- Oral presentation
- Open Access
Long-term efficacy and safety of adalimumab in 4-12 year old patients with juvenile idiopathic arthritis
© Ruperto et al; licensee BioMed Central Ltd. 2011
- Published: 14 September 2011
- Juvenile Idiopathic Arthritis
- Injection Site Reaction
- Juvenile Idiopathic Arthritis Patient
Adalimumab (ADA) has been shown to be safe and effective in a study of juvenile idiopathic arthritis (JIA) patients aged 4-17 years at a dose of 24 mg/m2 every other week.1
To determine the long-term efficacy and safety of ADA in a subgroup of BSA-dosed JIA patients aged 4-12 years.
Patients with polyarticular course JIA (N=171) were enrolled in a phase 3, randomized-withdrawal, double-blind (DB), stratified, parallel-group study, which consisted of a 16-wk open-label (OL) lead-in, a 32-wk DB phase, and an up to 5 year OL extension phase that included BSA dosing prior to a switch to fixed dose (FD). Patients on ADA (24 mg/m2; max dose, 40 mg) were evaluated based on ACR pediatric response criteria for improvement (ACR Pedi 30/50/70/90) and monitored for adverse events (AEs).
ACR indicates American College of Rheumatology; AJC, active joint count; DI-CHAQ, disability index of childhood health assessment questionnaire; PaGA, parent global assessment of well-being; PhyGA, physician’s global assessment of disease activity.
ADA was efficacious and well tolerated in a BSA-dosed JIA subpopulation aged 4-12 years. ACR Pedi 30/50/70/90 responses were maintained through 106 weeks. Overall, efficacy was comparable to the entire study population, in whom maintenance of response was observed throughout the entire study with ADA for up to 6 years.
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