Table 2. Proportion of patients with/without relapse during the observation period by covariates.
| Covariates | Remission maintenance | Relapse | P-value a | |
|---|---|---|---|---|
| Sex, n (%) | ||||
| Male | 13 (37.1) | 22 (62.9) | 0.253 | |
| Female | 5 (20.0) | 20 (80.0) | ||
| Age (years), Mean (SD) | 42.7 (11.4) | 40.8 (12.3) | 0.586 | |
| Body weight, (kg), Mean (SD) | 66.4 (14.2) | 57.2 (12.6) | 0.014 | |
| Endoscopic subscore at end of treatment with budesonide foam, n (%) | ||||
| Score 0 | 12 (32.4) | 25 (67.6) | 0.773 | |
| Score 1 | 6 (26.1) | 17 (73.9) | ||
| Regimen of budesonide foam, n (%) | ||||
| Once daily | 4 (22.2) | 14 (77.8) | 0.542 | |
| Twice daily | 14 (33.3) | 28 (66.7) | ||
| Smoking habit, n (%) | ||||
| Yes | 1 (100.0) | 0 (0.0) | 0.300 | |
| No | 17 (28.8) | 42 (71.2) | ||
| Duration of disease (years), n (%) | ||||
| <1 | 2 (18.2) | 9 (81.8) | 0.706 | |
| ≥1 to <5 | 7 (31.8) | 15 (68.2) | ||
| ≥5 | 9 (33.3) | 18 (66.7) | ||
| Clinical course at the phase 2 or phase 3 trials, n (%) | ||||
| First attack | 2 (40.0) | 3 (60.0) | 0.631 | |
| Relapsing-remitting | 16 (29.1) | 39 (70.9) | ||
| Extension of Disease, n (%) | ||||
| Proctitis | 10 (37.0) | 17 (63.0) | 0.075 | |
| Left-sided colitis | 5 (17.9) | 23 (82.1) | ||
| Pancolitis | 3 (60.0) | 2 (40.0) | ||
| Extension of Disease 2, n (%) | ||||
| Proctitis | 10 (37.0) | 17 (63.0) | 0.397 | |
| Left-sided colitis or Pancolitis | 8 (24.2) | 25 (75.8) | ||
| Extension of Disease 3, n (%) | ||||
| Proctitis or left-sided colitis | 15 (27.3) | 40 (72.7) | 0.154 | |
| Pancolitis | 3 (60.0) | 2 (40.0) | ||
| Severity, n (%) | ||||
| Mild | 10 (40.0) | 15 (60.0) | 0.168 | |
| Moderate | 8 (22.9) | 27 (77.1) | ||
| Concomitant medication at start of the observation study, n (%) | ||||
| Oral 5-ASA | No | 4 (36.4) | 7 (63.6) | 0.870 |
| <Max dose b | 6 (27.3) | 16 (72.7) | ||
| Max dose a | 8 (29.6) | 19 (70.4) | ||
| Topical 5-ASA | No | 14 (32.6) | 29 (67.4) | 0.550 |
| Yes | 4 (23.5) | 13 (76.5) | ||
| Topical corticoid c | No | 18 (33.3) | 36 (66.7) | 0.165 |
| Yes | 0 (0.0) | 6 (100.0) | ||
5-ASA, 5-Aminosalicylic acid; SD, standard deviation
a Two-tailed P-value with Fisher’s exact test or two sample t test
b Max dose of 5-ASA: Pentasa tablet and Salazopyrin tablet (4000 mg), Asacol tablet (3600 mg)
c Suppository or enema. One case used corticoid injection.