Table 1:
Opportunistic Infections in Vedolizumab Clinical Trials
| GEMINI 1 and GEMINI 2 | GEMINI LTS | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vedolizumab, n = 1434, PY = 1058 | Placebo, n = 297, PY = 171 | Ulcerative colitis, n = 894, PY = 2285 | Crohn’s disease, n = 1349, PY = 3145 | Total in LTS, n = 2243, PY = 5430.3 | |||||||||||
| n* | % | IR† | n* | % | IR† | n* | % | IR† | n* | % | IR† | n* | % | IR† | |
| All opportunistic infections | 7 | 0.5 | 0.7 | 0 | – | – | 27 | 3.0 | 1.2 | 24 | 1.8 | 0.8 | 51 | 2.3 | 1.0 |
| Drug-related | 2 | 0.1 | 0.2 | 0 | – | – | 10 | 1.1 | 0.4 | 8 | 0.6 | 0.3 | 18 | 0.8 | 0.3 |
| Resulted in study discontinuation | 1 | <0.1 | 0.1 | 0 | – | – | 4 | 0.4 | 0.2 | 0 | – | – | 4 | 0.2 | <0.1 |
| Serious | 1‡ | <0.1 | 0.1 | 0 | – | – | 9§ | 1.0 | 0.4 | 9║ | 0.7 | 0.3 | 18¶ | 0.8 | 0.3 |
| Serious and drug-related | 1‡ | <0.1 | 0.1 | 0 | – | – | 5 | 0.6 | 0.2 | 3 | 0.2 | 0.1 | 8 | 0.4 | 0.2 |
| Serious and resulted in discontinuation | 0 | – | – | 0 | – | – | 3 | 0.3 | 0.1 | 0 | – | – | 3 | 0.1 | <0.1 |
| Fatal | 0 | – | – | 0 | – | – | 0 | – | – | 0 | – | – | 0 | – | – |
| Type of opportunistic infection | |||||||||||||||
| C. difficile colitis | 5 | 0.3 | 0.5 | 0 | – | – | 14 | 1.6 | 0.6 | 13 | 1.0 | 0.4 | 27 | 1.2 | 0.5 |
| Clostridial infection | – | – | – | – | – | – | 11 | 1.2 | 0.5 | 4 | 0.3 | 0.1 | 15 | 0.7 | 0.3 |
| Esophageal candidiasis | – | – | – | – | – | – | 2 | 0.2 | 0.1 | 5 | 0.4 | 0.2 | 7 | 0.3 | 0.1 |
| CMV colitis | 1 | <0.1 | 0.1 | 0 | – | – | 3 | 0.3 | 0.1 | 2 | 0.1 | 0.1 | 5 | 0.2 | 0.1 |
| CMV infection | 1 | <0.1 | 0.1 | 0 | – | – | |||||||||
| CMV gastrointestinal infection | – | – | – | – | – | – | 1 | 0.1 | <0.1 | 1 | <0.1 | <0.1 | 2 | <0.1 | <0.1 |
*Number of patients who each experienced at least one occurrence of that type of adverse event.
†Exposure-adjusted incidence rate per 100 PY.
‡A patient with C. difficile colitis.
§C. difficile colitis (7 patients), clostridial infection (1 patient), and CMV colitis (2 patients).
║C. difficile colitis (5 patients), clostridial infection (3 patients), CMV colitis (1 patient), and esophageal candidiasis (1 patient).
¶Two of the 18 patients reported 2 serious events each: C. difficile colitis and CMV colitis in one patient, and C. difficile colitis and clostridial infection in the second patient.
CMV indicates cytomegalovirus; IR, incidence rate; LTS, long-term safety; PY, patient-years.