Table 1.
Baseline demographics and clinical characteristics of patients in the Placebo-controlled UC and Pivotal UC cohorts.
| Baseline demographic/clinical characteristic | Placebo-controlled UC cohort a | Pivotal UC cohort b | ||||
|---|---|---|---|---|---|---|
| Placebo OD (N = 314) | Etrasimod 2 mg OD (N = 577) | Etrasimod 1 mg OD (N = 52) | Etrasimod (combined; N = 629) | Placebo OD (N = 260) | Etrasimod 2 mg OD (N = 527) | |
| Mean age, years (SD) | 40.5 (14.0) | 40.8 (13.6) | 43.2 (12.2) | 41.0 (13.5) | 39.6 (13.7) | 40.8 (13.8) |
| Female sex, n (%) | 121 (38.5) | 263 (45.6) | 22 (42.3) | 285 (45.3) | 99 (38.1) | 240 (45.5) |
| Extent of disease, n (%) c | ||||||
| Pancolitis | 111 (35.4) | 184 (31.9) | 20 (38.5) | 204 (32.4) | 88 (33.8) | 170 (32.3) |
| Left-sided colitis/proctosigmoiditis | 179 (57.0) | 339 (58.8) | 23 (44.2) | 362 (57.6) | 153 (58.8) | 318 (60.3) |
| Proctitis | 18 (5.7) | 37 (6.4) | 0 | 37 (5.9) | 18 (6.9) | 37 (7.0) |
| Baseline MMS 4–6, n (%) | 131 (41.7) | 242 (41.9) | 21 (40.4) | 263 (41.8) | 110 (42.3) | 222 (42.1) |
| Baseline MMS 7–9, n (%) | 180 (57.3) | 335 (58.1) | 31 (59.6) | 366 (58.2) | 150 (57.7) | 305 (57.9) |
| Mean duration of UC, years (SD) | 7.1 (6.6) | 7.3 (7.2) | 7.1 (6.2) | 7.3 (7.1) | 6.8 (6.4) | 7.4 (7.4) |
| Baseline CS use, n (%) | 94 (29.9) | 176 (30.5) | 13 (25.0) | 189 (30.0) | 76 (29.2) | 158 (30.0) |
| Prior biologic or JAKi exposure, n (%) | 83 (26.4) | 162 (28.1) | 0 | 162 (25.8) | 83 (31.9) | 162 (30.7) |
a
The Placebo-controlled UC cohort comprised the Pivotal UC cohort plus all patients from the phase II OASIS trial.
b
The Pivotal UC cohort comprised all patients from the phase III ELEVATE UC 52 and ELEVATE UC 12 trials.
c
Extent of disease at baseline was recorded by investigators on the clinical report form.
CS, corticosteroid; JAKi, JAK inhibitor; MMS, modified Mayo score; n, number of patients with characteristic; N, number of patients in the group; OD, once daily; SD, standard deviation; UC, ulcerative colitis.