Table 7.
Adverse events of ustekinumab treatment for patients with ulcerative colitis
No. of studies, n | Total patients, n | Patients with AE, n, (%) | Source | |
Any AEs | 5 | 258 | 28 (10.9) | Fumery M et al,7
Chaparro M et al,19 Dalal RS et al,20 Ochsenkühn T et al,21 Chiappetta MF et al22 |
Infection | 4 | 11 (4.3) | ||
Pneumonia | 1 | 1 (0.4) | Fumery M et al7 (n=1) | |
Dental abscess | 1 | 2 (0.8) | Fumery M et al7 (n=2) | |
Clostridium difficile infection | 2 | 2 (0.8) | Fumery M et al7 (n=1),
Dalal RS et al20 (n=1) |
|
Urinary tract infection | 1 | 1 (0.4) | Chaparro M et al19 (n=1) | |
Rhinopharyngitis | 1 | 1 (0.4) | Fumery M et al7 (n=1) | |
Lateral pharyngitis | 1 | 1 (0.4) | Ochsenkühn T et al21 (n=1) | |
Otitis media | 1 | 1 (0.4) | Ochsenkühn T et al21 (n=1) | |
Covid 19 | 1 | 1 (0.4) | Chaparro M et al19 (n=1) | |
Malignancies | 1 | 1 (0.4) | ||
Breast cancer | 1 | 1 (0.4) | Ochsenkühn T et al21 (n=1) | |
Others | 5 | 17 (6.6) | ||
Skin rash | 2 | 4 (1.6) | Fumery M et al7 (n=3),
Chaparro M et al19 (n=1) |
|
Arthralgia | 1 | 5 (1.9) | Fumery M et al7 (n=5) | |
IBD exacerbation | 2 | 10 (3.9) | Fumery M et al 7 (n=6),
Dalal RS et al 20 (n=4) |
|
Symptomatic urolithiasis | 1 | 1 (0.4) | Fumery M et al7 (n=1) | |
Gastroenteritis | 1 | 2 (0.8) | Fumery M et al7 (n=2) | |
Myocardial infarction | 1 | 1 (0.4) | Fumery M et al7 (n=1) | |
Fatigue | 1 | 1 (0.4) | Fumery V et al7 (n=1) | |
Rectal adenoma | 1 | 1 (0.4) | Ochsenkühn T et al21 (n=1) | |
Hearing loss | 1 | 1 (0.4) | Ochsenkühn T et al21 (n=1) | |
Atrial fibrillation | 1 | 1 (0.4) | Ochsenkühn T et al21 (n=1) | |
Pituitary adenoma | 1 | 1 (0.4) | Chiappetta MF et al22 (n=1) | |
Retinal detachment | 1 | 1 (0.4) | Ochsenkühn T et al21 (n=1) |
AE: adverse events
IBD: inflammatory bowel disease