Table 2.
Primary and secondary efficacy endpoints
| PBO N=16 |
DAZ 3000 mg×1 N=16 |
DAZ 1500 mg×2 N=16 |
DAZ 3000 mg×2 N=15 |
DAZ 1500 mg×4 N=15 |
|
| DAS28-CRP, n | 15 | 14 | 15 | 14 | 14 |
| LS mean CFB (SE) | −1.06 (0.26) | −1.90 (0.27) | −1.87 (0.27) | −1.87 (0.27) | −1.83 (0.28) |
| LS mean difference (SE) | −0.84 (0.38) | −0.81 (0.38) | −0.81 (0.38) | −0.77 (0.38) | |
| P value | 0.0296 | 0.0355 | 0.0364 | 0.0478 | |
| DAS28-CRP <2.6, n | 16 | 16 | 16 | 15 | 15 |
| Responder, n (%) | 3 (18.8) | 3 (18.8) | 1 (6.3) | 2 (13.3) | 2 (13.3) |
| OR (90% CI) | 1.4 (0.2 to 8.0) | 0.6 (<0.1 to 5.5) | 0.9 (0.1 to 5.7) | 0.9 (0.2 to 5.1) | |
| P value | 0.7750 | 0.6974 | 0.9318 | 0.9108 | |
| Time to start rescue medication | |||||
| Rescued, n (%) | 1 (6.3) | 1 (6.3) | 1 (6.3) | 3 (20.0) | 1 (6.7) |
| Censored, n (%) | 15 (93.8) | 15 (93.8) | 15 (93.8) | 12 (80.0) | 14 (93.3) |
| HR (90% CI) | 1.04 (0.10 to 10.60) | 1.04 (0.10 to 10.60) | 3.01 (0.45 to 20.09) | 1.04 (0.10 to 10.60) | |
| P value | 0.9805 | 0.9805 | 0.3407 | 0.9805 | |
DAS28-CRP score (primary endpoint) and DAS28-CRP-defined clinical remission (DAS28-CRP <2.6; secondary endpoint) at day 113; time to start rescue medication (secondary endpoint) through day 309.
CFB, change from baseline; DAS28-CRP, Disease Activity Score in 28 joints using C reactive protein; LS, least-squares; PBO, placebo.