PReS-FINAL-2001: The impact of adalimumab on growth in patients with juvenile idiopathic arthritis

Methods Pts aged 4-17 with polyarticular course JIA were enrolled in a phase 3, randomized-withdrawal, doubleblind (DB), stratified, parallel-group study, which consisted of a 16-wk open-label (OL) lead-in phase, a 32-wk DB phase, and an OL extension (OLE) phase. In the OLE phase, pts were dosed based on body surface area (24 mg/m2, max 40 mg dose), followed by a switch to 20 or 40 mg eow based on a body weight of ≤30 kg or >30 kg, respectively. To enter the DB phase, pts had to achieve an American College of Rheumatology Pediatric score ≥30% (ACR Pedi 30) during the OL lead-in. Pts could enter the OLE after 32 wks in the DB phase or at time of first flare (whichever came sooner). For this analysis, pts in the DB phase were grouped by baseline weight into 2 groups: ≤33rd percentile and >33rd percentile based on the US Centers for Disease Control and Prevention (CDC) growth charts. All pts who received ≥1 dose of ADA ± methotrexate (MTX) were included in the analysis. Mean CDC percentile changes in height, weight, and body mass index (BMI) percentiles were calculated through 104 weeks. Growth and efficacy data were analyzed using last observation carried forward (LOCF).