Table 1.

Demographic and baseline characteristics, modified intention-to-treat population.

Characteristic	Budesonide MMX 9 mg n = 230	Placebo n = 228
Age, years, mean [SD]	44.5 [14.1]	44.6 [13.7]
Sex, male, n [%]	121 [52.6]	127 [55.7]
Race, White, n [%]	219 [95.2]	210 [92.1]
BMI, kg/m2, mean [SD]	25.7 [5.2]	25.6 [5.0]
Duration of disease, months, mean [SD]	80.4 [91.0]	78.9 [90.5]
Duration of current flare, n [%]
≤ 4 weeks	43 [18.7]	36 [15.8]
5–12 weeks	87 [37.8]	94 [41.2]
> 12 weeks	90 [39.1]	94 [41.2]
Missing	10 [4.3]	4 [1.8]
Extent of disease, n [%]
Proctosigmoiditis	94 [40.9]	85 [37.3]
Left-sided UC	84 [36.5]	94 [41.2]
Extensive colitis	13 [5.7]	16 [7.0]
Pancolitis	39 [17.0]	33 [14.5]
Severity of current flare, n [%]
Mild	42 [18.3]	47 [20.6]
Moderate	188 [81.7]	181 [79.4]
Baseline UCDAI total score, mean [SD]	6.5a [1.5]	6.6 [1.6]
Baseline UCDAI rectal bleeding subscore, n [%]
0	29 [12.6]	34 [14.9]
1	128 [55.7]	111 [48.7]
2	69 [30.0]	77 [33.8]
3	3 [1.3]	6 [2.6]
Baseline UCDAI stool frequency subscore, n [%]
0	28 [12.2]	25 [11.0]
1	85 [37.0]	85 [37.3]
2	69 [30.0]	75 [32.9]
3	47 [20.4]	43 [18.9]
Baseline UCDAI mucosal appearance subscore, n [%]
0	0	0
1	40 [17.4]	43 [18.9]
2	161 [70.0]	155 [68.0]
3	29 [12.6]	30 [13.2]
Baseline UCDAI physician’s rating of disease activity subscore, n [%]
0	0	0
1	45 [19.6]	49 [21.5]
2	185 [80.4]	179 [78.5]
3	0	0
Total daily dose of background mesalamine equivalent, n [%]
< 2.4 g	33 [14.3]	42 [18.4]
≥ 2.4 g to < 4.8 g	170 [73.9]	158 [69.3]
≥ 4.8 g	27 [11.7]	28 [12.3]
Mean dose, g [SD]	3.1 [1.4]	3.0 [1.2]
Prior biologic therapy use, n [%]b
Adalimumab	2 [0.8]	1 [0.4]
Golimumab	0	1 [0.4]
Infliximab	10 [3.9]	9 [3.5]

BMI, body mass index; MMX, multimatrix; SD, standard deviation; UC, ulcerative colitis; UCDAI, ulcerative colitis disease activity index.

^aData missing for 1 patient.

^bData presented for safety population; budesonide MMX [n = 255] and placebo [n = 255].