Table 1.
Baseline characteristics of the phase 3 safety population
| Characteristic | UC (n=1114) | CD (n=1770) | UC and CD* (N=2884) | UC and CD Placebo† (n=504) |
|---|---|---|---|---|
| Received ≥1 dose of vedolizumab, n (%) | 1077 (97) | 1712 (97) | 2789 (97) | 409 (81) |
| Age, mean years±SD | 40.4±13.4 | 36.8±12.5 | 38.2±13.0 | 38.8±13.1 |
| Sex, female, n (%) | 462 (42) | 974 (55) | 1436 (50) | 254 (50) |
| Disease duration, n (%)‡ | ||||
| <7 years | 679 (61) | 833 (47) | 1512 (52) | 269 (53) |
| ≥7 years | 404 (36) | 929 (53) | 1333 (46) | 235 (47) |
| Mean years±SD | 7.2±6.8 | 9.5±8.1 | 8.7±7.7 | 8.6±7.8 |
| Disease activity, mean score±SD | ||||
| Partial Mayo score | 5.9±1.8 | N/A | 5.9±1.8 | 6.1±1.5 |
| HBI score | N/A | 11.0±3.6 | 11.0±3.6 | 10.7±3.4 |
| Prior anti-TNF therapy failure, n (%) | 483 (45) | 1127 (64) | 1610 (57) | 289 (57) |
| Concomitant medications, n (%) | ||||
| Corticosteroid | 591 (53) | 925 (52) | 1516 (53) | 263 (52) |
| Immunosuppressive | 359 (32) | 558 (32) | 917 (32) | 164 (33) |
| Narcotic analgesic use, n (%) | 102 (9) | 310 (18) | 412 (14) | 70 (14) |
| Current smoker, n (%) | 60 (5) | 469 (27) | 529 (18) | 103 (20) |
*Phase 3 safety population includes patients from studies GEMINI 1, GEMINI 2, GEMINI 3 and GEMINI LTS. Patients in study C13004 who rolled over to GEMINI LTS are included.
†Includes patients who were randomised to placebo in studies GEMINI 1, GEMINI 2 and GEMINI 3.
‡Does not include patients who began treatment in study C13002 or C13004.
anti-TNF, tumour necrosis factor α antagonist; CD, Crohn's disease; HBI, Harvey-Bradshaw index; LTS, long-term safety; N/A, not applicable; SD, standard deviation; UC, ulcerative colitis.