Table 1.
Demographics and baseline characteristics (safety population)
| Characteristic | Budesonide foam (n = 719) | Placebo (n = 278) |
|---|---|---|
| Age (year), mean (SD) | 43.4 (13.3) | 41.6 (13.2) |
| Sex [n (%)] | ||
| Male | 342 (47.6) | 115 (41.4) |
| Female | 377 (52.4) | 163 (58.6) |
| Race [n (%)] | ||
| White | 672 (93.5) | 257 (92.4) |
| Black | 33 (4.6) | 13 (4.7) |
| Other | 14 (1.9) | 8 (2.9) |
| Body mass index (kg/m2), mean (SD) | 25.7 (4.9)a | 26.0 (5.1) |
| Duration of disease (year), mean (SD) | 5.9 (7.3) | 4.4 (6.0) |
| Extent of disease [n (%)] | ||
| Proctitisb | 241 (33.5) | 81 (29.1) |
| Proctosigmoiditisc | 475 (66.1) | 196 (70.5) |
| Missing | 3 (0.4) | 1 (0.4) |
| Severity of disease [n (%)]d | ||
| MMDAI score < 4 | 4 (0.6) | 0 |
| Mild | 192 (26.7) | 34 (12.2) |
| Moderate | 505 (70.2) | 244 (87.8) |
| Severe | 14 (1.9) | 0 |
| Missing | 4 (0.6) | 0 |
| Baseline use of 5-ASA [n (%)] | 228 (31.7) | 154 (55.4) |
5-ASA 5-aminosalicylic acid, CAI clinical disease activity index, DAI disease activity index, MMDAI Modified Mayo Disease Activity Index
a n = 715
bProctitis was defined as disease limited to the rectum (up to ~15 cm from the anal verge)
cProctosigmoiditis was defined as disease limited to the rectum and sigmoid colon (up to ~40 cm from the anal verge)
dMild (MMDAI score 4–6); moderate (MMDAI score 7–10), and severe (MMDAI score 11–12) in BUCF3001 and BUCF3002. Assessment of disease severity in study BUF-6/UCA by DAI and in study BUF-9/UCA by CAI and DAI [17, 18]