Table 2 Primary (DAS28-ESR) and key secondary endpoints at day 85
Pateclizumab | ADA | Placebo | |
|---|---|---|---|
(n = 84) | (n = 84) | (n = 43) | |
DAS28(4)-ESR score at baseline | |||
Mean (SD) | 6.95 (0.89) | 6.84 (0.90) | 6.80 (0.74) |
DAS28(4)-ESR score at day 85 | |||
Mean (SD) | 5.06 (1.52) | 4.31 (1.46) | 5.26 (1.44) |
DAS28(4)-ESR score change from baseline | |||
Mean (SD) | -1.89 (1.38) | -2.52 (1.43) | -1.54 (1.34) |
P value of difference of change scorea | |||
Versus placebo | 0.5172 | 0.0004 | - |
Versus ADA | 0.0003 | - | - |
ACR20 response | |||
n (%) | 50 (64.1%) | 58 (77.3%) | 17 (45.9%) |
ACR50 response | |||
n (%) | 26 (33.3%) | 43 (57.3%) | 9 (24.3%) |
ACR70 response | |||
n (%) | 11 (14.1%) | 26 (34.7%) | 3 (8.1%) |
ACR components, mean (P value vs. placebob) | |||
Swollen joint count | -8.9 (0.04) | -10.4 (<0.01) | -6.1 |
Tender joint count | -13.3 (0.10) | -16.3 (<0.01) | -9.8 |
Patient-s global VAS (mm) | -28.8 (0.27) | -37.0 (<0.01) | -24.0 |
Physician-s global VAS (mm) | -33.8 (<0.01) | -34.1 (<0.01) | -23.2 |
Patient's pain VAS | -26.7 (0.24) | -33.5 (<0.01) | -21.6 |
CRP | -0.5 (0.08) | -1.2 (<0.01) | 0.3 |
ESR | -11.9 (0.47) | -22.9 (0.04) | -14.7 |
HAQ-DI | -0.5 (0.09) | -0.8 (<0.01) | -0.3 |