Table 2.
Summary of Primary and Secondary Efficacy Endpoints
| Naproxen 1000 mg | Etoricoxib 60 mg | LS mean difference vs. naproxen | Etoricoxib 90 mg | LS mean difference vs. naproxen | LS mean difference between 60 mg and 90 mg; p-Value | |
|---|---|---|---|---|---|---|
| Primary Endpoint | n = 143 | n = 660 | n = 144 | |||
| Time-weighted LS Mean Change from Baseline in Spinal Pain Intensity (95 % CI) (PP population) | −30.59 (−34.07, −27.10) | −29.00 (−30.69, −27.31) | 1.59 (−2.19, 5.37) | −31.23 (−34.70, −27.76) | −0.64 (−5.47, 4.19) | -- |
| Secondary and Tertiary Endpoints | n = 154 | n = 694 | n = 154 | |||
| Time-weighted LS Mean Change from Baseline in Spinal Pain Intensity (95 % CI) (mITT population) | −30.84 (−34.19, −27.50) | −28.94 (−30.58, −27.29) | 1.91 (−1.73, 5.55) | −30.51 (−33.87, −27.15) | 0.33 (−4.33, 4.99) | −1.58 (−3.96, 0.81); p = 0.396 |
| Time-weighted Average (LS Mean) Response over 6 Weeks in PGART (95 % CI) (mITT population) | 2.19 (2.05, 2.32) | 2.22 (2.16, 2.29) | 0.03 (−0.11, 0.18) | 2.29 (2.15, 2.42) | 0.10 (−0.09, 0.29) | N/A |
| Proportion of Subjects Who Discontinued due to Lack of Efficacy (%) | 2/154 (1.30) | 20/694 (2.88) | 1.58 (−0.60, 3.76) | 2/154 (1.30) | 0.65 (−2.17, 3.47) | N/A |
| Time-weighted LS Mean Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (0–100 mm VAS) | −19.09 (−21.76, −16.42) | −19.34 (−20.65, −18.02) | −0.25 (−3.15, 2.66) | −20.60 (−23.28, −17.92) | −1.51 (−5.23, 2.21) | N/A |
| Time-weighted LS Mean Change from Baseline in Duration of Morning Stiffness (95 % CI) (0- to 100-mm VAS) | −15.13 (−17.98, −12.27) | −16.24 (−17.65, −14.83) | 1.11 (−4.22, 2.00) | −18.29 (−21.16, −15.42) | −3.16 (−7.15, 0.82) | −2.05 (−5.17, 1.07) |
| Time-weighted LS Mean Change from Baseline in Level of Morning Stiffness over 6 weeks of Treatment (95 % CI) (0- to 100-mm VAS) | −19.35 (−22.49, −16.20) | −20.20 (−21.75, −18.64) | −0.85 (−4.27, 2.58) | −22.72 (−25.89, −19.56) | −3.38 (−7.76, 1.01) | −2.53 (−5.96, 0.91) |
| Time-weighted LS Mean Change from Baseline in Spinal Pain Intensity (95%CI) (PP population) for comparison of etoricoxib 60 mg vs. etoricoxib 90 mg | -- | -- | -- | -- | -- | −2.23 (−4.69, 0.23); p = 0.246 |
LS least squares, PP per protocol, mITT modified intention to treat, VAS visual analog scale, CI confidence interval