Baseline patient demographics and clinical characteristics (safety population; n=511)
| Parameter | Placebo (n=129) | Budesonide MMX 9 mg, (n=128) | Budesonide MMX 6 mg, (n=128) | Entocort EC (n=126) |
|---|---|---|---|---|
| Mean age, years (range) | 39.9 (12–68) | 37.6 (13–66) | 37.9 (14–66) | 36.7 (12–67) |
| Gender, n (%) | ||||
| Men | 77 (59.7) | 70 (54.7) | 67 (52.3) | 66 (52.4) |
| Women | 52 (40.3) | 58 (45.3) | 61 (47.7) | 60 (47.6) |
| Race, n (%) | ||||
| White | 129 (100.0) | 126 (98.2) | 128 (100.0) | 126 (100.0) |
| Asian | 0 | 1 (0.9) | 0 | 0 |
| Other | 0 | 1 (0.9) | 0 | 0 |
| UC history | ||||
| Mean disease duration, years | 6.3 | 5.5 | 5.7 | 6.3 |
| Duration ≤1 year, n (%) | 23 (17.8) | 28 (21.9) | 19 (14.8) | 22 (17.5) |
| Duration >1 to ≤5 years, n (%) | 55 (42.6) | 55 (43.0) | 62 (48.4) | 45 (35.7) |
| Duration >5 years, n (%) | 51 (39.5) | 44 (34.4) | 47 (36.7) | 59 (46.8) |
| Disease extent, n (%) | ||||
| Proctosigmoiditis | 64 (49.6) | 58 (45.3) | 58 (45.3) | 51 (40.5) |
| Left-sided colitis | 44 (34.1) | 37 (28.9) | 40 (31.3) | 49 (38.9) |
| Extensive/pancolitis | 20 (15.5) | 31 (24.2) | 29 (22.7) | 26 (20.6) |
| Mean baseline UCDAI score | 6.2 | 6.5 | 6.6 | 6.7 |
| Mean baseline EI score | 6.6 | 6.5 | 7.2 | 6.5 |
| Prior mesalazine use* | 75 (58.1) | 66 (51.6) | 77 (60.2) | 70 (55.6) |
| Prior sulfasalazine use* | 28 (21.7) | 33 (25.8) | 27 (21.1) | 30 (23.8) |
*Prior medications are medications which started prior to the first dose of study drug.
EI, Endoscopic Index; MMX, Multi-Matrix System, UC, ulcerative colitis; UCDAI, UC Disease Activity Index.