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 .
A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis.
OBJECTIVE To evaluate the safety and efficacy of infliximab in the treatment of juvenile rheumatoid arthritis ( JRA ) . METHODS This was an international , multicenter , r and omized , placebo-controlled , double-blind study . One hundred twenty-two children with persistent polyarticular JRA despite prior methotrexate ( MTX ) therapy were r and omized to receive infliximab or placebo for 14 weeks , after which all children received infliximab through week 44 . Patients received MTX plus infliximab 3 mg/kg through week 44 , or MTX plus placebo for 14 weeks followed by MTX plus infliximab 6 mg/kg through week 44 . RESULTS Although a higher proportion of patients in the 3 mg/kg infliximab group than in the placebo group had achieved responses according to the American College of Rheumatology ( ACR ) Pediatric 30 ( Pedi 30 ) criteria for improvement at week 14 ( 63.8 % and 49.2 % , respectively ) , the between-group difference in this primary efficacy end point was not statistically significant ( P = 0.12 ) . By week 16 , after the crossover from placebo to infliximab 6 mg/kg when all patients were receiving infliximab , an ACR Pedi 30 response was achieved in 73.2 % of all patients . By week 52 , ACR Pedi 50 and ACR Pedi 70 responses had been reached in 69.6 % and 51.8 % , respectively , of patients . Infliximab was generally well tolerated , but the safety profile of infliximab 3 mg/kg appeared less favorable than that of infliximab 6 mg/kg , with more frequent occurrences of serious adverse events , infusion reactions , antibodies to infliximab , and newly induced antinuclear antibodies and antibodies to double-str and ed DNA observed with the 3 mg/kg dose . CONCLUSION While infliximab at 3 mg/kg and 6 mg/kg showed durable efficacy at 1 year , achievement of the primary efficacy end point at 3 months did not differ significantly between  infliximab-treated  and  placebo-treated  patients . Safety data indicated that the 6-mg/kg dose may provide a more favorable risk/benefit profile . These results warrant further investigation in children with JRA
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 .