Table 1.
Comparison of Demographics Between the GEMINI 1 and the VICTORY Cohorts
| GEMINI 1 Trial Cohort | VICTORY Cohort | ||
|---|---|---|---|
| Vedolizumab Derivation Cohort (n = 620) | Vedolizumab Validation Cohort (n = 199) | P value | |
| Female | 256 (41) | 104 (52) | <.01 |
| Smoker (never) | 380 (61) | 144 (72) | <.01 |
| Age, y | 40.1 ± 13 | 41.5 ± 17.3 | .23 |
| Body mass index, kg/m2 | 25.1 ± 5.6 | 25.3 ± 5.83 | .66 |
| Disease duration, y | 5.0 (2.3–9.1) | 6.0 (2–12) | <.01 |
| Disease duration <2 y | 120 (20) | 31 (16) | .25 |
| Prior hospitalization | 211 (34) | 55 (28) | .10 |
| Prior TNF antagonist exposure | 311 (50) | 135 (68) | <.01 |
| Prior TNF antagonist failure | 266 (43) | 117 (59) | <.01 |
| Extensive baseline disease | 308 (50) | 112 (56) | .12 |
| Baseline moderate endoscopic disease | 278 (45) | 126 (63) | <.01 |
| Baseline albumin, g/L | 37 ± 4.96 | 39.4 ± 5.41 | <.01 |
| Concomitant corticosteroids only | 226 (36) | 69 (35) | .67 |
| Concomitant IMMs only | 114 (18) | 36 (18) | 1.00 |
| Concomitant corticosteroids and IMMs | 99 (16) | 49 (25) | <.01 |
Values are n (%), mean ± SD, or median (interquartile range).
IMM, immunomodulator; TNF, tumor necrosis factor; VICTORY, Vedolizumab for Health Outcomes in Inflammatory Bowel Diseases.