We conducted a double-masked controlled randomized (Phase I) and open label pilot study (Phase II) study to describe the efficacy of TNFR:Fc (Etancercept, Enbrel) in the treatment of uveitis associated with Juvenile Rheumotoid Arthritis and also to provide limited safety information on the possible therapeutic activity of TNFR:Fc. Children between the ages of 2 and 18 years who meet the American College of Rheumatology criteria for Juvenile Rheumatoid Arthritis and have active anterior uveitis have been eligible for the study. Patients received either the Enbrel or placebo twice weekly at a dose of 0.4 mg/kg. Patients who completed the masked Phase I portion of the protocol were eligible to participate in the open label Phase II portion of the study. The primary outcomes for successful treatment of uveitis were a reduction of AC cells to zero or trace while using corticosteroid drops less than three times a day or a 50% reduction in the number or dosage of other anti-inflammatory medications without an increase in inflammation. Five patients received placebo and 7 received etanercept. Three of the 7 patients treated with etanercept and 2 of the 5 placebo-treated patients were considered ophthalmic successes (p=1.0). One patient in each treatment group was considered a treatment failure. Three of the 7 etanercept-treated and 2 of the 5 placebo patients were neither successes nor failures by our definition. There were no serious adverse events for any patient during the entire study period. Reports of minor infections were comparable in each treatment group, 71 % for etanercept and 60% for placebo, (p=0.58). In this small pilot study there was no apparent difference in the anterior segment inflammation between patients treated with etanercept and placebo. The stringent criteria used to measure ophthalmic success of treatment and the small patient population, limit the implications of our findings.
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|Smith, Janine A; Thompson, Darby J S; Whitcup, Scott M et al. (2005) A randomized, placebo-controlled, double-masked clinical trial of etanercept for the treatment of uveitis associated with juvenile idiopathic arthritis. Arthritis Rheum 53:18-23|