Table 2.
Baseline values and LSM changes from baseline at week 12
| PRO | Baseline value, mean ± SD | LSM change from baseline (95% CI) | ||||
|---|---|---|---|---|---|---|
| Placebo | Upadacitinib 15 mg | Upadacitinib 30 mg | Placebo | Upadacitinib 15 mg | Upadacitinib 30 mg | |
| PtGA | 66.3 ± 22.7 (n = 166) | 67.2 ± 19.6 (n = 163) | 64.7 ± 21.1 (n = 163) | − 10.03 (− 14.22, − 5.84) (n = 145) | − 26.04* (− 30.16, − 21.93) (n = 156) | − 29.27* (− 33.43, − 25.12) (n = 147) |
| Pain VAS | 68.9 ± 21.0 (n = 166) | 68.2 ± 19.8 (n = 163) | 65.3 ± 20.7 (n = 161) | − 10.38 (− 14.60, − 6.16) (n = 145) | − 25.91* (− 30.05, − 21.76) (n = 156) | − 30.92* (− 35.12, − 26.72) (n = 146) |
| HAQ-DI | 1.6 ± 0.6 (n = 166) | 1.7 ± 0.6 (n = 163) | 1.6 ± 0.6 (n = 161) | − 0.16 (− 0.25, − 0.08) (n = 145) | − 0.41* (− 0.50, − 0.33) (n = 156) | − 0.44* (− 0.52, − 0.35) (n = 146) |
| SF-36 PCS | 31.6 ± 7.2 (n = 166) | 30.6 ± 7.8 (n = 163) | 31.5 ± 7.3 (n = 162) | 2.39 (1.14, 3.64) (n = 145) | 5.83* (4.60, 7.05) (n = 156) | 7.02* (5.78, 8.25) (n = 147) |
| SF-36 MCS | 45.9 ± 12.6 (n = 166) | 44.0 ± 11.7 (n = 163) | 45.9 ± 12.3 (n = 162) | 3.01 (1.65, 4.37) (n = 145) | 4.54 (3.22, 5.87) (n = 156) | 3.37 (2.03, 4.72) (n = 147) |
| SF-36 PF | 32.0 ± 8.9 (n = 166) | 30.6 ± 9.3 (n = 163) | 31.2 ± 8.1 (n = 162) | 1.54 (0.25, 2.84) (n = 145) | 4.56* (3.29, 5.83) (n = 156) | 6.15* (4.87, 7.43) (n = 147) |
| SF-36 RP | 34.2 ± 8.0 (n = 166) | 33.0 ± 8.8 (n = 163) | 34.9 ± 7.6 (n = 162) | 2.15 (0.95, 3.35) (n = 145) | 5.10* (3.93, 6.27) (n = 156) | 5.17* (3.99, 6.36) (n = 147) |
| SF-36 BP | 33.2 (6.4) (n = 166) | 33.1 (6.4) (n = 163) | 34.5 (6.9) (n = 162) | 4.71 (3.38, 6.04) (n = 145) | 8.12* (6.82, 9.42) (n = 156) | 9.09* (7.78, 10.41) (n = 147) |
| SF-36 GH | 38.9 ± 9.7 (n = 166) | 37.1 ± 8.2 (n = 163) | 38.1 ± 9.1 (n = 162) | 2.17 (1.01, 3.34) (n = 145) | 4.31** (3.17, 5.45) (n = 156) | 4.25*** (3.10, 5.41) (n = 147) |
| SF-36 VT | 40.6 ± 9.3 (n = 166) | 37.7 ± 10.0 (n = 163) | 39.2 ± 9.4 (n = 162) | 3.10 (1.69, 4.51) (n = 145) | 6.28* (4.90, 7.65) (n = 156) | 6.86* (5.47, 8.26) (n = 147) |
| SF-36 SF | 39.5 ± 10.9 (n = 166) | 37.3 ± 10.4 (n = 163) | 39.1 ± 10.8 (n = 162) | 3.45 (2.10, 4.81) (n = 145) | 5.87*** (4.55, 7.19) (n = 156) | 5.35*** (4.01, 6.69) (n = 147) |
| SF-36 RE |
41.0 ± 12.6 (n = 166) |
39.2 ± 12.7 (n = 163) | 41.5 ± 12.8 (n = 162) | 2.66 (1.24, 4.07) (n = 145) | 4.72*** (3.34, 6.10) (n = 156) | 3.78 (2.38, 5.17) (n = 147) |
| SF-36 MH |
43.6 ± 12.5 (n = 166) |
42.9 ± 11.3 (n = 163) | 44.2 ± 11.4 (n = 162) | 2.96 (1.63, 4.29) (n = 145) | 3.83 (2.53, 5.12) (n = 156) | 3.53 (2.21, 4.84) (n = 147) |
| AM stiffness duration, minutes |
138.4 ± 178.6 (n = 169) |
140.4 ± 189.7 (n = 164) |
184.5 ± 284.9 (n = 165) |
− 15.07 (− 43.30, 13.16) (n = 147) | − 81.47* (− 109.52, − 53.42) (n = 157) | − 79.13* (− 107.26, − 51.00) (n = 148) |
| AM stiffness severity | 6.8 ± 2.3 (n = 169) | 6.8 ± 2.1 (n = 164) | 6.5 ± 2.2 (n = 165) | − 1.57 (− 1.98, − 1.17) (n = 146) | − 2.86* (− 3.26, − 2.46) (n = 157) | − 3.22* (− 3.62, − 2.82) (n = 147) |
| ISI | 12.3 ± 6.9 (n = 153) | 12.3 ± 6.9 (n = 152) | 12.3 ± 6.6 (n = 151) | − 1.69 (− 2.55, − 0.83) (n = 130) | − 2.53 (− 3.36, − 1.70) (n = 142) | − 3.32** (− 4.15, − 2.49) (n = 138) |
| EQ-5D-5L | 49.7 ± 24.9 (n = 166) | 50.7 ± 23.0 (n = 163) | 51.8 ± 21.8 (n = 160) | 7.45 (3.86, 11.04) (n = 145) | 15.03** (11.55, 18.51) (n = 156) | 15.12** (11.55, 18.69) (n = 145) |
AM morning, BP bodily pain, CI confidence interval, EQ-5D-5L Euro Qol 5-Dimension 5-Level Questionnaire, GH general health, HAQ-DI Health Assessment Questionnaire Disability Index, LSM least squares mean, MCS Mental Component Summary, MH mental health, PCS Physical Component Summary, PF physical functioning, PRO patient-reported outcome, PtGA Patient Global Assessment of Disease Activity, RE role-emotional, RP role-physical, SD standard deviation, SF social functioning, SF-36 Short Form-36 Health Survey, VAS visual analog scale, VT vitality
*P ≤ 0.001 for upadacitinib vs placebo
**P < 0.01 for upadacitinib vs placebo
***P < 0.05 for upadacitinib vs placebo