Treatment target groups* | |||
Group 1 (N=89) | Group 2 (N=130) | Group 3 (N=213) | |
Week 16† | N=60 | N=93 | N=146 |
CS-free remission, n | 39 | 35 | 56 |
No remission, n | 21 | 58 | 90 |
Week 32† | N=15 | N=30 | N=62 |
CS-free remission, n | 6 | 8 | 10 |
No remission, n | 9 | 22 | 52 |
Week 48† | N=2 | N=13 | N=24 |
CS-free remission, n | 0 | 5 | 5 |
No remission, n | 2 | 8 | 19 |
1 March 2023 | |||
CS-free remission (cumulative), n | 45 | 48 | 71 |
CS-free remission among all randomised patients, % (95% CI) | 51 (40 to 61) | 37 (29 to 46) | 33 (27 to 40) |
CS-free remission among patients who reached at least week 16, % (95% CI) | 75 (62 to 85) | 52 (41 to 62) | 49 (40 to 57) |
*Group 1: CS-free symptomatic remission (Mayo RBS=0); group 2: CS-free endoscopic remission (MES≤1)+symptomatic remission; group 3: CS-free histologic remission (Geboes score<2B.0)+endoscopic remission+symptomatic remission.
†Patients who achieved remission at an earlier time point are not included in the subsequent visit’s population.
CS, corticosteroid; MES, Mayo Endoscopic Score; RBS, rectal bleeding subscore.