Table 3 Secondary efficacy analyses during the treatment in PP populationa
Efficacy endpoint | GS/ CS (N = 209) | RP (N = 223) | Difference between the treatmentsb | CI (95%) |
|---|---|---|---|---|
Absolute change in overall OA assessment by the patient (VAS), mm, mean (se) | ||||
Week 6 | - 20.2 (1.9) | - 18.8 (1.9) | - 1.37 (2.2) | (− 5.72; 3) |
Week 12 | - 24.4 (1.9) | - 24.5 (1.9) | 0.2 (2.2) | (− 4.2; 4.5) |
Week 24 | - 35. 5 (1.9) | - 32.6 (1.9) | - 2.9 (2.3) | (−7.3; 1.5) |
Absolute change in overall OA assessment by the physician (VAS), mm, mean (se) | ||||
Week 6 | - 20 (1.5) | - 21.6 (1.4) | 1.6 (1.7) | (− 1.7; 5) |
Week 12 | - 27.1 (1.5) | - 28.5 (1.5) | 1.4 (1.7) | (− 1.9; 4.8) |
Week 24 | - 37.6 (1.5) | - 36.7 (1.5) | - 0.9 (1.7) | (− 4.3; 2.5) |
Absolute change in SF-12 physical component, points, mean (se) | ||||
Week 24 | 5 (0.7) | 5.7 (0.7) | - 0.7 (0.7) | (−2.1; 0.8) |
Absolute change in SF-12 mental component, points, mean (se) | ||||
Week 24 | 2.7 (0.9) | 1.12 (0.9) | 1. 6 (0.9) | (− 0.2; 3.4) |
Treatment response rate by OMERACT-OARSI criteria, n (%) | ||||
Week 6 | 130 (62.5) | 137 (61.4) | 1.1 | (− 8.1; 10.2) |
Week 12 | 143 (69.8) | 155 (69.8) | - 0.1 | (− 8.8; 8.7) |
Week 24 | 166 (83.4) | 172 (80.4) | 3 | (− 4.4; 10.5) |
Number of tablets of rescue medication administered per week, mean (se) | ||||
SV to RV | 3.8 (4.8) | 3.7 (4.7) | ||
RV to V2 | 1.4 (2.2) | 1.3 (2) | ||
V2 to V3 | 0.9 (1.8) | 0.9 (1.7) | ||
V3 to V4 | 0.8 (1.7) | 0.8 (1.7) | ||
V4 to FV | 0.7 (1.6) | 0.8 (1.5) | ||