Dupilumab Shows No Increased Birth Defect Risk in Pregnancy Registry Results
Dupilumab Pregnancy Registry Finds No Signal for Birth Defects
Results from the dupilumab prospective pregnancy registry show no evidence of an increased risk for major structural birth defects among liveborn infants exposed to the drug. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026 in Vienna, Austria, the final results indicate that the point estimate for major structural birth defects was below 1 when compared to women with the same underlying conditions.
- Primary Safety Finding: The weighted relative risk for major structural birth defects was 0.77 (95% CI, 0.40-1.50) for dupilumab-exposed versus disease-matched patients.
- Secondary Outcomes: 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.
- Registry Attrition: The registry experienced a 14.1% loss to follow-up overall, running higher at approximately 17% in the disease-matched comparison group.
Dupilumab Shows Similar Pregnancy Outcomes to Comparison Groups
Led by Chambers, the study evaluated pregnancy outcomes for patients exposed to dupilumab.
Secondary outcomes demonstrated similar stability. Spontaneous abortion and preterm delivery displayed point estimates at or near 1, with confidence intervals crossing 1 across the overall cohort and the atopic-dermatitis-only subset. Infant growth and serious infections showed no significant between-group differences, except for a higher proportion of infants at or below the 10th percentile for birth weight in the dupilumab-exposed group compared directly with the non-diseased group. Subgroup analyses focused on specific indications yielded wider confidence intervals due to smaller sample sizes, though combining groups by overall dupilumab exposure produced tighter, more interpretable estimates.
Participant Retention Exceeds Historical Pregnancy Registry Benchmarks
Study retention metrics improved upon historical benchmarks for pregnancy registries. Chambers reported that 14.1% of participants were lost to follow-up overall, which she described as meaningfully lower than historical rates, although remaining slightly above the registry’s internal 10% target. Attrition reached approximately 17% within the disease-matched comparison group specifically. Researchers conducted systematic analyses to determine whether participants lost to follow-up differed systematically from those retained, concluding that the attrition did not threaten the validity of the study’s conclusions.
Pregnancy safety data for novel therapeutic agents typically require a decade or longer to accumulate, often leaving clinicians and patients to make treatment decisions without strong clinical evidence. The dupilumab registry completed recruitment within a 5-year window. Chambers credited this acceleration, alongside the resulting data integrity, to the hundreds of pregnant women who volunteered extensive time, releasing medical records and permitting infant examinations without direct personal benefit.
Study Findings Presented at EADV Congress 2026
The findings were formally detailed in a late-breaking abstract titled Safety of dupilumab in pregnancy: final results of the dupilumab prospective pregnancy registry (abstract LB-74) at the EADV Congress 2026, running from September 30 to October 3, 2026. This prospective data builds on prior investigative efforts, including a 2025 propensity-matched cohort study published in the Journal of European Academy of Dermatology and Venereology (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) which similarly found no elevated risk for maternal adverse pregnancy outcomes. Chambers reported no relevant financial disclosures.
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