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 .
2.3 Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular course juvenile rheumatoid arthritis (JRA): Findings from an open-label treatment extension
We report long-term safety & efficacy of infliximab (IFX)+ methotrexate ( MTX ) treatment in JRA patients . In an international , multicenter , r and omized , double-blind study , 122 children w/active polyarticular JRA despite prior MTX therapy  received MTX plus a 3-dose induction ( wks 0 , 2 , 6 ) of IFX 3 mg/kg through wk 44 , or placebo ( PBO ) for 14 wks followed by IFX 6 mg/kg ( wks 14 , 16 , 20 , & then q8 wks ) through wk 44 . Patients completing treatment through wk 44 were eligible to enter an open-label extension ( OLE ) of IFX 3 mg/kg , beginning at wk 52 & continuing q8 wks through wk 196 . All patients continued with concomitant MTX . Physicians could increase or decrease the IFX dose by ≤1.5 mg/kg/infusion q8 wks , up to 6 mg/kg or down to 3 mg/kg , based on clinical response . Primary endpoint was the proportion of patients meeting ACR-Pedi-30 , defined as improvement of ≥30 % in ≥3 of 6 core variables , & ≤1 of the remaining variables worsened by > 30 % . Remission was defined as 0 joints with active arthritis , normal ESR , & physician 's global assessment ≤10 mm on a 10-cm visual analog scale . 78/122(63.9 % ) children entered the OLE . The mean(SD ) IFX  dose at wk 196 was 4.4(1.6)mg/kg . IFX  was well-tolerated;14.1 % of patients discontinued due to adverse events ( AE ) from wks 52–204 . The distribution/types of AE were similar to those in the first 52 wks & no new safety issues were reported . Among the 36 study patients by wk 204 , ACR-Pedi-30/50/70/90 responses were 91.7%(33/36 ) , 83.3%(30/36 ) , 69.4%(25/36 ) , & 50%(18/36 ) , respectively . 39%(14/36 ) of patients achieved remission . From wk 52 through wk 216 , 36.6%(26/71 ) of patients were positive for IFXantibodies ; 57.7%(15/26 ) of these had an infusion reaction . Continuous IFX+MTX administered up to 4 yrs was safe & effective in JRA patients , although accompanied by a high rate of patient discontinuation , which included subjects in remission
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 .