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Table 3 Summary of adverse events

From: Real-world clinical effectiveness and safety of vedolizumab and anti-tumor necrosis factor alpha treatment in ulcerative colitis and Crohn’s disease patients: a German retrospective chart review

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)
  1. AE Adverse event, anti-TNFα Anti-tumor necrosis factor alpha, CI Confidence interval, SAE Serious adverse event, VDZ Vedolizumab