Table 3 Summary of adverse events
Patients with ulcerative colitis [N = 133] | ||||||
Index Treatment group | VDZ | Anti-TNFα | VDZ | Anti-TNFα | VDZ | Anti-TNFα |
Treatment history | Biologic-naïve [N = 22] | Biologic-naïve [N = 40] | Prior anti-TNFα [N = 54] | Prior anti-TNFα [N = 17] | Total [N = 76] | Total [N = 57] |
Any AE | ||||||
Patients with event, n (%) | 8 (36.4) | 21 (52.5) | 22 (40.7) | 4 (23.5) | 30 (39.5) | 25 (43.9) |
Patients with event per 100 patient-years, n (95% CI) | 36.3 (15.7–71.6) | 67.2 (41.6–102.7) | 42.6 (26.7–64.5) | 20.3 (5.5–52.1) | 40.7 (27.5–58.1) | 49.1 (31.8–72.4) |
Treatment-related AE | ||||||
Patients with event, n (%) | 1 (4.5) | 3 (7.5) | 3 (5.6) | 1 (5.9) | 4 (5.3) | 4 (7.0) |
Patients with event per 100 patient-years, n (95% CI) | 3.4 (0.1–18.8) | 6.4 (1.3–18.8) | 4.3 (0.9–12.5) | 4.4 (0.1–24.7) | 4.0 (1.1–10.3) | 5.8 (1.6–14.8) |
Any SAE | ||||||
Patients with event, n (%) | 1 (4.5) | 2 (5.0) | 9 (16.7) | 1 (5.9) | 10 (13.2) | 3 (5.3) |
Patients with event per 100 patient-years, n (95% CI) | 3.5 (0.1–19.5) | 4.2 (0.5–15.2) | 13.2 (6.0–25.1) | 4.4 (0.1–24.6) | 10.3 (5.0–19.0) | 4.3 (0.9–12.5) |
Any AE resulting in hospitalization | ||||||
Patients with event, n (%) | 1 (4.5) | 1 (2.5) | 8 (14.8) | 1 (5.9) | 9 (11.8) | 2 (3.5) |
Patients with event per 100 patient-years, n (95% CI) | 3.5 (0.1–19.5) | 2.1 (0.1–11.6) | 11.6 (5.0–22.9) | 4.4 (0.1–24.6) | 9.3 (4.2–17.6) | 2.8 (0.3–10.2) |
Patients with Crohn’s disease [N = 174] | ||||||
Index Treatment group | VDZ | Anti-TNFα | VDZ | Anti-TNFα | VDZ | Anti-TNFα |
Treatment history | Biologic-naïve [N = 10] | Biologic-naïve [N = 65] | Prior anti-TNFα [N = 59] | Prior anti-TNFα [N = 40] | Total [N = 69] | Total [N = 105] |
Any AE | ||||||
Patients with event, n (%) | 4 (40.0) | 30 (46.2) | 18 (30.5) | 15 (37.5) | 22 (31.9) | 45 (42.9) |
Patients with event per 100 patient-years, n (95% CI) | 45.2 (12.3–115.8) | 51.6 (34.8–73.6) | 31.3 (18.5–49.4) | 39.9 (22.3–65.8) | 33.1 (20.8–50.1) | 47.0 (34.3–62.9) |
Treatment-related AE | ||||||
Patients with event, n (%) | 1 (10.0) | 16 (24.6) | 5 (8.5) | 4 (10.0) | 6 (8.7) | 20 (19.0) |
Patients with event per 100 patient-years, n (95% CI) | 7.7 (0.2–43.2) | 21.7 (12.4–35.2) | 7.2 (2.3–16.8) | 8.0 (2.2–20.4) | 7.3 (2.7–15.8) | 16.1 (9.8–24.9) |
Any SAE | ||||||
Patients with event, n (%) | 1 (10.0) | 9 (13.8) | 6 (10.2) | 3 (7.5) | 7 (10.1) | 12 (11.4) |
Patients with event per 100 patient-years, n (95% CI) | 8.3 (0.2–46.3) | 11.3 (5.2–21.5) | 8.5 (3.1–18.5) | 5.9 (1.2–17.2) | 8.5 (3.4–17.5) | 9.2 (4.8–16.1) |
Any AE resulting in hospitalization | ||||||
Patients with event, n (%) | 1 (10) | 5 (7.7) | 3 (5.1) | 3 (7.5) | 4 (5.8) | 8 (7.6) |
Patients with event per 100 patient-years, n (95% CI) | 8.3 (0.2–46.3) | 6.1 (2.0–14.3) | 4.1 (0.9–12.1) | 5.9 (1.2–17.2) | 4.7 (1.3–12.1) | 6.0 (2.6–11.9) |