Disease characteristics and treatment history of remitters vs nonremitters at week 12 according to baseline disease activity (moderately active: MMS 5–7; severely active: MMS 8–9) in pooled data from ELEVATE UC 52 and ELEVATE UC 12.
| Baseline MMS 5–7 | Baseline MMS 8–9 | |||||||
| Clinical remitters | Clinical nonremitters | Clinical remitters | Clinical nonremitters | |||||
| Etrasimod 2 mg QD (N = 103) | Placebo QD (N = 22) | Etrasimod 2 mg QD (N = 241) | Placebo QD (N = 159) | Etrasimod 2 mg QD (N = 26) | Placebo QD (N = 5) | Etrasimod 2 mg QD (N = 126) | Placebo QD (N = 61) | |
| Extent of UC, n (%) | ||||||||
| Left-sided colitis/proctosigmoiditisa | 62 (60.2) | 12 (54.5) | 130 (54.4) | 87 (55.1) | 16 (61.5) | 2 (40.0) | 88 (69.8) | 41 (67.2) |
| Pancolitisa | 29 (28.2) | 9 (40.9) | 93 (38.9) | 58 (36.7) | 8 (30.8) | 3 (60.0) | 37 (29.4) | 17 (27.9) |
| Isolated proctitisb | 16 (15.5) | 3 (13.6) | 16 (6.6) | 14 (8.8) | 0 | 0 | 5 (4.0) | 2 (3.3) |
| MMS and subscores at baseline | ||||||||
| Baseline MMS, mean (SD) | 6.1 (0.8) | 6.0 (0.9) | 6.3 (0.7) | 6.4 (0.7) | 8.0 (0.0) | 8.0 (0.0) | 8.1 (0.3) | 8.1 (0.3) |
| Baseline RBS, n (%) | ||||||||
| 1 | 49 (47.6) | 12 (54.5) | 122 (50.6) | 74 (46.5) | 0 | 0 | 0 | 0 |
| 2 | 51 (49.5) | 10 (45.5) | 113 (46.9) | 85 (53.5) | 20 (76.9) | 5 (100.0) | 110 (87.3) | 50 (82.0) |
| 3 | 3 (2.9) | 0 | 6 (2.5) | 0 | 6 (23.1) | 0 | 16 (12.7) | 11 (18.0) |
| Baseline SFS, n (%) | ||||||||
| 0 | 0 | 0 | 2 (0.8) | 0 | 0 | 0 | 0 | 0 |
| 1 | 8 (7.8) | 1 (4.5) | 26 (10.8) | 20 (12.6) | 0 | 0 | 0 | 0 |
| 2 | 61 (59.2) | 13 (59.1) | 102 (42.3) | 72 (45.3) | 3 (11.5) | 0 | 2 (1.6) | 0 |
| 3 | 34 (33.0) | 8 (36.4) | 111 (46.1) | 67 (42.1) | 23 (88.5) | 5 (100.0) | 124 (98.4) | 61 (100.0) |
| Baseline ES, n (%) | ||||||||
| 2 | 74 (71.8) | 18 (81.8) | 126 (52.3) | 77 (48.4) | 3 (11.5) | 0 | 4 (3.2) | 4 (6.6) |
| 3 | 29 (28.2) | 4 (18.2) | 115 (47.7) | 82 (51.6) | 23 (88.5) | 5 (100.0) | 122 (96.8) | 57 (93.4) |
| Treatment history | ||||||||
| Baseline CS use, n (%) | 32 (31.1) | 12 (54.5) | 57 (23.7) | 41 (25.8) | 12 (46.2) | 2 (40.0) | 46 (36.5) | 17 (27.9) |
| Naïve to prior biologic/JAKi, n (%) | 80 (77.7) | 18 (81.8) | 160 (66.4) | 108 (67.9) | 21 (80.8) | 3 (60.0) | 81 (64.3) | 38 (62.3) |
| Number of prior biologic/JAKi use | ||||||||
| 0 | 80 (77.7) | 18 (81.8) | 160 (66.4) | 108 (67.9) | 21 (80.8) | 3 (60.0) | 81 (64.3) | 38 (62.3) |
| 1 | 13 (12.6) | 2 (9.1) | 37 (15.4) | 29 (18.2) | 4 (15.4) | 0 | 21 (16.7) | 13 (21.3) |
| >1 | 10 (9.7) | 2 (9.1) | 44 (18.3) | 22 (13.8) | 1 (3.8) | 2 (40.0) | 24 (19.0) | 10 (16.4) |
| Prior oral 5-ASA compound use, n (%) | 23 (22.3) | 2 (9.1) | 32 (13.3) | 31 (19.5) | 2 (7.7) | 0 | 10 (7.9) | 5 (8.2) |
| Prior immunomodulators use, n (%) | 32 (31.1) | 7 (31.8) | 95 (39.4) | 58 (36.5) | 11 (42.3) | 2 (40.0) | 49 (38.9) | 24 (39.3) |
| Baseline MMS 5–7 | Baseline MMS 8–9 | |||||||
| Clinical remitters | Clinical nonremitters | Clinical remitters | Clinical nonremitters | |||||
| Etrasimod 2 mg QD (N = 103) | Placebo QD (N = 22) | Etrasimod 2 mg QD (N = 241) | Placebo QD (N = 159) | Etrasimod 2 mg QD (N = 26) | Placebo QD (N = 5) | Etrasimod 2 mg QD (N = 126) | Placebo QD (N = 61) | |
| Extent of UC, n (%) | ||||||||
| Left-sided colitis/proctosigmoiditisa | 62 (60.2) | 12 (54.5) | 130 (54.4) | 87 (55.1) | 16 (61.5) | 2 (40.0) | 88 (69.8) | 41 (67.2) |
| Pancolitisa | 29 (28.2) | 9 (40.9) | 93 (38.9) | 58 (36.7) | 8 (30.8) | 3 (60.0) | 37 (29.4) | 17 (27.9) |
| Isolated proctitisb | 16 (15.5) | 3 (13.6) | 16 (6.6) | 14 (8.8) | 0 | 0 | 5 (4.0) | 2 (3.3) |
| MMS and subscores at baseline | ||||||||
| Baseline MMS, mean (SD) | 6.1 (0.8) | 6.0 (0.9) | 6.3 (0.7) | 6.4 (0.7) | 8.0 (0.0) | 8.0 (0.0) | 8.1 (0.3) | 8.1 (0.3) |
| Baseline RBS, n (%) | ||||||||
| 1 | 49 (47.6) | 12 (54.5) | 122 (50.6) | 74 (46.5) | 0 | 0 | 0 | 0 |
| 2 | 51 (49.5) | 10 (45.5) | 113 (46.9) | 85 (53.5) | 20 (76.9) | 5 (100.0) | 110 (87.3) | 50 (82.0) |
| 3 | 3 (2.9) | 0 | 6 (2.5) | 0 | 6 (23.1) | 0 | 16 (12.7) | 11 (18.0) |
| Baseline SFS, n (%) | ||||||||
| 0 | 0 | 0 | 2 (0.8) | 0 | 0 | 0 | 0 | 0 |
| 1 | 8 (7.8) | 1 (4.5) | 26 (10.8) | 20 (12.6) | 0 | 0 | 0 | 0 |
| 2 | 61 (59.2) | 13 (59.1) | 102 (42.3) | 72 (45.3) | 3 (11.5) | 0 | 2 (1.6) | 0 |
| 3 | 34 (33.0) | 8 (36.4) | 111 (46.1) | 67 (42.1) | 23 (88.5) | 5 (100.0) | 124 (98.4) | 61 (100.0) |
| Baseline ES, n (%) | ||||||||
| 2 | 74 (71.8) | 18 (81.8) | 126 (52.3) | 77 (48.4) | 3 (11.5) | 0 | 4 (3.2) | 4 (6.6) |
| 3 | 29 (28.2) | 4 (18.2) | 115 (47.7) | 82 (51.6) | 23 (88.5) | 5 (100.0) | 122 (96.8) | 57 (93.4) |
| Treatment history | ||||||||
| Baseline CS use, n (%) | 32 (31.1) | 12 (54.5) | 57 (23.7) | 41 (25.8) | 12 (46.2) | 2 (40.0) | 46 (36.5) | 17 (27.9) |
| Naïve to prior biologic/JAKi, n (%) | 80 (77.7) | 18 (81.8) | 160 (66.4) | 108 (67.9) | 21 (80.8) | 3 (60.0) | 81 (64.3) | 38 (62.3) |
| Number of prior biologic/JAKi use | ||||||||
| 0 | 80 (77.7) | 18 (81.8) | 160 (66.4) | 108 (67.9) | 21 (80.8) | 3 (60.0) | 81 (64.3) | 38 (62.3) |
| 1 | 13 (12.6) | 2 (9.1) | 37 (15.4) | 29 (18.2) | 4 (15.4) | 0 | 21 (16.7) | 13 (21.3) |
| >1 | 10 (9.7) | 2 (9.1) | 44 (18.3) | 22 (13.8) | 1 (3.8) | 2 (40.0) | 24 (19.0) | 10 (16.4) |
| Prior oral 5-ASA compound use, n (%) | 23 (22.3) | 2 (9.1) | 32 (13.3) | 31 (19.5) | 2 (7.7) | 0 | 10 (7.9) | 5 (8.2) |
| Prior immunomodulators use, n (%) | 32 (31.1) | 7 (31.8) | 95 (39.4) | 58 (36.5) | 11 (42.3) | 2 (40.0) | 49 (38.9) | 24 (39.3) |
aLeft-sided colitis and pancolitis were entered by investigators.
bIsolated proctitis was confirmed through a central read.
Abbreviations: 5-ASA, 5-aminosalicylates; CS, corticosteroid; ES, endoscopic subscore; JAKi, Janus kinase inhibitor; MMS, modified Mayo score; N, number of patients in the baseline disease activity subgroup by treatment; n, number of patients in the specified category; QD, once daily; RBS, rectal bleeding subscore; SD, standard deviation; SFS, stool frequency subscore; UC, ulcerative colitis.
Disease characteristics and treatment history of remitters vs nonremitters at week 12 according to baseline disease activity (moderately active: MMS 5–7; severely active: MMS 8–9) in pooled data from ELEVATE UC 52 and ELEVATE UC 12.
| Baseline MMS 5–7 | Baseline MMS 8–9 | |||||||
| Clinical remitters | Clinical nonremitters | Clinical remitters | Clinical nonremitters | |||||
| Etrasimod 2 mg QD (N = 103) | Placebo QD (N = 22) | Etrasimod 2 mg QD (N = 241) | Placebo QD (N = 159) | Etrasimod 2 mg QD (N = 26) | Placebo QD (N = 5) | Etrasimod 2 mg QD (N = 126) | Placebo QD (N = 61) | |
| Extent of UC, n (%) | ||||||||
| Left-sided colitis/proctosigmoiditisa | 62 (60.2) | 12 (54.5) | 130 (54.4) | 87 (55.1) | 16 (61.5) | 2 (40.0) | 88 (69.8) | 41 (67.2) |
| Pancolitisa | 29 (28.2) | 9 (40.9) | 93 (38.9) | 58 (36.7) | 8 (30.8) | 3 (60.0) | 37 (29.4) | 17 (27.9) |
| Isolated proctitisb | 16 (15.5) | 3 (13.6) | 16 (6.6) | 14 (8.8) | 0 | 0 | 5 (4.0) | 2 (3.3) |
| MMS and subscores at baseline | ||||||||
| Baseline MMS, mean (SD) | 6.1 (0.8) | 6.0 (0.9) | 6.3 (0.7) | 6.4 (0.7) | 8.0 (0.0) | 8.0 (0.0) | 8.1 (0.3) | 8.1 (0.3) |
| Baseline RBS, n (%) | ||||||||
| 1 | 49 (47.6) | 12 (54.5) | 122 (50.6) | 74 (46.5) | 0 | 0 | 0 | 0 |
| 2 | 51 (49.5) | 10 (45.5) | 113 (46.9) | 85 (53.5) | 20 (76.9) | 5 (100.0) | 110 (87.3) | 50 (82.0) |
| 3 | 3 (2.9) | 0 | 6 (2.5) | 0 | 6 (23.1) | 0 | 16 (12.7) | 11 (18.0) |
| Baseline SFS, n (%) | ||||||||
| 0 | 0 | 0 | 2 (0.8) | 0 | 0 | 0 | 0 | 0 |
| 1 | 8 (7.8) | 1 (4.5) | 26 (10.8) | 20 (12.6) | 0 | 0 | 0 | 0 |
| 2 | 61 (59.2) | 13 (59.1) | 102 (42.3) | 72 (45.3) | 3 (11.5) | 0 | 2 (1.6) | 0 |
| 3 | 34 (33.0) | 8 (36.4) | 111 (46.1) | 67 (42.1) | 23 (88.5) | 5 (100.0) | 124 (98.4) | 61 (100.0) |
| Baseline ES, n (%) | ||||||||
| 2 | 74 (71.8) | 18 (81.8) | 126 (52.3) | 77 (48.4) | 3 (11.5) | 0 | 4 (3.2) | 4 (6.6) |
| 3 | 29 (28.2) | 4 (18.2) | 115 (47.7) | 82 (51.6) | 23 (88.5) | 5 (100.0) | 122 (96.8) | 57 (93.4) |
| Treatment history | ||||||||
| Baseline CS use, n (%) | 32 (31.1) | 12 (54.5) | 57 (23.7) | 41 (25.8) | 12 (46.2) | 2 (40.0) | 46 (36.5) | 17 (27.9) |
| Naïve to prior biologic/JAKi, n (%) | 80 (77.7) | 18 (81.8) | 160 (66.4) | 108 (67.9) | 21 (80.8) | 3 (60.0) | 81 (64.3) | 38 (62.3) |
| Number of prior biologic/JAKi use | ||||||||
| 0 | 80 (77.7) | 18 (81.8) | 160 (66.4) | 108 (67.9) | 21 (80.8) | 3 (60.0) | 81 (64.3) | 38 (62.3) |
| 1 | 13 (12.6) | 2 (9.1) | 37 (15.4) | 29 (18.2) | 4 (15.4) | 0 | 21 (16.7) | 13 (21.3) |
| >1 | 10 (9.7) | 2 (9.1) | 44 (18.3) | 22 (13.8) | 1 (3.8) | 2 (40.0) | 24 (19.0) | 10 (16.4) |
| Prior oral 5-ASA compound use, n (%) | 23 (22.3) | 2 (9.1) | 32 (13.3) | 31 (19.5) | 2 (7.7) | 0 | 10 (7.9) | 5 (8.2) |
| Prior immunomodulators use, n (%) | 32 (31.1) | 7 (31.8) | 95 (39.4) | 58 (36.5) | 11 (42.3) | 2 (40.0) | 49 (38.9) | 24 (39.3) |
| Baseline MMS 5–7 | Baseline MMS 8–9 | |||||||
| Clinical remitters | Clinical nonremitters | Clinical remitters | Clinical nonremitters | |||||
| Etrasimod 2 mg QD (N = 103) | Placebo QD (N = 22) | Etrasimod 2 mg QD (N = 241) | Placebo QD (N = 159) | Etrasimod 2 mg QD (N = 26) | Placebo QD (N = 5) | Etrasimod 2 mg QD (N = 126) | Placebo QD (N = 61) | |
| Extent of UC, n (%) | ||||||||
| Left-sided colitis/proctosigmoiditisa | 62 (60.2) | 12 (54.5) | 130 (54.4) | 87 (55.1) | 16 (61.5) | 2 (40.0) | 88 (69.8) | 41 (67.2) |
| Pancolitisa | 29 (28.2) | 9 (40.9) | 93 (38.9) | 58 (36.7) | 8 (30.8) | 3 (60.0) | 37 (29.4) | 17 (27.9) |
| Isolated proctitisb | 16 (15.5) | 3 (13.6) | 16 (6.6) | 14 (8.8) | 0 | 0 | 5 (4.0) | 2 (3.3) |
| MMS and subscores at baseline | ||||||||
| Baseline MMS, mean (SD) | 6.1 (0.8) | 6.0 (0.9) | 6.3 (0.7) | 6.4 (0.7) | 8.0 (0.0) | 8.0 (0.0) | 8.1 (0.3) | 8.1 (0.3) |
| Baseline RBS, n (%) | ||||||||
| 1 | 49 (47.6) | 12 (54.5) | 122 (50.6) | 74 (46.5) | 0 | 0 | 0 | 0 |
| 2 | 51 (49.5) | 10 (45.5) | 113 (46.9) | 85 (53.5) | 20 (76.9) | 5 (100.0) | 110 (87.3) | 50 (82.0) |
| 3 | 3 (2.9) | 0 | 6 (2.5) | 0 | 6 (23.1) | 0 | 16 (12.7) | 11 (18.0) |
| Baseline SFS, n (%) | ||||||||
| 0 | 0 | 0 | 2 (0.8) | 0 | 0 | 0 | 0 | 0 |
| 1 | 8 (7.8) | 1 (4.5) | 26 (10.8) | 20 (12.6) | 0 | 0 | 0 | 0 |
| 2 | 61 (59.2) | 13 (59.1) | 102 (42.3) | 72 (45.3) | 3 (11.5) | 0 | 2 (1.6) | 0 |
| 3 | 34 (33.0) | 8 (36.4) | 111 (46.1) | 67 (42.1) | 23 (88.5) | 5 (100.0) | 124 (98.4) | 61 (100.0) |
| Baseline ES, n (%) | ||||||||
| 2 | 74 (71.8) | 18 (81.8) | 126 (52.3) | 77 (48.4) | 3 (11.5) | 0 | 4 (3.2) | 4 (6.6) |
| 3 | 29 (28.2) | 4 (18.2) | 115 (47.7) | 82 (51.6) | 23 (88.5) | 5 (100.0) | 122 (96.8) | 57 (93.4) |
| Treatment history | ||||||||
| Baseline CS use, n (%) | 32 (31.1) | 12 (54.5) | 57 (23.7) | 41 (25.8) | 12 (46.2) | 2 (40.0) | 46 (36.5) | 17 (27.9) |
| Naïve to prior biologic/JAKi, n (%) | 80 (77.7) | 18 (81.8) | 160 (66.4) | 108 (67.9) | 21 (80.8) | 3 (60.0) | 81 (64.3) | 38 (62.3) |
| Number of prior biologic/JAKi use | ||||||||
| 0 | 80 (77.7) | 18 (81.8) | 160 (66.4) | 108 (67.9) | 21 (80.8) | 3 (60.0) | 81 (64.3) | 38 (62.3) |
| 1 | 13 (12.6) | 2 (9.1) | 37 (15.4) | 29 (18.2) | 4 (15.4) | 0 | 21 (16.7) | 13 (21.3) |
| >1 | 10 (9.7) | 2 (9.1) | 44 (18.3) | 22 (13.8) | 1 (3.8) | 2 (40.0) | 24 (19.0) | 10 (16.4) |
| Prior oral 5-ASA compound use, n (%) | 23 (22.3) | 2 (9.1) | 32 (13.3) | 31 (19.5) | 2 (7.7) | 0 | 10 (7.9) | 5 (8.2) |
| Prior immunomodulators use, n (%) | 32 (31.1) | 7 (31.8) | 95 (39.4) | 58 (36.5) | 11 (42.3) | 2 (40.0) | 49 (38.9) | 24 (39.3) |
aLeft-sided colitis and pancolitis were entered by investigators.
bIsolated proctitis was confirmed through a central read.
Abbreviations: 5-ASA, 5-aminosalicylates; CS, corticosteroid; ES, endoscopic subscore; JAKi, Janus kinase inhibitor; MMS, modified Mayo score; N, number of patients in the baseline disease activity subgroup by treatment; n, number of patients in the specified category; QD, once daily; RBS, rectal bleeding subscore; SD, standard deviation; SFS, stool frequency subscore; UC, ulcerative colitis.
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