Biologic therapy for immune-mediated inflammatory diseases during pregnancy and lactation: Efficacy, safety, and challenges

Abstract

Immune-mediated inflammatory diseases (IMIDs) commonly affect women of reproductive age, and concerns regarding the impact of therapeutic drugs on pregnancy outcomes, fetal development, and infant health complicate medication decision-making during pregnancy and lactation. This article reviews the latest practice guidelines and clinical studies, analyzing the impact of IMIDs disease activity on pregnancy outcomes from the perspective of immune balance. It also explains drug exposure to biologics during pregnancy based on placental transport mechanisms and maternal physiological changes. We summarize recent advances and safety data regarding the use of biologics in pregnant and lactating IMIDs patients, compare and analyze guideline recommendations for the use of different biologics during pregnancy and lactation, and propose optimal suggestions regarding the timing of drug discontinuation during pregnancy and neonatal vaccination strategies. Multidisciplinary collaboration is believed to provide effective and safe therapeutic strategies for IMIDs patients in the peri-pregnancy period to safeguard maternal and infant health.

Keywords

Immune-mediated inflammatory diseases / Pregnancy / Lactation / Biologics / Safety

Declarations

Not applicable

Authors' contributions

L. Han, study conception, literature review, manuscript drafting; Z. Hou, manuscript revision, figure design; J. Li, feasibility analysis, supervision and quality control; H. Li, research protocol design, figure creation, funding acquisition; H. Li and Y. Wang, final version revision, responsibility for work integrity.

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

This study was supported by the Peking University Medicine Youth Science and Technology Innovation “Yangfan Program” Project (BMU2024YFJHPY040), Key Clinical Project of Peking University Third Hospital (BYSYZD2022022), Startup Research Fund for Returned Scholars of Peking University Third Hospital (BYSYLXHG2024010), and National Multidisciplinary Collaborative Diagnosis and Treatment Capacity Building Project for Major Diseases.

Declarations of Competing interests

The authors declare that they have no competing interests.

Acknowledgements

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Authors' other information

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