Baseline patient (anti-TNF-IR population) demographics and characteristics.
| Placebo + DMARD n = 158 | TCZ 4 mg/kg + DMARD n = 161 | TCZ 8 mg/kg + DMARD n = 170 | ||||
|---|---|---|---|---|---|---|
| ≥ 50% Improvement in SJC66 by Week 8 | Yes, n = 55 | No, n = 103 | Yes, n = 81 | No, n = 80 | Yes, n = 84 | No, n = 86 |
| Age, yrs, mean (SD) | 54.3 (13.8) | 53.0 (13.0) | 52.0 (12.6) | 49.8 (12.3) | 53.0 (11.5) | 54.9 (13.7) |
| Sex, n (%) | ||||||
| Female | 48 (87.3) | 77 (74.8) | 67 (82.7) | 63 (78.8) | 71 (84.5) | 72 (83.7) |
| Male | 7 (12.7) | 26 (25.2) | 14 (17.3) | 17 (21.3) | 13 (15.5) | 14 (16.3) |
| Race, n (%) | ||||||
| American Indian or Alaska Native | 0 (0.0) | 2 (1.9) | 1 (1.2) | 2 (2.5) | 0 (0.0) | 1 (1.2) |
| Asian | 0 (0.0) | 1 (1.0) | 3 (3.7) | 1 (1.3) | 3 (3.6) | 2 (2.3) |
| Black | 2 (3.6) | 1 (1.0) | 6 (7.4) | 4 (5.0) | 4 (4.8) | 3 (3.5) |
| Other | 2 (3.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (2.4) | 3 (3.5) |
| White | 51 (92.7) | 99 (96.1) | 71 (87.7) | 73 (91.3) | 75 (89.3) | 77 (89.5) |
| Baseline DAS28, mean (SD) | 6.7 (1.0) | 6.8 (1.1) | 6.6 (1.0) | 6.9 (1.0) | 6.8 (1.0) | 6.8 (0.9) |
| Oral corticosteroids at baseline, n (%) | 31 (56.4) | 60 (58.3) | 45 (55.6) | 49 (61.3) | 48 (57.1) | 42 (48.8) |
| Baseline RF-positive, n (%) | 40 (72.7) | 78 (75.7) | 55 (67.9) | 62 (77.5) | 67 (79.8) | 67 (77.9) |
| Previous DMARD/anti-TNF, n, median (range) | 3 (1–10) | 4 (1–9) | 3 (1–9) | 4 (1–10) | 3 (1–11) | 3 (1–9) |
| Duration of RA, yrs, mean (SD) | 14.1 (11.6) | 9.9 (7.3) | 10.8 (9.1) | 11.2 (7.8) | 13.9 (10.1) | 11.3 (8.4) |
| At least moderate RAPID3 response by Week 8 | Yes, n = 80 | No, n = 78 | Yes, n = 90 | No, n = 71 | Yes, n = 113 | No, n = 57 |
| Age, yrs, mean (SD) | 52.4 (13.5) | 54.5 (13.0) | 50.7 (12.5) | 51.2 (12.5) | 52.2 (12.5) | 57.4 (12.4) |
| Sex, n (%) | ||||||
| Female | 67 (83.8) | 58 (74.4) | 78 (86.7) | 52 (73.2) | 93 (82.3) | 50 (87.7) |
| Male | 13 (16.3) | 20 (25.6) | 12 (13.3) | 19 (26.8) | 20 (17.7) | 7 (12.3) |
| Race, n (%) | ||||||
| American Indian or Alaska | 1 (1.3) | 1 (1.3) | 3 (3.3) | 0 (0.0) | 1 (0.9) | 0 (0.0) |
| Native | ||||||
| Asian | 1 (1.3) | 0 (0.0) | 1 (1.1) | 3 (4.2) | 1 (0.9) | 4 (7.0) |
| Black | 3 (3.8) | 0 (0.0) | 7 (7.8) | 3 (4.2) | 4 (3.5) | 3 (5.3) |
| Other | 2 (2.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (3.5) | 1 (1.8) |
| White | 73 (91.3) | 77 (98.7) | 79 (87.8) | 65 (91.5) | 103 (91.2) | 49 (86.0) |
| Baseline DAS28, mean (SD) | 6.9 (1.0) | 6.7 (1.1) | 6.8 (0.9) | 6.7 (1.0) | 6.9 (0.9) | 6.6 (0.9) |
| Oral corticosteroids at baseline, n (%) | 47 (58.8) | 44 (56.4) | 55 (61.1) | 39 (54.9) | 61 (54.0) | 29 (50.9) |
| Baseline RF-positive, n (%) | 58 (72.5) | 60 (76.9) | 72 (80.0) | 45 (63.4) | 95 (84.1) | 39 (68.4) |
| Previous DMARD/anti-TNF, n, median (range) | 3 (1–10) | 4 (1–9) | 4 (1–10) | 3 (1–9) | 3 (1–10) | 3 (1–11) |
| Duration of RA, yrs, mean (SD) | 11.3 (9.9) | 11.4 (8.5) | 12.2 (9.0) | 9.4 (7.5) | 11.7 (7.6) | 14.4 (12.0) |
DAS28: Disease Activity Score using 28 joints; DMARD: disease-modifying antirheumatic drug; RAPID3: Routine Assessment of Patient Index Data 3; RA: rheumatoid arthritis; SJC66: swollen joint count based on 66 joints; TNF: tumor necrosis factor; anti-TNF-IR: TNF inadequate response; TCZ: tocilizumab; RF: rheumatoid factor;