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
| TNF | COMBO | MTX | TNF vs MTX | COMBO vs MTX | TNF vs COMBO | |
|---|---|---|---|---|---|---|
| Patients (n) | 19 | 20 | 20 | OR (95% CI) p Value† | ||
| ACR Pedi 30 response (n, %) | 19 (100) | 17 (85) | 12 (60) | 15 (4–59)*** | NS 0.06 | 5 (1–21)* |
| ACR Pedi 50 response (n, %) | 19 (100) | 16 (80) | 12 (60) | 8 (2–26)*** | NS 0.06 | NS 0.10 |
| ACR Pedi 70 response (n, %) | 19 (100) | 14 (70) | 12 (60) | 9 (3–28)*** | NS 0.12 | 4 (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 0.13 | NS 0.14 |
| Changes in ACR Pedi core criteria‡ | TNF† | COMBO† | MTX† | |||
| 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%) | NS | NS | *** |
| 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.