Efficacy results at week 24
| Variable | TCZ+MTX (N=277) | TCZ+PBO (N=276) | p Value (between group) |
|---|---|---|---|
| DAS28 remission rate, % | 40.4 | 34.8 | 0.19 |
| Change in DAS28, mean (SD) | −3.43 (1.33) | −3.21 (1.31) | 0.051 |
| LDAS, % | 61.7 | 51.4 | 0.029 |
| EULAR good plus moderate responders, % | 89.5 | 86.2 | 0.30 |
| ACR–EULAR Boolean remission rate, % | 6.9 | 5.4 | 0.53 |
| SDAI remission rate (≤3.3), % | 11.9 | 9.8 | 0.56 |
| CDAI remission rate (≤2.8), % | 11.9 | 7.6 | 0.12 |
| Change in tender joint count, mean (SD) | −17.25 (13.35) | −17.00 (13.64) | 0.52 |
| Change in swollen joint count, mean (SD) | −11.33 (8.04) | −11.75 (9.45) | 0.61 |
| Change in patient's global assessment of disease activity, mean (SD) | −34.3 (25.68) | −32.4 (24.34) | 0.20 |
| Change in physician's global assessment of disease activity, mean (SD) | −40.7 (19.55) | −38.5 (21.65) | 0.084 |
| Change in patient's global assessment of pain, mean (SD) | −29.3 (26.64) | −29.8 (24.92) | 0.30 |
| Change in RAQoL, mean (SD) | −5.97 (7.95) | −5.19 (7.06) | 0.31* |
| Change in total GSS, mean (SD) | 0.08 (1.88) | 0.22 (1.11) | 0.26 |
| Change in JSN score, mean (SD) | 0.08 (1.48) | 0.11 (0.70) | 0.76 |
| Change in erosion score, mean (SD) | −0.01 (0.78) | 0.11 (0.63) | 0.066 |
| Patients with no progression in GSS (≤SDC), % | 90.6 | 87.3 | 0.18 |
| Patients with no progression in GSS (≤0), % | 65.7 | 59.1 | 0.088 |
ACR, American College of Rheumatology; CDAI, clinical disease activity index; DMARD, disease-modifying antirheumatic drug; DAS28, disease activity score based on 28 joints; EULAR, European League Against Rheumatism; GSS, Genant-modified Sharp score; JSN, joint space narrowing; LDAS, low disease activity score; MTX, methotrexate; PBO, placebo; RAQoL, rheumatoid arthritis quality of life questionnaire; SDAI, simplified disease activity index; SDC, smallest detectable change; TCZ, tocilizumab. *p Value from a 2-sided Wilcoxon rank-sum test of no difference between the two treatment arms.