Table 1.
UC induction population demographics and baseline disease characteristics
| Characteristic | Age <35 years | Age 35 to <55 years | Age ≥55 years | |||
|---|---|---|---|---|---|---|
| PBO (n = 53) | VDZa (n = 300) | PBO (n = 78) | VDZa (n = 334) | PBO (n = 18) | VDZa (n = 112) | |
| Age (years), mean ± SD | 28.1 ± 4.7 | 27.3 ± 4.6 | 45.0 ± 5.5 | 44.3 ± 5.9 | 63.3 ± 6.0 | 61.9 ± 5.8 |
| Sex (male), n (%) | 34 (64) | 179 (60) | 49 (63) | 187 (56) | 9 (50) | 67 (60) |
| Duration of disease (years), mean ± SD | 4.3 ± 3.5 | 4.6 ± 3.6 | 8.0 ± 7.1 | 8.0 ± 6.2 | 11.5 ± 11.9 | 9.3 ± 9.1 |
| Mayo Clinic score, mean ± SD | 9.0 ± 1.7 | 8.6 ± 1.7 | 8.4 ± 1.7 | 8.6 ± 1.8 | 8.1 ± 1.6 | 8.3 ± 1.6 |
| Partial Mayo Clinic score, mean ± SD | 6.4 ± 1.5 | 6.1 ± 1.6 | 6.0 ± 1.5 | 6.0 ± 1.7 | 5.6 ± 1.5 | 5.7 ± 1.5 |
| IBDQ score, mean ± SD | 124 ± 33 | 120 ± 33 | 128 ± 34 | 122 ± 32 | 119 ± 36 | 125 ± 33 |
| Disease site | ||||||
| Rectum and sigmoid colon only, n (%) | 5 (9) | 40 (13) | 13 (17) | 42 (13) | 4 (22) | 12 (11) |
| Left side of colon, n (%) | 19 (36) | 91 (30) | 35 (45) | 135 (40) | 5 (28) | 54 (48) |
| Proximal to the splenic flexure, n (%) | 12 (23) | 43 (14) | 5 (6) | 35 (10) | 1 (6) | 13 (12) |
| All of the colon, n (%) | 17 (32) | 126 (42) | 25 (32) | 122 (37) | 8 (44) | 33 (29) |
| Concomitant medication for UC | ||||||
| CS only, n (%) | 21 (40) | 105 (35) | 30 (38) | 128 (38) | 7 (39) | 41 (37) |
| IS only, n (%) | 5 (9) | 64 (21) | 12 (15) | 56 (17) | 1 (6) | 21 (19) |
| CS and IS, n (%) | 10 (19) | 50 (17) | 13 (17) | 54 (16) | 3 (17) | 19 (17) |
| No CS or IS, n (%) | 17 (32) | 81 (27) | 23 (29) | 96 (29) | 7 (39) | 31 (28) |
| Prednisone equivalent dose (mg), median (min, max) | 20 (5.0, 30.0) | 20 (1.0, 176.3) | 20 (5.0, 40.0) | 20 (0.6, 156.3) | 22.5 (5.0, 35.0) | 15 (2.5, 30.0) |
| Prior anti-TNF therapy, n (%)b | 25 (47) | 146 (49) | 38 (49) | 161 (48) | 10 (56) | 51 (46) |
| Prior anti-TNF failure, n (%)a | 21 (40) | 121 (40) | 32 (41) | 140 (42) | 10 (56) | 43 (38) |
CS corticosteroid, IBDQ inflammatory bowel disease questionnaire, IS immunosuppressant, PBO placebo, SD standard deviation, TNF tumor necrosis factor alpha, UC ulcerative colitis, VDZ vedolizumab
aIncludes patients from cohort 1 and cohort 2
bPrior anti-TNF exposure was recorded on the interactive voice response system during screening and enrollment. Prior anti-TNF failure was recorded on the case report form at study baseline (week 0). Because of the different data sources, the number of patients with prior anti-TNF exposure does not equal those with prior anti-TNF failure