Table 2.

Adverse events

Adverse event	Clinical details	Age, y	Sex	IBD type	Duration of ustekinumab therapy	Combination therapy	Corticosteroid-free clinical remission	Discontinuation of therapy due to adverse event
Acute diarrhea leading to demise	N/A	16	Male	IBDU	19 months	Steroids and methotrexate	Yes	Yes
Interstitial nephritis	Resolved after steroid treatment, normal renal function after 6 months	12	Male	UC	1 dose	5-ASA	No	Yes
Hypersensitivity reaction	Flushing and vomiting during infusion	14	Female	UC	1 dose	5-ASA, azathioprine	Yes	Yes
Breast abscess	Resolution after drainage	13	Female	UC	38 months	None	Yes	No
Injection-site reaction	N/A	16	Male	UC	10 months	5-ASA, azathioprine	No	No
Cytomegalovirus infection	N/A	3	Male	UC	6 months	Azathioprine	Yes	No

5-ASA 5-aminosalicylic acid, IBDU unclassified inflammatory bowel disease, N/A not available, UC ulcerative colitis