Parameter | ETA + MTX (n = 35) | Placebo + MTX (n = 33) | p |
---|---|---|---|
Demographic characteristics | |||
Sex: | 0.471 | ||
female, n (%) | 22 (64.71%) | 25 (75.76%) | |
male, n (%) | 12 (35.29%) | 8 (24.24%) | |
Age at enrolment, years; median (IQR range) | 9.8 (5.82–12.94) | 6.62 (4.1–13.26) | 0.11 |
Disease duration (starting from the onset symptoms) to baseline years; median (IQR range) | 0.81 (0.29–1.68) | 0.74 (0.32–3.48) | 0.632 |
Age of onset of specific complaints years; median (IQR range) | 7.2 (4.38–10.82) | 4.7 (2.4–9.44) | 0.032 |
Age at diagnosis years; median (IQR range) | 9.16 (5.4–12.05) | 4.86 (2.49–11.37) | 0.035 |
Disease duration until diagnosis, years | 2.5 (1–9) | 3 (2–16) | 0.38 |
JIA category | |||
Seronegative Polyarthritis, n (%) | 21 (60%) | 16 (48%) | 0.47 |
Seropositive Polyarthritis, n (%) | 1 (2.9%) | 0 | 1.0 |
Extended Oligoarthritis, n (%) | 8 (23%) | 12 (36%) | 0.29 |
Polyarticular enthesitis associated arthritis, n (%) | 5 (14.3%) | 3 (9%) | 0.71 |
Unclassified polyarticular JIA, n (%) | 0 | 2 (6%) | 0.23 |
Prior treatment | |||
Conventional NSAIDs, n (%) | 31 (88.57%) | 27 (81.82%) | 0.507 |
COX-2 inhibitors, n (%) | 11 (32.35%) | 13 (39.39%) | 0.729 |
Sulfasalazine, n (%) | 6 (17.14%) | 9 (27.27%) | 0.475 |
Leflunomide, n (%) | 1 (2.86%) | 0 (0%) | > 0.999 |
Oral GCs, n (%) | 1 (2.86%) | 2 (6.06%) | 0.608 |
Other GCs, n (%) | 11 (31.43%) | 8 (24.24%) | 0.697 |
Clinical and laboratory characteristics | |||
Swollen joint count, median (IQR range) | 6 (4–9) | 4 (2–7) | 0.018 |
Tender joint count, median (IQR range) | 6 (4.5–12.5) | 6 (4–12) | 0.349 |
Number of joints with LOM, median (IQR range) | 6 (4.5–10.5) | 6 (3–14) | 0.521 |
Number of active joints, median (IQR range) | 7 (6–11.5) | 7 (4–12) | 0.191 |
Haemoglobin, median (IQR range) | 12 (11.45–12.8) | 12 (11.4–12.5) | 0.726 |
ESR, median (IQR range) | 12 (2–20) | 12 (8–23) | 0.301 |
CRP, median (IQR range) | 3.5 (1–13.45) | 0.7 (0–9) | 0.003 |
JADAS-71, median (IQR range) | 24 (18–34) | 19 (17–24.3) | 0.025 |
CHAQ, median (IQR range) | 1.5 (0.75–1.75) | 1 (0.5–1.5) | 0.057 |
Physician’s assessment of disease activity using VAS, median (IQR range) | 8 (6–9) | 6 (5–7) | 0.014 |
Patient’s assessment of well-being using VAS | 8 (5–9) | 7 (5–8) | 0.114 |
Patient’s assessment of disease activity using VAS, median (IQR range) | 7.5 (5–8) | 7 (5–8) | 0.353 |