Table 3.
Baseline characteristics of patients experiencing malignancies in the post-marketing setting
| Indication, n (%) | ||||||
|---|---|---|---|---|---|---|
| Characteristic | Crohn’s disease (n = 129) | Ulcerative colitis (n = 116) | Unspecified inflammatory bowel disease (n = 5) | Not reported (n = 34) | Other, including off-label usea (n = 9) | Total (N = 293) |
| Sex | ||||||
| Female | 71 (55) | 51 (44) | 3 (60) | 15 (44) | 5 (56) | 145 (49) |
| Male | 56 (43) | 63 (54) | 2 (40) | 19 (56) | 4 (44) | 144 (49) |
| Not reported | 2 (2) | 2 (2) | 0 (0) | 0 (0) | 0 (0) | 4 (1) |
| Age (y) | ||||||
| <18b | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (11) | 1 (<1) |
| 18–64 | 78 (60) | 64 (55) | 2 (40) | 12 (35) | 4 (44) | 160 (55) |
| ≥65 | 34 (26) | 35 (30) | 0 (0) | 4 (12) | 2 (22) | 75 (26) |
| Not reported | 17 (13) | 17 (15) | 3 (60) | 18 (53) | 2 (22) | 57 (19) |
| Medication history | ||||||
| Prior and/or concomitant anti-TNFα therapy | 70 (54) | 54 (47) | 2 (40) | 8 (24) | 4 (44) | 138 (47) |
| Concomitant corticosteroid therapy | 37 (29) | 42 (36) | 0 (0) | 2 (6) | 3 (33) | 84 (29) |
| Other concomitant immunomodulator therapyc | 19 (15) | 33 (28) | 1 (20) | 4 (12) | 3 (33) | 60 (20) |
| None reported | 25 (19) | 21 (18) | 2 (40) | 21 (62) | 2 (22) | 71 (24) |
Abbreviation: TNFα, tumour necrosis factor alpha.
a
Including two patients with graft-vs-host disease.
b
Vedolizumab is not approved for the treatment of patients < 18 y old.
c
Excluding anti-TNFα therapies, because these data are presented separately.