Index Treatment group | VDZ | Anti-TNFα | VDZ | Anti-TNFα | VDZ | Anti-TNFα |
---|---|---|---|---|---|---|
Treatment history [Total N] | Biologic-naïve [N = 22] | Biologic-naïve [N = 40] | Prior anti-TNFα [N = 54] | Prior anti-TNFα [N = 17] | Total [N = 76] | Total [N = 57] |
Female, % | 36 | 60 | 52 | 53 | 47 | 58 |
Age at index, years, median (range) | 46.5 (18–75) | 33.0 (19–76) | 35.0 (20–66) | 41.0 (22–60) | 39.5 (18–75) | 34.0 (19–76) |
UC duration, years, median (range) [n with available data]a | 5.8 (0–29) [21] | 4.2 (0–33) [40] | 6.7 (1–47) [54] | 6.7 (2–41) [17] | 6.1 (0–47) [75] | 4.7 (0–41) [57] |
UC location, [n] | [21] | [35] | [45] | [12] | [66] | [47] |
Ulcerative proctitis, % | 0 | 9 | 9 | 8 | 6 | 9 |
Left-sided, % | 29 | 40 | 29 | 42 | 29 | 40 |
Extensive colitis, % | 10 | 11 | 9 | 17 | 9 | 13 |
Pancolitis, % | 62 | 40 | 53 | 33 | 56 | 38 |
Prior IBD-related surgery, % | 5 | 5 | 2 | 0 | 3 | 4 |
Total Mayo score, mean (SD) [n] | 5.9 (3.2) [10] | 5.7 (2.7) [16] | 6.1 (2.8) [27] | 7.7 (3.0) [6] | 6.0 (2.9) [37] | 6.2 (2.9) [22] |
Partial Mayo score, mean (SD) [n] | 4.8 (2.7) [12] | 4.8 (2.5) [18] | 4.9 (2.5) [35] | 6.9 (2.1) [7] | 4.9 (2.6) [47] | 5.4 (2.5) [25] |
Rectal bleeding score, [n] | [14] | [26] | [44] | [12] | [58] | [38] |
0 (no blood seen), % | 36 | 38 | 41 | 25 | 40 | 34 |
1 (streaks of blood with stool < half of time), % | 36 | 23 | 30 | 17 | 31 | 21 |
2 (obvious blood with stool most of the time), % | 14 | 27 | 23 | 25 | 21 | 26 |
3 (blood alone passes), % | 14 | 12 | 7 | 33 | 9 | 18 |
Stool frequency score, [n] | [15] | [23] | [48] | [11] | [63] | [34] |
0 (normal number of stools), % | 7 | 4 | 17 | 0 | 14 | 3 |
1 (1–2 stools/day more than normal), % | 33 | 22 | 8 | 0 | 14 | 15 |
2 (3–4 stools/day more than normal), % | 13 | 22 | 19 | 9 | 17 | 18 |
3 (≥5 stools/day more than normal), % | 47 | 52 | 56 | 91 | 54 | 65 |
Endoscopic score, [n] | [12] | [20] | [27] | [8] | [39] | [28] |
0 (normal or inactive disease), % | 25 | 30 | 11 | 38 | 15 | 32 |
1 (mild disease), % | 33 | 35 | 19 | 13 | 23 | 29 |
2 (moderate disease), % | 25 | 25 | 48 | 25 | 41 | 25 |
3 (severe disease), % | 17 | 10 | 22 | 25 | 21 | 14 |
Corticosteroids in past 2 years, % | 73 | 68 | 78 | 76 | 76 | 70 |
Aminosalicylates in past 2 years, % | 86 | 70 | 78 | 71 | 80 | 70 |
Immunomodulators in past 2 years, % | 55 | 58 | 43 | 59 | 46 | 58 |
Duration of previous anti-TNFα treatment, months, mean (SD), [n] | – | – | 16.8 (16.9) [47] | 19.5 (17.0) [16] | 16.8 (16.9) [47] | 19.5 (17.0) [16] |
Duration from prior anti-TNFα discontinuation to index date, months, median (range), [n] | – | – | 1.4 (0–32) [50] | 1.2 (0–44) [17] | 1.4 (0–32) [50] | 1.2 (0–44) [17] |
Index treatment, anti-TNFα type | ||||||
Infliximab originator, % | – | 55 | – | 18 | – | 44 |
Infliximab biosimilar, % | – | 15 | – | 0 | – | 11 |
Adalimumab, % | – | 15 | – | 35 | – | 21 |
Golimumab, % | – | 15 | – | 47 | – | 25 |
Concomitant therapy at index | ||||||
Corticosteroids, % | 41 | 50 | 44 | 41 | 43 | 47 |
Immunomodulators, % | 23 | 28 | 20 | 35 | 21 | 30 |
Aminosalicylates, % | 59 | 50 | 56 | 53 | 57 | 51 |