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Inflammasome Targeted Therapy in Pregnancy: New Insights From an Analysis of Real-World Data From the FAERS Database and a Systematic Review

The published experience with biologics in childbearing age with autoimmune and inflammatory diseases mainly deals with the use of TNFα inhibitors (TNFα-i). Limited data are available for biologics targeting other cytokines or immunocompetent cells, especially for the inflammasome targeted therapy i...

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Autores principales: Carnovale, Carla, Tombetti, Enrico, Battini, Vera, Mazhar, Faizan, Radice, Sonia, Nivuori, Mariangela, Negro, Enrica, Tamanini, Silvia, Brucato, Antonio
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7854464/
https://www.ncbi.nlm.nih.gov/pubmed/33551814
http://dx.doi.org/10.3389/fphar.2020.612259
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author Carnovale, Carla
Tombetti, Enrico
Battini, Vera
Mazhar, Faizan
Radice, Sonia
Nivuori, Mariangela
Negro, Enrica
Tamanini, Silvia
Brucato, Antonio
author_facet Carnovale, Carla
Tombetti, Enrico
Battini, Vera
Mazhar, Faizan
Radice, Sonia
Nivuori, Mariangela
Negro, Enrica
Tamanini, Silvia
Brucato, Antonio
author_sort Carnovale, Carla
collection PubMed
description The published experience with biologics in childbearing age with autoimmune and inflammatory diseases mainly deals with the use of TNFα inhibitors (TNFα-i). Limited data are available for biologics targeting other cytokines or immunocompetent cells, especially for the inflammasome targeted therapy including IL-1 inhibitors and colchicine. We conducted a nested case-control study by using the US Food and Drug Administration Adverse Event Reporting System database aimed at quantifying the association between the use of IL-1 inhibitors/colchicine in pregnant women and the occurrence of maternal/fetal adverse effects. The reporting odds ratio was used as a measure of disproportional reporting. From the total cohort (40,033 pregnant women), we retrieved 7,620 reports related to neonatal AEs, 2,889 to fetal disorders, 8,364 to abortion, 8,787 to congenital disorders, and 7,937 to labor/delivery complications. Inflammasome-targeted drugs did not present any disproportionate reporting for all these clusters of AEs. TNFα-i confirmed their safety during pregnancy with aROR < 1 for all clusters of AEs except for labor complications. Finally, we performed a systematic review of the current literature. Data from the eligible studies (12 observational studies and 6 case reports; yielding a total of 2,075 patients) were reassuring. We found no major safety issues on malformations risk of inflammasome targeted therapies in pregnancy. However, due to limited data, the routine use of these agents should be considered in pregnancy only if risk benefit assessment justifies the potential risk to the fetus.
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spelling pubmed-78544642021-02-04 Inflammasome Targeted Therapy in Pregnancy: New Insights From an Analysis of Real-World Data From the FAERS Database and a Systematic Review Carnovale, Carla Tombetti, Enrico Battini, Vera Mazhar, Faizan Radice, Sonia Nivuori, Mariangela Negro, Enrica Tamanini, Silvia Brucato, Antonio Front Pharmacol Pharmacology The published experience with biologics in childbearing age with autoimmune and inflammatory diseases mainly deals with the use of TNFα inhibitors (TNFα-i). Limited data are available for biologics targeting other cytokines or immunocompetent cells, especially for the inflammasome targeted therapy including IL-1 inhibitors and colchicine. We conducted a nested case-control study by using the US Food and Drug Administration Adverse Event Reporting System database aimed at quantifying the association between the use of IL-1 inhibitors/colchicine in pregnant women and the occurrence of maternal/fetal adverse effects. The reporting odds ratio was used as a measure of disproportional reporting. From the total cohort (40,033 pregnant women), we retrieved 7,620 reports related to neonatal AEs, 2,889 to fetal disorders, 8,364 to abortion, 8,787 to congenital disorders, and 7,937 to labor/delivery complications. Inflammasome-targeted drugs did not present any disproportionate reporting for all these clusters of AEs. TNFα-i confirmed their safety during pregnancy with aROR < 1 for all clusters of AEs except for labor complications. Finally, we performed a systematic review of the current literature. Data from the eligible studies (12 observational studies and 6 case reports; yielding a total of 2,075 patients) were reassuring. We found no major safety issues on malformations risk of inflammasome targeted therapies in pregnancy. However, due to limited data, the routine use of these agents should be considered in pregnancy only if risk benefit assessment justifies the potential risk to the fetus. Frontiers Media S.A. 2021-01-20 /pmc/articles/PMC7854464/ /pubmed/33551814 http://dx.doi.org/10.3389/fphar.2020.612259 Text en Copyright © 2021 Carnovale, Tombetti, Battini, Mazhar, Radice, Nivuori, Negro, Tamanini and Brucato. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Carnovale, Carla
Tombetti, Enrico
Battini, Vera
Mazhar, Faizan
Radice, Sonia
Nivuori, Mariangela
Negro, Enrica
Tamanini, Silvia
Brucato, Antonio
Inflammasome Targeted Therapy in Pregnancy: New Insights From an Analysis of Real-World Data From the FAERS Database and a Systematic Review
title Inflammasome Targeted Therapy in Pregnancy: New Insights From an Analysis of Real-World Data From the FAERS Database and a Systematic Review
title_full Inflammasome Targeted Therapy in Pregnancy: New Insights From an Analysis of Real-World Data From the FAERS Database and a Systematic Review
title_fullStr Inflammasome Targeted Therapy in Pregnancy: New Insights From an Analysis of Real-World Data From the FAERS Database and a Systematic Review
title_full_unstemmed Inflammasome Targeted Therapy in Pregnancy: New Insights From an Analysis of Real-World Data From the FAERS Database and a Systematic Review
title_short Inflammasome Targeted Therapy in Pregnancy: New Insights From an Analysis of Real-World Data From the FAERS Database and a Systematic Review
title_sort inflammasome targeted therapy in pregnancy: new insights from an analysis of real-world data from the faers database and a systematic review
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7854464/
https://www.ncbi.nlm.nih.gov/pubmed/33551814
http://dx.doi.org/10.3389/fphar.2020.612259
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