Safety of dupilumab in pregnancy explored in final registry results

Registry data add to the existing literature, showing comparable risks for the outcomes studied in pregnancies exposed to dupilumab and those with the same underlying conditions managed without dupilumab.

Dupilumab is a monoclonal antibody that blocks interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling. Evidence on its safety during pregnancy remains limited, making treatment decisions challenging for women of childbearing age who receive dupilumab to manage atopic dermatitis or asthma.

To build on the available evidence, the Organization of Teratology Information Services (OTIS) Research Center conducted a prospective pregnancy registry study between 2018 and 2025. Final results were presented during a late-breaking session at the 2026 European Academy of Dermatology and Venereology (EADV) Congress.¹

The study enrolled 539 pregnant women from the USA and Canada. Researchers collected information through telephone interviews covering maternal characteristics, medical and pregnancy history, and medication and other exposures throughout pregnancy. These data were supplemented by medical records from maternal and infant healthcare providers and delivery hospitals.

We spoke with study investigator and presenter Dr Christina Chambers (University of California San Diego, La Jolla, CA, USA) about the outcomes measured, key findings, and what they could mean for pregnancy counseling, and women who are considering pregnancy or become pregnant while receiving dupilumab.

Q. How was the pregnancy registry designed, and what were the key findings?

We conducted a traditional pregnancy registry, which is a type of prospective cohort study. We recruited pregnant women across the USA and Canada who had asthma, atopic dermatitis, or both and had taken dupilumab at some point during pregnancy [n=238; 95 with atopic dermatitis alone and 143 with asthma with or without atopic dermatitis].

We also recruited two comparison groups. The main comparison group included women with the same underlying conditions who were not taking dupilumab [n=175; 33 with atopic dermatitis alone and 142 with asthma with or without atopic dermatitis]. The second included women who had neither asthma nor atopic dermatitis [n=126].

We then compared pregnancy and infant outcomes across the groups. We looked at major birth defects, preterm delivery, spontaneous abortion, and growth, both during pregnancy and around one year after birth. We also looked at serious or opportunistic infections during the first year of life and hospitalizations.

When we compared pregnancies exposed to dupilumab with those in the disease-matched comparison group, we found no differences in risk for any of the outcomes we assessed. That was very reassuring, as we saw no evidence of an increased risk for the outcomes we would be concerned about if the drug had an effect.

Q. How could the registry findings guide dupilumab treatment decisions during pregnancy?

There are a lot of factors to consider, and a healthcare provider will discuss these with a woman who is planning a pregnancy or finds out she is pregnant. One of the most important considerations is which medication is best for her condition. Keeping the underlying condition well controlled during pregnancy is beneficial for both the mother and the baby.

I think the dupilumab pregnancy registry provides some reassuring findings that can help inform those conversations, particularly for patients who want to continue dupilumab or become pregnant while taking it.

Note: This transcript has been lightly edited to ensure clarity.

References

1. Chambers C, Johnson D, Xu R, et al. Safety of dupilumab in pregnancy: final results of the dupilumab prospective pregnancy registry. Presented at: European Academy of Dermatology and Venereology (EADV) Congress 2026, Vienna, Austria, September 30–October 3, 2026. Abstr#74.

Sources: This information was presented at the EADV Congress 2026, Vienna, 30 September–3 October 2026. More information about the meeting is available here.