Table 1.
Comparison of Demographics Between GEMINI 2 and VICTORY Consortium Cohorts
| GEMINI 2 | VICTORY consortium | ||
|---|---|---|---|
| Overall cohort (n=814) |
Overall cohort (n=477) |
Validation cohort (n=336) |
|
| Female sex, n (%) | 435 (53) | 279 (58) | 192 (57) |
| Mean age, years (SD) | 35.5 (11.9) | 39.3 (15.4) | 38.1 (15.1) |
| Mean BMI, kg/m2 (SD) | 24.0 (6.0) | 25.4 (6.8) | 25.5 (6.9) |
| Mean disease duration, years (SD) | 9.1 (7.5) | 14.4 (11) | 14.1 (10.6) |
| Concomitant CS only, n (%) | 280 (34) | 133 (28) | 96 (28) |
| Concomitant IMMs only, n (%) | 133 (16) | 90 (19) | 66 (20) |
| Concomitant CS and IMMs, n (%) | 137 (17) | 105 (22) | 75 (22) |
| Prior TNFα antagonist exposure, n (%) | 535 (66) | 441 (92) | 309 (92) |
| Prior TNFα antagonist failure, n (%) | 497 (61) | 374 (78) | 263 (78) |
| Median CRP, mg/L (IQR) | 10.6 (4.5–31.6) | − | 5.0 (1.0–19.4) |
| Mean albumin, g/L (SD) | 34.9 (5.7) | − | 38.2 (5.7) |
| Disease localization, n (%)* Ileum only Colon only Ileocolonic |
141 (17) 230 (28) 443 (54) |
78 (16) 108 (23) 291 (61) |
48 (14) 76 (23) 212 (63) |
| Prior surgery for CD, n (%) | 355 (44) | 287 (60) | 199 (59) |
| Prior fistulizing disease, n (%) | 297 (36) | 183 (38) | 136 (40) |
*
As per patient history at the time of enrolment into GEMINI 2 or the initiation of vedolizumab therapy in the VICTORY consortium.
BMI, body mass index; CD, Crohn’s disease; CRP, C-reactive protein; CS, corticosteroid; IMM, immunomodulator; SD, standard deviation; TNFα, tumor necrosis factor-alpha.