Table 1

Baseline demographics and ACR Pedi core criteria in 59 patients with JIA, randomly assigned into three treatment arms: TNF, COMBO or MTX

TNFCOMBOMTXp Value*
Baseline demographics*
 N192020
 Age (years)0.07
  Mean (median)10.5±3.1 (11.6)8.3±2.7 (7.7)10.1±3.5 (9.6)
  Range4.5–14.94.8–13.34.0–14.4
 Duration of arthritis (months)0.44
  Mean (median)1.5±0.3 (1.5)2.3±1.8 (1.5)1.8±1.1 (1.5)
  Range1.5–2.71.5–6.01.5–6.0
 Onset of JIA (years)0.05
  Mean (median)10.4±3.2 (11.5)8.1±2.7 (7.3)10.0±3.5 (9.9)
  Range4.5–14.84.4–13.13.9–14.4
 Gender, n (%)0.62
  Female13 (68.4)14 (70.0)11 (55.0)
  Male6 (31.6)6 (30.0)9 (45.0)
 Prepubertal, n (%)8 (42.1)14 (70.0)10 (50.0)0.75
 JIA subcategory, n (%)0.43
  Seronegative polyarthritis18 (95.0)16 (80.0)15 (75.0)
  Enthesitis related arthritis1 (5.0)3 (15.0)4 (20.0)
  Seropositive polyarthritis01 (5.0)0
  Psoriatic arthritis001 (5.0)
 ANA positive, n (%)9 (47.4)7 (35.0)6 (30.0)0.56
 HLA-B27 positive, n (%)4 (21.1)5 (25.0)4 (20.0)1.00
 Weight (kg), mean (range)39 (20–65)29 (14–53)28 (14–103)0.09
ACR Pedi core criteria*
 Active joints, n0.95
  Mean (median)18±10 (17)17±10 (17)18±12 (14)
  Range5–395–417–54
 Joints with pain or tenderness and limitation of motion, n0.81
  Mean (median)11±8 (11)10±8 (7)10±7 (8)
  Range3–383–323–29
 Physician's VAS, mm0.13
  Mean (median)49±18 (51)55±19 (61)60±18 (63)
  Range15–8425–8530–87
 Patient/parent VAS, mm0.009
  Mean (median)18±19 (12)31±26 (21)41±25 (49)
  Range0–642–781–79
 CHAQ
  Mean (median)0.51±0.55 (0.31)0.71±0.63 (0.50)1.06±0.60 (1.25)0.02
  Range0–1.7500–2.0000–1.875
 ESR, mm/h
  Mean (median)28±20 (20)41±33 (37)39±30 (27)0.53
  Range2–666–1024–91
  • * Mean ±SD (median) values shown whenever appropriate. p Values show the difference between all treatment arms.

  • Mean infliximab dose 3.9 mg/kg (range 3–5).

  • ACR Pedi, American College of Rheumatology paediatric; ANA, antinuclear antibody; CHAQ, the childhood health assessment questionnaire; COMBO, methotrexate sulphasalazine and hydroxychloroquine; ESR, erythrocyte sedimentation rate; HLA-B27, human leucocyte antigen B7; JIA, juvenile idiopathic arthritis; MTX, methotrexate alone; TNF, infliximab and methotrexate; VAS, visual analogue scale (range 0–100 mm, 0 indicating inactive disease).