Table 1.
Baseline characteristics of patients with and without draining fistulae at maintenance baseline [Week 6]*.
| Patients with draining fistulae at baseline [n = 57] |
Patients without draining fistulae at baseline [n = 404] |
|||
|---|---|---|---|---|
| VDZ/PBO [n = 18] | VDZ/VDZ [n = 39] | VDZ/PBO [n = 135] | VDZ/VDZ [n = 269] | |
| Age [year], mean ± SDa | 35.8 ± 11.0 | 32.6 ± 9.5 | 37.4 ± 12.1 | 35.3 ± 12.5 |
| Male sex, n [%] | 8 [44] | 20 [51] | 64 [47] | 130 [48] |
| Current smoker, n [%] | 5 [28] | 10 [26] | 43 [32] | 77 [29] |
| Disease duration [year], mean ± SDa | 10.8 ± 9.9 | 9.1 ± 7.8 | 9.5 ± 8.7 | 7.9 ± 6.9 |
| CDAI score, mean ± SDa | 318.4 ± 74.0 | 340.6 ± 73.4 | 326.1 ± 64.3 | 318.4 ± 66.2b |
| CRP [mg/L], median | 15.1 | 12.4 | 9.6 | 8.9 |
| Disease site, n [%] | ||||
| Ileum only | 2 [11] | 3 [8] | 17 [13] | 60 [22] |
| Colon only | 7 [39] | 11 [28] | 36 [27] | 63 [23] |
| Ileum and colon | 9 [50] | 25 [64] | 82 [61] | 146 [54] |
| Prior surgery for CD, n [%] | 7 [39] | 21 [54] | 50 [37] | 97 [36] |
| Prior TNF antagonist failure, n [%] | 8 [44] | 19 [49] | 70 [52] | 140 [52] |
| Concomitant medication, n [%] | ||||
| CS | 5 [28] | 17 [44] | 51 [38] | 100 [37] |
| IMM | 2 [11] | 8 [21] | 21 [16] | 50 [19] |
| CS and IMM | 5 [28] | 6 [15] | 21 [16] | 39 [14] |
| Neither CS nor IMM | 6 [33] | 8 [21] | 42 [31] | 80 [30] |
| History of fistulising disease, n [%] | 18 [100] | 39 [100] | 39 [29] | 57 [21] |
| Concomitant antibiotic use, n [%] | ||||
| Yes | 6 [33] | 21 [54] | N/A | N/A |
| No | 12 [67] | 18 [46] | ||
| Number of draining fistulae per patient, n [%] | ||||
| 1 | 13 [72] | 30 [77] | N/A | N/A |
| 2 | 4 [22] | 6 [15] | ||
| ≥3 | 1 [6] | 3 [8] | ||
| Patients with perianal fistulae, n [%] | 13 [72] | 32 [82] | N/A | N/A |
Abbreviations: CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; CRP, C-reactive protein; CS, corticosteroids; IS, immunosuppressants; ITT, intent-to-treat; N/A, not applicable; PBO, placebo; SD, standard deviation; TNF, tumour necrosis factor; VDZ, vedolizumab.
Patients in the VDZ/PBO maintenance group received VDZ in the 6-week induction phase and then PBO in the 46-week maintenance phase. Patients in the VDZ/VDZ maintenance group received VDZ during induction and VDZ every 8 or 4 weeks during maintenance.
aMean values were similar to the median values [not shown] based on the distribution of the data. bn = 267.
*Patients with draining fistulae at baseline: n = 141, [14.7%] VDZ; n = 23 [15.5%] PBO