Table 1.
Demographic and Baseline Characteristics
| Characteristic | Placebo/placebo (n = 11) | Placebo/SER-287 weekly (n = 15) | Vancomycin/ SER-287 weekly (n = 17) | Vancomycin/ SER-287 daily (n = 15) | All subjects (n = 58) |
|---|---|---|---|---|---|
| Age, y, mean | 45.8 | 46.5 | 47.9 | 47.8 | 47.1 |
| Female sex, n (%) | 7 (63.6) | 9 (60.0) | 7 (41.2) | 8 (53.3) | 31 (53.4) |
| Extent of disease, n (%) | |||||
| Left-sided UC | 8 (72.7) | 10 (66.7) | 12 (70.6) | 9 (60.0) | 39 (67.2) |
| Extensive UC | 3 (27.3) | 5 (33.3) | 5 (29.4) | 6 (40.0) | 19 (32.8) |
| Smoking history, n (%) | 3 (27.3) | 5 (33.3) | 5 (29.4) | 6 (40.0) | 19 (32.8) |
| Severity of UC, n (%) | |||||
| Mild | 3 (27.3) | 6 (40.0) | 9 (52.9)a | 6 (40.0) | 24 (41.4) |
| Moderate | 8 (72.7) | 9 (60.0) | 7 (41.2)a | 9 (60.0) | 33 (56.9) |
| Mayo score at study entry, mean | 7.3 | 6.8 | 6.4 | 6.9 | 6.8 |
| UC medication(s) at study entry, n (%) | 9 (81.8) | 13 (86.7) | 11 (64.7) | 12 (80.0) | 45 (77.6) |
| Mesalamine | 7 (63.6) | 11 (73.3) | 9 (52.9) | 11 (73.3) | 38 (65.5) |
| Immunomodulator | 2 (18.2) | 4 (26.7) | 2 (11.8) | 1 (6.7) | 9 (15.5) |
| Steroid | 3 (27.3) | 2 (13.3) | 0 | 3 (20.0) | 8 (13.8) |
| Combination therapy | 3 (27.3) | 3 (20.0) | 0 | 3 (20.0) | 9 (15.5) |
| Endoscopy score at baseline, n (%) | |||||
| 1 | 1 (9.1) | 3 (20.0) | 5 (29.4) | 3 (20.0) | 12 (20.7) |
| 2 | 5 (45.4) | 7 (46.7) | 7 (41.2) | 9 (60.0) | 28 (48.3) |
| 3 | 5 (45.4) | 5 (33.3) | 5 (29.4) | 3 (20.0) | 18 (31.3) |
| Time since UC diagnosis, y, mean | 11.52 | 12.43 | 11.84 | 12.74 | 12.17 |
a
One subject in vancomycin/SER-287 weekly group with TMMS = 3 at entry is not included.