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Experts Develop Benefit-Risk Conceptual Framework for Biologic Use in Pregnancy


This framework considers both the pregnant patient who is taking the medication and the fetus who may be exposed to it while in the womb. It assesses potential benefits and risks for both parties.

Syda Productions/Adobe Stock
Syda Productions/Adobe Stock

Experts recently developed a benefit-risk conceptual framework for the use of biologics in pregnant patients. The proposed framework was published in Clinical Pharmacology and Therapeutics.1

As autoimmune diseases predominantly affect women, often occurring during their reproductive years, the safety of biologic therapies during pregnancy and breastfeeding has emerged as a concern.2

However, the absence of robust clinical data due to historical exclusion of pregnant individuals from trials complicates informed decision-making for both patients and health care providers, experts wrote. Studies exploring the placental transfer of biologics and their presence in breast milk have yielded conflicting results. Recent findings have spurred recommendations to delay live vaccinations in infants due to concerns over reduced efficacy or heightened risk of vaccine-related diseases.

Balancing these risks with the potential exacerbation of autoimmune conditions in pregnant individuals creates a question of benefit-risk (B-R), according to Bozzi et al.

In a mini-review, researchers proposed a framework, leveraging existing literature and expert opinions to outline a comprehensive approach to evaluating biologic therapy in pregnancy and breastfeeding.

They developed a nested conceptual model, delineating 4 scenarios from preconception through postpartum. Each scenario builds upon the previous, encompassing key decision contexts, benefits, and risks. Scenario 2, focusing on the continuation of biologic therapy during pregnancy, serves as the focal point of the review. It reflects the complex relationships between maternal health, fetal well-being, and postpartum considerations.

Drawing from the PhRMA Benefit–Risk Action Team framework, the review established decision contexts and identified key benefits and risks. The review detailed potential benefits such as improved disease control and mitigated pregnancy complications, alongside potential risks including hypersensitivity reactions and serious infections.

While evidence regarding pregnancy outcomes remains varied, studies generally have reported no elevated risks of congenital malformations or vaccine-related complications, reviewers said.

The review acknowledges the limitations inherent in current data sources, advocating for the integration of real-world data to enhance evidence generation. Furthermore, reviewers called for the formation of a consortium, uniting diverse stakeholders to validate and refine the proposed framework.

"Currently, in the absence of a structured B-R framework, these complex decisions, that are often made under time pressure, may suffer from an incomplete understanding of the relevant benefits and risks, resulting in decisions that may not best serve the patient," wrote Bozzi et al. "The framework provides a necessary and important foundation to build upon to advance evidence-based decision making in obstetrics, gynecology, perinatology, neonatology, and pediatrics surrounding biologic use during pregnancy. In addition, the proposed framework is highly adaptable, allowing for it to be tailored to specific biologic indications and mechanisms of action."


  1. Bozzi LM, Jacobson MH, Yost E, et al. A benefit-risk conceptual framework for biologic use during pregnancy: A mini-review. Clin Pharmacol Ther. March 20, 2024. Accessed March 26, 2024. doi:10.1002/cpt.3239
  2. Ghalandari, N., Dolhain, R.J.E.M., Hazes, J.M.W., van Puijenbroek, E.P., Kapur, M. & Crijns, H.J.M.J. Intrauterine exposure to biologics in inflammatory autoimmune diseases: a systematic review. Drugs 80, 1699–1722 (2020). Accessed March 26, 2024.
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