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 .
Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicentre, double-blind, randomised-withdrawal trial
Objective This report aims to determine the safety , pharmacokinetics ( PK ) and efficacy of subcutaneous golimumab in active polyarticular-course juvenile idiopathic arthritis ( polyJIA ) . Methods In this three-part r and omised double-blinded placebo-controlled withdrawal trial , all patients received open-label  golimumab ( 30 mg/m2 of body surface area ; maximum : 50 mg/dose ) every 4 weeks together with weekly methotrexate during Part 1 ( weeks 0–16 ) . Patients with at least 30 % improvement per American College of Rheumatology Criteria for JIA ( JIA ACR30 ) in Part 1 entered the double-blinded Part 2 ( weeks 16–48 ) after 1:1 r and omisation to continue golimumab or start placebo . In Part 3 , golimumab was continued or could be restarted as in Part 1 . The primary outcome was JIA flares in Part 2 ; secondary outcomes included JIA ACR50/70/90 responses , clinical remission , PK and safety . Results Among 173 patients with polyJIA enrolled , 89.0 % ( 154/173 ) had a JIA ACR30 response and 79.2%/65.9%/36.4 % demonstrated JIA ACR50/70/90 responses  in Part 1 . At week 48 , the primary endpoint was not met as treatment groups had comparable JIA flare rates  ( golimumab vs placebo : 32/78=41 % vs 36/76=47 % ; p=0.41 ) , and rates of clinical remission were comparable ( golimumab vs placebo : 10/78=12.8 % vs 9/76=11.8 % ) . Adverse event and serious adverse event rates were similar in the treatment groups during Part 2 . Injection site reactions occurred with < 1 % of all injections . PK analysis confirmed adequate golimumab dosing for polyJIA . Conclusion Although the primary endpoint was not met , golimumab result ed in rapid , clinical ly meaningful , improvement in children with active polyJIA . Golimumab was well tolerated , and no unexpected safety events occurred . Clinical Trial Registration NCT01230827 ; Results
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 .