Vedolizumab treatment for immune checkpoint inhibitor-induced enterocolitis
Open accessAbstract
Immune checkpoint inhibitors (ICPI), such as ipilimumab [anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody] and nivolumab or pembrolizumab [anti-programmed cell death protein-1 (PD-1) antibodies], improve survival in several cancer types. Since inhibition of CTLA-4 or PD-1 leads to non-selective activation of the immune system, immune-related adverse events (irAEs) are frequent. Enterocolitis is a common irAE, currently managed with corticosteroids and, if necessary, anti-tumor necrosis factor-α therapy. Such a regimen carries a risk of serious side-effects including infections, and may potentially imply impaired antitumor effects. Vedolizumab is an anti-integrin α4β7 antibody with gut-specific immunosuppressive effects, approved for Crohn's disease and ulcerative colitis. We report a case series of seven patients with metastatic melanoma or lung cancer, treated with vedolizumab off-label for ipilimumab- or nivolumab-induced enterocolitis, from June 2014 through October 2016. Clinical, laboratory, endoscopic, and histologic data were analyzed. Patients initially received corticosteroids but were steroid-dependent and/or partially refractory. One patient was administered infliximab but was refractory. The median time from onset of enterocolitis to start of vedolizumab therapy was 79 days. Following vedolizumab therapy, all patients but one experienced steroid-free enterocolitis remission, with normalized fecal calprotectin. This was achieved after a median of 56 days from vedolizumab start, without any vedolizumab-related side-effects noted. The patient in whom vedolizumab was not successful, due to active ulcerative colitis, received vedolizumab prophylactically. This is the first case series to suggest that vedolizumab is an effective and well-tolerated therapeutic for steroid-dependent or partially refractory ICPI-induced enterocolitis. A larger prospective study to evaluate vedolizumab in this indication is warranted.
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Vedolizumab is an effective and well-tolerated therapeutic for steroid-dependent or refractory ICI-induced enterocolitis.
“Based on two retrospective series, VDZ is an effective and well-tolerated therapeutic for steroid-dependent or refractory ICI-induced enterocolitis.69,70”
From Autoimmune diseases and immune-checkpoint inhibitors for cancer therapy: Review of the literature and personalized risk-based prevention strategy (2020) · cites this paper as [69]
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- Authors
- Bergqvist, V., Hertervig, E., Gedeon, P., Kopljar, M., Griph, H., Kinhult, S., Carneiro, A., & Marsal, J.
- Affiliations
- Skåne University Hospital (SE)
- Lund University (SE)
- Corresponding author
- Marsal, Jan
- Venue
- Cancer Immunology Immunotherapy
- Published
- 2017-02-15
- Volume
- 66
- Issue
- 5
- Pages
- 581-592
- ISSN
- 0340-7004 (ISSN-L)
- 1432-0851
- PMC
- PMC5406433
- OpenAlex
- W2588366403
- Cited by
- 234
- References
- 56
- Citations by year
- 2026: 10 · 2025: 14 · 2024: 20 · 2023: 13 · 2022: 24 · 2021: 33 · 2020: 41 · 2019: 37 · 2018: 35 · 2017: 6
- FWCI
- 14.35
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Cancer Immunology Immunotherapy (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Lund University Publications (Lund University) (submittedVersion)
- Funders
- Hedlund Foundation
- Alfred Österlunds Stiftelse
- Julin Foundation
- Kungliga Fysiografiska Sällskapet i Lund
- Svenska Läkaresällskapet
- Grants to researchers in the public health care from the Swedish government (ALFSKANE-539811)
- Healthcare Region of Southern Sweden
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Keywords
- vedolizumab, immune-related adverse events, ipilimumab, nivolumab, pembrolizumab, CTLA-4, PD-1, metastatic melanoma, lung cancer, off-label drug use, fecal calprotectin, ulcerative colitis
- MeSH terms
- Ipilimumab, Nivolumab, Adult, Aged, Antibodies, Monoclonal, Carcinoma, Non-Small-Cell Lung, Enterocolitis, Female, Gastrointestinal Agents, Humans, Lung Neoplasms, Male, Melanoma, Middle Aged, Cell Cycle Checkpoints, Antibodies, Monoclonal, Humanized
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