Biologic Therapy for Immune-mediated Inflammatory Diseases during Pregnancy and Lactation: Efficacy, Safety, and Challenges

doi:10.12114/j.issn.1007-9572.2025.0035

Chinese General Practice ›› 2026, Vol. 29 ›› Issue (35): 5161-5168.DOI: 10.12114/j.issn.1007-9572.2025.0035

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Biologic Therapy for Immune-mediated Inflammatory Diseases during Pregnancy and Lactation: Efficacy, Safety, and Challenges

1. Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing 100191, China
2. Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China
3. Institute for Drug Evaluation, Peking University Health Science Center, Beijing 100191, China
4. Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China

Received:2025-02-02 Revised:2025-04-10 Published:2026-12-15 Online:2026-10-26
Contact: WANG Yan, LI Huibo

免疫介导的炎症性疾病妊娠期和哺乳期生物制剂治疗：疗效、安全性和挑战

1．100191　北京市，北京大学第三医院妇产科
2．100191　北京市，北京大学第三医院药学部
3．100191　北京市，北京大学医学部药物评价中心
4．100191　北京市，北京大学第三医院消化科

通讯作者: 王妍, 李慧博
作者简介:
作者贡献：
韩琳负责文章构思、查阅文献与论文撰写；侯振彦负责论文修订与图表绘制；李军负责进行文章的可行性分析，进行监督管理；李慧博负责设计研究方案、图表绘制、课题基金的资助；王妍、李慧博负责最终版本修订，对论文负责。
本文为中文翻译版本，原文Biologic therapy for immune-mediated inflammatory diseases during pregnancy and lactation: efficacy, safety, and challenges发表于Precision Medication，已获得授权。翻译与出版遵循COPE和ICMJE关于二次发表的指南。
基金资助:
北大医学青年科技创新"扬帆计划"项目(BMU2024YFJHPY040); 北京大学第三医院临床重点项目(BYSYZD2022022); 北京大学第三医院回国人员启动科研基金(BYSYLXHG2024010); 国家重大疾病多学科合作诊疗能力建设项目

Abstract

Abstract:

Immune-mediated inflammatory diseases (IMIDs) frequently affect the physical health of women of reproductive age, posing challenges in managing drug treatments due to their potential impact on pregnancy outcomes, fetal development, and infant health. This article comprehensively reviews the latest national and international diagnostic and treatment guidelines, along with recent clinical research. It explores the influence of disease activity in IMIDs on pregnancy outcomes from the perspective of immune balance and elucidates drug exposure mechanisms of biologics during pregnancy based on placental transport and maternal physiological changes. Additionally, it integrates the latest advancements and safety profiles of biologic therapy for IMIDs patients during pregnancy and lactation. The article presents a comparative analysis of guideline recommendations for using various biological agents in these periods. It recommends optimal timing for discontinuation of these agents and neonatal vaccination. Through interdisciplinary collaboration, this work aims to promote the development of effective and safe treatment strategies for IMIDs patients during the perinatal period, thus safeguarding the health of both mothers and infants.

Key words: Immune-mediated inflammatory diseases, Pregnancy period, Breastfeeding period, Biological agents, Safety

摘要：

免疫介导的炎症性疾病（IMIDs）常影响育龄期女性的生理健康，药物对妊娠结局、胎儿发育和婴儿健康的影响使妊娠期与哺乳期的药物治疗决策复杂。本文回顾国内外最新诊疗指南和临床研究，从免疫平衡角度分析IMIDs疾病活动对妊娠结局的影响，从胎盘转运机制与母体生理变化解释生物制剂在妊娠期的药物暴露，综述妊娠期、哺乳期IMIDs患者生物制剂治疗的前沿进展和安全性，对比分析不同生物制剂在妊娠期和哺乳期应用的指南推荐意见，并提出妊娠期生物制剂停药时机和新生儿疫苗接种的最佳建议。通过多学科合作为围妊娠期IMIDs患者提供有效且安全的治疗方案，保障母婴健康。

关键词: 免疫介导的炎症性疾病, 妊娠期, 哺乳期, 生物制剂, 安全性

CLC Number:

R 364.5

HAN Lin,HOU Zhenyan,LI Jun, et al. Biologic Therapy for Immune-mediated Inflammatory Diseases during Pregnancy and Lactation: Efficacy, Safety, and Challenges[J]. Chinese General Practice, 2026, 29(35): 5161-5168. DOI: 10.12114/j.issn.1007-9572.2025.0035.
韩琳,侯振彦,李军等. 免疫介导的炎症性疾病妊娠期和哺乳期生物制剂治疗：疗效、安全性和挑战[J]. 中国全科医学, 2026, 29(35): 5161-5168. DOI: 10.12114/j.issn.1007-9572.2025.0035.

Figures/Tables 3

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药物	结构	妊娠期安全性				新生儿疫苗接种计划	哺乳期安全性	父源暴露安全性
药物	结构	2021年中华医学会风湿病学分会	2016年欧洲抗风湿病联盟（EULAR）	2023年英国风湿病学会（BSR）	2020年美国风湿病学会（ACR）	新生儿疫苗接种计划	哺乳期安全性	父源暴露安全性
TNF抑制剂
英夫利西单抗（IFX）	抗TNF-α单克隆抗体	需在妊娠晚期停药	妊娠20周内停药	妊娠16周内停药	可孕前、孕早期和孕中期使用，孕晚期在分娩前数个t_1/2停药	20周内停止，足月儿正常疫苗接种	可母乳喂养	是
依那西普（ETA）	连接在IgG1 Fc区TNF受体的融合蛋白		妊娠30~32周停药	孕中期结束前停药		32周内停止，足月儿正常疫苗接种
阿达木单抗（ADA）	抗TNF-α单克隆抗体		妊娠20周内停药	孕中期结束前停药		28周内停止，足月儿正常疫苗接种
戈利木单抗（GOL）	抗TNF-α单克隆抗体		缺乏数据支持	孕早期暴露不太可能有害		28周内停止，足月儿正常疫苗接种
培塞利珠单抗（CZP）	抗TNF-α单克隆抗体的抗原结合片段，不含Fc段	可整个妊娠期持续使用				是，无须修改疫苗接种计划
靶向B细胞（抗CD20）
利妥昔单抗（RTX）	人鼠嵌合性单克隆抗体	孕前6个月停药，孕中期和孕晚期避免使用	特殊情况可孕早期使用，孕晚期使用需注意新生儿B细胞耗竭和其他血细胞减少的风险	孕前6个月停药	如果病情需要，对于治疗妊娠中危及生命或器官的风湿性和肌肉骨骼疾病，可在妊娠早期使用	如果在孕晚期使用，则避免在婴儿接种计划中接种活疫苗，直到6月龄	数据有限，母乳中RTX的含量非常低，可酌情考虑母乳喂养	数据有限
IL-6受体抑制剂
托珠单抗（TCZ）	重组人源化抗人IL-6受体的单克隆抗体	孕前3个月停药，不建议孕期使用	缺乏数据支持，避免使用	孕前3个月停药，孕早期暴露不太可能有害	受孕后停用	如果在孕晚期使用，则避免在婴儿接种计划中接种活疫苗，直到6月龄	数据有限，暂无不良反应报告	数据有限
IL-1受体抑制剂
阿那白滞素	重组人IL-1受体拮抗剂（IL-1Ra）	无	特殊情况可孕前和孕期使用	孕早期暴露不太可能有害	受孕后停用	如果在孕晚期使用，则避免在婴儿接种计划中接种活疫苗，直到6月龄	数据有限	数据有限
共刺激因子抑制剂
阿巴西普（ABA）	由CTLA-4胞外区与人源化IgG1 Fc段组成的可溶性融合蛋白	孕前14周停药，不建议孕期使用	缺乏数据支持，避免使用	孕早期暴露不太可能有害	受孕后停用	如果在孕晚期使用，则避免在婴儿接种计划中接种活疫苗，直到6月龄	数据有限，治疗期间应停止哺乳，如需哺乳，应与末次给药时间至少间隔14周	数据有限
贝利尤单抗（BEL）	人源化单克隆抗体	孕前4个月停药	缺乏数据支持，避免使用	孕早期暴露不太可能有害	受孕后停用	如果在孕晚期使用，则避免在婴儿接种计划中接种活疫苗，直到6月龄	数据有限，建议暂停哺乳	数据有限

药物	结构	妊娠期安全性				新生儿疫苗接种计划	哺乳期安全性	父源暴露安全性
药物	结构	2021年中华医学会风湿病学分会	2016年欧洲抗风湿病联盟（EULAR）	2023年英国风湿病学会（BSR）	2020年美国风湿病学会（ACR）	新生儿疫苗接种计划	哺乳期安全性	父源暴露安全性
TNF抑制剂
英夫利西单抗（IFX）	抗TNF-α单克隆抗体	需在妊娠晚期停药	妊娠20周内停药	妊娠16周内停药	可孕前、孕早期和孕中期使用，孕晚期在分娩前数个t_1/2停药	20周内停止，足月儿正常疫苗接种	可母乳喂养	是
依那西普（ETA）	连接在IgG1 Fc区TNF受体的融合蛋白		妊娠30~32周停药	孕中期结束前停药		32周内停止，足月儿正常疫苗接种
阿达木单抗（ADA）	抗TNF-α单克隆抗体		妊娠20周内停药	孕中期结束前停药		28周内停止，足月儿正常疫苗接种
戈利木单抗（GOL）	抗TNF-α单克隆抗体		缺乏数据支持	孕早期暴露不太可能有害		28周内停止，足月儿正常疫苗接种
培塞利珠单抗（CZP）	抗TNF-α单克隆抗体的抗原结合片段，不含Fc段	可整个妊娠期持续使用				是，无须修改疫苗接种计划
靶向B细胞（抗CD20）
利妥昔单抗（RTX）	人鼠嵌合性单克隆抗体	孕前6个月停药，孕中期和孕晚期避免使用	特殊情况可孕早期使用，孕晚期使用需注意新生儿B细胞耗竭和其他血细胞减少的风险	孕前6个月停药	如果病情需要，对于治疗妊娠中危及生命或器官的风湿性和肌肉骨骼疾病，可在妊娠早期使用	如果在孕晚期使用，则避免在婴儿接种计划中接种活疫苗，直到6月龄	数据有限，母乳中RTX的含量非常低，可酌情考虑母乳喂养	数据有限
IL-6受体抑制剂
托珠单抗（TCZ）	重组人源化抗人IL-6受体的单克隆抗体	孕前3个月停药，不建议孕期使用	缺乏数据支持，避免使用	孕前3个月停药，孕早期暴露不太可能有害	受孕后停用	如果在孕晚期使用，则避免在婴儿接种计划中接种活疫苗，直到6月龄	数据有限，暂无不良反应报告	数据有限
IL-1受体抑制剂
阿那白滞素	重组人IL-1受体拮抗剂（IL-1Ra）	无	特殊情况可孕前和孕期使用	孕早期暴露不太可能有害	受孕后停用	如果在孕晚期使用，则避免在婴儿接种计划中接种活疫苗，直到6月龄	数据有限	数据有限
共刺激因子抑制剂
阿巴西普（ABA）	由CTLA-4胞外区与人源化IgG1 Fc段组成的可溶性融合蛋白	孕前14周停药，不建议孕期使用	缺乏数据支持，避免使用	孕早期暴露不太可能有害	受孕后停用	如果在孕晚期使用，则避免在婴儿接种计划中接种活疫苗，直到6月龄	数据有限，治疗期间应停止哺乳，如需哺乳，应与末次给药时间至少间隔14周	数据有限
贝利尤单抗（BEL）	人源化单克隆抗体	孕前4个月停药	缺乏数据支持，避免使用	孕早期暴露不太可能有害	受孕后停用	如果在孕晚期使用，则避免在婴儿接种计划中接种活疫苗，直到6月龄	数据有限，建议暂停哺乳	数据有限

Biologic Therapy for Immune-mediated Inflammatory Diseases during Pregnancy and Lactation: Efficacy, Safety, and Challenges

免疫介导的炎症性疾病妊娠期和哺乳期生物制剂治疗：疗效、安全性和挑战

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