Etanercept therapy in children with treatment-resistant uveitis

Objective. To evaluate the safety and efficacy of the tumor necrosis factor fusion protein etanercept in children with treatment-resistant uveitis. Methods. Ten children with chronic active uveitis (7 girls and 3 boys, mean age 7.5 years [range 3-12 years]) were enrolled in this prospective study. In 7 children, uveitis was associated with pauciarticular juvenile rheumat oid arthritis. Five children were antinuclear antibody positive. All patien ts had failed previous therapy with topical steroids and methotrexate and/o r cyclosporine. All were treated with etanercept at a dosage of 0.4 mg/kg t wice weekly for the first 3 months, and then, if eyes did not improve, with 25 mg twice weekly (mean 1.1 mg/kg) for at least 3 additional months. Results. At the beginning of the trial, uveitis affected 18 eyes in the 10 children. Within 3 months, 10 of 16 affected eyes (63%; P = 0.017) showed a rapid decrease in anterior chamber cell density, including remission of uv eitis in 4 eyes. In children with visual acuity of less than 20/25, 4 of 10 eyes (40%) improved. An exacerbation of uveitis during etanercept therapy occurred in only 1 child (1 of 14 eyes [7%]). Other ocular outcome paramete rs, such as intraocular pressure, synechia formation, and lens clarity, rem ained unchanged. Following a dosage increase to an average of 1.1 mg/kg aft er 3 months in 7 children, no further improvement was noted. Conclusion. Our data suggest that etanercept injected subcutaneously twice a week has a beneficial effect on treatment-resistant chronic uveitis in ch ildren. Further controlled studies with etanercept in systemic or topical f orm are necessary to confirm its efficacy and optimal mode of administratio n.