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 .
Long-term safety and efficacy of abatacept in children with juvenile idiopathic arthritis.
OBJECTIVE We previously documented that abatacept was effective and safe in patients with juvenile idiopathic arthritis ( JIA ) who had not previously achieved a satisfactory clinical response with disease-modifying antirheumatic drugs or tumor necrosis factor blockade . Here , we report results from the long-term extension ( LTE ) phase of that study . METHODS This report describes the long-term , open-label extension phase of a double-blind , r and omized , controlled withdrawal trial in 190 patients with JIA ages 6 - 17 years . Children were treated with 10 mg/kg abatacept administered intravenously every 4 weeks , with or without methotrexate . Efficacy results were based on data derived from the 153 patients who entered the open-label LTE phase and reflect > or=21 months ( 589 days ) of treatment . Safety results include all available open-label data as of May 7 , 2008 . RESULTS Of the 190 enrolled patients , 153 entered the LTE . By day 589 , 90 % , 88 % , 75 % , 57 % , and 39 % of patients treated with abatacept during the double-blind and LTE phases achieved responses according to the American College of Rheumatology ( ACR ) Pediatric 30 ( Pedi 30 ) , Pedi 50 , Pedi 70 , Pedi 90 , and Pedi 100 criteria for improvement , respectively . Similar response rates were observed by day 589 among patients previously treated with placebo . Among patients who had not achieved an ACR Pedi 30 response at the end of the open-label lead-in phase and who proceeded directly into the LTE , 73 % , 64 % , 46 % , 18 % , and 5 % achieved ACR Pedi 30 , Pedi 50 , Pedi 70 , Pedi 90 , and Pedi 100 responses , respectively , by day 589 of the LTE . No cases of tuberculosis and no malignancies were reported during the LTE . Pneumonia developed in 3 patients , and multiple sclerosis developed in 1 patient . CONCLUSION Abatacept provided clinical ly significant and durable efficacy in patients with JIA , including those who did not initially achieve an ACR Pedi 30 response during the initial 4-month open-label lead-in phase
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 .