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Table 1 Patient Baseline Characteristics

From: Real life results in using 5-ASA for maintaining mild to moderate UC patients in Japan, a multi-center study, OPTIMUM Study

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)
  1. a%: Percentage of a total of 5695 patients
  2. bSubjects other than those remaining in the active stage throughout the observation period from enrollment. %: Percentage of a total of 4677 patients