Skip to main content

Table 1 Patient demographics and baseline characteristics (efficacy full analysis set)

From: Sirukumab in rheumatoid arthritis refractory to sulfasalazine or methotrexate: a randomized phase 3 safety and efficacy study in Japanese patients

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)

  1. 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