TABLE 2:
Opportunistic Infections in Patients Receiving Vedolizumab in the Post-Marketing Setting
| MedDRA Preferred Term | Number of Nonserious Events | Number of Serious Events | Total |
|---|---|---|---|
| Total | 113 | 104 | 217* |
| Bronchopulmonary aspergillosis | 0 | 1 | 1 |
| C. difficile colitis | 10 | 9 | 19 |
| C. difficile infection | 83 | 44 | 127 |
| Cytomegalovirus colitis | 6 | 9 | 15 |
| Cytomegalovirus infection | 6 | 14 | 20 |
| Cytomegalovirus viremia | 2 | 0 | 2 |
| Cytomegalovirus mononucleosis | 0 | 1 | 1 |
| Disseminated tuberculosis | 0 | 1 | 1 |
| Epstein–Barr virus-associated lymphoma | 0 | 1 | 1 |
| Esophageal candidiasis | 1 | 1 | 2 |
| Fungal esophagitis | 1 | 0 | 1 |
| Herpes esophagitis | 1 | 0 | 1 |
| Herpes zoster infection neurological | 0 | 1 | 1 |
| Herpes zoster disseminated | 0 | 1 | 1 |
| Histoplasmosis disseminated | 0 | 1 | 1 |
| JC virus test positive† | 1 | 8 | 9 |
| Mycobacterium avium complex infection | 1 | 2 | 3 |
| Nocardiosis | 1 | 3 | 4 |
| Opportunistic infection | 0 | 2 | 2 |
| Pneumocystis jirovecii pneumonia | 0 | 3 | 3 |
| Posttransplant lymphoproliferative disorder | 0 | 1 | 1 |
| Presumed ocular histoplasmosis syndrome | 0 | 1 | 1 |
*217 events were reported in 210 patients.
†The background prevalence of anti-JCV antibody seropositivity is approximately 33–91%, based on published rates in multiple patient populations and healthy individuals.44 JCV infection can lead to the development of progressive multifocal leukoencephalopathy.
JC indicates John Cunningham; MedDRA, Medical Dictionary for Regulatory Activities.