TABLE 1.
Baseline characteristics of GEMINI LTS study patients
| Patients with at least 1 y of vedolizumab exposure | Patients experiencing a malignancy | |||||
|---|---|---|---|---|---|---|
| Characteristic | Crohn’s disease (n = 1034) | Ulcerative colitis (n = 751) | Total (N = 1785) | Crohn’s disease (n = 17) | Ulcerative colitis (n = 14) | Total (N = 31) |
| Sex, female, n (%) | 549 (53) | 331 (44) | 880 (49) | 9 (53) | 5 (36) | 14 (45) |
| Age (y) | ||||||
| Mean (SD) | 38.3 (12.64) | 41.3 (13.20) | 39.5 (12.96) | 51.8 (8.50) | 50.5 (12.82) | 51.2 (10.50) |
| Median | 36.8 | 40.8 | 38.1 | 52.7 | 49.7 | 52.1 |
| Race, n (%) | ||||||
| Asian | 65 (6) | 95 (13) | 160 (9) | 0 (0) | 1 (7) | 1 (3) |
| White | 937 (91) | 632 (84) | 1569 (88) | 17 (100) | 12 (86) | 29 (94) |
| Other | 32 (3) | 24 (3) | 56 (3) | 0 (0) | 1 (7) | 1 (3) |
| Duration of disease (y) | ||||||
| Mean (SD) | 10.0 (8.42) | 8.0 (6.79) | 9.2 (7.83) | 12.9 (10.36) | 10.5 (9.78) | 11.8 (10.01) |
| Median | 7.8 | 5.8 | 6.8 | 8.9 | 7.0 | 7.8 |
| Baseline disease activity, mean (SD) | ||||||
| Partial Mayo score | - | 3.8 (2.91) | - | - | 3.9 (3.34) | - |
| Harvey-Bradshaw Index score | 7.3 (4.89) | - | - | 8.2 (4.48) | - | - |
| Smoking history, n {%) | ||||||
| Current smoker | 275 (27) | 39 (5) | 314 (18) | 7 (41) | 0 (0) | 7 (23) |
| Former smoker | 254 (25) | 218 (29) | 472 (26) | 4 (24) | 5 (36) | 9 (29) |
| Never smoked | 499 (48) | 466 (62) | 965 (54) | 6 (35) | 9 (64) | 15 (48) |
| Unknown/missing data | 6 (1) | 28 (4) | 34 (2) | - | - | - |
| Treatment history, n (%) | ||||||
| Prior anti-TNFα therapy | 640 (62) | 321 (43) | 961 (54) | 11 (65) | 8 (57) | 19 (61) |
| Any prior anti-TNFα therapy failurea | 598 (58) | 290 (39) | 888 (50) | 10 (59) | 7 (50) | 17 (55) |
| Concomitant immunomodulatory therapy | 317 (31) | 204 (27) | 521 (29) | 8 (47) | 4 (29) | 12 (39) |
| Concomitant corticosteroid therapy | 452 (44) | 314 (42) | 766 (43) | 7 (41) | 8 (57) | 15 (48) |
Abbreviations: LTS, long-term safety; SD, standard deviation; TNFα, tumour necrosis factor alpha.
a
Patients who reported any prior anti-TNFα therapy failure are a subset of those reporting prior anti-TNFα therapy.