Values (mean±SD) of composite disease activity measures (CDAI, SDAI, DAS28) at baseline and 1 year, and progression of total joint damage score (change in TGSS), ERO and JSN in the patients with moderate/high disease activity according to the respective cut-off points at 1 year of treatment. The data are shown separately for placebo and for the combined tocilizumab (TCZ) groups and for the two TCZ doses. Differences were assessed by Kruskal–Wallis test (for median values of x-ray changes see text). According to established cut-off points, patients were regarded as in MDA/HDA with CDAI>10, SDAI>11, DAS28>3.2
| Placebo (76/117) | Tocilizumab 4 mg (97/197) | Tocilizumab 8 mg (100/217) | p Value vs placebo | Tocilizumab all (197/414) | p Value vs placebo | |
|---|---|---|---|---|---|---|
| Baseline values | ||||||
| CDAI | 40.5±10.8 | 41.72±12.13 | 45.42±12.74 | 0.0103 | 43.6±12.6 | 0.048 |
| SDAI | 42.5±11.4 | 44.04±12.76 | 48.17±13.93 | 0.0105 | 46.1±13.5 | 0.04 |
| DAS28 | 6.5±0.7 | 6.70± 0.9 | 6.95±0.87 | 0.0023 | 6.8±0.9 | 0.008 |
| HAQ | 1.61±0.61 | 1.56±0.58 | 1.64±0.63 | 0.566 | 1.60±0.60 | 0.78 |
| 1-Year values | ||||||
| CDAI | 21.7±10.4 | 19.34±9.26 | 20.96±9.36 | 0.12 | 20.2±9.3 | 0.19 |
| SDAI | 23.4±11.2 | 20.69±9.40 | 21.16±9.36 | 0.13 | 20.9±9.3 | 0.053 |
| DAS28 | 4.9±1.1 | 4.22±1.12 | 3.64±1.03 | <0.0001 | 3.9±1.1 | <0.0001 |
| HAQ | 1.31±0.63 | 1.22±0.59 | 1.18±0.63 | 0.45 | 1.20±0.61 | 0.237 |
| Change in TGSS at 1 year | 1.2±2.2 | 0.40±1.10 | 0.40±1.20 | 0.0038 | 0.4±1.2 | 0.0009 |
| Change in ERO at 1 year | 0.65±1.26 | 0.28±0.86 | 0.23±0.88 | 0.0247 | 0.25±0.87 | 0.00651 |
| Change in JSN at 1 year | 0.53±1.21 | 0.12±0.47 | 0.17±0.55 | 0.0154 | 0.14±0.51 | 0.00435 |
CDAI, clinical disease activity index; DAS28, disease activity score 28; ERO, erosion; HAQ, Health Assessment Questionnaire; HDA, high disease activity; JSN, joint space narrowing score; MDA, moderate disease activity; SDAI, simplified disease activity index; TGSS, total Genant-modified Sharp score.