Table 1.
Patient demographics and baseline characteristics (mITT population)
| Variable | Placebo (n = 37) |
Upadacitinib 3 mg BID (n = 39) |
Upadacitinib 6 mg BID (n = 37) |
Upadacitinib 12 mg BID (n = 36) | Upadacitinib 24 mg BID (n = 36) | Upadacitinib 24 mg QD (n = 35) | |
|---|---|---|---|---|---|---|---|
| Age, years, median (range) | 40 (20–68) | 37 (19–66) | 39 (22–76) | 41 (19–70) | 44 (20–65) | 41 (21–64) | |
| Female, n (%) | 24 (64.9) | 19 (48.7) | 21 (56.8) | 17 (47.2) | 25 (69.4) | 19 (54.3) | |
| Disease duration, years, median (range) | 8.7 (1.2–41.6) | 10.7 (0.1–44.7) | 8.8 (2.2–46.4) | 9.1 (1.2–38.3) | 14.1 (1.1–35.5) | 10.8 (0.7–36.3) | |
| CDAI, median (range) | 276 (188–447) | 288 (180–445) | 296 (230–599) | 280 (224–446) | 278 (162–556) | 305 (231–421) | |
| IBDQ | |||||||
| Mean ± SD | 118.0 ± 28.5 | 115.2 ± 27.5 | 113.7 ± 25.9 | 115.2 ± 36.1 | 113.8 ± 36.0 | 120.7 ± 36.3 | |
| Missing data | 0 | 1 | 1 | 1 | 0 | 1 | |
| EQ-5D index score | |||||||
| Mean ± SD | 0.65 ± 0.24 | 0.69 ± 0.17 | 0.71 ± 0.18 | 0.67 ± 0.21 | 0.69 ± 0.20 | 0.68 ± 0.22 | |
| Missing data | 0 | 0 | 0 | 1 | 0 | 1 | |
| EQ-5D VAS | |||||||
| Mean ± SD | 48.6 ± 14.6 | 49.4 ± 18.7 | 47.8 ± 16.4 | 50.7 ± 17.6 | 51.6 ± 18.5 | 50.7 ± 17.0 | |
| Missing data | 0 | 0 | 0 | 2 | 0 | 2 | |
| WPAI: % activity impairment | |||||||
| Mean ± SD | 60.3 ± 26.5 | 63.3 ± 19.8 | 61.9 ± 18.2 | 62.6 ± 24.2 | 57.5 ± 23.5 | 60.6 ± 24.1 | |
| Available dataa | 37 | 39 | 36 | 35 | 36 | 33 | |
| WPAI: % presenteeism | |||||||
| Mean ± SD | 41.8 ± 23.2 | 58.8 ± 26.4 | 57.2 ± 23.2 | 47.3 ± 27.9 | 47.5 ± 25.5 | 47.0 ± 26.5 | |
| Available dataa | 22 | 17 | 25 | 15 | 20 | 23 | |
| WPAI: % overall work impairment | |||||||
| Mean ± SD | 52.1 ± 29.1 | 66.5 ± 27.4 | 61.4 ± 25.0 | 57.1 ± 29.3 | 52.4 ± 29.8 | 53.3 ± 30.7 | |
| Available dataa | 23 | 19 | 24 | 15 | 20 | 24 | |
| WPAI: % absenteeism | |||||||
| Mean ± SD | 19.8 ± 29.5 | 24.0 ± 36.0 | 15.6 ± 26.2 | 23.4 ± 40.2 | 15.2 ± 26.5 | 20.7 ± 31.4 | |
| Available dataa | 23 | 19 | 24 | 15 | 20 | 24 | |
| Prior anti-TNF agents, n (%)[15] | |||||||
| 0 | 2 (5.4) | 2 (5.1) | 1 (2.7) | 2 (5.6) | 0 | 2 (5.7) | |
| 1 | 15 (40.5) | 17 (43.6) | 12 (32.4) | 6 (16.7) | 10 (27.8) | 10 (28.6) | |
| 2 | 15 (40.5) | 16 (41.0) | 20 (54.1) | 24 (66.7) | 15 (41.7) | 16 (45.7) | |
| ≥ 3 | 5 (13.5) | 4 (10.3) | 4 (10.8) | 4 (11.1) | 11 (30.6) | 7 (20.0) | |
aAvailable data for all patients that are employed
BID twice daily, CDAI Crohn’s Disease Activity Index, EQ-5D European Quality of Life-5 Dimensions, IBDQ Inflammatory Bowel Disease Questionnaire, mITT modified intent-to-treat, QD once daily, SD standard deviation, TNF tumor necrosis factor, VAS visual analog scale, WPAI Work Productivity and Activity Impairment questionnaire