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M.D. de Smet, RESCU Participants; Infliximab for Uveitis: Fourty Six Week Efficacy and Safety Results From the Remicade European Study for Chronic Uveitis (RESCU) . Invest. Ophthalmol. Vis. Sci. 2006;47(13):1525.
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Infliximab is a monoclonal IgG1 chimeric monoclonal antibody, active against soluble and membrane bound TNF–α. The objectives of this prospective non randomized study were to: (1) determine the response to infliximab in patients with intermediate and/or posterior uveitis intolerant or unresponsive to standard therapy; (2) determine the incidence of side effects; (3) determine if long term remission is possible after 46 weeks of treatment. The current report will address the first two objectives.
Uveitis patients from ten European centers were recruited to receive infliximab 5 mg/kg at weeks 0, 2, 6, and every 8 weeks through week 46. At week 6, and over a 6 week period, concomittant medications were tapered when in the view of the treating physician such a taper was warranted. Patients were allowed to remain on low dose prednisone (PRED) (range 0–7.5 mg/day), methotrexate (MTX) (range 0–7.5 mg/week) or azathioprine. Patients reached an exit criterion (EC) and were withdrawn from the study if their vision was reduced by ≥2 ETDRS lines, gained ≥ 2 vitreous haze grades, developed a retinal infarction, or if they were reinitiated on immunosuppressive therapy.
Fourty nine patients were included in the study, 6 patients were withdrawn (W) and, 7 patients reached an EC. The diagnostic groups included: Behçet’s disease (n=9, EC=1), sarcoidosis (n=5, W=1), intermediate uveitis (n=11, W=1, EC=1), birdshot retinochoroiditis (n=10)/idiopathic vasculitis (n=7) (combined group W=1, EC=4), and sympathetic ophthalmia/Vogt Koyanagi Harada (n=7, W=3, EC=1). Patients were withdrawn for the following reasons: tuberculosis (1) inclusion criteria violations (2), consent withdrawn(1), and drug reaction (2). Mean visual acuity (ETDRS letters) improved significantly as compared to baseline (OD: 9, standard deviation (sd) 14, p<0.001; OS: 7 sd 9, p<0.001). Fifty percent of all patients achieved a 10–letter improvement by week 22 in at least one eye. Compared to baseline, at week 46, vitreous haze grade decreased in 58% (OD) and 65% (OS) of patients (OD mean –0.75, sd 0.91 p<0.001; OS mean –0.76, sd 0.65, p<0.001). At week 46, eight patients were able to taper concomitant medications according to the guidelines in the protocol. PRED was reduced on average by 16 mg/day. Seventy–two percent (n=28) of patients were treated with low dose PRED with or without 1 other immunosuppressive.
Infliximab was generally well tolerated and was effective in the treatment of patients with Uveitis.
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