{"title":"A pharmacovigilance analysis of post-marketing safety of tezepelumab.","authors":"Huqun Li, Chongshu Wang, Cuilian Guo","doi":"10.1016/j.jaip.2024.10.045","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Tezepelumab has shown promising efficacy for adult patients with severe asthma since its approval. However, the post-marketing safety evaluation of tezepelumab is currently lacking.</p><p><strong>Objective: </strong>The present study aims to investigate the post-marketing safety of tezepelumab based on the FDA Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>Adverse events (AEs) reports from January 2022 to December 2023 were extracted from the FAERS database. Disproportionality analysis by reporting odds ratio (ROR) and empirical Bayesian geometric mean (EBGM) was performed to detect potential AEs related to tezepelumab. Clinical characteristics and time to onset of AEs were also assessed.</p><p><strong>Results: </strong>A total of 1,699 tezepelumab-related AE reports were identified during the study period. Thirty tezepelumab-related AE signals were detected by simultaneously applying the two algorithms. At the system organ class (SOC) level, the most common SOC related to tezepelumab was respiratory, thoracic and mediastinal disorders. At the preferred term (PT) level, common AEs including arthralgia and back pain were detected which were also documented in the label of tezepelumab and clinical trials. New unexpected AEs such as chest pain and myalgia were also identified. The median time to onset of tezepelumab-related AEs was 7.5 days, and the majority of AEs occurred within the first 1 month after tezepelumab initiation.</p><p><strong>Conclusion: </strong>The present study presents a comprehensive evaluation of the post-marketing safety of tezepelumab in the real-world setting. Our findings will provide valuable evidence for future clinical studies and management of safety issues of tezepelumab.</p>","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":" ","pages":""},"PeriodicalIF":8.2000,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Allergy and Clinical Immunology-In Practice","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jaip.2024.10.045","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ALLERGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Tezepelumab has shown promising efficacy for adult patients with severe asthma since its approval. However, the post-marketing safety evaluation of tezepelumab is currently lacking.
Objective: The present study aims to investigate the post-marketing safety of tezepelumab based on the FDA Adverse Event Reporting System (FAERS) database.
Methods: Adverse events (AEs) reports from January 2022 to December 2023 were extracted from the FAERS database. Disproportionality analysis by reporting odds ratio (ROR) and empirical Bayesian geometric mean (EBGM) was performed to detect potential AEs related to tezepelumab. Clinical characteristics and time to onset of AEs were also assessed.
Results: A total of 1,699 tezepelumab-related AE reports were identified during the study period. Thirty tezepelumab-related AE signals were detected by simultaneously applying the two algorithms. At the system organ class (SOC) level, the most common SOC related to tezepelumab was respiratory, thoracic and mediastinal disorders. At the preferred term (PT) level, common AEs including arthralgia and back pain were detected which were also documented in the label of tezepelumab and clinical trials. New unexpected AEs such as chest pain and myalgia were also identified. The median time to onset of tezepelumab-related AEs was 7.5 days, and the majority of AEs occurred within the first 1 month after tezepelumab initiation.
Conclusion: The present study presents a comprehensive evaluation of the post-marketing safety of tezepelumab in the real-world setting. Our findings will provide valuable evidence for future clinical studies and management of safety issues of tezepelumab.
期刊介绍：
JACI: In Practice is an official publication of the American Academy of Allergy, Asthma & Immunology (AAAAI). It is a companion title to The Journal of Allergy and Clinical Immunology, and it aims to provide timely clinical papers, case reports, and management recommendations to clinical allergists and other physicians dealing with allergic and immunologic diseases in their practice. The mission of JACI: In Practice is to offer valid and impactful information that supports evidence-based clinical decisions in the diagnosis and management of asthma, allergies, immunologic conditions, and related diseases.
This journal publishes articles on various conditions treated by allergist-immunologists, including food allergy, respiratory disorders (such as asthma, rhinitis, nasal polyps, sinusitis, cough, ABPA, and hypersensitivity pneumonitis), drug allergy, insect sting allergy, anaphylaxis, dermatologic disorders (such as atopic dermatitis, contact dermatitis, urticaria, angioedema, and HAE), immunodeficiency, autoinflammatory syndromes, eosinophilic disorders, and mast cell disorders.
The focus of the journal is on providing cutting-edge clinical information that practitioners can use in their everyday practice or to acquire new knowledge and skills for the benefit of their patients. However, mechanistic or translational studies without immediate or near future clinical relevance, as well as animal studies, are not within the scope of the journal.
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