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Area of Science:

  • Immunology
  • Pharmacology
  • Maternal-Fetal Medicine

Background:

  • In utero exposure to immunosuppressive biologics has led to recommendations for delayed infant vaccinations.
  • Concerns include reduced vaccine effectiveness and increased risk of vaccine-related disease in infants.
  • Alternative biologic cessation during pregnancy may worsen maternal autoimmune disease activity.

Purpose of the Study:

  • To develop a conceptual framework for assessing the benefits and risks (B-R) of continuing biologic therapy during pregnancy.
  • To consider the perspectives of both the pregnant individual and the exposed infant.
  • To guide clinical decision-making in complex therapeutic trade-offs.

Main Methods:

  • Literature review of biologic indications and clinical stakeholder consultations.
  • Development of a framework defining decision contexts, benefits, and risks.
  • Inclusion of attributes for both the pregnant person and the in utero-exposed infant.

Main Results:

  • A conceptual framework for B-R assessment was developed, encompassing benefits and risks for both mother and infant.
  • The framework considers various domains and attributes relevant to biologic use in pregnancy.
  • Identified need to address data biases and uncertainties for quantitative B-R assessment.

Conclusions:

  • A robust, validated B-R framework is needed for clinical adoption.
  • Formation of a consortium is recommended to develop and validate this framework.
  • This framework aims to balance maternal health and infant safety concerning biologic use during pregnancy.