Table 1 Patient Baseline Characteristics
Item | No. of enrolled patients (n = 5, 695)a | No. of patients receiving remission maintenance (n = 4, 677)b | ||||
|---|---|---|---|---|---|---|
No. of patients | (%) | No. of patients | (%) | |||
Sex | Male | 3188 | (56.0) | 2610 | (55.8) | |
Female | 2505 | (44.0) | 2065 | (44.2) | ||
Unknown | 2 | (0.0) | 2 | (0.0) | ||
Age (years) | <20 | 8 | (0.1) | 4 | (0.1) | |
20–30 | 713 | (12.5) | 538 | (11.5) | ||
31–40 | 1327 | (23.3) | 1063 | (22.7) | ||
41–50 | 1371 | (24.1) | 1114 | (23.8) | ||
51–60 | 1010 | (17.7) | 869 | (18.6) | ||
61 - 70 | 826 | (14.5) | 713 | (15.2) | ||
≥71 | 435 | (7.6) | 373 | (8.0) | ||
Not indicated | 5 | (0.1) | 3 | (0.1) | ||
BMI | <18.5 | 609 | (10.7) | 485 | (10.4) | |
18.5–<25.0 | 4061 | (71.3) | 3354 | (71.7) | ||
≥25.0 | 975 | (17.1) | 801 | (17.1) | ||
Not indicated | 50 | (0.9) | 37 | (0.8) | ||
Disease stage | Disease stage | No. of patients | (%) | No. of patients | (%) | |
Active stage | Mild | 1303 | (22.9) | 574 | (12.3) | |
Moderate | 236 | (4.1) | 89 | (1.9) | ||
Not indicated | 1 | (0.0) | 1 | (0.0) | ||
Remission stage | 4155 | (73.0) | 4013 | (85.8) | ||
Extent of lesion | Total colitis type | 2378 | (41.8) | 1942 | (41.5) | |
Left-sided colitis type | 1951 | (34.3) | 1391 | (34.0) | ||
Proctitis type | 1243 | (21.8) | 1043 | (22.3) | ||
Other | 121 | (2.1) | 99 | (2.1) | ||
Not indicated | 2 | (0.0) | 2 | (0.0) | ||
Clinical course | First onset type | 953 | (16.7) | 838 | (17.9) | |
Relapse-remitting type | 3995 | (70.1) | 3427 | (73.3) | ||
Chronic continuous type | 745 | (13.1) | 410 | (8.8) | ||
Not indicated | 2 | (0.0) | 2 | (0.0) | ||
Drinking habit | No | 3250 | (57.1) | 2631 | (56.3) | |
≤1 day/week | 1201 | (21.1) | 992 | (21.2) | ||
2 - 5 days/week | 712 | (12.5) | 595 | (12.7) | ||
≥6 days/week | 513 | (9.0) | 443 | (9.5) | ||
Not indicated | 19 | (0.3) | 16 | (0.3) | ||
Smoking habit | No | 4207 | (73.9) | 3442 | (73.6) | |
Yes | 1473 | (25.9) | 1222 | (26.1) | ||
Not indicated | 15 | (0.3) | 13 | (0.3) | ||
Complications | Yes | 1166 | (20.5) | 966 | (20.7) | |
No | 4529 | (79.5) | 3711 | (79.3) | ||
Employment status | Student | 136 | (2.4) | 108 | (2.3) | |
Part-time worker | 645 | (11.3) | 534 | (11.4) | ||
Full-time worker | 3242 | (56.9) | 2632 | (56.3) | ||
Other | 1666 | (29.3) | 1401 | (30.0) | ||
Not indicated | 6 | (0.1) | 1 | (0.0) | ||
Use of oral 5-ASA agent | Pentasa® | 3023 | (53.1) | 2528 | (54.1) | |
Asacol® | 2202 | (38.7) | 1743 | (37.3) | ||
Salazopyrin® | 419 | (7.4) | 368 | (7.9) | ||
Other (generic) | 20 | (0.4) | 16 | (0.3) | ||
Concomitant use (oral products) | 28 | (0.5) | 22 | (0.5) | ||
Not indicated | 3 | (0.1) | 0 | (0.0) | ||
concomitant medication | Yes | 2669 | (46.9) | 2076 | (44.4) | |
No | 3026 | (53.1) | 2601 | (55.6) | ||
probiotics | 960 | (16.9) | 789 | (16.9) | ||
topical 5-ASA | 810 | (14.2) | 593 | (12.7) | ||
topical steroid | 259 | (4.5) | 170 | (3.6) | ||
systemic steroid | 401 | (7.0) | 275 | (5.9) | ||
immunomodulator | 870 | (15.3) | 699 | (14.9) | ||
anti-TNF | 169 | (3.0) | 129 | (2.8) | ||
tacrolims | 52 | (0.9) | 26 | (0.6) | ||
cyclosporine | 1 | (0.0) | 0 | (0.0) | ||
leukocyte apheresis | 37 | (0.6) | 21 | (0.4) | ||
pUCDAI and score of each category (Mean ± SD) | pUCDAI | 0.9 ± 1.5 (n = 5694) | 0.6 ± 1.2 (n = 4677) | |||
Stool frequency | 0.4 ± 0.7 (n = 5694) | 0.3 ± 0.6 (n = 4677) | ||||
Bloody stool | 0.2 ± 0.5 (n = 5695) | 0.1 ± 0.4 (n = 4677) | ||||
PGA | 0.3 ± 0.5 (n = 5695) | 0.2 ± 0.4 (n = 4677) | ||||
Duration of disease (mean ± SD) (months) | 108.2 ± 93.5 | 110.5 ± 95.0 | ||||
(n = 5670) | (n = 4658) | |||||
Duration of remission maintenance until enrollment | 31.4 ± 40.3 | 31.6 ± 40.5 | ||||
(mean ± SD) (months) | (n = 4107) | (n = 3958) | ||||
Drug adherence (mean ± SD) | 90.5 ± 14.2% (n = 5648) | 90.7 ± 13.7% (n = 4646) | ||||