| アブストラクト | In pregnancy, immune checkpoint pathways are involved in the maintenance of fetomaternal immune tolerance. Preclinical studies have shown that immune checkpoint inhibitors (ICIs) increase the risk of fetal death. Despite the fact that using ICIs in pregnant women and women of childbearing potential is not recommended, some case reports of ICI exposure in pregnancy have been published showing favorable fetal outcomes. This study aimed to gain further insight into ICI safety in pregnancy by querying VigiBase((R)), the World Health Organization's spontaneous reporting system. We performed raw and subgroup disproportionality analyses using the reporting odds ratio and comparing ICIs with the entire database, other antineoplastic agents, and other antineoplastic agents gathered in VigiBase((R)) since 2011. Across 103 safety reports referring to ICI exposure during the peri-pregnancy period, 56 reported pregnancy-related outcomes, of which 46 were without concomitant drugs as potential confounding factors. No signals of disproportionate reporting were found for spontaneous abortion, fetal growth restriction, and prematurity. In light of the expanding indications of ICIs, continuous surveillance by clinicians and pharmacovigilance experts is warranted, along with pharmacoepidemiological studies on other sources of real-world evidence, such as birth records, to precisely assess ICI exposure during the peri-pregnancy period and further characterize relevant outcomes. |
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| ジャーナル名 | Cancers |
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| 投稿日 | 2023/1/9 |
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| 投稿者 | Noseda, Roberta; Muller, Laura; Bedussi, Francesca; Fusaroli, Michele; Raschi, Emanuel; Ceschi, Alessandro |
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| 組織名 | Division of Clinical Pharmacology and Toxicology, Institute of Pharmacological;Sciences of Southern Switzerland, Ente Ospedaliero Cantonale, 6900 Lugano,;Switzerland.;Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater;Studiorum-University of Bologna, 40126 Bologna, Italy.;Clinical Trial Unit, Ente Ospedaliero Cantonale, 6900 Lugano, Switzerland.;Faculty of Biomedical Sciences, Universita della Svizzera Italiana, 6900 Lugano,;Department of Clinical Pharmacology and Toxicology, University Hospital Zurich,;8091 Zurich, Switzerland. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36612168/ |
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