Dupilumab shows no elevated risk for maternal adverse pregnancy outcomes: A propensity-matched cohort study.

Abstract

Background: Type 2 chronic inflammatory diseases (T2IDs) are highly prevalent among women of reproductive age. Dupilumab, a monoclonal antibody, is increasingly used to treat T2IDs. While dupilumab is not approved during pregnancy, smaller studies suggest no increased risk of pregnancy complications (adverse pregnancy outcomes (APOs)). Additional data are required to better assess the drug's safety during pregnancy.

Objectives: To retrospectively assess the risk of APOs in dupilumab-treated pregnant women in a large real-world database.

Methods: Pregnant women with T2ID and dupilumab treatment during pregnancy were retrieved from the US Collaborative Network of TriNetX. Pregnant women with T2ID and without dupilumab treatment served as controls. Propensity score matching (PSM) for demographics, diagnoses, medications and putative APO risk factors was employed. Outcomes analysed included various maternal pregnancy complications, including premature obstetric labour, pregnancy-induced hypertension, gestational diabetes, puerperal infections and spontaneous abortion. Survival analyses were assessed using the Kaplan-Meier method, outcome differences the log-rank test and hazard ratios (HR) the Cox regression model.

Results: During pregnancy, 293 women were exposed to dupilumab. Following PSM, no increased risks for APOs were noted. Of note, reduced risks for premature obstetric labour (HR: 0.11, confidence interval (CI): 0.03-0.45, p = 0.0002) and 'any APO' (HR: 0.53, CI: 0.33-0.84, p = 0.0067) in the dupilumab-treated group were found. Furthermore, no difference in risks for any APO was noted between dupilumab-treated and untreated women up to 6 months before pregnancy or during the postpartum period.

Conclusions: This large-scale propensity-matched retrospective cohort study suggests a favourable safety profile of dupilumab during pregnancy. Given the difficulties of prospective studies during pregnancy, it provides valuable insights, though further studies are needed to confirm these findings and explore causal relationships.