Observational studyJournal of neuro-oncology2021
Neuroimmunological adverse events associated with immune checkpoint inhibitor: a retrospective, pharmacovigilance study using FAERS database.
Observational study in Journal of neuro-oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 60 papers, 5 of them syntheses that pooled it.
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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.
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Who cites it
60 citing papers in PubMed, 5 syntheses or guidelines pooled it, 98 citations in OpenAlex.
- Clinical characteristics, management and outcomes in immune checkpoint inhibitor-induced central nervous system demyelinating disease.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026Pooled it
- Antibody-positive paraneoplastic neurological syndromes associated with immune checkpoint inhibitors: a systematic review.Journal of neurology · 2025Pooled it
- Immune-related aseptic meningitis and strategies to manage immune checkpoint inhibitor therapy: a systematic review.Journal of neuro-oncology · 2022Pooled it
- Exploring the role of immune checkpoint inhibitors in the etiology of myasthenia gravis and Lambert-Eaton myasthenic syndrome: A systematic review.Frontiers in neurology · 2022Pooled it
- Guillain-Barré Syndrome-Like Polyneuropathy Associated with Immune Checkpoint Inhibitors: A Systematic Review of 33 Cases.BioMed research international · 2021Pooled it
- Risk of Neurological Adverse Events Between PD-L1 and PD-1 Inhibitors in South Korean Patients with Lung Cancer: A Target Trial Emulation Framework.Clinical drug investigation · 2026Article
- Neurological Adverse Events Associated With Immune Checkpoint Inhibitors Identified Through Disproportionality Analysis of the FDA Adverse Event Reporting System.Cancer medicine · 2026Article
- Safety of Immune-Targeted Therapy in Patients with Hepatocellular Carcinoma in the Real-World.Journal of gastrointestinal cancer · 2026Observational
- Case Report: Rare Peripheral Neuropathy With Abdominal Wall Allodynia in Extensive-Stage Small-Cell Lung Cancer Treated Using Durvalumab.Thoracic cancer · 2026Article
- Severe Immune-Related Neurological Adverse Events Associated With Immune Checkpoint Inhibitor Treatment: A Retrospective Single-Center Study.European journal of neurology · 2026Article
- Article
- Comparative neurologic toxicity profiles of chemotherapy versus immune checkpoint inhibitors in melanoma: a propensity score-matched analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- Immune-Related Adverse Events Associated with Immune Checkpoint Inhibitors: A Scoping Review.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Case Report: Neurological immune-related adverse events with anti-PD-1 based immunotherapy in cervical cancer.Frontiers in oncology · 2026Article
- Ipilimumab and nivolumab for cancer treatment: a pharmacovigilance study based on the FDA adverse event reporting system database.Frontiers in endocrinology · 2026Article
- Elevated C-Reactive Protein as a Potential Biomarker for Neurological Adverse Events in Immune Checkpoint Inhibitor Therapy: A Prospective Cohort Study.Oncology research · 2026Article
- Neurotoxicity of immune checkpoint inhibitors: a retrospective pharmacovigilance study using FAERS database.Frontiers in immunology · 2026Article
- Article
- Neurological immune-related adverse events of immune checkpoint inhibitors: clinical and hematological risk factors.Journal of neurology · 2025Article
- Article
Corrections and comments
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Authors and funding
9 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo investigate the characteristics and risk factors for neurologic adverse events (AEs) induced by immune checkpoint inhibitors (ICIs).
methodsAn observational, retrospective, and pharmacovigilance study based on the FAERS database collected between January 2014 and December 2019 was conducted. ICI-related AEs were defined as adverse reactions in patients using anti-PD-1 (nivolumab and pembrolizumab), anti-PD-L1 (atezolizumab, avelumab, and durvalumab), and anti-CTLA-4 (ipilimumab and tremelimumab). Neurologic AEs previously reported to be associated with ICI were evaluated in the disproportionality analysis using the reporting odds ratio (ROR).
resultsAmong 50,406 ICI-related reports, 3619 (7.2%) neurological case was found: 1985 with anti-PD-1, 372 with anti-PD-L1, 366 with anti-CTLA-4, and 896 with the combination of ICIs. In comparison to non-ICI drug use, ICI use demonstrated higher risk for neurologic complication, including hypophysitis/hypopituitarism, myasthenia gravis, encephalitis/myelitis, meningitis, Guillain-Barre syndrome, vasculitis, and neuropathy. The risk of neurologic AEs associated with ICI combination therapy was as high as or even higher than ICI monotherapy, most significantly in hypophysitis/hypopituitarism. The proportion of serious neurological events and death related to combination therapy has been decreasing in recent years. Older age, male and female sex, and metastasis were not significant risk factors for the incidence of neurologic ICI-related AEs. Patients at older age, with melanoma or non-small cell lung cancer, or on dual ICI therapy may be at higher risk of fatal neurologic AEs.
conclusionICI use is associated with a higher risk of neurological complications, with dual ICI therapy posing a higher risk, while older age, sex, or metastasis were not. Patients at older age, with certain cancer types, or on dual ICI therapy may be at higher risk of fatal neurologic AEs.
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