Related Experiment Video
Updated: Apr 28, 2026
Identifying PD-1/PD-L1 Inhibitors with Surface Plasmon Resonance Technology
Published on: May 2, 2025
Respiratory adverse events associated with PD-1/PD-L1 inhibitors: an analysis based on the FDA adverse event
Zhenyu Wang1,2, Shuting Cui1, Guimei Wang1
1Pulmonary and Critical Care Medicine, Regional Medical Center for National Institute of Respiratory Disease, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
Background:
Respiratory adverse events associated with programmed cell death protein 1 and programmed death-ligand 1 (PD-1/PD-L1) inhibitors have emerged as an important safety concern in clinical oncology. With the expanding use of immune checkpoint inhibitors (ICIs), a comprehensive evaluation of real-world respiratory toxicity is essential to optimize clinical risk management. This study aimed to systematically characterize the occurrence patterns and pharmacovigilance signals of respiratory adverse events related to PD-1/PD-L1 inhibitors using the FDA Adverse Event Reporting System (FAERS).
Methods:
Reports of suspected adverse events associated with PD-1/PD-L1 inhibitors were extracted from the FAERS database, covering the period from the first quarter of 2004 to the second quarter of 2025. Respiratory, thoracic, and mediastinal disorders were identified according to the System Organ Class (SOCs) and Preferred Terms (PTs) of MedDRA version 27.0. Disproportionality analyses were performed using reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC025), and empirical Bayesian geometric mean (EBGM). Univariable and multivariable logistic regression analyses were further conducted to explore factors associated with respiratory adverse event reporting.
Results:
A total of 163,193 reports identified PD-1/PD-L1 inhibitors as the primary suspected drugs. Pneumonia-related signals were consistently detected across most ICIs, indicating a shared pattern of pulmonary toxicity encompassing both infectious pneumonia and immune-related pneumonitis. Respiratory adverse events predominantly occurred during the early treatment phase, particularly within the first 60 days, with a secondary increase observed after prolonged exposure exceeding six months. Elderly patients (≥65 years) accounted for a substantial proportion of cases and exhibited a higher frequency of fatal outcomes. Regression analyses demonstrated that sex, reporting region, and drug class were significantly associated with respiratory adverse event reporting.
Conclusions:
PD-1/PD-L1 inhibitors are associated with a significant risk of respiratory adverse events in real-world clinical practice. Early and targeted respiratory monitoring is warranted, particularly during the initial treatment phase and among elderly patients. These findings highlight the need for optimized risk stratification and proactive management strategies to improve the safety of PD-1/PD-L1 inhibitor therapy.
Insights
Immune checkpoint inhibitors like PD-1/PD-L1 drugs can cause serious respiratory issues, especially early in treatment or in older patients. Early monitoring and risk management are crucial for patient safety during cancer therapy.
Area of Science:
- Oncology
- Immunology
- Pharmacovigilance
Background:
- Immune checkpoint inhibitors (ICIs), specifically PD-1/PD-L1 inhibitors, are increasingly used in cancer treatment.
- Respiratory adverse events are a significant safety concern associated with these therapies.
- Real-world data analysis is essential for understanding and managing ICI-related pulmonary toxicity.
Purpose of the Study:
- To systematically characterize the patterns and pharmacovigilance signals of respiratory adverse events linked to PD-1/PD-L1 inhibitors.
- To identify specific risk factors and temporal trends in ICI-induced respiratory toxicity.
- To inform clinical risk management strategies for optimizing patient safety.
Main Methods:
- Extracted adverse event reports from the FDA Adverse Event Reporting System (FAERS) database (2004-2025).
- Utilized MedDRA classification for respiratory, thoracic, and mediastinal disorders.
- Performed disproportionality analyses (ROR, PRR, IC025, EBGM) and logistic regression to identify signals and associated factors.
Main Results:
- Pneumonia-related signals were consistently detected across various PD-1/PD-L1 inhibitors, indicating shared pulmonary toxicity.
- Respiratory adverse events peaked within the first 60 days of treatment, with a secondary rise after six months.
- Elderly patients (≥65 years) had a higher incidence of events and fatal outcomes; sex, region, and drug class influenced reporting.
Conclusions:
- PD-1/PD-L1 inhibitors pose a significant risk of real-world respiratory adverse events.
- Targeted respiratory monitoring is crucial, especially during early treatment phases and in elderly populations.
- Optimized risk stratification and proactive management are necessary to enhance the safety of ICI therapy.
More Related Videos
Related Concept Videos
01:17Other Pulmonary Disorders
01:30Pneumonia I: Introduction
Risk Factors
Various factors influence the likelihood of developing pneumonia. Age plays a crucial role, with infants, children under two, and individuals over 65 at increased risk due to their...
01:29Pneumonia I: Introduction
01:30Acute Respiratory Failure-III
01:24Chronic Obstructive Pulmonary Disease
Smoking is a primary risk factor for COPD, with over 80% of patients having a history of it. Patients typically experience progressive dyspnea or labored breathing, frequent coughing, and recurrent pulmonary infections. Many eventually succumb to respiratory failure, characterized by...
01:19Chronic Obstructive Pulmonary Disease IV: Clinical Manifestations