Table 2 Summary of primary and secondary efficacy endpoints during part I (6 weeks of treatment)
Placebo | Etoricoxib 60 mg | LS Mean Difference vs. Placebo; p-valuea,b | Etoricoxib 90 mg | LS Mean Difference vs. Placebo; p-value | LS Mean Difference Between 60 mg and 90 mg; p-valuea,b | |
|---|---|---|---|---|---|---|
Co-Primary Endpointsa | ||||||
LS mean change from baseline DAS28-CRP (95 % CI) | - 1.10 (-1.29, -0.90) | - 1.39(-1.48, -1.30) | -0.29 (-0.49, -0.09); p = 0.004 | - 1.37 (-1.48, -1.26) | -0.27 (-0.48, -0.06); p = 0.034 | 0.02 (-0.10, 0.14); p = 0.730 |
LS mean change from baseline in Pain - PGAP (95 % CI) | - 20.26 (-24.04, -16.48) | - 28 .25 (-30.05, -26.44) | -7.99 (-11.85, -4.13); p < 0.001 | - 30.96 (-33.13, -28.79) | -10.70 (-14.74, -6.66); p < 0.001 | -2.71 (-4.98, -0.45); p = 0.019 |
Secondary Endpointsb | ||||||
Proportions of Patients Who Met ACR20 (%) | 41/111 (36.94) | 377/769 (49.02) | 12.09 (2.52, 21.66); p = 0.017 | 242/440 (55.00) | 18.19 (8.17, 28.22); p < 0.001 | 6.03 (0.22, 11.85); p = 0.043 |
Time-weighted Average (LS Mean) Response over 6 Weeks in PGART (95 % CI) | 2.00 (1.83, 2.18) | 2.46 (2.38, 2.55) | 0.46 (0.28, 0.64); p < 0.001 | 2.48 (2.38, 2.58) | 0.47 (0.29, 0.66); p < 0.001 | 0.01 (-0.09, 0.12); p = 0.815 |
Proportion of Patients Who Discontinued due to Lack of Efficacy (%) | 15/111 (13.51) | 29/769 (3.77) | -9.74 (-16.24, -3.24); p < 0.001 | 10/440 (2.27) | -11.24 (-17.75, -4.73); p < 0.001 | -1.50 (-3.44, 0.44); p = 0.178 |