Baseline demographics (per-protocol population)
| Tocilizumab-SC 162 mg qw (n=558) | Tocilizumab-IV 8 mg/kg q4w (n=537) | |
|---|---|---|
| Sex, n (%) | ||
| Female | 461 (82.6) | 444 (82.7) |
| Age, years, mean (SD) | 52.4 (12.29) | 52.5 (12.50) |
| Weight, kg, mean (SD) | 74.07 (18.73) | 73.82 (18.99) |
| Weight group, n (%) | ||
| <60 kg | 131 (23.5) | 129 (24.0) |
| 60–100 kg | 374 (67.0) | 358 (66.7) |
| ≥100 kg | 53 (9.5) | 50 (9.3) |
| Duration of RA, years, mean (SD) | 8.7 (8.18) | 8.7 (7.94) |
| Tender joints (68-joint count), mean (SD) | 27.5 (15.54) | 28.8 (16.42) |
| Swollen joints (66-joint count), mean (SD) | 15.1 (9.03) | 16.8 (10.55) |
| HAQ-DI score, mean (SD) | 1.6 (0.62) | 1.7 (0.65) |
| Patient's assessment of pain, mean (SD) | 60.2 (22.48) | 61.8 (21.86) |
| Patient's global assessment of disease activity, mean (SD) | 67.3 (21.65) | 67.5 (21.63) |
| Physician's global assessment of disease activity, mean (SD) | 61.2 (17.91) | 62.6 (18.55) |
| RF positive, n (%) | 456 (73.5)* | 465 (74.4)† |
| ACPA positive, n (%) | 434 (72.2)‡ | 471 (74.4)§ |
| CRP level, mg/dL, mean (SD) | 2.1 (2.22) | 2.2 (2.25) |
| DAS28, mean (SD) | 6.6 (1.00) | 6.7 (1.01) |
| Patients receiving methotrexate,¶ n (%) | 503 (79.7)** | 514 (81.5)** |
| Patients receiving glucocorticoids at baseline, n (%) | 300 (53.8) | 290 (54.0) |
| Previously failed anti-TNF treatment, n (%) | 121 (21.7) | 112 (20.9) |
*Of patients tested in the safety population, n=620.
†Of patients tested in the safety population, n=625.
‡Of patients tested in the safety population, n=601.
§Of patients tested in the safety population, n=621.
¶Includes up to 6 months before the study screening and ongoing at baseline.
**Of the safety population, n=631.
ACPA, anti-citrullinated protein antibody; CRP, C-reactive protein; DAS28, disease activity score using 28 joints; DMARD, disease-modifying antirheumatic drug; HAQ-DI, health assessment questionnaire–disability index; IV, intravenous; qw, every week; q4w, every 4 weeks; RA, rheumatoid arthritis; RF, rheumatoid factor; SC, subcutaneous; TNF, tumour necrosis factor.