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Table 1 Patient demographics, disease history, and baseline disease characteristics

From: ASP5094, a humanized monoclonal antibody against integrin alpha-9, did not show efficacy in patients with rheumatoid arthritis refractory to methotrexate: results from a phase 2a, randomized, double-blind, placebo-controlled trial

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
  1. aSafety analysis set
  2. bFull analysis set
  3. cBased on 100-mm analog scale
  4. 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