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The use of biological agents in pregnant women affected by autoimmune disorders: Why we need more research of this neglected area.
Carnovale, Carla; Parisi, Francesca; Battini, Vera; Zavatta, Alice; Cheli, Stefania; Cattaneo, Dario; Gringeri, Michele; Mosini, Giulia; Guarnieri, Greta; Cammarata, Gianluca; Cetin, Irene.
Afiliação
  • Carnovale C; Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences L. Sacco, "Luigi Sacco" University Hospital, Università di Milano, Milan, Italy. Electronic address: carla.carnovale@unimi.it.
  • Parisi F; Department of Woman, Mother and Neonate, "V. Buzzi" Children Hospital, ASST Fatebenefratelli Sacco, 20141 Milan, Italy.
  • Battini V; Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences L. Sacco, "Luigi Sacco" University Hospital, Università di Milano, Milan, Italy.
  • Zavatta A; Department of Woman, Mother and Neonate, "V. Buzzi" Children Hospital, ASST Fatebenefratelli Sacco, 20141 Milan, Italy.
  • Cheli S; Unit of Clinical Pharmacology, ASST Fatebenefratelli Sacco University Hospital, Via GB Grassi 74, 20157 Milan, Italy.
  • Cattaneo D; Unit of Clinical Pharmacology, ASST Fatebenefratelli Sacco University Hospital, Via GB Grassi 74, 20157 Milan, Italy.
  • Gringeri M; Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences L. Sacco, "Luigi Sacco" University Hospital, Università di Milano, Milan, Italy.
  • Mosini G; Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences L. Sacco, "Luigi Sacco" University Hospital, Università di Milano, Milan, Italy.
  • Guarnieri G; Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences L. Sacco, "Luigi Sacco" University Hospital, Università di Milano, Milan, Italy.
  • Cammarata G; Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences L. Sacco, "Luigi Sacco" University Hospital, Università di Milano, Milan, Italy.
  • Cetin I; Department of Woman, Mother and Neonate, "V. Buzzi" Children Hospital, ASST Fatebenefratelli Sacco, 20141 Milan, Italy; Department of Biomedical and Clinical Sciences, "Luigi Sacco", University of Milan, 20157 Milan, Italy.
Pharmacol Res ; 171: 105786, 2021 09.
Article em En | MEDLINE | ID: mdl-34314858
Women of childbearing age are largely affected by several autoimmune disorders (the estimates range between 1.5 and 10 per 10,000). The increasing number of effective biological agents has dramatically revolutionized the treatment of these clinical conditions, ameliorating the patient's quality of life. The use of these agents by women during pregnancy is growing to ensure the disease activity control and avoid adverse health outcomes. However, for many newer biological agents, the degree of information concerning their use in pregnancy is often incomplete to perform a conclusive risk assessment on fetal and maternal health given the exclusion of this specific population from pharmacological clinical trials. More recently, the COVID-19 pandemic has confirmed the unacceptable inequities of pharmacological research and medical treatment for pregnant and lactating women, exacerbating the need for filling the gaps of quantitative and qualitative pharmacology data in this sensitive population. ere we summarize (i) what is already known about safety and effectiveness of biological agents in this understudied population (with specific focus on pregnancy-related health outcomes), and what we are going to learn from the on-going studies among pregnant women treated with biological agents; (ii) the methodological and ethical considerations that characterize the pharmacological research in pregnancy, also discussing emerging evidence on the use of therapeutic drug monitoring (TDM) in this clinical setting.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Complicações na Gravidez / Doenças Autoimunes / Resultado da Gravidez / Fatores Biológicos / Gestantes Tipo de estudo: Qualitative_research / Risk_factors_studies Limite: Female / Humans / Pregnancy Idioma: En Revista: Pharmacol Res Assunto da revista: FARMACOLOGIA Ano de publicação: 2021 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Complicações na Gravidez / Doenças Autoimunes / Resultado da Gravidez / Fatores Biológicos / Gestantes Tipo de estudo: Qualitative_research / Risk_factors_studies Limite: Female / Humans / Pregnancy Idioma: En Revista: Pharmacol Res Assunto da revista: FARMACOLOGIA Ano de publicação: 2021 Tipo de documento: Article