TABLE 4:

Tuberculosis Patients Receiving Vedolizumab in the Post-Marketing Setting

Sex, Age, Indication	Events	Days From First VDZ Dose to TB	Serious?	Other Medical History	Concomitant Medication	Prior Medication	Was VDZ Discontinued?	Country (Total VDZ Exposure in Country)	Incidence of TB in Country of Origin (per 100,000 People)
Male, NR, ulcerative colitis	Latent TB,* Rash	Not specified	No†	Mycobacterium tuberculosis complex test (result NR) Rash with unspecified biologic	NR	Adalimumab	Yes	US (~61,488 PY)	3.2
Female, 33, hemorrhagic rectocolitis‡	Disseminated TB, Dyspnea	48	Yes	TB vaccine TB	NR	Prednisolone (Solupred), infliximab (Remicade), interferon	Yes, but restarted after the event	France (~5524 PY)	8.2
Male, 20, Crohn’s disease	Cutaneous TB	97	Yes	Cutaneous TB (healed in the past)	NR	NR	Yes, but restarted after the event	Germany (~14,222 PY)	8.1
Female, NR, NR	TB,§ C. difficile infection	NR	Yes	NR	NR	NR	NR	US (~61,488 PY)	3.2
Male, 46, ulcerative colitis	TB§	196	Yes	None║	NR	NR	Yes	US (~61,488 PY)	3.2
NR, NR, IBD (unspecified)	Pulmonary TB	NR	Yes	Failed TNF antagonist therapy (unspecified)	NR	TNF antagonist therapy (unspecified)	Yes	US (~61,488 PY)	3.2
Female, NR, NR	Latent TB*	154	No†	NR	Augmentin	Adalimumab, infliximab	No	US (~61,488 PY)	3.2

*Not reported as part of the patient’s concomitant or previous medical history (diagnosed after the start of treatment with VDZ).

†Reported as not serious despite TB being a significant event.

‡VDZ is not approved for use in hemorrhagic rectocolitis.

§Not reported whether patient had symptomatic or active TB.

║No other medical history reported.

IBD indicates inflammatory bowel disease; NR, not reported; PY, patient-years; TB, tuberculosis; TNF, tumor necrosis factor; VDZ, vedolizumab.