Baseline demographics and disease characteristics (ITT population)
| Placebo+MTX n=287 | 4 mg/kg TCZ+MTX n=288 | 8 mg/kg TCZ+MTX n=290 | 8 mg/kg TCZ +placebo n=292 | Missing values (all groups), n | |
|---|---|---|---|---|---|
| Female, n (%) | 229 (80) | 228 (79) | 228 (79) | 219 (75) | 0 |
| Age, years | 49.6±13.10 (50.0) | 51.2±13.84 (53.0) | 49.5±13.70 (50.5) | 49.9±13.22 (51.0) | 0 |
| Duration of RA, years | 0.4±0.48 (0.2) | 0.4±0.49 (0.2) | 0.5±0.53 (0.3) | 0.5±0.48 (0.2) | 0 |
| DMARD naive, n (%)* | 228/282 (80.9) | 236/289 (81.7) | 230/290 (79.3) | 223/292 (76.4) | 4 |
| Number of previous DMARDs† | 0.2±0.41 (0.0) | 0.2±0.41 (0.0) | 0.2±0.49 (0.0) | 0.3±0.52 (0.0) | 0 |
| 0, n (%) | 228 (80.9) | 236 (81.7) | 230 (79.3) | 223 (76.4) | – |
| 1, n (%) | 53 (18.8) | 51 (17.6) | 53 (18.3) | 60 (20.5) | – |
| 2, n (%) | 1 (0.4) | 2 (0.7) | 6 (2.1) | 8 (2.7) | – |
| 3, n (%) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 1 (0.3) | – |
| Receiving corticosteroids, n (%) | 109 (38) | 107 (37) | 95 (33) | 118 (40) | 0 |
| RF positive, n (%) | 254 (89) | 255 (89) | 264 (91) | 262‡ (90) | 1 |
| Anti-CCP antibody positive, n (%) | 246 (86) | 245§ (86) | 252 (87) | 247 (86) | 6 |
| DAS28-ESR | 6.6±0.99 (6.5) | 6.7±1.05 (6.7) | 6.7±1.11 (6.8) | 6.7±0.99 (6.7) | 0 |
| CRP, mg/dL | 2.31±2.667 (1.28) | 2.59±3.053 (1.58) | 2.58±2.978 (1.69) | 2.48±3.186 (1.26) | 0 |
| ESR, mm/h | 50.4±26.81 (44.0) | 55.7±30.62 (48.0) | 52.8±30.15 (46.0) | 51.3±28.39 (41.5) | 0 |
| Tender joint count (68 joints) | 27.4±16.54 (23.0) | 28.1±15.63 (25.0) | 28.7±16.74 (24.5) | 28.7±16.33 (25.0) | 0 |
| Swollen joint count (66 joints) | 16.2±10.44 (13.0) | 16.1±10.16 (13.0) | 17.6±12.38 (14.0) | 16.5±10.10 (13.0) | 0 |
| HAQ-DI score | 1.48±0.665 (1.50) | 1.62±0.662 (1.75) | 1.50±0.625 (1.50) | 1.58±0.672 (1.63) | 11 |
| Patient pain VAS | 59.8±22.02 (62.0) | 59.5±22.62 (61.0) | 61.6±22.10 (65.0) | 62.5±21.82 (65.0) | 4 |
| Physician VAS | 62.7±17.27 (65.0) | 62.4±17.03 (63.0) | 63.6±18.12 (65.0) | 63.9±18.09 (65.0) | 0 |
| Patient global VAS | 63.8±21.51 (66.0) | 65.3±22.50 (66.0) | 66.5±21.46 (70.0) | 67.5±22.39 (71.0) | 0 |
| mTSS | 5.66±14.581 (1.50) | 7.72±17.155 (2.00) | 6.17±11.078 (2.00) | 6.85±16.100 (1.50) | 4 |
| JSN score | 2.34±7.452 (0.00) | 3.60±9.600 (0.00) | 2.67±6.488 (0.00) | 3.00±8.598 (0.00) | 4 |
| Erosion score | 3.32±7.642 (1.00) | 4.13±8.510 (1.50) | 3.49±5.722 (1.50) | 3.85±8.299 (1.00) | 4 |
Data are presented as mean±SD (median) unless stated otherwise.
*Reported for the safety population. Note: all patients were MTX naive per protocol.
†Rates of previous DMARD use included for placebo+MTX, 4 mg/kg TCZ+MTX, 8 mg/kg TCZ+MTX and 8 mg/kg TCZ+placebo, respectively, are as follows: hydroxychloroquine, 7%, 4%, 8% and 10%; chloroquine, 4%, 3%, 3% and 4%; sulfasalazine, 6%, 9%, 10% and 9%; leflunomide, 2%, 1%, 1% and 3%; azathioprine, 0%, 0%, 1% and 1%; gold, 0%, <1%, 0% and <1%; and penicillamine, 0%, 0%, <1% and 0%.
‡Based on 291 patients.
§Based on 286 patients.
CCP, cyclic citrullinated peptide; CRP, C reactive protein; DAS28, Disease Activity Score using 28 joints; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire–Disability Index; ITT, intent-to-treat; JSN, joint space narrowing; mTSS, modified total Sharp score; MTX, methotrexate; RA, rheumatoid arthritis; RF, rheumatoid factor; TCZ, tocilizumab; VAS, Visual Analogue Scale.