May 2005
Volume 46, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2005
Ten Week Efficacy and Safety Results From the Remicade European Study for Chronic Uveitis (RESCU)
Author Affiliations & Notes
  • M.D. de Smet
    Department of Ophthalmology, Academic Ctr Univ of Amsterdam, Amsterdam, The Netherlands
  • RESCU Study Group
    Department of Ophthalmology, Academic Ctr Univ of Amsterdam, Amsterdam, The Netherlands
  • Footnotes
    Commercial Relationships  M.D. de Smet, Centocor F, C.
  • Footnotes
    Support  Centocor
Investigative Ophthalmology & Visual Science May 2005, Vol.46, 1139. doi:
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      M.D. de Smet, RESCU Study Group; Ten Week Efficacy and Safety Results From the Remicade European Study for Chronic Uveitis (RESCU) . Invest. Ophthalmol. Vis. Sci. 2005;46(13):1139.

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Abstract

Abstract: : Purpose: Infliximab is a monoclonal IgG1 chimeric monoclonal antibody, active against soluble and membrane bound TNF–α. The objectives of the current study were (1) to determine the response to infliximab in a prospective series of uveitis patients with intermediate and/or posterior uveitis intolerant or unresponsive to standard therapy; (2) to determine if long term remission could be induced in uveitis patients; (3) to determine the incidence of side effects. Methods: Patients with various uveitic conditions were recruited from 10 European centers. After screening for tuberculosis and other contraindications, patients received infliximab 5 mg/kg at weeks 0, 2, 6, and then every 8 weeks through week 46. Starting at week 6, an attempt was made to taper concomitant anti–inflammatory medications except for low dose prednisone (7.5 mg/day), methotrexate (7.5 mg/week), or azathioprine. Patients were withdrawn from the study if their vision dropped by 2+ ETDRS lines, if there was a significant rise in vitreous haze, if the patient experienced a retinal infarction or restarted immunosuppressive therapy. Patients will be followed prospectively for an additional 2 years after the last infusion or until there is evidence of a disease recurrence. Results: 49 patients were included in the study. The diagnostic groups included: Behçet’s disease (n=9), sarcoidosis (n=5), intermediate uveitis (n=11), birdshot retinochoroiditis (n=10), idiopathic vasculitis (n=7), and sympathetic ophthalmia/Vogt Koyanagi Harada (n=7). By week 10, infliximab was stopped in 4 patients: decreased vision with 2 ETDRS lines (1), tuberculosis (1), drug reaction (2). The median ETDRS visual acuity score at entry was: OD (right eye) 70, range 0 to 90; OS (left eye) 68, range 6 to 87. These scores improved significantly at week 10: OD 79, range 6 to 94, (p < 0.001); OS 78, range 20 to 94, (p < 0.001) at week 10. The percentage of patients without vitreous haze significantly increased from baseline to week 10: 27% to 68% OD (p < 0.001); 22% to 77% OS (p < 0.001). By week 10, 38 patients (78%) had successfully started to taper immunosuppressives. The median prednisolone equivalent score at baseline was 15 mg (range, 0 to 50 mg), and was tapered to 10 mg (range, 0 to 35 mg) at week 10 (p < 0.001). Similarly, by week 10, there was a reduction in the dosage and number of other concomitant immunosuppressives. Conclusions: The 10–week data from the RESCU trial suggest that infliximab is effective in uveitis, originating from a broad range of diseases. Infliximab was well tolerated.

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