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Ipilimumab-Induced Enterocolitis: A Systematic Review and Meta-Analysis
Kelcie Witges1,2, Leigh Anne Shafer1,3, Ryan Zarychanski3,2
1IBD Clinical and Research Centre, University of Manitoba, 804F-715 McDermot Avenue, Winnipeg, MB, R3E3P4, Canada.
Drug Safety
|August 5, 2020
Summary
Checkpoint inhibitor ipilimumab can cause intestinal injury. This study found a significant risk of severe enterocolitis and diarrhea in patients receiving ipilimumab, but could not distinguish chronic from acute cases.
Area of Science:
- Immunology
- Gastroenterology
- Oncology
Background:
- Checkpoint inhibitors, such as ipilimumab, are increasingly used in cancer therapy.
- These drugs can induce immune-related adverse events, including intestinal injury.
Purpose of the Study:
- To evaluate the risk of chronic enterocolitis (lasting over 6 weeks) after ipilimumab administration.
- To determine the likelihood of enteritis, colitis, or enterocolitis presentation.
Main Methods:
- Meta-analyses of randomized controlled trials (RCTs) and prospective observational studies.
- Searched major databases (MEDLINE, EMBASE, CENTRAL) and clinical trial registries.
Main Results:
- In RCTs, ipilimumab significantly increased the risk of severe (≥ grade 3) enterocolitis (RR 13.31) and diarrhea (RR 6.72).
- Observational studies showed a 4% 3-monthly risk of severe enteritis, colitis, or enterocolitis.
- Small bowel involvement occurred in 1% per 3 months.
Conclusions:
- Data are insufficient to differentiate acute versus chronic enterocolitis risk with ipilimumab.
- Given the impact on quality of life and cancer treatment, future trials need detailed reporting of gastrointestinal events.
