PRO assessment | UPA 15 mg (n=303) | ABA IVa (n=309) | ||||
---|---|---|---|---|---|---|
Baseline Mean ± SD | Difference at week 12 LSM (95%CI) | Difference at week 24 LSM (95%CI) | Baseline Mean ± SD | Difference at week 12 LSM (95%CI) | Difference at week 24 LSM (95%CI) | |
PtGA | 66.8 ± 19.9 | − 33.9* (− 37.1, − 30.6) | − 38.7 (− 42.1, − 35.3) | 69.6 ± 20.8 | − 28.4 (− 31.5, − 25.2) | − 36.9 (− 40.2, − 33.5) |
Pain (VAS) | 68.0 ± 20.2 | − 35.3* (− 38.5, − 32.0) | − 41.5 (− 44.8, − 38.2) | 70.8 ± 19.5 | − 30.0 (− 33.2, − 26.8) | − 37.7 (− 41.0, − 34.4) |
HAQ-DI | 1.7 ± 0.6 | − 0.65* (− 0.72, − 0.57) | − 0.79* (− 0.87, − 0.70) | 1.7 ± 0.6 | − 0.48 (− 0.55, − 0.40) | − 0.66 (− 0.74, − 0.58) |
FACIT-F | 25.3 ± 11.2 | 9.6 (8.3, 10.9) | 10.7 (9.4, 12.1) | 25.6 ± 11.3 | 8.4 (7.1, 9.6) | 10.3 (9.0, 11.7) |
Morning stiffness | ||||||
 Severityb | 6.4 ± 2.3 | − 3.3* (− 3.6, − 3.0) | − 3.9* (− 4.2, − 3.6) | 6.5 ± 2.4 | − 2.8 (− 3.1, − 2.5) | − 3.5 (− 3.8, − 3.2) |
 Durationc | 185.5 ± 280.5 | − 74.4 (− 110.1, − 38.6) | − 97.1 (− 134.1, − 60.1) | 207.2 ± 311.5 | − 70.8 (− 105.9, − 35.8) | − 92.8 (− 129.5, − 56.0) |
EQ-5D-5L index score | 0.5 ± 0.3 | 0.26* (0.23, 0.28) | 0.28 (0.26, 0.30) | 0.5 ± 0.3 | 0.21 (0.19, 0.24) | 0.25 (0.23, 0.28) |
WPAI domains | ||||||
 Absenteeism | 22.4 ± 30.8 | − 11.0 (− 16.5, − 5.4) | − 15.8 (− 21.2, − 10.4) | 21.6 ± 30.7 | − 13.0 (− 18.8, − 7.1) | − 10.5 (− 16.3, − 4.6) |
 Presenteeism | 54.3 ± 23.3 | − 26.0* (− 32.4, − 19.6) | − 26.0 (− 32.6, − 19.4) | 52.7 ± 27.3 | − 17.5 (− 24.2, − 10.8) | − 23.0 (− 30.3, − 15.7) |
 Overall work impairment | 62.2 ± 26.8 | − 25.7 (− 32.8, − 18.5) | − 29.8 (− 37.0, − 22.5) | 60.9 ± 30.0 | − 22.1 (− 29.7, − 14.6) | − 25.5 (− 33.4, − 17.7) |
 Activity impairment | 64.4 ± 22.0 | − 26.8* (− 30.1, − 23.5) | − 31.5* (− 35.0, − 28.0) | 67.2 ± 22.5 | − 21.0 (− 24.2, − 17.7) | − 25.8 (− 29.3, − 22.3) |
SF-36 composite scores | ||||||
 SF-36 PCS | 31.2 ± 7.4 | 9.6* (8.6, 10.7) | 11.0* (9.8, 12.1) | 31.3 ± 6.8 | 7.0 (6.0, 8.1) | 9.4 (8.3, 10.5) |
 SF-36 MCS | 43.7 ± 11.6 | 5.6 (4.5, 6.8) | 6.4 (5.2, 7.7) | 42.8 ± 12.1 | 5.8 (4.7, 7.0) | 6.4 (5.2, 7.6) |
SF-36 domain scores | ||||||
 SF-36 PF | 30.7 ± 8.4 | 8.6* (7.5, 9.8) | 10.1 (8.9, 11.3) | 30.5 ± 8.3 | 5.9 (4.8, 7.1) | 8.7 (7.5, 9.9) |
 SF-36 RP | 33.4 ± 7.6 | 7.9 (6.9, 9.0) | 9.6 (8.4, 10.7) | 32.8 ± 7.7 | 7.0 (5.9, 7.9) | 8.5 (7.4, 9.7) |
 SF-36 BP | 32.9 ± 6.5 | 12.2* (11.1, 13.4) | 13.4* (12.3, 14.6) | 32.5 ± 6.6 | 9.8 (8.7, 10.9) | 11.7 (10.6, 12.9) |
 SF-36 GH | 37.3 ± 8.9 | 6.7* (5.5, 7.9) | 7.1 (6.0, 8.3) | 37.3 ± 7.9 | 5.0 (3.8, 6.1) | 6.4 (5.2, 7.5) |
 SF-36 VT | 40.2 ± 9.6 | 8.6 (7.4, 9.9) | 10.0 (8.6, 11.3) | 40.3 ± 9.3 | 7.7 (6.4, 8.9) | 9.3 (8.0, 10.7) |
 SF-36 SF | 37.7 ± 10.5 | 7.8 (6.6, 8.9) | 9.3 (8.1, 10.5) | 37.4 ± 10.6 | 6.6 (5.5, 7.8) | 8.0 (6.7, 9.2) |
 SF-36 RE | 39.2 ± 11.3 | 5.5 (4.4, 6.7) | 6.8 (5.6, 8.1) | 37.7 ± 11.9 | 5.5 (4.3, 6.7) | 6.5 (5.3, 7.8) |
 SF-36 MH | 41.0 ± 11.1 | 6.9 (5.7, 8.1) | 7.3 (6.1, 8.6) | 40.2 ± 11.4 | 6.3 (5.1, 7.5) | 7.1 (5.9, 8.4) |