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 |
a P value from analysis of covariance; b P value for least squares mean change from baseline compared with placebo. ACR, American College of Rheumatology; ADA, adalimumab; CRP, C-reactive protein; DAS28(4), 4-variable, 28-joint disease activity score; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire disability index; SD, standard deviation; VAS, visual analog scale (0 to 100).