Table 1. Patient demographics and baseline characteristics (analysis set).
| Sex, n (%) | ||
| Male | 35 (58.3) | |
| Female | 25 (41.7) | |
| Age (years), Mean (SD) | 41.4 (12.0) | |
| Body weight, (kg), Mean (SD) | 59.9 (13.7) | |
| Mayo endoscopic subscore at end of treatment with budesonide foam, n (%) | ||
| Score 0 | 37 (61.7) | |
| Score 1 | 23 (38.3) | |
| Regimen of budesonide foam, n (%) | ||
| Once daily | 18 (30.0) | |
| Twice daily | 42 (70.0) | |
| Smoking habit, n (%) | ||
| Yes | 1 (1.7) | |
| No | 59 (98.3) | |
| Duration of disease (years), n (%) | ||
| <1 | 11 (18.3) | |
| ≥1 to <5 | 22 (36.7) | |
| ≥5 | 27 (45.0) | |
| Clinical course at the phase 2 or phase 3 trials, n (%) | ||
| First attack | 5 (8.3) | |
| Relapsing-remitting | 55 (91.7) | |
| Extension of Disease, n (%) | ||
| Proctitis | 27 (45.0) | |
| Left-sided colitis | 28 (46.7) | |
| Pancolitis | 5 (8.3) | |
| Extension of Disease 2, n (%) | ||
| Proctitis | 27 (45.0) | |
| Left-sided colitis or pancolitis | 33 (55.0) | |
| Extension of Disease 3, n (%) | ||
| Proctitis or left-sided colitis | 55 (91.7) | |
| Pancolitis | 5 (8.3) | |
| Severity, n (%) | ||
| Mild | 25 (41.7) | |
| Moderate | 35 (58.3) | |
| Concomitant medication at start of the observation study, n (%) | ||
| Oral 5-ASA | No | 11 (18.3) |
| < Max dose | 22 (36.7) | |
| Max dose a | 27 (45.0) | |
| Topical 5-ASA | No | 43 (71.7) |
| Yes | 17 (28.3) | |
| Topical corticoidb | No | 54 (90.0) |
| Yes | 6 (10.0) | |
5-ASA, 5-Aminosalicylic acid; max, maximum; SD, standard deviation
a Max dose of 5-ASA: Pentasa tablet and Salazopyrin tablet (4000 mg), Asacol tablet (3600 mg)
b Suppository or enema. One case used corticoid injection.