Etanercept in Treatment of Juvenile Idiopathic Arthritis
Molly Miloslavsky
Eli Miloslavsky
Etanercept in Children With Polyarticular Juvenile Rheumatoid Arthritis. Pediatric Rheumatology Collaborative Study Group
Lovell DJ, Giannini EH, Reiff A, et al. N Engl J Med. 2000;342(11):763–769
Background
Juvenile idiopathic arthritis (JIA) is the most common type of arthritis in children and can lead to significant functional impairment. Methotrexate had been the mainstay of treatment when nonsteroidal anti-inflammatory drugs (NSAIDs) were insufficient; however, a significant percentage of patients did not achieve disease control with these agents. Tumor necrosis factor (TNF) is a proinflammatory cytokine implicated in the pathogenesis of JIA. Anti-TNF agents, such as etanercept, had been shown to be effective for rheumatoid arthritis in the adult population, but pediatric data were lacking.
Objectives
To evaluate the safety and efficacy of etanercept in children with polyarticular JIA refractory to methotrexate.
Methods
Double-blind, randomized, placebo-controlled trial at 10 centers in the US and Canada.
Patients
69 patients ages 4 to 17 years with active polyarticular arthritis (≥5 joints) with inadequate response to methotrexate. Select exclusion criteria: pregnancy, lactation.
Intervention
Open-label phase: all patients received etanercept (0.4 mg/kg, up to 25 mg) twice weekly for up to 3 months. Randomized double-blind phase: patients who improved either continued to receive etanercept or received placebo for 4 months, unless disease flare occurred. Methotrexate was discontinued but stable doses of NSAIDs or corticosteroids were allowed. Disease activity was evaluated every 2 weeks.
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