Table 1.
Patient demographics and baseline characteristics (efficacy full analysis set)
| Characteristic | Sirukumab 50 mg q4w (N = 61) | Sirukumab 100 mg q2w (N = 61) | All (N = 122) |
|---|---|---|---|
| Sex (women), n (%) | 47.0 (77.0) | 43.0 (70.5) | 90 (73.8) |
| Age (years), mean (SD) | 55.4 (10.70) | 54.7 (12.16) | 55.1 (11.41) |
| Weight (kg), mean (SD) | 55.0 (12.23) | 56.8 (9.71) | 55.9 (11.03) |
| Height (cm), mean (SD) | 157.9 (7.90) | 158.4 (7.80) | 158.1 (7.82) |
| BMI (kg/m2), mean (SD) | 22.0 (3.98) | 22.6 (3.13) | 22.3 (3.58) |
| Disease duration (years), median (range) | 5.0 (0.4–41.0) | 6.3 (0.4–30.0) | 5.8 (0.4–41.0) |
| Swollen joints (number 0–66), median (range) | 11.0 (6.0–22.0) | 11.0 (5.0–32.0) | 11.0 (5.0–32.0) |
| Tender joints (number 0–68), median (range) | 14.0 (6.0–56.0) | 15.0 (5.0–48.0) | 14.0 (5.0–56.0) |
| Patient’s assessment of pain (VAS; 0–10 cm), median (range) | 7.4 (0.7–10.0) | 7.4 (0.5–10.0) | 7.4 (0.5–10.0) |
| Patient’s global assessment of disease activity (VAS; 0–10 cm), median (range) | 7.6 (0.6–10.0) | 7.1 (0.6–10.0) | 7.5 (0.6–10.0) |
| Physician’s global assessment of disease activity (VAS; 0–10 cm), median (range) | 6.5 (2.6–10.0) | 6.9 (2.0–10.0) | 6.6 (2.0–10.0) |
| HAQ-DI score (0–3), median (range) | 1.4 (0.00–2.75) | 1.1 (0.00–2.75) | 1.3 (0.00–2.75) |
| CRP (mg/dl), median (range) | 2.7 (0.20– 9.20) | 2.5 (0.31–16.60) | 2.6 (0.20–16.60) |
| DAS28-CRP score, median (range) | 5.6 (5.14–6.11) | 5.9 (4.88–6.57) | 5.7 (4.93–6.29) |
| SDAI score, median (range) | 33.2 (28.42–40.38) | 38.2 (26.83–52.20) | 34.7 (27.70–42.48) |
| CDAI score, median (range) | 30.9 (24.90–37.80) | 33.5 (24.20–47.40) | 31.8 (24.60–38.80) |
| Rheumatoid factor-positive, n (%) | 48 (78.7) | 44 (72.1) | 92 (75.4) |
| Anti-CCP antibody positive, n (%) | 55 (90.2) | 51 (83.6) | 106 (86.9) |
BMI body mass index, CCP cyclic citrullinated peptide, CDAI Clinical Disease Activity Index, CRP C-reactive protein, HAQ-DI Health Assessment Questionnaire-Disability Index, q4w once in 4 weeks, q2w once in 2 weeks, SDAI Simplified Disease Activity Index, SD standard deviation, VAS visual analog scale