Table 2.
Baseline demographics and clinical characteristics of patients with Crohn’s disease
| Index Treatment group | VDZ | Anti-TNFα | VDZ | Anti-TNFα | VDZ | Anti-TNFα |
|---|---|---|---|---|---|---|
| Treatment history [Total N] | Biologic-naïve [N = 10] | Biologic-naïve [N = 65] | Prior anti-TNFα [N = 59] | Prior anti-TNFα [N= 40] | Total [N = 69] | Total [N = 105] |
| Female, % | 60 | 52 | 68 | 60 | 67 | 55 |
| Age at index, years, median (range) | 39.0 (21–70) | 38.0 (18–72) | 42.0 (20–73) | 40.5 (21–58) | 41.0 (20–73) | 39.0 (18–72) |
| CD duration, years, median (range) [n with available data]a | 8.2 (0–30) [10] | 3.7 (0–50) [65] | 10.1 (1–35) [58] | 7.2 (0–33) [40] | 9.8 (0–35) [68] | 5.6 (0–50) [105] |
| CD location, [n] | [9] | [57] | [57] | [34] | [66] | [91] |
| Ileal, % | 22 | 18 | 26 | 24 | 26 | 20 |
| Colonic, % | 33 | 28 | 23 | 15 | 24 | 23 |
| Ileocolonic, % | 44 | 54 | 51 | 62 | 50 | 57 |
| Disease behavior, [n] | [9] | [60] | [52] | [34] | [61] | [94] |
| Non-stricturing, non-penetrating, % | 44 | 65 | 67 | 38 | 64 | 55 |
| Stricturing, % | 44 | 22 | 21 | 41 | 25 | 29 |
| Penetrating, % | 11 | 13 | 12 | 21 | 11 | 16 |
| Prior IBD-related surgery, % | 20 | 35 | 42 | 45 | 39 | 39 |
| HBI score, [n] | [3] | [10] | [10] | [13] | [13] | [23] |
| 0–4 (remission), % | 33 | 40 | 30 | 46 | 31 | 43 |
| 5–7 (mild activity), % | 33 | 60 | 30 | 15 | 31 | 35 |
| 8–16 (moderate activity), % | 33 | 0 | 40 | 38 | 38 | 22 |
| ≥ 17 (severe activity), % | 0 | 0 | 0 | 0 | 0 | 0 |
| Abdominal pain score, [n] | [5] | [46] | [36] | [22] | [41] | [68] |
| 0 (none), % | 20 | 39 | 25 | 41 | 24 | 40 |
| 1 (mild), % | 0 | 20 | 19 | 18 | 17 | 19 |
| 2 (moderate), % | 80 | 37 | 47 | 27 | 51 | 34 |
| 3 (severe), % | 0 | 4 | 8 | 14 | 7 | 7 |
| Liquid/soft stools per day, mean (SD) [n] | 3.7 (2.5) [3] | 3.6 (3.8) [35] | 5.2 (4.9) [26] | 3.8 (4.7) [21] | 5.0 (4.7) [29] | 3.7 (4.1) [56] |
| Endoscopic score, [n] | [6] | [39] | [30] | [26] | [36] | [65] |
| 0 (normal or inactive disease), % | 17 | 10 | 27 | 27 | 25 | 17 |
| 1 (mild disease), % | 17 | 21 | 20 | 19 | 19 | 20 |
| 2 (moderate disease), % | 33 | 46 | 20 | 23 | 22 | 37 |
| 3 (severe disease), % | 33 | 23 | 33 | 31 | 33 | 26 |
| Corticosteroids in past 2 years, % | 60 | 69 | 58 | 53 | 58 | 63 |
| Aminosalicylates in past 2 years, % | 20 | 37 | 31 | 45 | 29 | 40 |
| Immunomodulators in past 2 years, % | 20 | 57 | 29 | 48 | 28 | 53 |
| Duration of previous anti-TNFα treatment, months, mean (SD), [n] | – | – | 31.6 (24.3) [52] | 22.3 (20.7) [39] | 31.6 (24.3) [52] | 22.3 (20.7) [39] |
| Duration from prior anti-TNFα discontinuation to index date, months, median (range), [n] | – | – | 1.1 (0–103) [57] | 2.1 (0–57) [39] | 1.1 (0–103) [57] | 2.1 (0–57) [39] |
| Index treatment, anti-TNFα type | ||||||
| Infliximab originator, % | – | 42 | – | 45 | – | 43 |
| Infliximab biosimilar, % | – | 18 | – | 20 | – | 19 |
| Adalimumab, % | – | 40 | – | 35 | – | 38 |
| Concomitant therapy at index | ||||||
| Corticosteroids, % | 20 | 25 | 29 | 28 | 28 | 26 |
| Immunomodulators, % | 10 | 19 | 8 | 18 | 9 | 18 |
| Aminosalicylates, % | 0 | 14 | 15 | 20 | 13 | 16 |
Anti-TNFα Anti-tumor necrosis factor alpha, CD Crohn’s disease, HBI Harvey Bradshaw Index, IBD Inflammatory bowel disease, SD Standard deviation, VDZ Vedolizumab
aUnless otherwise indicated, data from the full population were available for analysis