Safety of dupilumab use during pregnancy: A composite evaluation of pregnancy outcomes

Background: Dupilumab is a monoclonal antibody that targets interleukin 4 and interleukin 13 pathways, increasingly used to treat asthma, eczema, and eosinophilic esophagitis (EoE). Currently, there is minimum literature that evaluated the safety of dupilumab during pregnancy. Objective: This study assessed whether dupilumab use is associated with increased pregnancy complications. Methods: We conducted a multicenter, retrospective study of pregnant patients exposed to dupilumab between 2017 and 2024 compared with age- and comorbidity-matched controls who were not receiving biologic therapy. The primary outcome was the composite rate of any pregnancy-related complication, analyzed via multivariate logistical regression. The data were analyzed both with no covariates and with four covariates (adjusted for age, race/ethnicity, hypertension, and parity). Statistical analyses were conducted by using statistical software, with a two-sided α level of 0.05 considered statistically significant. Secondary outcomes investigated complication rates by subgroups (maternal, labor, and fetal complications). Subgroup data were analyzed via the Wald test. Results: Of the 301 patients identified with both dupilumab exposure and a pregnancy classification of diseases code, 69 unique pregnancies met inclusion criteria for confirmed dupilumab exposure during pregnancy. Several patients carried more than one type 2 inflammatory diagnosis; therefore, diagnosis counts exceed the total number of patients. Among these 69 pregnancies, 39 involved asthma, 37 atopic dermatitis, and 3 EoE, with overlap across diagnoses. There was no significant difference in overall complication rates between the study and control groups (69.6% versus 65.2%; p = 0.5861). This held true in the adjusted model (n = 129) (odds ratio 1.131 [95% confidence interval, 0.505‐2.533]; p = 0.7650). No significant differences were noted in the subgroups. The most prominent complications were gestational diabetes, gestational hypertension, preeclampsia, unplanned caesarean sections, and spontaneous abortion (SAB). Although SAB trended toward a higher frequency in the dupilumab group compared with the controls (14.0% versus 5.8%; p = 0.164), it remained within the expected general population rates (10‐15%). Conclusion: Dupilumab exposure during pregnancy was not associated with an increased risk of pregnancy complications. These findings support the relative safety of dupilumab in pregnancy and provide reassurance to clinicians managing asthma, eczema, or EoE. Larger prospective studies are needed to confirm these results and assess long-term maternal and neonatal outcomes.