Table 1.
Baseline demographics and clinical characteristics a
| Parameter | Ulcerative colitis (N = 894) | Crohn's disease (N = 1349) |
|---|---|---|
| Age, b y, mean (SD) | 41.2 (13.6) | 37.8 (12.7) |
| ≤35 years of age, n (%) | 333 (37.2) | 645 (47.8) |
| ≥65 years of age, n (%) | 42 (4.7) | 34 (2.5) |
| Male sex, n (%) | 522 (58.4) | 606 (44.9) |
| Race, n (%) | ||
| White | 762 (85.2) | 1219 (90.4) |
| Black | 14 (1.6) | 28 (2.1) |
| Asian | 105 (11.7) | 82 (6.1) |
| Other/not reported | 13 (1.5) | 20 (1.5) |
| Disease duration, years, mean (SD) | 8.1 (7.0) | 10.1 (8.3) |
| Partial Mayo score, mean (SD) | 6.0 (1.5) | NA |
| HBI score, mean (SD) | NA | 10.9 (3.4) |
| CDAI score, mean (SD) | NA | 314.0 (63.2) |
| History of extraintestinal disease manifestations, n (%) c | 299 (34.6) | 1124 (83.8) |
| Concomitant medications corticosteroids at enrolment, n (%) | 330 (36.9) | 545 (40.4) |
| Prior therapy, n (%) | ||
| Corticosteroids | 868 (97.1) | 1295 (96.0) |
| Immunomodulators | 666 (74.5) | 1158 (85.8) |
| TNF antagonist therapies | 415 (46.4) | 898 (66.6) |
| Prior TNF antagonist failure, d n (%) | 380 (46) | 848 (65) |
| Vedolizumab exposure, months, median (range) e | 42.4 (0.03‐112.2) | 31.5 (0.03‐100.3) |
Abbreviation: CDAI, Crohn's disease activity index; HBI, Harvey‐Bradshaw Index; NA, not available; SD, standard deviation; TNF, tumour necrosis factor.
Baseline for rollover patients was defined as the last assessment before the first dose of vedolizumab in the previous studies. Baseline for de novo patients was defined as the last assessment before the first dose of vedolizumab in GEMINI LTS.
Age was defined as (1 + first dose date in GEMINI LTS—birth date)/365.25.
History of extraintestinal disease manifestations were not collected for patients in the Phase 2 long‐term safety study.
Calculation includes only patients for whom TNF antagonist failure status was known.
Includes exposure to vedolizumab in previous clinical studies, without incorporating data up to 16 weeks after last dose.