Changes from baseline at 12 week and 24 week for PRO measures
| Score, LSM change from baseline (SE) LSM difference vs PBO 97.5% CI for LSM difference | Week 12 | Week 24 | ||
|---|---|---|---|---|
| OKZ q2w (n=143) | OKZ q4w (n=142) | OKZ q2w (n=143) | OKZ q4w (n=142) | |
| PtGA | -30.6 (1.72) -17.5 -23.0, -12.0 | -31.0 (1.73) -17.9 -23.4, -12.4 | -32.1 (1.92) -12.7 -18.8, -6.6 | -36.3 (1.96) -16.8 -23.0, -10.6 |
| Pain | -31.6 (1.82) -18.7 -24.6, -12.9 | -31.8 (1.83) -19.0 -24.8, -13.1 | -34.5 (2.05) -13.0 -19.5, -6.5 | -37.1 (2.08) -15.7 -22.3, -9.1 |
| HAQ-DI† | -0.54 (0.04) -0.34*** -0.47, -0.21 | -0.56 (0.04) -0.36*** -0.49, -0.23 | -0.55 (0.05) -0.27 -0.43, -0.12 | -0.65 (0.05) -0.37 -0.53, -0.22 |
| SF-36 PCS | 6.72 (0.57) 4.53 2.72, 6.33 | 6.03 (0.57) 3.84 2.01, 5.67 | 7.84 (0.67) 4.30 2.19, 6.41 | 8.73 (0.68) 5.20 3.04, 7.35 |
| SF-36 MCS | 6.48 (0.73) 3.01 0.69, 5.33 | 7.04 (0.73) 3.57 1.23, 5.92 | 6.21 (0.79) 3.72 1.23, 6.22 | 8.86 (0.80) 6.37 3.82, 8.92 |
| EQ-5D Health Today Score | 19.7 (1.69) 12.2 6.8, 17.6 | 18.7 (1.72) 11.2 5.8, 16.7 | 20.9 (1.95) 12.6 6.5, 18.7 | 23.6 (2.01) 15.3 8.9, 21.7 |
| FACIT-F | 8.2 (0.67) 4.6 2.4, 6.8 | 8.7 (0.68) 5.1 2.9, 7.3 | 8.5 (0.80) 4.8 2.3, 7.3 | 10.6 (0.81) 6.9 4.3, 9.5 |
†, secondary endpoint; *** P‹0.0001.
PRO changes were analyzed using ANCOVA model adjusted for the baseline value of the corresponding parameter. Missing data resulted from study withdrawal imputed based on the return to baseline assumption.