表征与免疫检查点抑制剂avelumab相关的肺部不良事件：2013年至2024年基于faers的药物警戒研究

IF 1.8 4区医学 Q3 INFECTIOUS DISEASES

Journal of Chemotherapy Pub Date : 2025-09-17 DOI:10.1080/1120009X.2025.2561969

Connor Frey

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引用次数: 0

摘要

免疫疗法的兴起，特别是像avelumab这样的PD-L1抑制剂，已经有了晚期癌症治疗，但其肺安全性仍不清楚。使用2013-2023年的FAERS数据，我们通过OpenVigil 2.1的歧化分析评估了与avelumab相关的呼吸并发症。出现了几个显著的关联：细菌性肺炎（ROR 6.79, 95% CI 2.19-21.10, n=3）、肺炎（ROR 4.37, 95% CI 1.96-9.74, n=6）、呼吸衰竭（ROR 3.99, 95% CI 2.31-6.90）、肺水肿（ROR 3.40）、呼吸窘迫（ROR 3.31）和肺栓塞（ROR 2.87）。相比之下，非特异性肺炎（ROR 0.97）和呼吸困难（ROR 0.97）无信号。这些结果表明，avelumab可能倾向于特定的严重肺毒性。临床医生应监测早期呼吸损害，并进行前瞻性研究以阐明因果关系和预防策略。

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Characterizing pulmonary adverse events associated with the immune checkpoint inhibitor avelumab: a FAERS-based pharmacovigilance study from 2013 to 2024.

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.

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来源期刊

Journal of Chemotherapy 医学-药学

CiteScore

3.70

自引率

0.00%

发文量

144

审稿时长

6-12 weeks

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.