Table 3.
LSM change (95% CI) from baseline to weeks 4 and 12
| PRO measures | Week 4 | Week 12 | ||||
|---|---|---|---|---|---|---|
| PBO, n = 221 | UPA 15 mg, n = 221 | UPA 30 mg, n = 219 | PBO, n = 221 | UPA 15 mg, n = 221 | UPA 30 mg, n = 219 | |
| PtGA (mm) | − 8.39 (− 11.69, − 5.10) | − 20.22 (− 23.57, − 16.87)*** | − 25.06, (− 28.39, − 21.74)*** | − 10.36 (− 13.84, − 6.88) | − 29.67 (− 33.18, − 26.16)*** | − 30.51 (− 34.03, − 27.00)*** |
| Pain VAS (mm) | − 8.84 (− 12.13, − 5.55) | − 20.86 (− 24.21, − 17.52)*** | − 26.33 (− 29.65, − 23.01)*** | − 10.26 (− 13.71, − 6.80) | − 29.92 (− 33.40, − 26.44)*** | − 31.71 (− 35.20, − 28.22)*** |
| HAQ-DI | − 0.22 (− 0.29, − 0.15) | − 0.43 (− 0.50, − 0.36)*** | − 0.44 (− 0.51, − 0.37)*** | − 0.26 (− 0.33 to − 0.18) | − 0.61 (− 0.68, − 0.53)*** | − 0.55 (− 0.62, − 0.47)*** |
| FACIT-F | 2.78 (1.49, 4.06) | 5.83 (4.52, 7.14)*** | 6.24 (4.94, 7.55)*** | 2.96 (1.62, 4.30) | 7.91 (6.56, 9.27)*** | 7.74 (6.38, 9.11)*** |
| SF-36 component scores | ||||||
| PCS | 2.42 (1.42, 3.42) | 5.14 (4.12, 6.16)*** | 5.91 (4.89, 6.92)*** | 3.03 (1.88, 4.18) | 7.58 (6.43, 8.74)*** | 8.01 (6.84, 9.18)*** |
| MCS | 2.22 (1.02, 3.42) | 3.43 (2.21, 4.64) | 3.19 (1.98, 4.41) | 2.58 (1.30, 3.87) | 4.69 (3.40, 5.99)** | 3.67 (2.36, 4.98) |
| SF-36 domainsa | ||||||
| PF | 2.24 (1.21, 3.26) | 4.30 (3.25, 5.34)** | 5.00 (3.96, 6.04)*** | 2.96 (1.80, 4.12) | 6.92 (5.75, 8.09)*** | 6.81* (5.63, 8.00)*** |
| RP | 2.30 (1.23, 3.37) | 4.17 (3.08, 5.25)** | 4.92 (3.84, 6.00)*** | 2.88 (1.69, 4.08) | 6.40 (5.20, 7.61)*** | 6.36 (5.14, 7.58)*** |
| BP | 3.49 (2.42, 4.56) | 6.77 (5.68, 7.86)*** | 8.18 (7.09, 9.26)** | 4.66 (3.44, 5.88) | 9.44 (8.21, 10.66)*** | 10.38 (9.14, 11.62)*** |
| GH | 1.78 (0.73, 2.82) | 4.40 (3.33, 5.46)*** | 3.35 (2.29, 4.41)* | 1.92 (0.78, 3.06) | 5.61 (4.47, 6.76)*** | 5.00 (3.84, 6.15)*** |
| VT | 2.53 (1.36, 3.69) | 5.14 (3.95, 6.32)*** | 5.58 (4.40, 6.76)*** | 2.52 (1.21, 3.83) | 6.77 (5.45, 8.09)*** | 7.05 (5.72, 8.38)*** |
| SF | 2.30 (1.05, 3.56) | 3.95 (2.67, 5.23)* | 3.56 (2.29, 4.83) | 2.53 (1.24, 3.82) | 6.17 (4.88, 7.47)*** | 4.81 (3.50, 6.12)** |
| RE | 1.87 (0.60, 3.14) | 3.56 (2.27, 4.85)* | 3.32 (2.03, 4.61) | 2.62 (1.31, 3.94) | 5.59 (4.26, 6.91)*** | 4.10 (2.76, 5.44) |
| MH | 2.67 (1.54, 3.80) | 3.61 (2.46, 4.76) | 4.13 (2.99, 5.28)* | 3.39 (2.14, 4.63) | 4.78 (3.53, 6.03) | 4.77 (3.51, 6.04) |
| SF-6D Utility Index | 0.04 (0.02, 0.05) | 0.06 (0.04, 0.07)* | 0.07 (0.06, 0.09)*** | 0.04 (0.02, 0.05) | 0.09 (0.07, 0.10)*** | 0.09 (0.07, 0.10)*** |
| EQ-5D-5 L Index | 0.07 (0.04, 0.10) | 0.14 (0.11, 0.17)*** | 0.14 (0.12, 0.17)*** | 0.08 (0.05, 0.11) | 0.19 (0.16, 0.21)*** | 0.18 (0.16, 0.21)*** |
| EQ-5D VAS (mm) | 4.25 (1.10, 7.39) | 9.63 (6.43, 12.83)** | 14.09 (10.90, 17.28)*** | 5.17 (1.82, 8.53) | 15.86 (12.48, 19.24)*** | 17.19 (13.78, 20.61)*** |
| AM joint stiffness | ||||||
| Duration (min) | − 21.37 (− 40.31, − 2.43) | − 60.73 (− 79.75, − 41.71)** | − 63.06 (− 82.06, − 44.06)** | − 34.27 (− 54.63, − 13.91) | − 85.28 (− 105.61, − 64.95)*** | − 85.13 (− 105.65, − 64.62)*** |
| Severityb | − 1.03 (− 1.35, − 0.71) | − 2.02 (− 2.35, − 1.70)*** | − 2.48 (− 2.80, − 2.15)*** | − 1.38 (− 1.73, − 1.03) | − 2.88 (− 3.23, − 2.53)*** | − 3.26 (− 3.61, − 2.90)*** |
| RA-WISc | − 1.70 (− 2.78, − 0.62) | − 3.08 (− 4.18, − 1.99)* | − 2.62 (− 3.80, − 1.44) | − 1.55 (− 2.69, − 0.42) | − 4.28 (− 5.41, − 3.14)*** | − 3.48 (− 4.72, − 2.24)** |
AM morning, BP Bodily Pain, CI confidence interval, FACIT-F Functional Assessment of Chronic Illness Therapy-Fatigue, GH General Health, HAQ-DI Health Assessment Questionnaire-Disability Index, LSM least squares mean, MCS mental component summary, MH Mental Health, PBO placebo, PCS physical component summary, PF Physical Functioning, PRO patient-reported outcome, PtGA Patient’s Global Assessment of Disease Activity, RA-WIS Work Instability Scale for RA, RE Role-Emotional, RP Role-Physical, SD standard deviation, SF Social Functioning, SF-36 Short Form 36 Health Survey, UPA upadacitinib, VAS visual analogue scale, VT Vitality
***P < 0.001 for UPA versus PBO
**P < 0.01 for UPA versus PBO
*P < 0.05 for UPA versus PBO
aThe baseline values and LSM changes for SF-36 domains were transformed based on the mean and standard deviation of the 1998 general US population
bAssessed on a numeric scale of 1 to 10, with 10 being the worst level
cCalculated only for employed patients