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Review | Open Access

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

Lin HanaZhenyan Houb,cJun LidYan Wanga( )Huibo Lib,c( )
Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing 100191, China
Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China
Institute for Drug Evaluation, Peking University Health Science Center, Beijing 100191, China
Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China
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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.

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Precision Medication

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Cite this article:
Han L, Hou Z, Li J, et al. Biologic therapy for immune-mediated inflammatory diseases during pregnancy and lactation: Efficacy, safety, and challenges. Precision Medication, 2025, 2(2). https://doi.org/10.1016/j.prmedi.2025.100029

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Received: 11 February 2025
Revised: 01 March 2025
Accepted: 20 March 2025
Published: 16 June 2025
© 2025 Chinese General Practice Publishing House Co., Ltd.

This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).