ArticleAge and ageing2025
Immune-related adverse events in older adults receiving immune checkpoint inhibitors: a comprehensive analysis of the Food and Drug Administration Adverse Event Reporting System.
Article in Age and ageing, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis 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
22 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Immune checkpoint inhibitors-related cytokine storm syndrome: a systematic review of characteristics, treatment, and outcomes.Frontiers in immunology · 2026Pooled it
- Review
- Post-marketing safety profile of bictegravir/emtricitabine/tenofovir alafenamide: a FAERS pharmacovigilance study with EudraVigilance validation and mechanistic investigation of pancreatitis.Virology journal · 2026Article
- Predictors of severe immune-related adverse events during first-line immune checkpoint inhibitor therapy for advanced non-small cell lung cancer.Scientific reports · 2026Article
- Immunosenescence and Cancer: Cellular Aging Programs That Reshape Antitumor Immunity.Immune network · 2026Review
- Risk Factors and Comparative Safety of Anti-PD-1 Combination Therapies in Advanced Melanoma: A Nationwide Real-World Cohort Study From China.Cancer medicine · 2026Article
- [Heterogeneity of Response to PD-1/PD-L1 Inhibitors in Elderly Patients with Advanced NSCLC under the Background of Immunosenescence and Intervention Strategies].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2026Review
- Effectiveness and safety of avelumab maintenance in patients aged ≥75 years with advanced urothelial cancer: a sub-analysis of the meet-URO 25 (MALVA) study.Frontiers in immunology · 2026Article
- Risk factors for cutaneous immune-related adverse events: a systematic scoping review.Frontiers in immunology · 2026Article
- Ipilimumab and nivolumab for cancer treatment: a pharmacovigilance study based on the FDA adverse event reporting system database.Frontiers in endocrinology · 2026Article
- FAERS database reveals latent signals of neuro-ophthalmic toxicity associated with immune checkpoint inhibitors: feature mining and clinical warnings.Frontiers in immunology · 2026Article
- Management of brain metastases in older adults with non-small cell lung cancer.Frontiers in oncology · 2026Review
- Respiratory adverse events associated with PD-1/PD-L1 inhibitors: an analysis based on the FDA adverse event reporting system.Frontiers in oncology · 2026Article
- Disparities and trends in drug-related adverse reaction mortality in the United States, 1999-2020.Therapeutic advances in drug safety · 2026Article
- Severe IL-6-dominant immune-mediated inflammatory response complicated by probable arginine vasopressin deficiency following ivonescimab-based therapy in advanced EGFR-mutant lung squamous cell carcinoma: a case report.Frontiers in oncology · 2026Article
- Age and Clinical Outcomes of Immune Checkpoint Inhibitor Toxicities in Portugal: A Decade of Pharmacovigilance.Cancers · 2025Article
- Article
- Application of Immune Checkpoint Inhibitors in Cancer.MedComm · 2025Review
- Improving assessment of financial toxicity of cancer immunotherapy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Article
- The real-world safety profile of pemetrexed and platinum with or without pembrolizumab: insights from a comparative analysis of FAERS database.BMC cancer · 2025Article
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundImmune checkpoint inhibitors (ICIs) have revolutionised cancer therapy, yet they carry a unique spectrum of immune-related adverse events (irAEs). Given the ageing global population and the underrepresentation of older adults in clinical trials for ICIs, we investigated the occurrence and characteristics of irAEs in older versus younger adults as well as among different age subsets within the older adult population.
methodsWe analysed the U.S. Food and Drug Administration Adverse Event Reporting System database reports from 2015 to 2023, focusing on ICIs. We categorised irAEs into 11 distinct types and performed descriptive and multivariate analyses to compare the prevalence and clinical characteristics of irAEs across different age groups, adjusting for potential confounding factors.
resultsAmong 47 513 patients aged 18-100 reporting irAEs, the 65-74 and 75-84 age groups had significantly increased risks compared to 18-64 (OR 1.13, 95% CI [1.09-1.18]; 1.15 [1.1-1.21]). Cardiovascular irAEs rose with age, peaking at 75-84, while endocrine irAEs decreased. Hepatobiliary, gastrointestinal and ocular irAEs decreased with age, but renal and musculoskeletal irAEs increased, showing higher risks in older adults. Serious outcomes slightly decreased in the 85+ group, while the proportion of deaths increased with age.
conclusionWe discuss the potential changes in the immune system contributing to the decreased prevalence of irAEs in the oldest age group. Additionally, conservative treatment approaches and underreporting of irAEs in older patients may influence these findings. Our findings highlight the need for personalised decision-making for ICI therapies, considering performance status and comorbidities rather than age alone.
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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.