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 |