Table 1.
Baseline demographics and disease characteristics (pooled placebo-controlled population and TCZ all-exposure population)
| Pooled placebo-controlled population |
TCZ all-exposure population |
||||
|---|---|---|---|---|---|
| TCZ±MTX/DMARD n=2644 |
Placebo+MTX/DMARDs n=1454 |
Total N=4009 |
DMARD-IR n=2904 |
aTNF-IR n=464 |
|
| Female, n (%) | 2179 (82) | 1184 (81) | 3286 (82) | 2398 (83) | 373 (80) |
| Age, years | 52.2 (12.50) | 51.8 (12.83) | 52.0 (12.54) | 52.2 (12.39) | 52.6 (12.73) |
| Race, n (%) | |||||
| White | 1952 (74) | 1082 (74) | 2970 (74) | 2075 (71) | 421 (91) |
| Asian | 202 (8) | 112 (8) | 304 (8) | 247 (9) | 11 (2) |
| American | |||||
| Indian/Alaska | 190 (7) | 95 (7) | 274 (7) | 218 (8) | 5 (1) |
| Native | |||||
| Black | 113 (4) | 60 (4) | 176 (4) | 124 (4) | 20 (4) |
| Other | 187 (7) | 105 (7) | 285 (7) | 240 (8) | 7 (2) |
| Duration of RA, years | 9.2 (8.41) | 8.7 (8.47) | 9.3 (8.51) | 9.4 (8.33) | 11.9 (9.10) |
| DAS28 | 6.7 (0.98) | 6.7 (0.96) | 6.4 (1.28) | 6.4 (1.23) | 6.7 (1.12) |
| Oral corticosteroid use, n (%) | NA | NA | 2318 (58) | 1746 (60) | (275 (59) |
| ≥1 background DMARD, n (%) | NA | NA | 3456 (86) | 2887 (99) | 464 (100) |
| CRP, mg/dL | 2.6 (3.03) | 2.7 (3.64) | 2.4 (2.90) | 2.3 (2.73) | 3.1 (3.59) |
| ESR, mm/h | 48.3 (26.75) | 49.1 (27.23) | 46.1 (26.83) | 46.1 (26.44) | 50.2 (28.24) |
| Tender joint count | 30.4 (15.36) | 29.9 (15.13) | 28.0 (16.60) | 27.8 (16.41) | 31.0 (16.57) |
| Swollen joint count | 18.8 (10.8) | 18.5 (10.61) | 17.3 (11.51) | 17.3 (11.32) | 18.7 (11.42) |
All data are mean (SD) unless stated otherwise.
aTNF-IR, antitumour necrosis factor-inadequate responders; CRP, C reactive protein; DAS28, Disease Activity Score based on 28 joints; DMARD, disease-modifying antirheumatic drug; DMARD-IR, disease-modifying antirheumatic drug-inadequate responders; ESR, erythrocyte sedimentation rate; MTX, methotrexate; NA, not available; RA, rheumatoid arthritis; TCZ, tocilizumab.