Table 1.
Patient demographics, disease history, and baseline disease characteristics
| Parameter | ||
|---|---|---|
| Demographics and disease historya | Placebo (n = 33) | ASP5094 (n = 33) |
| Age, years, mean ± SD | 57.9 ± 9.1 | 55.7 ± 13.8 |
| Median (range) | 57.0 (41–77) | 55.5 (30–77) |
| ≥ 65 years, n (%) | 9 (27.3%) | 10 (30.3%) |
| Female, n (%) | 26 (78.8%) | 21 (63.6%) |
| Weight, kg, mean ± SD | 57.82 ± 11.13 | 62.83 ± 15.16 |
| BMI, kg/m2, mean ± SD | 22.81 ± 4.09 | 24.33 ± 4.20 |
| Duration of RA, years, mean ± SD | 9.28 ± 8.27 | 9.87 ± 9.41 |
| MTX dose at screening, mg/week, mean ± SD | 10.08 ± 2.86 | 9.65 ± 3.46 |
| > 0 ≤ 8 mg/week, n (%) | 10 (30.3) | 15 (45.5) |
| > 8 ≤ 12 mg/week, n (%) | 18 (54.5) | 11 (33.3) |
| > 12 mg/week, n (%) | 5 (15.2) | 7 (21.2) |
| Baseline disease activity, mean ± SDb | Placebo (n = 33) | ASP5094 (n = 32) |
| Tender joint count (68 joints) | 12.3 ± 5.7 | 12.6 ± 5.1 |
| Swollen joint count (66 joints) | 11.2 ± 5.1 | 11.5 ± 4.6 |
| Patient’s global assessment of arthritis paina | 42.58 ± 23.20 | 54.42 ± 23.13 |
| Patient’s global assessment of arthritisa | 47.94 ± 22.36 | 51.42 ± 23.83 |
| Physician’s global assessment of arthritisa | 51.82 ± 16.20 | 52.89 ± 15.78 |
| CRP, mg/dL | 1.406 ± 1.031 | 1.668 ± 1.418 |
| ESR, mm/h | 42.48 ± 21.26 | 43.09 ± 24.55 |
| DAS28-CRP score | 4.98 ± 0.68 | 5.15 ± 0.61 |
| DAS28-ESR score | 5.66 ± 0.79 | 5.67 ± 0.82 |
| SDAI score | 28.90 ± 8.39 | 30.32 ± 8.21 |
| CDAI score | 27.49 ± 8.17 | 28.65 ± 8.10 |
| HAQ-DI score | 0.750 ± 0.537 | 0.754 ± 0.712 |
aSafety analysis set
bFull analysis set
cBased on 100-mm analog scale
BMI body mass index, CDAI Clinical Disease Activity Index, CRP C-reactive protein, DAS28 Disease Activity Score in 28 Joints, ESR erythrocyte sedimentation rate, FAS full analysis set, HAQ-DI Health Assessment Questionnaire-Disability Index, MTX methotrexate, RA rheumatoid arthritis, SD standard deviation, SDAI, Simplified Disease Activity Index