Table 1.
Baseline HRQoL measures in patients enrolled in ELEVATE UC 52 and ELEVATE UC 12.
| ELEVATE UC 52 | ELEVATE UC 12 | |||
|---|---|---|---|---|
| Placebo QD (N = 144) | Etrasimod 2 mg QD (N = 289) | Placebo QD (N = 116) | Etrasimod 2 mg QD (N = 238) | |
| IBDQ | ||||
| Total score, mean (SD) | 119.2 (34.6) | 117.5 (34.6) | 121.3 (33.4) | 125.0 (35.1) |
| Domain scores, mean (SD) | ||||
| Bowel symptoms | 35.9 (10.0) | 35.2 (10.3) | 36.5 (10.6) | 37.2 (10.1) |
| Systemic symptoms | 17.8 (5.9) | 17.1 (5.8) | 17.6 (5.7) | 18.6 (6.0) |
| Social function | 19.0 (7.5) | 19.1 (7.7) | 19.7 (7.1) | 20.5 (8.2) |
| Emotional health | 46.4 (14.7) | 46.2 (14.5) | 47.4 (14.5) | 48.7 (14.4) |
| SF-36 | ||||
| Domain scores, mean (SD) | ||||
| Physical function | 69.2 (25.9) | 68.2 (24.2) | 72.4 (23.0) | 73.9 (22.3) |
| Role physical | 49.5 (26.9) | 50.3 (25.5) | 50.1 (26.1) | 53.5 (27.2) |
| Role emotional | 67.0 (27.2) | 65.8 (27.1) | 64.8 (26.7) | 66.0 (27.5) |
| Vitality | 39.9 (22.9) | 38.4 (20.1) | 41.0 (20.4) | 41.1 (21.6) |
| Mental health | 54.5 (21.2) | 54.9 (18.9) | 55.2 (19.4) | 56.4 (20.4) |
| Social function | 54.9 (26.1) | 53.0 (25.9) | 54.0 (27.5) | 56.7 (29.1) |
| Bodily pain | 53.3 (24.2) | 49.1 (21.8) | 51.0 (21.8) | 53.0 (22.3) |
| General health | 40.8 (19.4) | 40.5 (19.1) | 41.7 (17.6) | 39.6 (17.3) |
| Summary scores, mean (SD) | ||||
| Physical component summary | 42.7 (8.3) | 42.2 (7.8) | 43.3 (7.4) | 43.7 (7.4) |
| Mental component summary | 40.3 (10.7) | 40.0 (10.2) | 39.9 (10.7) | 40.3 (11.2) |
| SF-6D health utility index score, mean (SD) | 0.6 (0.1) | 0.6 (0.1) | 0.6 (0.1) | 0.6 (0.1) |
| WPAI:UC domain scores, mean (SD) | ||||
| Absenteeism | 19.7 (31.7) | 17.6 (28.1) | 19.4 (29.5) | 20.2 (30.3) |
| Presenteeism | 44.3 (24.5) | 45.0 (25.3) | 42.9 (24.0) | 46.0 (24.3) |
| Overall work impairment | 54.4 (29.2) | 55.3 (30.0) | 52.1 (28.1) | 55.4 (29.1) |
| Impairment in nonwork activities | 49.0 (25.7) | 47.5 (25.2) | 48.6 (24.2) | 47.9 (25.6) |
Abbreviations: HRQoL, health-related quality of life; IBDQ, Inflammatory Bowel Disease Questionnaire; N, number of patients in the full analysis set; QD, once daily; SF-36, 36-Item Short Form Survey; SF-6D, Short-Form Six-Dimension; WPAI:UC, Work Productivity and Activity Impairment Questionnaire: Ulcerative Colitis.