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International Consensus Supports Asthma Biologic Use During Pregnancy with Shared Decision-Making

• An international panel of 141 clinicians from 32 countries has reached consensus supporting the use of asthma biologics during pregnancy and conception when clinically indicated and agreed upon by patients.

• The consensus statement recommends that pregnant patients on asthma biologics should receive coordinated care from respiratory and obstetric teams, with treatment documented in national or international registries.

• While established biologics like omalizumab show strong support, newer treatments such as tezepelumab require additional safety data, highlighting the need for continued research in this area.

A new international consensus statement has established guidelines supporting the use of biologic medications for severe asthma during pregnancy, marking a significant development in maternal-fetal medicine. The statement, published in Lancet Respiratory Medicine, represents the collective agreement of 141 clinicians from 32 countries, providing clear guidance in an area previously lacking formal recommendations.

Key Recommendations for Clinical Practice

The expert panel reached substantial consensus on several crucial aspects of asthma biologic use during pregnancy. For patients of childbearing age, healthcare providers should initiate documented discussions about biologic use in pregnancy before starting treatment. The consensus supports both continuing and initiating biologics during conception efforts and pregnancy, provided there is proper patient agreement following risk-benefit discussions.
"There is no specific reason for biologics to be risky in pregnancy," explains Dr. Hitasha Rupani from University Hospital Southampton NHS Foundation Trust, the study's lead author. "However, due to the absence of clinical trial data on their safety, there are general concerns around any influence on pregnancy, premature birth, development of the fetus, congenital abnormalities, and long-term effects on the baby."

Treatment Management and Monitoring

The statement emphasizes the importance of coordinated care, recommending that pregnant patients with severe asthma receive reviews from trained healthcare professionals within the first trimester. The guidelines advocate for:
  • Shared care between respiratory and obstetric teams throughout pregnancy
  • Registration of cases in national or international registries
  • Flexibility in medication administration settings
  • Continuation of treatment through all trimesters for most biologics

Differential Recommendations Among Biologics

The panel expressed varying levels of confidence in different biologic agents. Omalizumab, the oldest biologic in the category, received the strongest support. However, newer medications like tezepelumab did not achieve consensus regarding continuation during pregnancy, partly due to limited availability and safety data in some countries.

Postpartum Care and Vaccination Guidelines

The consensus extends to postpartum care, supporting the immediate resumption of biologics after delivery if previously discontinued. Importantly, the statement confirms that mothers who received most asthma biologics during pregnancy can proceed with inactivated vaccinations for their infants without concern.

Expert Commentary

Dr. Jennifer Namazy, a San Diego-based allergist/immunologist not involved in the consensus process, emphasizes that while the guidelines are helpful, they "should not be interpreted as a statement that all asthma biologics are 'safe' to use during pregnancy and that further research is unnecessary."
Dr. Dharani Narendra from Ben Taub Hospital adds that the primary concerns revolve around placental transfer of biologics, particularly during the third trimester, and potential effects on fetal development. While limited studies show no significant harm signals, continued vigilance and data collection remain essential.

Future Directions

The position paper acknowledges current gaps in knowledge, particularly regarding live-attenuated vaccination schedules for infants whose mothers received biologics during pregnancy. Several registries for newer biologics like mepolizumab and dupilumab are actively collecting data, which will help inform future recommendations and enhance understanding of long-term outcomes.
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