitis requiring systemic immunosuppression, warranting further study in phase III clinical trials.

Clinical Trial: : www.clinicaltrials.gov NCT00685399

Keywords: uveitis-clinical/animal model • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • inflammation 

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