Patients demographics and baseline characteristics (PP and ITT populations)
| Characteristics | Tocilizumab 8 mg/kg | Methotrexate | ||
| PP(n = 265) | ITT(n = 286) | PP(n = 259) | ITT(n = 284) | |
| Age (years), mean (SD) | 51.1 (13.1) | 50.7 (13.1) | 50.1 (12.8) | 50.0 (12.9) |
| Female, n (%) | 219 (83) | 236 (83) | 211 (81) | 224 (79) |
| Duration of disease, years | ||||
| Mean (SD) | 6.4 (7.7) | 6.4 (7.9) | 6.3 (7.9) | 6.2 (7.8) |
| Median (min–max) | 3.2 (0.1–44.7) | 3.1 (0.1–44.7) | 3.2 (0.2–49.6) | 3.1 (0.2–49.6) |
| Disease duration <2 years, n (%)* | 117 (41) | 125 (44) | ||
| DAS28, mean (SD) | 6.8 (1.0) | 6.8 (1.0) | 6.8 (0.9) | 6.8 (0.9) |
| Previous DMARDs/anti-TNF blockers (n), mean (SD) | 1.2 (1.3) | 1.2 (1.3) | 1.1 (1.4) | 1.1 (1.4) |
| Methotrexate naïve, n (%) | 176 (66) | 191 (67) | 171 (66) | 190 (67) |
| Previous use of anti-TNFs, n (%)* | 24 (8.3) | 21 (7.4) | ||
| Oral steroid use, n (%) | 128 (48) | 137 (48) | 122 (47) | 133 (47) |
| Haemoglobin value <LLN, n (%) | 101 (38) | 115 (44) | ||
| TJC, mean (SD) | 32.2 (14.7) | 31.8 (14.8) | 31.1 (13.9) | 31.1 (14.1) |
| SJC, mean (SD) | 19.3 (11.2) | 19.1 (11.0) | 18.9 (10.3) | 19.2 (10.6) |
| CRP (mg/dl), mean (SD) | 2.9 (3.2) | 3.0 (3.3) | 3.0 (3.4) | 3.1 (3.4) |
| ESR (mm/h), mean (SD) | 49.9 (27.6) | 49.9 (27.9) | 48.9 (26.2) | 49.4 (26.1) |
| HAQ-DI, mean (SD) | 1.6 (0.7) | 1.6 (0.7) | 1.5 (0.6) | 1.5 (0.6) |
| Pain VAS 100 mm, mean (SD) | 59.2 (22.5) | 58.7 (22.9) | 61.3 (20.4) | 61.5 (20.6) |
| Patient VAS 100 mm, mean (SD) | 64.0 (21.5) | 63.9 (21.9) | 65.4 (19.5) | 65.6 (19.8) |
| Physician VAS 100 mm, mean (SD) | 63.2 (15.7) | 63.0 (16.1) | 63.2 (16.3) | 63.6 (16.7) |
*Safety population (tocilizumab 8 mg/kg, n = 288; methotrexate, n = 284).
CRP, C-reactive protein; DAS28, 28-joint Disease Activity Score; DMARDs, disease-modifying antirheumatic drugs; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire-Disability Index; ITT, intention to treat; LLN, lower limit of normal; PP, per-protocol; SD, standard deviation; SJC, swollen join count; TJC, tender joint count; TNF, tumour necrosis factor; VAS, visual analogue scale.