Safety Analysis of Biologic Therapies for Chronic Obstructive Pulmonary Disease: A Real-World Study Based on the FAERS Database

Background Biologic therapies targeting type 2 inflammation have emerged as promising treatment options for Chronic Obstructive Pulmonary Disease (COPD), particularly in patients with eosinophilic phenotypes. However, their safety profiles in real-world clinical practice remain inadequately characterized. To address this gap, we conducted a pharmacovigilance study using data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) to evaluate the safety of four biologic therapies commonly used in COPD management: Dupilumab, Benralizumab, Mepolizumab, and Tezepelumab. Methods Disproportionality analyses were conducted using the reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma Poisson shrinker (MGPS), and empirical Bayes geometric mean (EBGM) to identify adverse event (AE) signals at both the System Organ Class (SOC) and Preferred Term (PT) levels. Furthermore, data from published clinical trials were included to facilitate comparison. Results The FAERS analysis largely corroborated previously reported AEs from clinical trials while also identifying several new potential safety concerns. Across all four biologic therapies, the most frequently reported AEs were related to “respiratory, thoracic, and mediastinal disorders,” with asthma consistently appearing as a common event. Specific signal patterns varied by drug: Dupilumab was notably associated with skin barrier disruption, impaired social functioning, and frequent injection site reactions. Benralizumab demonstrated strong associations with device-related AEs. Mepolizumab exhibited significant psychosocial risk signals and potential concerns related to transdermal exposure. Tezepelumab was linked to immune dysregulation, joint symptoms, and emerging cardiac AEs. Conclusion This study comprehensively characterized the real-world safety profiles of four biologic therapies used in COPD treatment. By confirming known AEs and identifying novel safety signals, these findings offer valuable insights to inform clinical decision-making and support the development of targeted risk management strategies.