Table 1.
Patient demographics and baseline characteristics (final study ITT population).
| M1000 group (n = 151) | M2x500 group (n = 155) | |
|---|---|---|
| Female gender, n (%) | 72 (47.7) | 82 (52.9) |
| Age (years), mean (SD) | 41.4 (12.9) | 43.3 (14.0) |
| Body mass index (kg/m2), mean (SD) | 25.2 (4.8) | 24.5 (4.4) |
| Smoking habit, n (%) | ||
| Current | 14 (9.3) | 7 (4.5) |
| Former | 17 (11.3) | 25 (16.1) |
| Never | 120 (79.5) | 123 (79.4) |
| Duration of UC (years), median (IQR) | 2.9 (0.5, 8.2) | 2.8 (0.8, 8.4) |
| Time since first symptoms (years), median (IQR) | 3.5 (1.1, 8.9) | 3.6 (1.4, 10.2) |
| Type of disease, n (%) | ||
| New | 29 (19.2) | 26 (16.8) |
| Established | 122 (80.8) | 129 (83.2) |
| Continuous | 15 (9.9) | 15 (9.7) |
| Recurrent | 107 (70.9) | 114 (73.5) |
| Frequency of previous episodes, n (%) | ||
| >1 every month | 3 (2.8) | 2 (1.8) |
| 1 every 6 months | 16 (15.0) | 23 (20.2) |
| 1 every 6–12 months | 53 (49.5) | 52 (45.6) |
| <1 every year | 35 (32.7) | 37 (32.5) |
| Duration of current acute episode (months), median (IQR) | 1.4 (0.7, 2.4) | 1.4 (0.8, 2.4) |
| Localisation of disease, n (%) | ||
| Proctosigmoiditis | 93 (61.6) | 76 (49.0) |
| Left-sided colitis | 22 (14.6) | 32 (20.6) |
| Subtotal/total colitis | 29 (19.2) | 41 (26.5) |
| Not assessable | 7 (4.6) | 6 (3.9) |
| Length of lesion ab ano (cm), median (IQR) | 40 (30, 52) | 42 (30, 60) |
| Number of stools per week, mean (SD) | 30.0 (13.3) | 29.3 (11.4) |
| Number of bloody stools per week, mean (SD) | 17.8 (12.7) | 16.7 (11.4) |
| CAI, mean (SD) | 7.5 (1.7) | 7.7 (1.9) |
| EI, mean (SD) | 6.9 (1.7) | 6.7 (1.7) |
| HI, mean (SD) | 2.5 (1.0) | 2.4 (0.9) |
| Fecal calprotectin (µg/g), mean (SD) | 1067 (1754) | 1045 (2036) |
ITT: intent-to-treat; SD: standard deviation; CAI: clinical activity index; EI: endoscopic index; HI: histological index; IQR: interquartile range; UC: ulcerative colitis.