Table 3.

Adverse events for HD IFX patients.

148.5 pt-yrs	Events, n [per 100 pt-yrs]		Events occurring on combination therapya, n		Events requiring admission or surgery, n [per 100 pt-yrs]		Events leading to discontinuation of HD IFX, n [per 100 pt-yrs]
Infection	59	[38.7]	24	40.7%	11	[7.41]	1	[0.67]
Respiratory infection	21	[14.1]	11		2		0
Skin infection	10	[6.73]	2		1		0
Herpes zoster	6	[4.04]	2		0		0
Non-perianal abscess	5	[3.37]	1		2		0
Local fungal infection	4	[2.63]	2		0		0
Catheter/surgical material infection	3	[2.02]	1		2		0
Urinary / gynecological infection	3	[2.02]	1		0		0
Systemic fungal infection	2	[1.37]	2		1		1
Bacterial diarrheab	2	[1.37]	1		1		0
Perianal abscess	2	[1.37]	0		2		0
Coxsackie virus infection	1	[0.67]	1		0		0
Mycobacterial infection	0	[0.00]	0		0		0
Autoimmune	8	[5.39]	2	25%	0	[0.00]	1	[0.67]
Inflammatory skin disorder	4	[2.63]	1		0		1
Drug-induced lupus-like reaction	3	[2.02]	1		0		0
Asymptomatic +dsDNA titer	1	[0.67]	0		0		0
Neoplasia	3	[2.02]	2	66.7%	3	[2.02]	0	[0.00]
Squamous cell carcinoma of skin	1	[0.67]	1		1		0
Melanoma in situ	2	[1.37]	1		2		0

HD IFX, high dose infliximab; pt-yrs, patient-years.

^aCombination therapy included 6-mercaptourine, azathioprine, methotrexate, or tacrolimus.

^bOne patient was stool culture positive for salmonella; one was positive for Clostridium difficile.