Table 2.
Exposure-adjusted incidence rate per 100 patient-years of respiratory tract infections in the GEMINI 1, GEMINI 2, and GEMINI LTS trials by preferred terms.
| Category | GEMINI 1: UC | GEMINI 2: CD | Pooled GEMINI 1 and GEMINI 2 | GEMINI LTS: all vedolizumab-treated patientsa | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Safety population | Vedolizumab [n= 620] TPY = 471.9 | Placebo [n= 149] TPY = 81.2 | Vedolizumab [n= 814] TPY = 586.2 | Placebo[n= 148TPY = 90.1 | Vedolizumab [n= 1434] TPY = 1058.2 | Placebo [n= 297] TPY = 171.3 | UC [n= 894] TPY = 2285.4 |
CD [n= 1349] TPY = 3145.0 |
Total [N= 2243] TPY = 5430.3 |
|||||||||
| n [%] | IRb [95% CI] | n [%] | IRb [95% CI] | n [%] | IRb [95% CI] | n [%] | IRb [95% CI] | n [%] | IRb [95% CI] | n [%] | IRb [95% CI] | n [%] | IRb [95% CI] | n [%] | IRb [95% CI] | n [%] | IRb [95% CI] | |
| Upper respiratory tract infections | ||||||||||||||||||
| URTIs | 155 [25.0] |
40.1 [33.5–46.7] |
23 [15.4] |
30.7 [17.7–43.7] |
184 [22.6] |
37.6 [32.0–43.2] |
27 [18.2] |
35.2 [21.1–49.2] |
339 [23.6] |
38.7 [34.4–43.0] |
50 [16.8] |
33.0 [23.4–42.6] |
347[38.8] | 22.3 [19.7–24.9] |
518 [38.4] |
24.3 [22.0–26.7] |
865 [38.6] |
23.5 [21.7–25.2] |
| Nasopharyngitis | 80 [12.9] |
18.6 [14.5–22.8] |
11 [7.4] |
14.0 [5.5–22.4] |
100 [12.3] |
18.7 [14.9–22.4] |
10 [6.8] |
11.8 [4.3–19.3] |
180 [12.6] |
18.6 [15.9–21.4] |
21 [7.1] |
12.8 [7.2–18.5] |
203 [22.7] |
10.8 [9.3–12.4] |
285 [21.1] |
11.0 [9.6–12.3] |
488 [21.8] |
10.9 [9.9–11.9] |
| URTI [preferred term] | 52 [8.4] |
11.7 [8.5–14.9] |
8 [5.4] |
10.1 [3.1–17.1] |
54 [6.6] |
9.6 [7.0–12.2] |
11 [7.4] |
13.0 [5.1–20.8] |
106 [7.4] |
10.5 [8.5–12.6] |
19 [6.4] |
11.6 [6.3–16.9] |
130 [14.5] |
6.4 [5.3–7.5] |
172 [12.8] |
6.0 [5.0–6.9] |
302 [13.5] |
6.1 [5.4–6.8] |
| Sinusitis | 15 [2.4] |
3.2 [1.6–4.9] |
2 [1.3] |
2.5 [0.0–6.0] |
29 [3.6] |
5.1 [3.2–6.9] |
1 [0.7] |
1.1 [0.0–3.3] |
44 [3.1] |
4.3 3.0–5.5] |
3 [1.0] |
1.8 [0.0–3.8] |
75 [8.4] |
3.5 [2.7–4.3] |
121 [9.0] |
4.1 [3.4–4.9] |
196 [8.7] |
3.8 [3.3–4.4] |
| Pharyngitis | 9 [1.5] |
1.9 [0.7–3.2] |
0 | – | 15 [1.8] |
2.6 [1.3–3.9] |
1 [0.7] |
1.1 [0.0–3.3] |
24 [1.7] |
2.3 [1.4–3.2] |
1 [0.3] |
0.6 [0.0–1.7] |
28 [3.1] |
1.2 [0.8–1.7] |
38 [2.8] |
1.2 [0.8–1.6] |
66 [2.9] |
1.2 [0.9–1.5] |
| Rhinitis | 8 [1.3] |
1.7 [0.5–2.9] |
3 [2.0] |
3.8 [0.0–8.1] |
5 [0.6] |
0.9 [0.1–1.6] |
1 [0.7] |
1.1 [0.0–3.3] |
13 [0.9] |
1.2 [0.6–1.9] |
4 [1.3] |
2.4 [<0.1–4.7] |
10 [1.1] |
0.4 [0.1–0.7] |
25 [1.9] |
0.8 [0.5–1.1] |
35 [1.6] |
0.6 [0.4–0.8] |
| Tonsillitis | 4 [0.6] |
0.9 [<0.1–1.7] |
0 | – | 1 [0.1] |
0.2 [0.0–0.5] |
0 | – | 5 [0.3] |
0.5 [0.1–0.9] |
0 | – | 10 [1.1] |
0.4 [0.2–0.7] |
15[1.1] | 0.5 [0.2–0.7] |
25 [1.1] |
0.5 [0.3–0.6] |
| Laryngitis | 2 [0.3] |
0.4 [0.0–1.0] |
0 | – | 1 [0.1] |
0.2 [0.0–0.5] |
2 [1.4] |
2.2 [0.0–5.3] |
3 [0.2] |
0.3 [0.0–0.6] |
2 [0.7] |
1.2 [0.0–2.8] |
3 [0.3] |
0.1 [0.0–0.3] |
16 [1.2] |
0.5 [0.3–0.8] |
19 [0.8] |
0.4 [0.2–0.5] |
| Tracheitis | 1 [0.2] |
0.2 [0.0–0.6] |
0 | – | 2 [0.2] |
0.3 [0.0–0.8] |
1 [0.7] |
1.1 [0.0–3.3] |
3 [0.2] |
0.3 [0.0–0.6] |
1 [0.3] |
0.6 [0.0–1.7] |
2 [0.2] |
0.1 [0.0–0.2] |
0 | – | 2 [<0.1] |
<0.1 [0.0–0.1] |
| Acute sinusitis | 0 | – | 1 [0.7] |
1.2 [0.0–3.7] |
2 [0.2] |
0.3 [0.0–0.8] |
0 | – | 2 [0.1] |
0.2 [0.0–0.5] |
1 [0.3] |
0.6 [0.0–1.7] |
3 [0.3] |
0.1 [0.0–0.3] |
5 [0.4] |
0.2 [<0.1–0.3] |
8 [0.4] |
0.2 [<0.1–0.3] |
| Acute tonsillitis | 1 [0.2] |
0.2 [0.0–0.6] |
0 | – | 1 [0.1] |
0.2 [0.0–0.5] |
1 [0.7] |
1.1 [0.0–3.3] |
2 [0.1] |
0.2 [0.0–0.5] |
1 [0.3] |
0.6 [0.0–1.7] |
5 [0.6] |
0.2 [<0.1–0.4] |
11 [0.8] |
0.4 [0.1–0.6] |
16 [0.7] |
0.3 [0.2–0.4] |
| Chronic sinusitis | 1 [0.2] |
0.2 [0.0–0.6] |
0 | – | 1 [0.1] |
0.2 [0.0–0.5] |
0 | – | 2 [0.1] |
0.2 [0.0–0.5] |
0 | – | 4 [0.4] |
0.1 [0.0–0.3] |
4 [0.3] |
0.1 [<0.1–0.3] |
8 [0.4] |
0.1 [<0.1–0.2] |
| Sinobronchitis | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 1 [0.1] |
<0.1 [0.0–0.1] |
1 [<0.1] |
<0.1 [0.0–0.1] |
2 [<0.1] |
<0.1 [0.0–0.1] |
| Tracheobronchitis | 1 [0.2] |
0.2 [0.0–0.6] |
0 | – | 0 | – | 0 | – | 1 [<0.1] |
0.1 [0.0–0.3] |
0 | – | 0 | – | 1 [<0.1] |
<0.1 | 1 [<0.1] |
<0.1 [0.0–0.1] |
| Rhinolaryngitis | 0 | – | 0 | – | 0 | – | 1 [0.7] |
1.1 [0.0–3.3] |
0 | – | 1 [0.3] |
0.6 [0.0–1.7] |
0 | – | 0 | – | 0 | – |
| Peritonsillar abscess | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 1 [0.1] |
<0.1 [0.0–0.1] |
0 | – | 1 [<0.1] |
<0.1 [0.0–0.1] |
| Pharyngotonsillitis | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 1 [0.1] |
<0.1 [0.0–0.1] |
0 | – | 1 [<0.1] |
<0.1 [0.0–0.1] |
| Serious URTIs | 1 [0.2] |
0.2 [0.0–0.6] |
0 | – | 1 [0.1] |
0.2 [0.0–0.5] |
0 | – | 2 [0.1] |
0.2 [0.0–0.5] |
0 | – | 2 [0.2] |
0.1 [0.0–0.2] |
4 [0.3] |
0.1 [<0.1–0.3] |
6 [0.3] |
0.1 [<0.1–0.2] |
| Acute sinusitis | 0 | – | 0 | – | 1 [0.1] |
0.2 [0.0–0.5] |
0 | – | 1 [<0.1] |
0.1 0.0–0.3] |
0 | – | 0 | – | 0 | – | 0 | – |
| Sinusitis | 0 | – | 0 | – | 1 [0.1] |
0.2 [0.0–0.5] |
0 | – | 1 [<0.1] |
0.1 [0.0–0.3] |
0 | – | 0 | – | 2 [0.1] |
0.1 [0.0–0.2] |
2 [<0.1] |
<0.1 [0.0–0.1] |
| Tonsillitis | 1 [0.2] |
0.2 [0.0–0.6] |
0 | – | 0 | – | 0 | – | 1 [<0.1] |
0.1 [0.0–0.3] |
0 | – | 0 | – | 0 | – | 0 | – |
| URTI [preferred term] | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 1 [0.1] |
<0.1 [0.0–0.1] |
0 | – | 1 [<0.1] |
<0.1 [0.0–0.1] |
| Laryngitis | 0 | – | – | – | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 1 [<0.1] |
<0.1 [0.0–0.1] |
1 [<0.1] |
<0.1 [0.0–0.1] |
| Nasopharyngitis | 0 | – | – | – | – | – | 0 | – | 0 | – | 0 | – | 0 | – | 1 [<0.1] |
<0.1 [0.0–0.1] |
1 [<0.1] |
<0.1 [0.0–0.1] |
| Peritonsillar abscess | 0 | – | – | – | – | 0 | – | 0 | – | 0 | – | 1 [0.1] |
<0.1 [0.0–0.1] |
0 | – | 1 [<0.1] |
<0.1 [0.0–0.1] |
|
| Lower respiratory tract infections | ||||||||||||||||||
| LRTIs | 31 [5.0] |
6.7 [4.4–9.2] |
7 [4.7] |
9.0 [2.3–15.6] |
48 [5.9] |
8.5 [6.1–10.9] |
7 [4.7] |
8.0 [2.0–14.0] |
79 [5.5] |
7.7 [6.0–9.4] |
14 [4.7] |
8.5 [4.0–12.9] |
88 [9.8] |
4.1 [3.2–5.0] |
163 [12.1] |
5.7 [4.8–6.5] |
251 [11.2] |
5.0 [4.4–5.6] |
| Bronchitis | 24 [3.9] |
5.2 [3.1–7.3] |
5 [3.4] |
6.4 [0.7–12.0] |
33 [41] |
5.8 3.8–7.8] |
5 [3.4] |
5.7 [0.6–10.8] |
57 [4.0] |
5.5 [4.1–7.0] |
10 [3.4] |
6.0 [2.2–9.8] |
54 [6.0] |
2.4 [1.8–3.1] |
118 [8.7] |
4.0 [3.3–4.7] |
172 [7.7] |
3.3 [2.8–3.8] |
| Pneumonia | 2 [0.3] |
0.4 [0.0–1.0] |
1 [0.7] |
1.2 [0.0–3.7] |
9 [1.1] |
1.5 [0.5–2.6] |
1 [0.7] |
1.1 [0.0–3.3] |
11 [0.8] |
1.0 [0.4–1.7] |
2 [0.7] |
1.2 [0.0–2.8] |
20 [2.2] |
0.9 [0.5–1.3] |
29 [2.1] |
0.9 [0.6–1.3] |
49 [2.2] |
0.9 [0.7–1.2] |
| LRTI [preferred term] | 5 [0.8] |
1.1 [0.1–2.0] |
1 [0.7] |
1.2 [0.0–3.6] |
5 [0.6] |
0.9 [0.1–1.6] |
0 | – | 10 [0.7] |
1.0 [0.4–1.5] |
1 [0.3] |
0.6 [0.0–1.7] |
17 [1.9] |
0.8 [0.4–1.1] |
29 [2.1] |
0.9 [0.6–1.2] |
46 [2.1] |
0.8 [0.6–1.1] |
| Bronchopneumonia | 1 [0.2] |
0.2 [0.0–0.6] |
0 | – | 0 | – | 1 [0.7] |
1.1 [0.0–3.3] |
1 [0.1] |
0.1 [0.0–0.3] |
1 [0.3] |
0.6 [0.0–1.7] |
0 | – | 1 [<0.1] |
<0.1 [0.0–0.1] |
1 [<0.1] |
<0.1 [0.0–0.1] |
| Lung infection | 0 | – | 0 | – | 1 [0.1] |
0.2 [0.0–0.5] |
0 | – | 1 [<0.1] |
0.1 [0.0–0.3] |
0 | – | 0 | – | 1 [<0.1] |
<0.1 [0.0–0.1] |
1 [<0.1] |
<0.1 [0.0–0.1] |
| Primary atypical pneumonia | 0 | – | 0 | – | 1 [0.1] |
0.2 [0.0–0.5] |
0 | – | 1 [0.1] |
0.1 [0.0–0.3] |
0 | – | 0 | – | 1 [<0.1] |
<0.1 [0.0–0.1] |
1 [<0.1] |
<0.1 [0.0–0.1] |
| Lobar pneumonia | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 2 [0.2] |
0.1 [0.0–0.2] |
3 [0.2] |
0.1 [0.0–0.2] |
5 [0.2] |
0.1 [<0.1–0.2] |
| Serious LRTIs | 2 [0.3] |
0.4 [0.0–1.0] |
0 | – | 3 [0.4] |
0.5 [0.0–1.1] |
1 [0.7] |
1.1 [0.0–3.3] |
5 [0.3] |
0.5 [0.1–0.9] |
1 [0.3] |
0.6 [0.0–1.7] |
10 [1.1] |
0.4 [0.2–0.7] |
11 [0.8] |
0.3 [0.1–0.5] |
21 [0.9] |
0.4 [0.2– 0.5] |
| Pneumonia | 0 | – | 0 | – | 2 [0.2] |
0.3 [0.0–0.8] |
0 | – | 2 [0.1] |
0.2 [0.0–0.5] |
0 | – | 8 [0.9] |
0.4 [0.1–0.6] |
11 [0.8] |
0.3 [0.1–0.5] |
19 [0.8] |
0.3 [0.2–0.5] |
| Bronchitis | 1 [0.2] |
0.2 [0.0–0.6] |
0 | – | 0 | – | 0 | – | 1 [<0.1] |
0.1 [0.0–0.3] |
0 | – | 0 | – | 0 | – | 0 | – |
| LRTI [preferred term] | 1 [0.2] |
0.2 [0.0–0.6] |
0 | – | 0 | – | 0 | – | 1 [<0.1] |
0.1 [0.0–0.3] |
0 | – | 0 | – | 0 | – | 0 | – |
| Lobar pneumonia | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 2 [0.2] |
0.1 [0.0–0.2] |
0 | – | 2 [<0.1] |
<0.1 [0.0–0.1] |
| Lung infection | 0 | – | 0 | – | 1 [0.1] |
0.2 [0.0–0.5] |
0 | – | 1 [<0.1] |
0.1 [0.0–0.3] |
0 | – | 0 | – | 0 | – | 0 | – |
| Bronchopneumonia | 0 | – | 0 | – | 0 | – | 1 [0.7] |
1.1 [0.0–3.3] |
0 | – | 1 [0.3] |
0.6 [0.0–1.7] |
0 | – | 0 | – | 0 | – |
Except where otherwise noted, LRTI is defined according to the MedDRA high-level term ‘lower respiratory tract and lung infection’. Patients with one or more adverse events within a level of the MedDRA term are counted only once in that level.
CD, Crohn’s disease; CI, confidence interval; IR, incidence rate; LRTI, lower respiratory tract infection; MedDRA, Medical Dictionary for Regulatory Activities; LTS, long-term safety; TPY, total number of patient-years of exposure; UC, ulcerative colitis; URTI, upper respiratory tract infection.
aInterim data cut-off: May 19, 2015.
bIR, exposure-adjusted incidence rate per 100 patient-years ([number of patients experiencing an adverse event of interest/total patient exposure time in years] × 100).