Skip to main content

Table 1 Patient demographics and baseline disease characteristics

From: Pharmacokinetic and safety profile of tofacitinib in children with polyarticular course juvenile idiopathic arthritis: results of a phase 1, open-label, multicenter study

  Cohort 1
(12 to < 18 years)
N = 8
Cohort 2
(6 to < 12 years)
N = 9
Cohort 3
(2 to < 6 years)
N = 9
All patients
(2 to < 18 years)
N = 26
Age at enrollment, years
 Median (Q1–Q3) 14.0 (12.0–16.0) 10.0 (8.0–11.0) 4.0 (4.0–5.0) 9.5 (5.0–12.0)
Gender, n (%)
 Female 5 (62.5) 5 (55.6) 7 (77.8) 17 (65.4)
Body mass index,a kg/m2
 Median (Q1–Q3) 19.9 (17.1–21.9) 16.6 (15.9–20.4) 14.4 (14.3–16.2) 16.5 (15.0–20.2)
Height, cm
 Median (Q1–Q3) 168.8 (157.5–171.7) 135.0 (129.7–141.7) 109.7 (99.6–111.6) 134.5 (111.4–155.0)
Disease duration (years)
 Median (Q1–Q3) 1.2 (0.7–1.7) 0.5 (0.3–2.0) 2.8 (1.3–3.1) 1.4 (0.6–2.8)
JIA categories
 Polyarthritis (RF-)b, n (%) 6 (75.0) 7 (77.8) 9 (100.0) 22 (84.6)
 Psoriatic arthritis, n (%) 1 (12.5) 1 (11.1) 0 2 (7.7)
 Extended oligoarthritis, n (%) 1 (12.5) 1 (11.1) 0 2 (7.7)
Disease characteristics
Physician’s global assessment of overall disease activityc
 Median (Q1–Q3) 7.5 (6.3–8.0) 8.0 (6.0–8.5) 6.5 (6.0–7.5) 7.3 (6.0–8.0)
Number of joints with active arthritisc,d
 Median (Q1–Q3) 15.5 (13.0–18.0) 17.0 (10.0–21.0) 10.0 (8.0–20.0) 14.0 (8.0–21.0)
Number of joints with limitation of motionc
 Median (Q1–Q3) 14.0 (8.5–16.5) 9.0 (8.0–15.0) 8.0 (6.0–20.0) 10.0 (7.0–17.0)
CHAQ functional ability
 Median (Q1–Q3) NA 1.0 (0.4–1.6) 0.9 (0.6–1.5) 0.9 (0.4–1.6)
C-reactive protein, mg/Le
 Median (Q1–Q3) 0.3 (0.2–0.5) 0.6 (0.4–2.3) 2.2 (0.3–13.9) 0.5 (0.2–5.2)
Concomitant drugs
Methotrexate use, mg/week
 n (%) 1 (12.5%) 0 8 (88.9%) 9 (34.6%)
 Median dose (Q1–Q3) 25.0 (25.0–25.0)   10.0 (9.4–11.9) 10.0 (10.0–13.7)
Prednisone use, mg/day
 n (%)    2 (22.2%) 2 (7.7%)
 Median dose (Q1–Q3)  0  0 3.5 (2.0–5.0) 3.5 (2.0–5.0)
  1. CHAQ Childhood Health Assessment Questionnaire, N number of patients in each cohort, NA not applicable, RF rheumatoid factor, SD standard deviation
  2. aBMI was calculated as weight in kg/(height in meters)2
  3. bNo patients with polyarthritis were RF+
  4. cBaseline was defined as the Day 1 measurement for open-label long-term extension study
  5. dDefined as a joint with swelling or a joint with pain/tenderness on movement
  6. eValues < 0.2 mg/L were set to 0.1999 in summaries and analyses