Table 5.
Incidence of respiratory tract infections by duration of vedolizumab exposure in the GEMINI LTS trial.a
| MedDRA HLT and preferred term | Duration of vedolizumab exposure, monthsb | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Patients treated | 0 to <12 [n= 2243] |
12 to <24 [n= 1583] |
24 to <36 [n= 1270] |
36 to <48 [n= 901] |
48 to <60 [n= 412] |
60 to <72 [n= 94] |
||||||
| n | % | n | % | n | % | n | % | n | % | n | % | |
| URTI AEs | 556 | 24.8 | 361 | 22.8 | 271 | 21.3 | 168 | 18.6 | 48 | 11.7 | 9 | 9.6 |
| Nasopharyngitis | 310 | 13.8 | 188 | 11.9 | 135 | 10.6 | 83 | 9.2 | 22 | 5.3 | 6 | 6.4 |
| URTI [preferred term] | 157 | 7.0 | 102 | 6.4 | 84 | 6.6 | 54 | 6.0 | 16 | 3.9 | 2 | 2.1 |
| Sinusitis | 102 | 4.5 | 64 | 4.0 | 40 | 3.1 | 24 | 2.7 | 7 | 1.7 | 2 | 2.1 |
| Pharyngitis | 29 | 1.3 | 26 | 1.6 | 16 | 1.3 | 9 | 1.0 | 3 | 0.7 | 0 | - |
| Rhinitis | 14 | 0.6 | 11 | 0.7 | 7 | 0.6 | 6 | 0.7 | 0 | - | 0 | - |
| Tonsillitis | 10 | 0.4 | 11 | 0.7 | 4 | 0.3 | 2 | 0.2 | 0 | - | 0 | - |
| Laryngitis | 7 | 0.3 | 5 | 0.3 | 4 | 0.3 | 4 | 0.4 | 2 | 0.5 | 0 | - |
| Tracheitis | 1 | <0.1 | 1 | <0.1 | 0 | - | 1 | 0.1 | 0 | - | 0 | - |
| Acute sinusitis | 4 | 0.2 | 2 | 0.1 | 3 | 0.2 | 0 | - | 1 | 0.2 | 0 | - |
| Acute tonsillitis | 8 | 0.4 | 6 | 0.4 | 1 | <0.1 | 0 | - | 1 | 0.2 | 0 | - |
| Chronic sinusitis | 4 | 0.2 | 1 | <0.1 | 1 | <0.1 | 0 | - | 1 | 0.2 | 0 | - |
| Sinobronchitis | 0 | - | 2 | 0.1 | 0 | - | 0 | - | 0 | - | 0 | - |
| Tracheobronchitis | 1 | <0.1 | 0 | - | 0 | - | 0 | - | 0 | - | 0 | - |
| Peritonsillar abscess | 1 | <0.1 | 0 | - | 0 | - | 0 | - | 0 | - | 0 | - |
| Pharyngotonsilitis | 1 | <0.1 | 0 | - | 0 | - | 0 | - | 0 | - | 0 | - |
| LRTI AEs | 127 | 5.7 | 78 | 4.9 | 58 | 4.6 | 33 | 3.7 | 14 | 3.4 | 1 | 1.1 |
| Bronchitis | 80 | 3.6 | 53 | 3.3 | 37 | 2.9 | 30 | 3.3 | 12 | 2.9 | 1 | 1.1 |
| Pneumonia | 22 | 1.0 | 15 | 0.9 | 10 | 0.8 | 2 | 0.2 | 1 | 0.2 | 0 | - |
| LRTI [preferred term] | 27 | 1.2 | 13 | 0.8 | 9 | 0.7 | 1 | 0.1 | 1 | 0.2 | 0 | - |
| Lobar pneumonia | 2 | <0.1 | 0 | - | 3 | 0.2 | 0 | - | 0 | - | 0 | - |
| Bronchopneumonia | 1 | <0.1 | 0 | - | 0 | - | 0 | - | 0 | - | 0 | - |
| Lung infection | 0 | - | 1 | <0.1 | 0 | - | 0 | - | 0 | - | 0 | - |
| Primary atypical pneumonia | 0 | - | 0 | - | 1 | <0.1 | 0 | - | 0 | - | 0 | - |
Except where otherwise noted, LRTI is defined according to the MedDRA HLT ‘lower respiratory tract and lung infection’.
AE, adverse event; HLT, high-level term; LRTI, lower respiratory tract infection; LTS, long-term safety; MedDRA, Medical Dictionary for Regulatory Activities; URTI, upper respiratory tract infection.
aInterim data cut-off’: May 19, 2015.
bExposure was calculated as last assessment date first dose date + 1 day. Exposure includes exposure from previous vedolizumab studies.