No Signal for Birth Defects in Dupilumab Pregnancy Registry, With Tina Chambers, PhD, MPH

Dupilumab in Pregnant Women: An Unstudied Population?

Final results from a 7-year prospective pregnancy registry for dupilumab found no evidence of increased risk for major structural birth defects among infants exposed to the drug in utero, according to Christina D. Chambers, PhD, MPH, professor of pediatrics at UC San Diego and president of OTIS. Chambers discussed the registry data, presented at the 2026 European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria, held September 30-October 3, in an interview with HCPLive.

The registry (NCT04173442), conducted by the OTIS Research Center between 2018 and 2025, enrolled 539 pregnant women across 3 groups: 238 exposed to dupilumab (95 for atopic dermatitis alone, 143 for asthma with or without atopic dermatitis), 175 with the same underlying conditions but no dupilumab exposure, and 126 with neither condition nor exposure.¹ Chambers said the primary comparison, dupilumab-exposed women versus the disease-matched group, is the most informative, since it isolates the drug's potential effect from the risks already associated with asthma or atopic dermatitis themselves.

"For the primary comparison, which is dupilumab compared to women who have the same underlying conditions, for the primary outcome we saw no evidence of an increased risk. The point estimate was actually below 1, and the confidence interval is pretty tight," she said.

What Did the Registry Find?

For major structural birth defects among liveborn infants, the weighted relative risk was 0.77 (95% CI, 0.40-1.50) for dupilumab-exposed versus disease-matched, and 1.17 (95% CI, 0.51-2.69) versus the non-diseased group, with no pattern of birth defects identified in the dupilumab-exposed group.¹ Secondary outcomes, including spontaneous abortion and preterm delivery, showed point estimates at or near 1 with confidence intervals crossing 1 in both the overall cohort and the atopic-dermatitis-only subset, and there were no significant between-group differences in infant growth or serious infections, aside from a higher proportion of infants at or below the 10th percentile for birth weight in the dupilumab-exposed group compared with the non-diseased group.¹ Chambers noted that subgroup analyses by specific indication produced wider confidence intervals due to smaller sample sizes, but that combining groups by overall dupilumab exposure yielded tighter, more interpretable estimates.

Chambers said 14.1% of participants were lost to follow-up overall, which she called meaningfully lower than rates historically seen in pregnancy registries, though still above the registry's 10% target; the rate ran higher, around 17%, in the disease-matched comparison group specifically. She said the team examined whether participants lost to follow-up differed systematically from those retained to help gauge whether attrition threatened the study's conclusions, and did not believe it did.

Chambers emphasized that pregnancy safety data for new drugs typically take a decade or longer to accumulate, if they are generated at all, leaving clinicians and patients to make treatment decisions without adequate evidence; this registry completed recruitment in 5 years. She credited that pace, and the findings themselves, to the hundreds of pregnant women who volunteered extensive time, including releasing medical records and allowing their infants to be examined, often with no direct personal benefit.

"It's an incredible gift that they give to participate in this," she said.

Chambers has no relevant disclosures.

References

1. Chambers C, Johnson D, Xu R, et al. Safety of dupilumab in pregnancy: final results of the dupilumab prospective pregnancy registry. Late-breaking abstract LB-74 presented at: European Academy of Dermatology and Venereology (EADV) Congress 2026; September 30-October 3, 2026; Vienna, Austria.

2. Preuß SL, Bieber K, Vorobyev A, et al. Dupilumab shows no elevated risk for maternal adverse pregnancy outcomes: a propensity-matched cohort study. J Eur Acad Dermatol Venereol. 2025;39(9):1576-1587. doi:10.1111/jdv.20670