Table 1.
Summary of baseline patient demographic and disease characteristics
| Part 1 | Part 2 | All randomised patients | ||
| Placebo | Golimumab | |||
| Patients, n | 173 | 76 | 78 | 154 |
| Female, n (%) | 131 (75.7) | 57 (75.0) | 59 (75.6) | 116 (75.3) |
| Age, years | 11.2±4.4 | 11.1±4.5 | 11.1±4.4 | 11.1±4.5 |
| JIA categories, n (%) | ||||
| Polyarticular RF-negative | 90 (52.0) | 40 (52.6) | 37 (47.4) | 77 (50.0) |
| Polyarticular RF-positive | 34 (19.7) | 13 (17.1) | 18 (23.1) | 31 (20.1) |
| Oligoarticular extended | 22 (12.7) | 9 (11.8) | 12 (15.4) | 21 (13.6) |
| Psoriatic arthritis | 15 (8.7) | 7 (9.2) | 8 (10.3) | 15 (9.7) |
| Systemic JIA | 12 (6.9) | 7 (9.2) | 3 (3.8) | 10 (6.5) |
| JIA CRVs | ||||
| Joints with active arthritis | 15.0±10.0 | 15.0±10.6 | 14.8±9.2 | 14.9±9.9 |
| Joints with LROM | 12.2±10.6 | 11.6±10.9 | 12.3±9.9 | 11.9±10.3 |
| PGA | 5.6±2.0 | 5.5±2.0 | 5.7±1.8 | 5.6±1.9 |
| PatGA | 4.4±2.3 | 4.5±2.3 | 4.3±2.5 | 4.4±2.4 |
| Physical function (CHAQ) | 1.0±0.7 | 1.0±0.7* | 0.9±0.7 | 1.0±0.7 |
| ESR, mm/h | 21.6±19.9 | 12.6±12.0 | 13.9±12.9 | 13.3±12.4 |
| CRP, mg/dL | 1.1±2.2 | 1.2±2.4 | 0.9±1.9 | 1.0±2.2 |
| JADAS71-ESR score | 25.8±12.3 | 25.6±11.4* | 25.7±12.8 | 25.7±12.1 |
| Concomitant medications | ||||
| Oral prednisone | ||||
| Patients, n (%) | 42 (24.3) | 14 (18.4) | 19 (24.4) | 33 (21.4) |
| Dose, mg/day | 5.3±2.8 | 4.0±2.3 | 5.6±2.6 | 4.9±2.5 |
| Dose, mg/kg/day | 0.13±0.07 | 0.10±0.03 | 0.14±0.07 | 0.12±0.06 |
| Methotrexate | ||||
| Dose, mg/m2 BSA/week | 12.8±3.3 | 12.6±3.4 | 13.3±3.4 | 12.9±3.4 |
| Dose, mg/week‡ | 16.0±5.0† | 15.4±4.5 | 16.7±5.4 | 16.1±5.0 |
| Prior biological DMARD use | ||||
| Adalimumab | 2 (1.2) | 1 (1.3) | 0 | 1 (0.6) |
| Etanercept | 16 (9.2) | 7 (9.2) | 6 (7.7) | 13 (8.4) |
| Infliximab | 3 (1.7) | 1 (1.3) | 2 (2.6) | 3 (1.9) |
Data are presented as mean ± SD unless otherwise noted.
*n=75.
†n=172.
‡127 (73.4%) patients had previously received MTX ≥15 mg/week.
BSA, body surface area; CHAQ, Children’s Health Assessment Questionnaire; CRP, C reactive protein (normal: 1.0 mg/dL); CRVs, core response variables; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; JADAS71-ESR, Juvenile Arthritis Disease Activity Score using ESR; JIA, juvenile idiopathic arthritis; LROM, limitation in range of motion; PGA, physician global assessment of disease activity; PatGA, global assessment of patient overall well-being; RF, rheumatoid factor.