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 .
Safety and efficacy of up to eight years of continuous etanercept therapy in patients with juvenile rheumatoid arthritis.
OBJECTIVE To evaluate the safety and efficacy of up to 8 years of etanercept treatment in patients with polyarticular-course juvenile rheumatoid arthritis ( JRA ) . METHODS Patients with JRA who previously participated in a r and omized controlled trial ( RCT ) of etanercept were eligible to receive etanercept in a long-term open-label extension ( OLE ) trial . Safety end points included the incidences of serious adverse events ( SAEs ) , medically important infections ( MIIs ) , and death . Efficacy end points included the American College of Rheumatology ( ACR ) Pediatric 30 ( Pedi 30 ) , Pedi 50 , Pedi 70 , Pedi 90 , and Pedi 100 criteria for improvement . RESULTS Of the 69 patients originally enrolled in the RCT , 58 ( 84 % ) participated in the OLE , for a total of 318 patient-years of etanercept exposure . A total of 42 of the 58 patients ( 72 % ) entered the fourth year of continuous etanercept treatment , and 26 patients ( 45 % ) entered the eighth year . Sixteen patients ( 23 % of those entering the RCT ) reported 39 SAEs . The overall rate of SAEs ( 0.12 per patient-year ) did not increase with long-term exposure to etanercept . The rate of MIIs ( 0.03 per patient-year ) remained low ; 1 new MII was reported in patients with > or = 5 years of etanercept exposure . No cases of tuberculosis , opportunistic infections , malignancies , lymphomas , lupus , demyelinating disorders , or deaths were reported . An ACR Pedi 70 response or higher was achieved by 100 % of patients with 8 years of data ( 11 of 11 ) and by 61 % of patients according to the last observation carried forward data ( 28 of 46 ) . CONCLUSION These data suggest that the acceptable safety profile of etanercept therapy is maintained for up to 8 years in this population of JRA patients . Improvements in the signs and symptoms of JRA were also maintained for up to 8 years
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 .