Table 2.
Demographics and clinical characteristics of patients with UC at enrollment by change in urgency severity at 6 months
| Improvement a (N = 111) |
No change a (N = 108) |
Improvement versus no change P-value | Worsening b (N = 84) |
No change b (N = 210) |
Worsening versus no change P-value | |
|---|---|---|---|---|---|---|
| Age at enrollment (years), mean (SD) | 43.9 (14.21) | 42.0 (14.01) | 0.318 | 46.3 (13.90) | 40.6 (13.85) | 0.002 |
| Gender, n (%) | 0.117 | 0.911 | ||||
| Female | 53 (47.7) | 63 (58.3) | 47 (56.0) | 116 (55.2) | ||
| Male | 58 (52.3) | 45 (41.7) | 37 (44.0) | 94 (44.8) | ||
| Disease duration at enrollment (years), mean (SD) | 11.4 (11.13) | 10.4 (8.08) | 0.479 | 13.0 (10.73) | 11.0 (8.97) | 0.135 |
| Age at diagnosis (years), mean (SD) | 32.5 (12.92) | 31.8 (14.50) | 0.721 | 32.8 (13.16) | 29.7 (12.86) | 0.065 |
| UCDAI 6-point score, mean (SD) | 2.4 (2.01) | 1.7 (1.78) | 0.011 | 0.9 (1.30) | 0.7 (1.24) | 0.382 |
| UCDAI 9-point score mean (SD) | 3.4 (2.58) | 3.0 (2.46) | 0.280 | 1.6 (2.07) | 1.1 (1.80) | 0.120 |
| Fatigue, n (%) | 24 (46.2) | 26 (49.1) | 0.766 | 21 (44.7) | 35 (33.3) | 0.180 |
| Enrollment number of daily bowel movement, mean (SD) | 2.5 (1.86) | 2.6 (2.32) | 0.727 | 2.1 (1.63) | 2.1 (1.84) | 0.881 |
| Current average number of daily bowel movement, mean (SD) | 5.3 (4.00) | 4.1 (3.34) | 0.016 | 3.2 (2.76) | 2.7 (2.06) | 0.170 |
| Current average number of daily liquid bowel movement, mean (SD) | 3.3 (4.21) | 2.7 (3.68) | 0.281 | 1.1 (1.85) | 1.0 (2.02) | 0.889 |
| Daily stool frequency, n (%) | 0.026 | 0.513 | ||||
| Normal | 29 (26.6) | 47 (43.5) | 59 (70.2) | 154 (73.3) | ||
| 1–2 stools per day more than normal | 32 (29.4) | 32 (29.6) | 12 (14.3) | 35 (16.7) | ||
| 3–4 stools per day more than normal | 25 (22.9) | 13 (12.0) | 7 (8.3) | 10 (4.8%) | ||
| 5 or more stools per day more than normal | 23 (21.1) | 16 (14.8) | 6 (7.1) | 9 (4.3%) | ||
| Stool description, n (%) | 0.726 | 0.278 | ||||
| Formed | 27 (32.1) | 24 (30.0) | 27 (43.5) | 81 (55.1) | ||
| Soft or semi-formed | 37 (44.0) | 40 (50.0) | 30 (48.4) | 58 (39.5) | ||
| Mostly or all liquid | 20 (23.8) | 16 (20.0) | 5 (8.1) | 8 (5.4) | ||
| Blood in stool, n (%) | 0.083 | 0.798 | ||||
| No blood seen | 55 (49.5) | 61 (56.5) | 64 (76.2) | 165 (78.9) | ||
| Blood less than 50% of the time | 26 (23.4) | 31 (28.7) | 14 (16.7) | 33 (15.8) | ||
| Blood passed 50% or more or blood passed alone | 30 (27.0) | 16 (14.8) | 6 (7.1%) | 11 (5.3) | ||
| Abdominal pain, n (%) | 0.101 | 0.005 | ||||
| None | 46 (41.4) | 53 (49.1) | 44 (52.4) | 148 (70.5) | ||
| Mild | 47 (42.3) | 31 (28.7) | 28 (33.3) | 50 (23.8) | ||
| Moderate or severe | 18 (16.2) | 24 (22.2) | 12 (14.3) | 12 (5.7) | ||
| Bowel urgency, n (%) | < 0.001 | 0.560 | ||||
| None | – | – | 56 (66.7) | 132 (62.9) | ||
| Mild | 36 (32.4) | 67 (62.0) | 22 (26.2) | 67 (31.9) | ||
| Moderate | 33 (29.7) | 11 (10.2%) | 6 (7.1) | 11 (5.2) | ||
| Moderately severe to severe | 42 (37.8) | 30 (27.8) | – | – | ||
| General well-being, n (%) | 0.409 | 0.315 | ||||
| Generally well | 52 (46.8) | 59 (54.6) | 60 (71.4) | 166 (79.0) | ||
| Slightly under par | 36 (32.4) | 33 (30.6) | 19 (22.6) | 37 (17.6) | ||
| Poor to terrible | 23 (20.7) | 16 (14.8) | 5 (6.0) | 7 (3.3) | ||
| Physician's Global Assessment of current disease status, n (%) | 0.382 | 0.099 | ||||
| Quiescent | 28 (34.1) | 33 (40.7) | 39 (60.0) | 116 (73.9) | ||
| Mild | 26 (31.7) | 18 (22.2) | 14 (21.5) | 19 (12.1) | ||
| Moderate or severe | 28 (34.1) | 30 (37.0) | 12 (18.5) | 22 (14.0) | ||
| Bowel incontinence while awake in the last month, n (%) | 16 (19.3) | 15 (18.8) | 0.932 | 8 (13.1) | 9 (6.2) | 0.097 |
| Nighttime bowel movement in the last month, n (%) | 30 (36.1) | 32 (40.0) | 0.612 | 15 (24.6) | 21 (14.4) | 0.077 |
| Leakage of stool during sleep in the last month, n (%) | 4 (4.8) | 4 (5.0) | 1.000 | 2 (3.3) | 0 (0.0) | 0.086 |
| Number of days of work/school missed due to illness in past 12 months, mean (SD) | 10.5 (58.47) | 0.9 (2.10) | 0.311 | 1.3 (4.11) | 1.0 (3.73) | 0.727 |
| Fecal calprotectin (μg/g), mean (SD) | 555.7 (750.06) | 294.7 (455.20) | 0.084 | 323.5 (505.46) | 187.4 (371.54) | 0.157 |
| Biologics, n (%) | 47 (50.5) | 35 (40.7) | 0.187 | 34 (50.0) | 74 (43.5) | 0.365 |
| TNFi | 25 (26.9) | 21 (24.4%) | 0.706 | 20 (29.4) | 51 (30.0) | 0.929 |
| Non-TNFi | 22 (23.7) | 14 (16.3) | 0.219 | 14 (20.6) | 23 (13.5) | 0.175 |
| 5-aminosalicylates, (%), n (%) | 44 (47.3) | 42 (48.8) | 0.838 | 29 (42.6%) | 84 (49.4) | 0.345 |
| Antibiotics, n (%) | 1 (1.1) | 2 (2.3) | 0.609 | 0 (0.0) | 3 (1.8) | 0.560 |
| Immunomodulators, n (%) | 17 (18.3) | 17 (19.8) | 0.800 | 16 (23.5) | 46 (27.1) | 0.575 |
| Steroids, n (%) | 21 (22.6) | 20 (23.3) | 0.914 | 6 (8.8) | 11 (6.5) | 0.524 |
SD standard deviation, TNFi tumor necrosis factor inhibitor, UC ulcerative colitis, UCDAI UC Disease Activity Index, N otal number of patients, n number of patients reporting the information
aPatients with UC, excluding those with no urgency at enrollment
bPatients with UC, excluding those with severe urgency at enrollment