Baseline patient demographics and disease characteristics (full analysis set)
| PBO Q2W (N=22) | OKZ 60 mg Q2W (N=20) | OKZ 120 mg Q2W (N=22) | OKZ 240 mg Q2W (N=23) | PBO Q4W (N=22) | OKZ 60 mg Q4W (N=22) | OKZ 120 mg Q4W (N=23) | OKZ 240 mg Q4W (N=22) | TCZ 8 mg/kg Q4W (N=43) | All patients (N=219) | |
|---|---|---|---|---|---|---|---|---|---|---|
| Population demographic | ||||||||||
| Age, mean years | 59.36 | 55.50 | 53.09 | 55.48 | 58.18 | 52.64 | 53.52 | 54.55 | 56.58 | 55.53 |
| Female, % | 86.4 | 80.0 | 86.4 | 91.3 | 77.3 | 90.9 | 87.0 | 77.3 | 86.0 | 84.9 |
| Prior and concomitant medication | ||||||||||
| Prior failed TNF-inhibitor, n (%) | ||||||||||
| 1 | 12 (54.5) | 14 (70.0) | 12 (54.5) | 14 (60.9) | 12 (54.5) | 12 (54.5) | 12 (52.2) | 13 (59.1) | 25 (58.1) | 126 (57.5) |
| ≥2 | 10 (45.5) | 6 (30.0) | 10 (45.5) | 9 (39.1) | 10 (45.5) | 10 (45.5) | 11 (47.8) | 9 (40.9) | 18 (41.9) | 93 (42.5) |
| Concomitant MTX, n (%) | 20 (90.9) | 19 (95.0) | 20 (90.9) | 22 (95.7) | 21 (95.5) | 21 (95.5) | 22 (95.7) | 21 (95.5) | 42 (97.7) | 208 (95.0) |
| Baseline disease characteristics | ||||||||||
| Disease duration, median years | 10.56 | 12.30 | 8.07 | 8.22 | 7.45 | 10.89 | 11.58 | 7.83 | 10.55 | 9.99 |
| CRP >15 mg/L, n (%) | 5 (22.7) | 4 (20.0) | 6 (27.3) | 8 (34.8) | 7 (31.8) | 7 (31.8) | 7 (30.4) | 6 (27.3) | 16 (37.2) | 66 (30.1) |
| DAS28(CRP), mean | 5.53 | 5.57 | 5.96 | 5.94 | 5.69 | 6.14 | 5.61 | 5.83 | 5.72 | 5.77 |
| DAS28(CRP) >5.1, n (%) | 14 (63.6) | 14 (70.0) | 15 (68.2) | 18 (78.3) | 16 (72.7) | 19 (86.4) | 16 (69.6) | 14 (63.6) | 33 (76.7) | 159 (72.6) |
| TJC, median (min-max) | 32.74 (9.3–56.7) | 18.50 (9.0–68.0) | 26.50 (8.0–62.0) | 33.00 (6.0–51.0) | 22.00 (8.0–58.0) | 36.00 (9.0–68.0) | 29.29 (7.0–57.0) | 25.86 (11.0–59.8) | 25.00 (4.0–66.0) | 27.00 (4.0–68.0) |
| SJC, median (min-max) | 12.00 (6.0–30.0) | 16.50 (6.0–50.0) | 14.50 (6.0–58.0) | 18.86 (7.0–41.6) | 13.17 (4.0–44.7) | 21.50 (6.0–58.0) | 13.00 (5.2–36.7) | 14.50 (6.0–38.9) | 12.38 (6.0–32.0) | 14.00 (4.0–58.0) |
| CDAI, median (min-max) | 36.83 (20.7–53.9) | 36.28 (22.2–66.3) | 42.90 (20.2–71.2) | 45.20 (18.1–64.3) | 36.25 (19.0–60.0) | 46.60 (21.4–69.2) | 39.92 (14.3–59.7) | 40.50 (24.2–59.2) | 35.65 (17.7–62.5) | 38.90 (14.3–71.2) |
| HAQ-DI, median (min-max) | 1.56 (0.3–2.6) | 1.63 (0.5–2.1) | 1.44 (0.6–3.0) | 1.75 (0.6–2.6) | 1.38 (0.0–2.4) | 1.81 (0.1–2.9) | 1.50 (0.3–2.9) | 1.69 (0.0–2.8) | 1.63 (0.0–2.9) | 1.63 (0.0–3.0) |
CDAI, Clinical Disease Activity Index; CRP, C-reactive protein; DAS28, Disease Activity Score 28-joint count; HAQ-DI, HAQ (Health Assessment Questionnaire) Disability Index; MTX, methotrexate; OKZ, Olokizumab; PBO, placebo; SJC, swollen joint count; TCZ, Tocilizumab; TJC, tender joint count; TNF, tumour necrosis factor.