Table 1.
Baseline characteristics [safety population].
| Treatment in OLE: | Etrasimod 2 mg | Placebo | |||
|---|---|---|---|---|---|
| Treatment in DB study: | Placebo [n = 42] |
Etrasimod 1 mg [n = 38] |
Etrasimod 2 mg [n = 32] |
Overall [n = 112] |
Total [n = 6] |
| Age, mean [SD], y | 46.2 [15.1] | 44.6 [12.2] | 39.2 [11.0] | 43.7 [13.3] | 50.2 [13.9] |
| Female, n [%] | 15 [35.7] | 16 [42.1] | 13 [40.6] | 44 [39.3] | 3 [50.0] |
| Race, n [%]a | |||||
| White | 39 [92.9] | 35 [92.1] | 32 [100] | 106 [94.6] | 6 [100] |
| Weight, mean [SD], kg | 75.9 [15.9] | 73.1 [12.6] | 70.9 [17.3] | 73.5 [15.3] | 84.7 [22.2] |
| BMI, mean [SD], kg/m2 | 25.8 [4.8] | 24.8 [3.5] | 24.0 [5.2] | 24.9 [4.5] | 28.6 [6.3] |
| Baseline total MCS, mean [SD] | 6.6 [2.6] | 5.8 [3.1] | 4.9 [3.4] | 5.8 [3.1] | 5.8 [1.9] |
| Baseline mMCS, mean [SD] | 5.0 [2.1] | 4.3 [2.5] | 3.6 [2.5] | 4.4 [2.4] | 4.7 [1.4] |
| Duration of UC, median, yb | 5.8 | 4.7 | 4.4 | 4.9 | 6.7 |
| Disease extent, n [%]b,c | |||||
| Proctosigmoiditis | 27 [64.3] | 27 [71.1] | 21 [65.6] | 75 [67.0] | 1 [16.7] |
| Pancolitis | 20 [47.6] | 11 [28.9] | 6 [18.8] | 37 [33.0] | 3 [50.0] |
| Baseline faecal calprotectin, mean [SD], µg/g | 2276 [3055] | 2267 [4448] | 988 [1592] | 1896 [3293] | 1475 [938] |
| Baseline C-reactive protein, mean [SD], nmol/L | 10.0 [18.6] | 9.1 [13.1] | 8.6 [13.6] | 9.3 [15.4] | 3.4 [3.4] |
| Previous and concomitant treatments for UC | |||||
| Current oral corticosteroids at DB baseline, n [%]b | 14 [33.3] | 11 [28.9]d | 13 [40.6] | 38 [33.9]d | 3 [50.0] |
| Previous anti-TNFα agents, n [%]b | 15 [35.7] | 8 [21.1] | 9 [28.1] | 32 [28.6] | 4 [66.7] |
| Previous immunosuppressants, n [%]b | 24 [57.1] | 12 [31.6] | 16 [50.0] | 52 [46.4] | 4 [66.7] |
| Previous anti-integrin agents, n [%]b | 9 [21.4] | 3 [7.9] | 3 [9.4] | 15 [13.4] | 2 [33.3] |
| Previous or current oral 5-aminosalicylates at DB baseline, n [%]b | 41 [97.6] | 37 [97.4] | 29 [90.6] | 107 [95.5] | 5 [83.3] |
Unless noted, demographic and baseline characteristics are presented as at DB Week 12 [OLE Day −1]. The overall group includes patients who received any treatment [placebo, etrasimod 1 mg, or etrasimod 2 mg] during the DB period.
BMI, body mass index; DB, double-blind; MCS, Mayo Clinic score; mMCS, modified Mayo Clinic score; OLE, open-label extension; SD, standard deviation; TNFα, tumour necrosis factor alpha; UC, ulcerative colitis; y, year.
aPatients with multiple races were counted once in each race category.
bCollected at DB baseline.
cFor history of proctosigmoiditis and pancolitis, the responses are not mutually exclusive. Some patients reported a history of both proctosigmoiditis and pancolitis: for patients receiving etrasimod 2 mg in the OLE [by DB treatment group], placebo, n = 8; etrasimod 1 mg, n = 7; etrasimod 2 mg, n = 3; for total patients receiving placebo in the OLE, n = 0.
dOne patient in the group who received etrasimod 1 mg during the DB study received oral corticosteroid treatment for a condition other than UC and is not included in the number of patients with current oral corticosteroid treatment for UC.