Recent reports related to in utero exposure of marketed immunosuppressive biologics led to clinical recommendations to delay live vaccinations for infants due to the concern of reduced vaccine effectiveness and/or increased risk of vaccine‐related disease. These delays can increase the risk of children contracting vaccine preventable diseases, yet the alternative cessation of biologics during pregnancy may result in increased autoimmune disease activity for the pregnant person, raising complex benefit–risk (B‐R) considerations and trade‐offs. Our goal is to develop a conceptual framework for B‐R assessment based on the key benefits and risks pregnant people would consider for themselves and their children when continuing (vs. discontinuing) a biologic during pregnancy. The proposed framework defines the decision contexts, key domains and attributes for potential benefits, and risks of biologic use during pregnancy, informed by a literature review of indications for biologics and refined with key clinical stakeholders. The framework includes both the pregnant person taking the biologic and the infant potentially exposed to the biologic in utero, with potential benefit and risk domains and attributes for each participant. To advance this conceptual framework, there are considerations of potential biases and uncertainty of available data that will be imperative to address when quantifying the B‐R framework. For these reasons, we recommend the formation of a consortium to ensure development of a robust, validated framework that can be adopted in the healthcare setting.

中文翻译：

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怀孕期间生物制剂使用的效益-风险概念框架：小型回顾

最近的相关报道在子宫内由于担心疫苗有效性降低和/或疫苗相关疾病风险增加，市售免疫抑制生物制剂的暴露导致临床建议推迟婴儿活疫苗接种。这些延迟可能会增加儿童感染疫苗可预防疾病的风险，但在怀孕期间替代停止使用生物制剂可能会导致孕妇自身免疫性疾病活动增加，从而引发复杂的利益-风险 (B-R) 考虑和权衡。我们的目标是根据孕妇在怀孕期间继续（与停止）生物制剂时为自己及其孩子考虑的主要益处和风险，制定 B-R 评估的概念框架。拟议的框架定义了妊娠期间使用生物制剂的潜在益处和风险的决策背景、关键领域和属性，并通过生物制剂适应症的文献综述提供信息，并与主要临床利益相关者一起完善。该框架包括服用生物制剂的孕妇和可能接触生物制剂的婴儿在子宫内，为每个参与者提供潜在的利益和风险领域和属性。为了推进这一概念框架，在量化 B-R 框架时必须考虑可用数据的潜在偏差和不确定性。出于这些原因，我们建议成立一个联盟，以确保开发一个可在医疗保健环境中采用的强大且经过验证的框架。