Trial reportCancer immunity2010
Blockade of cytotoxic T-lymphocyte antigen-4 by ipilimumab results in dysregulation of gastrointestinal immunity in patients with advanced melanoma.
Trial report in Cancer immunity, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 109 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
109 citing papers in PubMed, 3 syntheses or guidelines pooled it, 227 citations in OpenAlex.
- Infusion-Related Reactions Among Cancer Patients Receiving Immune Checkpoint Inhibitors: The ARON-MOUSEION-013 Systematic Review and Meta-Analysis.Drug design, development and therapy · 2025Pooled it
- Ipilimumab-Induced Enterocolitis: A Systematic Review and Meta-Analysis.Drug safety · 2020Pooled it
- CTLA-4 and MDR1 polymorphisms increase the risk for ulcerative colitis: A meta-analysis.World journal of gastroenterology · 2015Pooled it
- Patients with gastrointestinal irritability after TGN1412-induced cytokine storm displayed selective expansion of gut-homing αβ and γδT cells.Cancer immunology, immunotherapy : CII · 2021Trial
- Gene expression profiling of whole blood in ipilimumab-treated patients for identification of potential biomarkers of immune-related gastrointestinal adverse events.Journal of translational medicine · 2013Trial
- Navigating the gut-metabolite-immune axis: enhancing efficacy and mitigating toxicity of immune checkpoint inhibitors.Frontiers in immunology · 2026Review
- The Microbiota-Diet-Immunity Axis in Cancer Care: From Prevention to Treatment Modulation and Survivorship.Nutrients · 2025Review
- The intestinal microbiome and metabolome discern disease severity in cytotoxic T-lymphocyte-associated protein 4 deficiency.Microbiome · 2025Article
- Akkermania muciniphila: a rising star in tumor immunology.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024Review
- Severe Dysphagia With Eosinophilic Esophagitis Pattern of Injury Related to Pembrolizumab Therapy.ACG case reports journal · 2024Article
- Novel treatments for novel side effects: a case report and review of baricitinib use in the treatment of chronic inflammatory demyelinating polyneuropathy caused by immune checkpoint inhibitor use.Journal for immunotherapy of cancer · 2023Article
- Drug-Associated Gastropathy: Diagnostic Criteria.Diagnostics (Basel, Switzerland) · 2023Review
- Microbiome influencers of checkpoint blockade-associated toxicity.The Journal of experimental medicine · 2023Article
- Review
- The gut microbiome, immune check point inhibition and immune-related adverse events in non-small cell lung cancer.Cancer metastasis reviews · 2022Review
- Construction, bioinformatics analysis, and validation of competitive endogenous RNA networks in ulcerative colitis.Frontiers in genetics · 2022Article
- Biologic Therapy for Refractory Immune Checkpoint Inhibitor Colitis.Biologics : targets & therapy · 2022Review
- A Review of Cancer Immunotherapy Toxicity: Immune Checkpoint Inhibitors.Journal of medical toxicology : official journal of the American College of Medical Toxicology · 2021Review
- Diagnosis and Management of Immune Checkpoint Inhibitor Colitis.Gastroenterology & hepatology · 2021Article
- Checkpoint Inhibitor-Induced Colitis-A Clinical Overview of Incidence, Prognostic Implications and Extension of Current Treatment Options.Pharmaceuticals (Basel, Switzerland) · 2021Review
49 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 1 institution in 1 country.
Funding
Abstract
Blockade of cytotoxic T-lymphocyte antigen-4 (CTLA-4) by ipilimumab leads to immune-mediated tumor regression and immune-related adverse events (irAEs), including diarrhea and colitis. The current analyses were undertaken to promote an understanding of the underlying mechanism of action and to identify potential biomarkers that could help in the prediction and management of ipilimumab-induced gastrointestinal irAEs. Treatment-naïve or previously treated patients with unresectable stage III/IV melanoma (n = 115) received open-label ipilimumab (10 mg/kg every 3 weeks for four doses) and were randomized to receive concomitant blinded prophylactic oral budesonide (9 mg/d with gradual taper through week 16) or placebo. Outcome measures included histologic assessment of bowel biopsies and assessment of serologic markers of inflammatory bowel disease (IBD), fecal calprotectin levels, and polymorphisms in immune-related genes. Ipilimumab resulted in dysregulation of gastrointestinal mucosal immunity as evidenced by altered antibody levels to enteric flora, inflammatory cell infiltration into gastrointestinal mucosa, and increased fecal calprotectin associated with diarrhea and clinical evidence of colitis. The pattern of ipilimumab-induced antibody titers to microbial flora and the histologic features and location of the inflammation were distinct from classic IBD. Prophylactic budesonide did not prevent ipilimumab-induced bowel inflammation. Despite an observed association between colonic inflammation and grade 2 or higher diarrhea, no baseline biomarkers could reliably predict development of gastrointestinal toxicity. Although classic IBD and ipilimumab-related gastrointestinal toxicity are both immune mediated, the observed pattern of biomarkers suggests ipilimumab-related gastrointestinal toxicity may be a distinct clinicopathologic entity.
Indexed as
Identifiers
21090563PMC2999944W1948621219What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.