No abstract

Objective. To evaluate the safety and efficacy of infliximab in the treatment of juvenile rheumatoid arthritis (JRA).Methods. This was an international, multicenter, randomized, placebo-controlled, double-blind study. One hundred twenty-two children with persistent polyarticular JRA despite prior methotrexate (MTX) therapy were randomized to receive infliximab or placebo ClinicalTrials.gov identifier: NCT00036374.

OBJECTIVES To determine if aggressive treatment initiated early in the course of rheumatoid factor positive or negative polyarticular juvenile idiopathic arthritis (poly-JIA) can induce clinical inactive disease (CID) within 6 months. METHODS Between May 2007 and October 2010 a multi-center, prospective, double blind, randomized, placebo controlled trial of two aggressive treatments was conducted in 85 children aged 2 to 16 years with polyarticular JIA of less than 12 months duration. Patients received either methotrexate 0.5 mg/kg/wk SQ (40 mg max), etanercept 0.8 mg/kg/wk (50 mg max), prednisolone 0.5 mg/kg/d (60 mg max) tapered to 0 by 17 weeks (Arm 1), or methotrexate (same dose as Arm 1), etanercept placebo, and prednisolone placebo (Arm 2). The primary outcome was CID at 6 months. An exploratory phase determined the rate of clinical remission on medication (6 months of continuous CID) at 12 months. RESULTS By 6 months, 17 of 42 (40%) of patients in Arm 1 and 10 of 43 (23%) in Arm 2 had achieved CID (X2 = 2.91; p = 0.088). After 12 months, 9 patients in Arm 1 and 3 in Arm 2 achieved clinical remission on medication (p = 0.0534). There were no significant inter-arm differences in adverse events. CONCLUSIONS Although this study did not meet its primary endpoint, early aggressive therapy in this cohort of children with recent onset polyarticular JIA resulted in substantial proportions of patients in both arms achieving CID by 6 months and clinical remission on medication within 12 months of treatment.

The PedsQL 4.0 (Pediatric Quality of Life Inventory) Generic Core Scales are child self-report and parent proxy-report scales developed to measure health-related quality of life (HRQOL) in children and adolescents ages 2-18. The PedsQL 4.0 Generic Core Scales consist of 23 items applicable for healthy school and community populations and pediatric populations with acute and chronic health conditions. The 4 PedsQL 4.0 Generic Core Scales (Physical, Emotional, Social, School) were administered to 209 children and 269 parents (289 subjects accrued overall) recruited from pediatric cardiology, orthopedics, and rheumatology clinics. Sensitivity, responsiveness, and the impact on clinical decision-making were determined. The PedsQL was differentially sensitive to increasing degrees of cardiac disease severity in the cardiology clinic setting and responsive to clinical change over time in the pediatric orthopedics clinic setting. In the pediatric rheumatology clinic setting, the PedsQL demonstrated an impact on clinical decision-making, resulting in subsequent increases in HRQOL.