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

作者：Sophie L Preuß, Katja Bieber, Artem Vorobyev, Andreas Recke, Eva Lotta Moderegger, Henner Zirpel, Evelyn Gaffal, Diamant Thaçi, Khalaf Kridin, Ralf Joachim Ludwig · 发表于：Journal of the European Academy of Dermatology and Venereology · 年份：2025 · DOI：10.1111/jdv.20670 · 被引用次数：14 · 研究领域：Pregnancy and Medication Impact、Reproductive System and Pregnancy、Cancer Risks and Factors

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....