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Table 1 Baseline demographics and disease characteristics

From: Intravenous dosing of tocilizumab in patients younger than two years of age with systemic juvenile idiopathic arthritis: results from an open-label phase 1 clinical trial

 

Patients < 2 years of age < 30 kg (NP25737) n = 11

Patients 2–17 years of age (TENDER)a < 30 kg n = 38

Age, years

1.3 (0.33)

6.6 (3.3)

 Min, max

0.83, 1.83

2, 16

Females, n (%)

7 (63.6)

18 (47)

Weight, kg

9.97 (1.38)

20.07 (5.93)

Disease duration, years

0.319 (0.17)

4.03 (3.160)

JADAS-71, median (min, max)

20.50b (9.0, 37.6)

32.70 (12.6, 96.1)

No. of active joints, median (min, max)

4.0 (2, 19)

13.5 (3, 71)

No. of joints with LOM, median (min, max)

3.0 (0, 15)

14.5 (0, 67)

Physician global VAS score, median (min, max)

62.0 (30, 98)

71.0 (28, 100)

ESR, mm/h

59.4b (27.5)

64.1 (29.76)

CRP level, mg/L, median (min to max)

33.3 (18.0 to 1190.0)

123.2 (5.36 to 1704.9)

Fever, n (%)

5 (45.5)

20 (53.0)c

Rash, n (%)

8 (72.7)

13 (34.0)

No. of patients exposed to previous biologics, n (%)

2 (18.2)d

28 (73.7)

Previous MTX use, n (%)

2 (18.2)

31 (81.6)

Previous glucocorticoid use, n (%)

8 (72.7)

36 (94.7)

  1. All values are mean (SD) unless otherwise noted
  2. CRP C-reactive protein, ESR erythrocyte sedimentation rate, IV intravenous, JADAS-71 Juvenile Arthritis Disease Activity Score in 71 joints, LOM limitation of movement, MTX methotrexate, Q2W every 2 weeks, SD standard deviation, TCZ tocilizumab, VAS visual analog scale
  3. aPatients weighing < 30 kg, TCZ 12 mg/kg IV Q2W
  4. bEfficacy-evaluable patients, n = 10
  5. cFever present for the past 7 days
  6. dTwo patients had received anakinra before study entry
  7. Concomitant use