Cited by 942Cancer Immunotherapy and BiomarkersPharmacovigilance and Adverse Drug ReactionsViral Infections and Immunology Research

Increased reporting of fatal immune checkpoint inhibitor-associated myocarditis

Open access
Moslehi, Javid J, Salem, Joe-Elie, Sosman, Jeffrey A, Lebrun-Vignes, Bénédicte, Johnson, Douglas B·2018·The Lancet

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Registry

Crossref · 10.1016/s0140-6736(18)30533-6

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1 of 1 references verified0 citation errors · 0 not checkable

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  • ICI myocarditis is an infrequent but potentially fatal condition associated with ICI therapies, especially when used in combination.

    “ICI myocarditis emerges as an infrequent but potentially fatal condition associated with ICI therapies, especially when used in combination”

    From Autoimmune Myocarditis, Old Dogs and New Tricks. (2024) · cites this paper as [35]

    In the paper’s main text (page unavailable), the authors report 101 severe ICI-associated myocarditis cases and a high mortality rate, with severe cases more frequent under combination PD-1/CTLA-4 blockade. The copy does not establish that ICI myocarditis is infrequent overall; a safety-case series does not provide its incidence among treated patients. (LLM, conf=0.86)

    Experimental — accuracy not yet measured
  • ICI targeting PD-1 and CTLA-4 is clinically effective in enhancing T-cell-mediated antitumor responses.

    “Although proving to be clinically effective in enhancing T-cell-mediated antitumor responses”

    From Autoimmune Myocarditis, Old Dogs and New Tricks. (2024) · cites this paper as [35]

    The opening section (page not provided) says immune checkpoint inhibitors have dramatically improved clinical outcomes in multiple cancer types, supporting the clinical-effectiveness part. It discusses PD-1 and CTLA-4 blockade but does not state that the benefit comes from enhancing T-cell-mediated antitumor responses. (LLM, conf=0.86)

    Experimental — accuracy not yet measured
  • irAEs affect a broad spectrum of organs, including the colon, liver, lungs, heart, nervous system, skin, and endocrine system.

    “These events, which can be severe with combination immunotherapies, affect a broad spectrum of organs, including the colon, liver, lungs, heart, nervous system, skin, and endocrine system.5, 6, 7, 8”

    From irAE-GPT: leveraging large language models to identify immune-related adverse events in electronic health records and clinical trial datasets (2026) · cites this paper as [6]

    In “Rapid increase in reporting of fatal immune checkpoint inhibitor associated myocarditis” (page not provided), the paper documents heart involvement, reports myasthenia gravis among concurrent severe irAEs, and finds higher myocarditis fatality with combination therapy. It does not describe irAEs affecting the colon, liver, lungs, skin, or endocrine system, so it does not support the full organ list. (LLM, conf=0.88)

    Experimental — accuracy not yet measured
  • Immune checkpoint inhibitors are associated with myocarditis.

    “immune checkpoint inhibitors (ICIs), which activate the immune system and have proven effective in therapies, are associated with myocarditis”

    From Autoimmune Myocarditis, Old Dogs and New Tricks. (2024) · cites this paper as [35]

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Cites

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Research works printed but not linked: 4

  1. [1]Wolchok JD. PD-1 Blockers. Cell 2015; 162(5): 937. 26317459
  2. [2]Johnson DB, Balko JM, Compton ML, Fulminant Myocarditis with Combination Immune Checkpoint Blockade. The New England journal of medicine 2016; 375(18): 1749– 55. 27806233 PMC5247797
  3. [4]Escudier M, Cautela J, Malissen N, Clinical Features, Management, and Outcomes of Immune Checkpoint Inhibitor-Related Cardiotoxicity. Circulation 2017; 136(21): 2085– 7. 29158217
  4. [5]Lindquist M VigiBase, the WHO Global ICSR Database System: Basic Facts. Drug Inf J 2008; 42(5): 409– 19.

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Authors
Moslehi, J. J., Salem, J.-E., Sosman, J. A., Lebrun-Vignes, B., & Johnson, D. B.
Affiliations
  • Vanderbilt University Medical Center (US)
  • Inserm (FR)
  • Northwestern University (US)
Corresponding author
Johnson, Douglas B
Venue
The Lancet
Publisher
Elsevier BV
Published
2018-03
Volume
391
Issue
10124
Pages
933
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
OpenAlex
W2793167197
Cited by
942
References
1
Citations by year
2026: 101 · 2025: 104 · 2024: 103 · 2023: 103 · 2022: 125 · 2021: 125 · 2020: 132 · 2019: 105 · 2018: 42 · 2014: 1
FWCI
37.96
Type
journal article
Language
en
Open access
Locations
  • The Lancet (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
  • HAL (submittedVersion)
Funders
National Cancer Institute (K23CA204726, K12CA090625)
Topics
  • Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Viral Infections and Immunology Research
Keywords
immune checkpoint inhibitors, myocarditis, immune-related adverse events, drug safety reporting, fatal outcome, VigiBase, adverse event monitoring, cancer immunotherapy
MeSH terms
Immune Checkpoint Inhibitors, Antibodies, Monoclonal, Humans, Myocarditis

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