Table 3.
Placebo [n = 42] |
Etrasimod 1 mg [n = 38] |
Etrasimod 2 mg [n = 32] | Overall [n = 112] | Placebo [n = 42] | Etrasimod 1 mg [n = 38] | Etrasimod 2 mg [n = 32] | Overall [n = 112] | |
---|---|---|---|---|---|---|---|---|
Efficacy outcome | Week 12 | End of treatment | ||||||
Patients with clinical response | ||||||||
n [%] 90% CI | 13 [31.0] 19.4, 44.6 | 16 [42.1] 28.5, 56.7 | 17 [53.1] 37.3, 68.5 | 46 [41.1] 33.2, 49.3 | 25 [59.5] 45.7, 72.3 | 28 [73.7] 59.5, 85.0 | 19 [59.4] 43.3, 74.0 | 72 [64.3] 56.2, 71.8 |
Patients with clinical remission | ||||||||
n [%] 90% CI | 4 [9.5] 3.3, 20.5 | 6 [15.8] 7.1, 28.8 | 15 [46.9] 31.5, 62.7 | 25 [22.3] 16.0, 29.8 | 12 [28.6] 17.4, 42.1 | 14 [36.8] 23.8, 51.5 | 11 [34.4] 20.6, 50.4 | 37 [33.0] 25.7, 41.1 |
Patients with endoscopic improvement | ||||||||
n [%] 90% CI | 7 [16.7] 8.1, 29.0 | 8 [21.1] 10.9, 34.8 | 16 [50.0] 34.4, 65.6 | 31 [27.7] 20.8, 35.5 | 15 [35.7] 23.5, 49.5 | 20 [52.6] 38.2, 66.7 | 13 [40.6] 26.0, 56.7 | 48 [42.9] 34.9, 51.1 |
All patients received etrasimod 2 mg during the OLE. Groups are based on treatment during the DB period. The overall group includes patients who received any treatment [placebo, etrasimod 1 mg, or etrasimod 2 mg] during the DB period. Week 12 was the end of the DB period. The ITT population included all patients who received any etrasimod 2 mg during the OLE. In the NRI analysis, data missing due to any reason, including study discontinuation, were imputed as non-response. 90% CI are exact CI for the % of patients with the given endpoint.
CI, confidence interval; DB, double-blind; n, number of patients; NRI, non-responder imputation; OLE, open-label extension; ITT, intention-to-treat.