Table 2.
Between-group differences in primary and secondary continuous outcomes at baseline and at the end of the RCT phase
| Placebo | Infliximab | ||||
|---|---|---|---|---|---|
| Baseline | Week 12 | Baseline | Week 12 | p* | |
| Active joints, no. | 6.1 (3.7) | 4.1 (3.0) | 4.5 (1.7) | 1.4 (2.4) | 0.0002 |
| Tender joints, no. | 10.6 (6.8) | 7.8 (7.9) | 6.7 (3.1) | 1.0 (2.0) | 0.0001 |
| Swollen joints, no. | 6.5 (3.6) | 4.5 (3.0) | 5.0 (2.0) | 1.5 (2.4) | 0.0003 |
| Tender entheses, no. | 9.2 (4.8) | 7.1 (5.9) | 9.5 (9.7) | 1.4 (2.3) | 0.004 |
| CHAQ score, 0–3 | 2.0 (0.5) | 2.0 (0.4) | 1.9 (0.5) | 1.6 (0.8) | 0.1 |
| BASDAI score, 0–10 | 6.1 (1.9) | 5.5 (1.8) | 5.5 (2.5) | 3.4 (2.3) | 0.07 |
| BASFI score, 0–10 | 5.4 (2.6) | 4.9 (2.0) | 5.5 (2.8) | 3.0 (2.8) | 0.12 |
| hsCRP level, mg/dl | 30.1 (23.4) | 19.7 (17.3) | 23.1 (9.5) | 3.1 (5.0) | 0.003 |
| Modified Schober’s, cm | 4.5 (1.1) | 4.6 (1.3) | 4.5 (1.5) | 4.7 (1.0) | 0.84 |
| Lateral flexion, cm | 17.6 (7.0) | 16.7 (5.4) | 25.4 (14.6) | 18.1 (7.1) | 0.81 |
| Chest expansion, cm | 4.5 (1.5) | 4.8 (1.4) | 4.4 (1.3) | 4.7 (1.5) | 0.94 |
| Hip rotation, cm | 39.9 (8.9) | 42.3 (11.8) | 50 (16.1) | 47.4 (9.9) | 0.92 |
| Physician assessment of disease activity, 10-cm NRS | 6.7 (1.6) | 5.1 (2.8) | 6.4 (1.0) | 1.3 (2.1) | 0.0006 |
| Physician assessment of health status, 10-cm NRS | 3.7 (2.1) | 5.0 (2.7) | 4.1 (1.3) | 7.6 (2.0) | 0.01 |
| Parent/patient assessment of well-being, 10-cm NRS | 6.4 (1.3) | 5.3 (2.6) | 3.8 (1.9) | 2.3 (2.2) | 0.39 |
| Pain score, 0–10 NRS | 7.5 (1.8) | 5.8 (2.7) | 7.2 (1.9) | 2.4 (1.9) | 0.003 |
Values represent the mean (SD)
BASDAI Bath Ankylosing Spondylitis Disease Activity Index, BASFI Bath Ankylosing Spondylitis Functional Index, CHAQ Childhood Health Assessment Questionnaire, hsCRP high-sensitive C-reactive protein
*p-values reflect the comparison of the outcomes at week 12 and obtained with ANCOVA analysis adjusting for baseline values