Characterizing pulmonary adverse events associated with the immune checkpoint inhibitor avelumab: a FAERS-based pharmacovigilance study from 2013 to 2024.
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引用次数: 0
Abstract
The rise of immunotherapies, particularly PD-L1 inhibitors like avelumab, has advanced cancer care, but its pulmonary safety profile remains unclear. Using FAERS data from 2013-2023, we evaluated respiratory complications linked to avelumab through disproportionality analysis with OpenVigil 2.1. Several significant associations emerged: bacterial pneumonia (ROR 6.79, 95% CI 2.19-21.10, n=3), pneumonitis (ROR 4.37, 95% CI 1.96-9.74, n=6), respiratory failure (ROR 3.99, 95% CI 2.31-6.90), pulmonary edema (ROR 3.40), respiratory distress (ROR 3.31), and pulmonary embolism (ROR 2.87). By contrast, non-specific pneumonia (ROR 0.97) and dyspnea (ROR 0.97) showed no signal. These results suggest avelumab may predispose to specific severe pulmonary toxicities. Clinicians should monitor for early respiratory compromise, with prospective studies warranted to clarify causality and preventative strategies.
期刊介绍：
The Journal of Chemotherapy is an international multidisciplinary journal committed to the rapid publication of high quality, peer-reviewed, original research on all aspects of antimicrobial and antitumor chemotherapy.
The Journal publishes original experimental and clinical research articles, state-of-the-art reviews, brief communications and letters on all aspects of chemotherapy, providing coverage of the pathogenesis, diagnosis, treatment, and control of infection, as well as the use of anticancer and immunomodulating drugs.
Specific areas of focus include, but are not limited to:
· Antibacterial, antiviral, antifungal, antiparasitic, and antiprotozoal agents;
· Anticancer classical and targeted chemotherapeutic agents, biological agents, hormonal drugs, immunomodulatory drugs, cell therapy and gene therapy;
· Pharmacokinetic and pharmacodynamic properties of antimicrobial and anticancer agents;
· The efficacy, safety and toxicology profiles of antimicrobial and anticancer drugs;
· Drug interactions in single or combined applications;
· Drug resistance to antimicrobial and anticancer drugs;
· Research and development of novel antimicrobial and anticancer drugs, including preclinical, translational and clinical research;
· Biomarkers of sensitivity and/or resistance for antimicrobial and anticancer drugs;
· Pharmacogenetics and pharmacogenomics;
· Precision medicine in infectious disease therapy and in cancer therapy;
· Pharmacoeconomics of antimicrobial and anticancer therapies and the implications to patients, health services, and the pharmaceutical industry.
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