Demographic and disease characteristics at baseline
| Tocilizumab 8 mg/kg <30 kg n=34 | Tocilizumab 10 mg/kg <30 kg n=35 | Tocilizumab 8 mg/kg ≥30 kg n=119 | All Tocilizumab N=188* | |
|---|---|---|---|---|
| Age (years) | 7.6 (2.71) | 6.9 (3.02) | 13.1 (2.78) | 11.0 (4.01) |
| Females, n (%) | 24 (71) | 30 (86) | 90 (76) | 144 (77) |
| Weight (kg) | 22.4 (5.3) | 20.7 (5.7) | 50.0 (12.6) | 39.6 (17.3) |
| Disease duration (years) | 3.5 (2.57) | 3.4 (2.39) | 4.7 (4.16) | 4.2 (3.67) |
| Rheumatoid factor positive, n (%) | 2 (6) | 4 (11) | 48 (40) | 54 (29) |
| Previous DMARD use, n (%) | 26 (76) | 21 (60) | 87 (73) | 134 (71) |
| Previous biological agent use, n (%)† | 6 (18) | 8 (23) | 47 (39) | 61 (32) |
| Joints with active arthritis, n | 21.2 (13.6) | 23.9 (18.3) | 18.9 (13.0) | 20.3 (14.3) |
| Joints with LOM, n | 17.3 (13.3) | 23.1 (19.2) | 16.0 (12.7) | 17.6 (14.4) |
| Assessment of patient overall well-being VAS | 59.1 (26.2) | 51.5 (26.9) | 51.6 (24.1) | 52.9 (25.0) |
| Physician global assessment of JIA activity VAS | 64.7 (18.5) | 64.7 (20.5) | 59.4 (21.3) | 61.4 (20.7) |
| CRP (mg/L)‡ | 26.6 (33.6) | 21.8 (32.3) | 22.8 (38.8) | 23.3 (36.6) |
| CHAQ-DI score | 1.8 (0.68) | 1.7 (0.71) | 1.2 (0.69) | 1.4 (0.74) |
| ESR (mm/h)§ | 36.6 (23.0) | 35.1 (24.1) | 34.2 (26.7) | 34.8 (25.5) |
| Concurrent MTX use, n (%) | 30 (88) | 29 (83) | 89 (75) | 148 (79) |
| Dose (mg/m2/week) | 13.8 (2.9) | 16.5 (11.1) | 11.6 (2.7) | 13.0 (5.7) |
| Concurrent glucocorticoid use, n (%)¶ | 18 (53) | 15 (43) | 54 (45) | 87 (46) |
| Dose (mg/kg/day)¶ | 0.15 (0.038) | 0.15 (0.033) | 0.12 (0.052) | 0.13 (0.048) |
Values are mean (SD) unless stated otherwise.
*Included are all patients randomly assigned to receive tocilizumab 10 mg/kg (patients weighing <30 kg), tocilizumab 8 mg/kg (patients weighing <30 kg) or tocilizumab 8 mg/kg (patients weighing ≥30 kg) in part 1.
†Nine per cent of patients previously received three or more biological agents. TNF inhibitors were administered to 56 patients, anakinra to 5 patients, abatacept to 5 patients and canakinumab to 1 patient.
‡Standard reference range was 0–10 mg/L.
§Standard reference range was 0–18 mm/h.
¶These were measured in prednisone equivalents.
CHAQ-DI, Childhood Health Assessment Questionnaire-Disability Index; CRP, C-reactive protein; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; JIA, juvenile idiopathic arthritis; LOM, limitation of movement; MTX, methotrexate; TNF, tumour necrosis factor; VAS, visual analogue scale (range, 0–100 mm).