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 of etanercept and adalimumab compared to methotrexate in patients with juvenile idiopathic arthritis (JIA)
Importance Published evidence on the long-term safety of etanercept ( ETA ) and adalimumab ( ADA ) in patients with polyarticular juvenile idiopathic arthritis ( pJIA ) is still limited . Objectives To investigate the rates of serious adverse events ( SAE ) and of events of special interest ( ESI ) under ETA and ADA treatment . Design , setting and participants Patients with pJIA were prospect ively observed in the national JIA biological register , Biologika in der Kinderrheumatologie , and its follow-up register , Juvenile arthritis Methotrexate/Biologics long-term Observation . Main outcomes and measures We calculated the relative risks of SAE and ESI for ETA and ADA compared with methotrexate ( MTX ) . Results Among the 1414 patients treated with ETA ( n=1414 ; 4461 exposure years ( EY ) ) and ADA ( n=320 ; 493 EY ) , significantly more SAE , infections and medically important infections were observed ( ETA : 4.5 , 5.7 , 0.9 ; ADA : 4.7 , 11.4 , 0.4 per 100 EY ) compared with those treated with MTX alone ( n=1455 ; 2.907 EY ; 2.6 , 5.5 , 0.5 per 100 EY ) . The risk for malignancies was not significantly increased for ETA and ADA compared with MTX ( 0.09 , 0.27 and 0.07/100 person-years ) . Patients under ETA monotherapy developed more frequently incident inflammatory bowel disease ( IBD ) and incident uveitis ( 0.5 and 0.8/100 EY ) than patients treated by ETA in combination with MTX ( 0.1 and 0.2/100 EY ) or MTX alone ( 0.03 and 0.1/100 EY ) . Conclusions and relevance Our data confirm the acceptable long-term tolerability of ETA and ADA in pJIA . However , whether the onset of IBD and uveitis during ETA monotherapy is a paradoxical effect or an inadequate response to therapy remains unclear and requires further investigation in this growing cohort
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 .