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Abstract
BACKGROUND
Tumor necrosis factor (TNF) has a pathogenic role in juvenile rheumatoid arthritis.
We evaluated the efficacy and safety of adalimumab, a fully human monoclonal anti-
TNF antibody, in children with polyarticular-course juvenile rheumatoid arthritis.
METHODS
Patients 4 to 17 years of age with active juvenile rheumatoid arthritis who had previously
received treatment with nonsteroidal antiinflammatory drugs underwent stratification
according to methotrexate use and received 24 mg of adalimumab per square
meter of body-surface area (maximum dose, 40 mg) subcutaneously every other week
for 16 weeks. We randomly assigned patients with an American College of Rheumatology
Pediatric 30% (ACR Pedi 30) response at week 16 to receive adalimumab
or placebo in a double-blind fashion every other week for up to 32 weeks.
RESULTS
Seventy-four percent of patients not receiving methotrexate (64 of 86) and 94% of
those receiving methotrexate (80 of 85) had an ACR Pedi 30 response at week 16 and
were eligible for double-blind treatment. Among patients not receiving methotrexate,
disease flares (the primary outcome) occurred in 43% of those receiving adalimumab
and 71% of those receiving placebo (P = 0.03). Among patients receiving methotrexate,
flares occurred in 37% of those receiving adalimumab and 65% of those receiving
placebo (P = 0.02). At 48 weeks, the percentages of patients treated with methotrexate
who had ACR Pedi 30, 50, 70, or 90 responses were significantly greater for
those receiving adalimumab than for those receiving placebo; the differences between
patients not treated with methotrexate who received adalimumab and those
who received placebo were not significant. Response rates were sustained after 104
weeks of treatment. Serious adverse events possibly related to adalimumab occurred
in 14 patients.
CONCLUSIONS
Adalimumab therapy seems to be an efficacious option for the treatment of children with juvenile rheumatoid arthritis. (ClinicalTrials.gov number, NCT00048542.