Table 2

ACR Pedi 30, 50, 70, 90 and 100 responses, and changes in individual ACR Pedi core criteria at 54 weeks in the three treatment arms

TNFCOMBOMTXTNF vs MTXCOMBO vs MTXTNF vs COMBO
Patients (n)192020OR (95% CI) p Value
ACR Pedi 30 response (n, %)19 (100)17 (85)12 (60)15 (4–59)***NS 0.065 (1–21)*
ACR Pedi 50 response (n, %)19 (100)16 (80)12 (60)8 (2–26)***NS 0.06NS 0.10
ACR Pedi 70 response (n, %)19 (100)14 (70)12 (60)9 (3–28)***NS 0.124 (1–12)**
ACR Pedi 90 response (n, %)16 (84)12 (60)9 (45)8 (3–21)***3 (1-9)*NS 0.06
ACR Pedi 100 response (n, %)13 (68)10 (50)7 (35)6 (2–8)**NS 0.13NS 0.14
Changes in ACR Pedi core criteriaTNFCOMBOMTX
p Value
Active joints, n±SE (final %)−17±2 (97%)−14±2 (84%)−12±2 (70%)*********
Joints with pain or tenderness and limitation of motion, n±SE (final %)−11±2 (97%)−8±2 (78%)−6±2 (72%)*********
Physician's VAS, mm±SE (final %)−47±4 (95%)−44±5 (78%)−37±7 (72%)*********
Patient/parent VAS, mm±SE (final %)−12±4 (71%)−16±5 (73%)−23±7 (70%)******
CHAQ, ±SE (final %)−0.40±0.1 (86%)−0.30±0.1 (66%)−0.57±0.1 (65%)NSNS***
ESR, mm/h ±SE (final %)−19±5 (62%)−28±7 (63%)−24±7 (59%)*****
  • Comparisons are based on longitudinal general estimation equation models (ACR Pedi responses) or on Friedman's test (six ACR Pedi core criteria).

  • Change from baseline to the end of the trial (54 weeks or at the time of exclusion due to treatment failure).

  • * p <0.05, **p <0.01, ***p <0.001.

  • ACR Pedi, American College of Rheumatology paediatric; CHAQ, childhood health assessment questionnaire; COMBO, sulphasalazine and hydroxychloroquine; ESR, erythrocyte sedimentation rate; MTX, methotrexate alone; NS, non-significant; TNF, infliximab and methotrexate; VAS, visual analogue scale; final %, improvement (%) from the baseline to 54 weeks or until failure.