Patients characteristics at study treatment onset
| Characteristics | Anakinra (n = 12) | Placebo (n = 12) | All patients (n = 24) |
|---|---|---|---|
| Demographic features | |||
| Female, n (%) | 7 (58) | 8 (67) | 15 (63) |
| Age, mean value, years (SD) | 9.5 (5.19) | 7.5 (3.73) | 8.5 (4.54) |
| Disease mean duration, years (SD) | 4.2 (3.33) | 3.2 (1.95) | 3.7 (2.73) |
| Systemic features | |||
| Fever (>38°C), no. of patients (%) | 4 (33.3) | 5 (41.7) | 9 (37.5) |
| CRP, mg/l (n≤6), mean value (SD) | 66 (64.40) | 84 (65.74) | 75 (64.35) |
| ESR first hour (n≤10), mean value (SD) | 44 (23.37) | 57 (27.85) | 50 (25.89) |
| SAA, mg/l (n≤6.4), mean value (SD) | 366 (262) | 368 (229) | 367 (241) |
| High serum ferritin*, no. of patients | 2 | 3 | 5 |
| Joint assessment | |||
| Active joints, mean no. (SD) | 16 (13.12) | 16 (15.84) | 16 (14.23) |
| Joints with LOM, mean no. (SD) | 16 (14.88) | 17 (14.91) | 17 (14.57) |
| Global assessments | |||
| Physician's VAS, mean value (SD) | 63 (20.57) | 57 (29.74) | 60 (25.21) |
| Parent's global VAS, mean value (SD) | 50 (24.39) | 55 (26.51) | 52 (25.04) |
| Parent's pain VAS, mean value (SD) | 50 (25.73) | 53 (25.89) | 51 (25.28) |
| CHAQ, mean value (SD) | 1.67 (0.845) | 1.44 (0.625) | 1.55 (0.736) |
| Treatment with steroids (predniso(lo)ne) | |||
| Duration, mean, years (SD) | 3.9 (2.93) | 2.7 (2.10) | 3.3 (2.56) |
| Daily dose, mean, mg/kg (SD) | 0.52 (0.237) | 0.66 (0.373) | 0.59 (0.313) |
| Previous treatments with DMARDs, biological agents | |||
| DMARD and/or biological agent, no. of patients | 8 | 11 | 19 |
| DMARD, no biological agent, no. of patients | 3 | 3 | 6 |
| DMARD and biological agent, no. of patients | 5 | 8 | 13 |
| Methotrexate, no. of patients | 8 | 11 | 19 |
| Etanercept, no. of patients | 5 | 8 | 13 |
| Others, no. of patients (no. of DMARDs) | 4 (7†) | 4 (6‡) | 8 (13) |
↵* Ferritin level was highly variable and it was elevated (>100 µg/l in patients <13 years, >200 in female patients >13 years and >300 in male patients >13 years) in only five patients (range 347–3135 µg/l), with low glycosylated ferritin (<40%) in these five patients (range 14–30%).
↵† Thalidomide (n=2), tocilizumab (n=2, one single infusion, phase II trial), azathioprine (n=1), ciclosporin (n=1), leflunomide (n=1).
↵‡ Azathioprine (n=2), thalidomide (n=1), tocilizumab (n=1, one single infusion, phase II trial), ciclosporin (n=1), intravenous immunoglobulins (n=1).
CHAQ, Childhood Health Assessment Questionnaire (0–3); CRP, C-reactive protein; DMARDs, disease-modifying antirheumatic drugs; ESR, erythrocyte sedimentation rate; LOM, joints with limitation of passive motion; SAA, serum amyloid A; VAS, visual assessment (0–100 mm scale) of disease activity by the physician, disease effect on overall wellbeing and pain by the parents.