Table 1. Demographics and baseline characteristics on entry into the parent studies (safety population).
MMX mesalazine 2.4 g/day (given once daily) (n = 225) | MMX mesalazine 2.4 g/day (1.2 g given twice daily) (n = 234) | |
Male n (%) | 106 (47.1) | 114 (48.7) |
Mean (SD) age, years | 42.4 (12.1) | 42.6 (13.2) |
Non-/previous smoker, n (%) | 213 (94.7) | 215 (91.9) |
Caucasian, n (%) | 193 (85.8) | 202 (86.3) |
Diagnosis, n (%) | ||
Newly diagnosed | 32 (14.2) | 34 (14.5) |
History of UC | 193 (85.8) | 200 (85.5) |
Mean (SD) time since diagnosis, weeks | 244.5 (314.1) | 288.4 (338.8) |
Relapses in last 2 years, n (%) | ||
0–2 | 135 (60.0) | 144 (61.5) |
3–6 | 76 (33.8) | 82 (35.0) |
⩾7 | 4 (1.8) | 5 (2.1) |
Missing | 10 (4.4) | 3 (1.3) |
Classification of disease*, n (%) | ||
Left-sided | 175 (77.8) | 179 (76.5) |
Upper limit in transverse colon | 14 (6.2) | 14 (6.0) |
Pancolitis | 36 (16.0) | 40 (17.1) |
Baseline modified UC-DAI score (at parent study entry), mean (SD) | 6.3 (1.5) | 6.5 (1.4) |
Treatment received in parent studies, n (%) | ||
Placebo | 57 (25.3) | 61 (26.1) |
MMX mesalazine 2.4 g/day | 68 (30.2) | 67 (28.6) |
MMX mesalazine 4.8 g/day | 72 (32.0) | 70 (29.9) |
Asacol | 28 (12.4) | 36 (15.4) |
*Based on patient disease history.
UC, ulcerative colitis; UC-DAI, UC Disease Activity Index.