Good disease control , with therapeutic escalation to achieve low disease activity , was recommended .
OBJECTIVE To develop treatment recommendations for children with juvenile idiopathic arthritis manifesting as non-systemic polyarthritis , sacroiliitis , or enthesitis .
Methotrexate in resistant juvenile rheumatoid arthritis. Results of the U.S.A.-U.S.S.R. double-blind, placebo-controlled trial. The Pediatric Rheumatology Collaborative Study Group and The Cooperative Children's Study Group.
BACKGROUND The antimetabolite methotrexate has been shown in placebo-controlled trials to be effective in adults with rheumatoid arthritis .  Methotrexate may also be effective in children with resistant juvenile rheumatoid arthritis , but the supporting data are from uncontrolled trials . METHODS Centers in the United States and the Soviet Union participated in this r and omized , controlled , double-blind trial design ed to evaluate the effectiveness and safety of orally administered methotrexate . Patients received one of the following treatments each week for six months : 10 mg of methotrexate per square meter of body-surface area ( low dose ) , 5 mg of methotrexate per square meter ( very low dose ) , or placebo . The use of prednisone ( less than or equal to 10 mg per day ) and two nonsteroidal antiinflammatory drugs was also allowed . RESULTS The 127 children ( mean age , 10.1 years ) had a mean duration of disease of 5.1 years ; 114 qualified for the analysis of efficacy . According to a composite index of several response variables , 63 percent of the children who received low-dose methotrexate  improved , as compared with 32 percent of those in the very-low-dose group and 36 percent of those in the placebo group ( P = 0.013 ) . As compared with the placebo group , the low-dose group also had significantly larger mean reductions from base line in the number of joints with pain on motion ( -11.0 vs. -7.1 ) , the pain-severity score ( -19 vs. -11.5 ) , the number of joints with limited motion ( -5.4 vs. -0.7 ) , and the erythrocyte sedimentation rate ( -19.0 vs. -6 mm per hour ) . In the methotrexate groups only three children had the drug discontinued because of mild-to-moderate side effects ; none had severe toxicity . CONCLUSIONS Methotrexate given weekly in low doses is an effective treatment for children with resistant juvenile rheumatoid arthritis , and at least in the short term this regimen is safe
Good disease control , with therapeutic escalation to achieve low disease activity , was recommended .
OBJECTIVE To develop treatment recommendations for children with juvenile idiopathic arthritis manifesting as non-systemic polyarthritis , sacroiliitis , or enthesitis .