ArticleFrontiers in pharmacology2020
Immune Checkpoint Inhibitors and Immune-Related Adverse Drug Reactions: Data From Italian Pharmacovigilance Database.
Article in Frontiers in pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 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
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.
- Comparative cardiotoxicity risk of pembrolizumab versus nivolumab in cancer patients undergoing immune checkpoint inhibitor therapy: A meta-analysis.Frontiers in oncology · 2023Pooled it
- Uncovering prognostic biomarkers through a pharmacovigilance study: the case of RDW.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025Article
- Post marketing safety surveillance of atezolizumab based on a retrospective analysis of the FDA adverse events reporting system (FAERS).Scientific reports · 2025Article
- Advances in Lung Cancer Treatment: Integrating Immunotherapy and Chinese Herbal Medicines to Enhance Immune Response.Chinese journal of integrative medicine · 2025Review
- Machine-Learning Parsimonious Prediction Model for Diagnostic Screening of Severe Hematological Adverse Events in Cancer Patients Treated with PD-1/PD-L1 Inhibitors: Retrospective Observational Study by Using the Common Data Model.Diagnostics (Basel, Switzerland) · 2025Article
- Adverse skin reactions secondary to sintilimab for advanced gastric adenocarcinoma: A case report and literature review.Molecular and clinical oncology · 2025Article
- Nivolumab Safety in Renal Cell Carcinoma: A Case Report.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2024Article
- Immune Checkpoint Inhibitors and Scleroderma: Data from the European Pharmacovigilance Database.Drugs - real world outcomes · 2024Article
- Sex and gender differences and pharmacovigilance: a knot still to be untied.Frontiers in pharmacology · 2024Article
- Assessment of Neurologic Safety Profile of Immune Checkpoint Inhibitors: Evaluation of Adverse Drug Reaction Reports.Current drug safety · 2024Article
- Cardiac safety profile of type II kinase inhibitors: Analysis of post-marketing reports from databases of European Medicine Agency & World Health Organization.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2023Article
- A bibliometric analysis of research progress on pharmacovigilance and cancer from 2002 to 2021.Frontiers in oncology · 2023Review
- Do peripheral neuropathies differ among immune checkpoint inhibitors? Reports from the European post-marketing surveillance database in the past 10 years.Frontiers in immunology · 2023Article
- Adverse skin reactions induced by sintilimab in advanced lung squamous carcinoma: a case report and review of the literature.Annals of translational medicine · 2022Article
- Knowledge Gaps Among Dermatologists Regarding Immunotherapy for Non-melanoma Skin Cancer.The Journal of clinical and aesthetic dermatology · 2022Article
- European Safety Analysis of mRNA and Viral Vector COVID-19 Vaccines on Glucose Metabolism Events.Pharmaceuticals (Basel, Switzerland) · 2022Article
- The Reporting Frequency of Ketoacidosis Events with Dapagliflozin from the European Spontaneous Reporting System: The DAPA-KETO Study.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Maternal, fetal and neonatal outcomes among pregnant women receiving COVID-19 vaccination: The preg-co-vax study.Frontiers in immunology · 2022Article
- The Safety Profile of General and Local Anaesthetic Agents: Data Collected during 20 Years of Spontaneous Reporting Activities in the Campania Region (Southern Italy).Pharmaceuticals (Basel, Switzerland) · 2021Article
- Immune Checkpoint Inhibitors and Cardiotoxicity: An Analysis of Spontaneous Reports in Eudravigilance.Drug safety · 2021Article
Corrections and comments
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Authors and funding
11 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe introduction of immune checkpoint inhibitors (ICIs) in clinical practice has brought significant benefits for patients. Seven ICIs are available in Europe: nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, cemiplimab, and ipilimumab. Despite their proven clinical efficacy, these innovative drugs may cause serious immune-related adverse drugs reactions (irADRs). Given the significance of these ADRs for patients' health, we analyzed individual case safety reports (ICSRs) related to ICIs, focusing on those reporting irADRs, collected in the Italian spontaneous reporting database.
methodsWe analyzed ICI-induced irADRs collected in the Italian Pharmacovigilance database (Rete Nazionale di Farmacovigilanza [RNF]) from January 1, 2002, to February 28, 2019, focusing on those reported in the Campania Region. We retrieved from an open-access Italian pharmacovigilance system, the RAM system (for national safety data), and from the RNF (for Campania safety data) all ICSRs reporting ADRs related to ICIs authorized until the analysis date. Focusing on irADRs, we performed descriptive and disproportionality analyses through the reporting odds ratio (ROR) with 95% confidence interval.
results
conclusionsOur results showed that during the study period several serious irADRs were reported, some of which had fatal outcome. Given the clinical relevance of irADRs, further investigations in real-life context are necessary for a better characterization of ICIs safety profiles. Oncologists should be trained to early recognize and adequately manage irADRs. Patients should also be educated to immediately report any new symptom or worsening of pre-existed ones during the ICI treatment.
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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.