Table 2.
Clinical effectiveness endpoints at the end of treatment.
| Cohort 1 (n = 59) | Cohort 2 (n = 260) | Cohort 3 (n = 30) | Total (N = 349) | ||
|---|---|---|---|---|---|
| Clinical benefit (≥3 point reduction UCDAI clinical sub-score) | N (%) | 36 (64.3%) | 151 (62.1%) | 9 (33.3%) | 196 (60.1%) |
| [95% CI] | [50.4–76.6] | [55.7–68.3] | [16.5–54.0] | [54.6–65.5] | |
| Clinical remission (UCDAI clinical sub-score ≤ 1) | N (%) | 32 (57.1%) | 128 (52.7%) | 9 (33.3%) | 169 (51.8%) |
| [95% CI] | [43.2–70.3] | [46.2–59.1] | [16.5–54.0] | [46.3–57.4] | |
| Symptoms resolution (RB = 0 + SF ≤ 1 and no urgency) | N (%) | 40 (71.4%) | 153 (63.0%) | 13 (48.1%) | 206 (63.2%) |
| [95% CI] | [57.8–82.7] | [56.6–69.0] | [28.7–68.1] | [57.7–68.4] | |
| Full symptoms resolution (RB = 0 + SF = 0 and no urgency) | N (%) | 29 (51.8%) | 110 (45.3%) | 8 (29.6%) | 147 (45.1%) |
| [95% CI] | [38.0–65.3] | [38.9–51.8] | [13.8–50.2] | [39.6–50.7] | |
| UC status | N (%) | ||||
| No response/relapse | 22 (12.2%) | 11 (15.9%) | 3 (14.3%) | 36 (13.3%) | |
| Partial response | 54 (29.8%) | 19 (27.5%) | 4 (19.0%) | 77 (28.4%) | |
| Complete response | 105 (58.0%) | 39 (56.5%) | 14 (66.7%) | 158 (58.3%) |
UCDAI = Ulcerative Colitis Disease Activity Index