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Ceschi_2023_MDPI_cancers
Journal article

Immune checkpoint inhibitors and pregnancy : analysis of the VigiBase® spontaneous reporting system

  • Noseda, Roberta ORCID Division of Clinical Pharmacology and Toxicology, Institute of Pharmacological Sciences of Southern Switzerland, Ente Ospedaliero Cantonale, Lugano, Switzerland
  • Müller, Laura Division of Clinical Pharmacology and Toxicology, Institute of Pharmacological Sciences of Southern Switzerland, Ente Ospedaliero Cantonale, Lugano, Switzerland
  • Bedussi, Francesca Division of Clinical Pharmacology and Toxicology, Institute of Pharmacological Sciences of Southern Switzerland, Ente Ospedaliero Cantonale, Lugano, Switzerland
  • Fusaroli, Michele ORCID Pharmacology Unit, Department ofMedical and Surgical Sciences, AlmaMater Studiorum-University of Bologna, Bologna, Italy
  • Raschi, Emanuel ORCID Pharmacology Unit, Department ofMedical and Surgical Sciences, AlmaMater Studiorum-University of Bologna, Bologna, Italy
  • Ceschi, Alessandro ORCID Division of Clinical Pharmacology and Toxicology, Institute of Pharmacological Sciences of Southern Switzerland, Ente Ospedaliero Cantonale, Lugano, Switzerland ; Clinical Trial Unit, Ente Ospedaliero Cantonale, Lugano, Switzerland ; Faculty of Biomedical Sciences, Università della Svizzera italiana, Switzerland ; Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, Zurich, Switzerland
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  • 2022
Published in:
  • Cancers. - 2022, vol. 15, no. 1, p. 173
Immune checkpoint inhibitors
Pregnancy
Safety
Pharmacovigilance
VigiBase®
Disproportionality analysis
English 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®, 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® 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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Language
  • English
Classification
Medicine
License
CC BY
Open access status
gold
Identifiers
Persistent URL
https://n2t.net/ark:/12658/srd1326699
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