| アブストラクト | Background: Due to its apparent efficacy and safety, dupilumab, a monoclonal antibody that blocks Interleukin 4 (IL-4) and Interleukin 13 (IL-13), has been approved for treating T-helper 2 (Th2) disorders. However, adverse effects like local injection site reactions, conjunctivitis, headaches, and nasopharyngitis have been reported. Sex differences are known to influence both adaptive and innate immune responses and, thus, may have a bearing on the occurrence of these adverse effects. Nevertheless, the literature lacks a comprehensive exploration of this influence, a gap this study aims to bridge. Materials and Methods: A comprehensive data mining of VigiBase, the World Health Organization (WHO) global pharmacovigilance database which contains case safety reports of adverse drug reactions (ADRs) was performed to test for sex -specific safety response to dual IL4/IL13 blockade by dupilumab. The information component (IC), a measure of the disproportionality of ADR occurrence, was evaluated and compared between males and females to identify potential sexual dimorphism. Results: Of the 94,065 ADRs recorded in the WHO global pharmacovigilance database, 2,001 (57.4%) were reported among female dupilumab users, and 1,768 (50.7%) were among males. Immune/autoimmune T-helper 1 (Th1)-, innate- and T-helper 17 (Th17)-driven diseases and degenerative ones were consistently reported with a stronger association with Dupilumab in males than females. Some adverse events were more robustly associated with Dupilumab in females. Conclusion: Dupilumab has an excellent safety profile, even though some ADRs may occur. The risk is higher among male patients, further studies, including ad hoc studies, are needed to establish causality. |
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| ジャーナル名 | Frontiers in pharmacology |
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| Pubmed追加日 | 2023/11/13 |
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| 投稿者 | Sharif, Kassem; Omar, Mahmud; Lahat, Adi; Patt, Yonatan Shneor; Amital, Howard; Zoabi, Ghanem; Bragazzi, Nicola Luigi; Watad, Abdulla |
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| 組織名 | Department of Gastroenterology, Sheba Medical Centre, Ramat Gan, Israel.;Department of Medicine B, Zabludowicz Center for Autoimmune Diseases, Sheba;Medical Center, Ramat Gan, Israel.;Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv-Yafo, Israel.;Laboratory for Industrial and Applied Mathematics (LIAM), Department of;Mathematics and Statistics, York University, Toronto, ON, Canada.;Section of Musculoskeletal Disease, NIHR Leeds Musculoskeletal Biomedical;Research Unit, Leeds Institute of Molecular Medicine, Chapel Allerton Hospital,;University of Leeds, Leeds, United Kingdom. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37954855/ |
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