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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