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 .
Double-blind, placebo-controlled randomized trial with adalimumab for treatment of juvenile onset ankylosing spondylitis (JoAS): significant short term improvement
Introduction While adalimumab is licensed for ankylosing spondylitis ( AS ) , open uncontrolled studies suggest therapeutic efficacy of TNF-inhibitors in juvenile onset AS ( JoAS ) . Methods A total of 32 patients aged 12 to 17 years with severe , active and refractory JoAS were enrolled in a multicenter , r and omized , double-blind , placebo-controlled parallel study of 12 weeks , followed by open-label adalimumab until week 24 for all patients . ASAS40 was used as the primary , and ASAS20 , PedACR and single items were used as the secondary outcome measures for the intention to treat population . Results A total of 17 patients were r and omized to receive adalimumab 40 mg/2 weeks and 15 patients received placebo .  Two patients ( one of each group ) discontinued prematurely due to insufficient efficacy and were labeled as non-responders . In the double-blind part , more patients on adalimumab achieved an ASAS40 at week 4 ( 41 % ) , week 8 ( 53 % ) and week 12 ( 53 % ) than on placebo ( 20 % , 33 % , 33 % ) , while differences at week 8 only reached borderline significance ( P = 0.05 ) . Also , at 4 , 8 and 12 weeks ASAS20/PedACR30/70 response rates were higher in the adalimumab group ( 53%/53%/29 % ; 59%/76%/41 % ; 53%/65%/53 % ) compared to placebo ( 27%/27%/7 % ; 27%/33%/13 % ; 33%/40%/27 % ) . In the adalimumab group a significant decrease of all disease activity parameters was noted at week 12 and was even more pronounced at week 24 . At week 12 the Bath Ankylosing Spondylitis Disease activity spinal inflammation score decreased by 65 % ( P < 0.001 ) , the back pain score decreased by 50 % ( P < 0.005 ) , the Bath AS Functional Index ( BASFI ) score decreased by 47 % ( P < 0.02 ) , while the Childhood Health Assessment Question naire-Disability Index ( CHAQ-DI ) score improved by 65 % ( P < 0.005 ) . ANCOVA analysis demonstrated superiority of adalimumab over placebo for the physician global assessment of disease activity , parents ' global assessment of subject 's overall well-being , active joint count ( all P < 0.05 ) and erythrocyte sedimentation rate ( ESR ) ( P < 0.01).During the 12-week controlled phase , 29 AEs occurred in 10 patients on placebo compared to 27 AEs in 11 patients on adalimumab . Injection site reactions were the most common adverse events . There were 17 various infections occurring in the double-blind phase , 8 on placebo , 9 on adalimumab and a further 19 in the open label period . Conclusions Adalimumab was well tolerated and highly effective in a double-blind r and omized trial in patients with JoAS . Treatment effects rapidly occurred and persisted for at least 24 weeks of treatment . Trial registration EudraCT 2007 - 003358 - 27
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 .