{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T05:52:34Z","timestamp":1782885154725,"version":"3.54.5"},"reference-count":20,"publisher":"Oceanside Publications Inc.","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["allergy asthma proc"],"published-print":{"date-parts":[[2026,7,1]]},"abstract":"\n Background:<\/jats:bold>\n 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.\n Objective:<\/jats:bold>\n This study assessed whether dupilumab use is associated with increased pregnancy complications.\n Methods:<\/jats:bold>\n We conducted a multicenter, retrospective study of pregnant patients exposed to dupilumab between 2017 and 2024 compared with age- and comorbidity-matched\n controls who were not receiving biologic therapy. The primary outcome was the composite rate of any pregnancy-related complication, analyzed\n via<\/jats:italic>\n multivariate logistical regression. The data were analyzed both with no covariates and with four covariates (adjusted for age, race\/ethnicity,\n hypertension, and parity). Statistical analyses were conducted by using statistical software, with a two-sided \u03b1 level of 0.05 considered statistically significant. Secondary outcomes investigated complication rates by subgroups (maternal, labor, and fetal complications). Subgroup data\n were analyzed via the Wald test.\n Results:<\/jats:bold>\n 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\n 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\n the study and control groups (69.6% versus 65.2%; p\u2009=\u20090.5861). This held true in the adjusted model (n = 129) (odds ratio 1.131 [95% confidence interval, 0.505\u20102.533]; p\u2009=\u20090.7650). No significant differences were noted in the subgroups. The most prominent\n 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\u2009= 0.164), it remained\n within the expected general population rates (10\u201015%).\n Conclusion:<\/jats:bold>\n 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\n to clinicians managing asthma, eczema, or EoE. Larger prospective studies are needed to confirm these results and assess long-term maternal and neonatal outcomes.\n <\/jats:p>","DOI":"10.2500\/aap.2026.47.260026","type":"journal-article","created":{"date-parts":[[2026,6,25]],"date-time":"2026-06-25T04:30:30Z","timestamp":1782361830000},"page":"291-296","source":"Crossref","is-referenced-by-count":1,"title":["Safety of dupilumab use during pregnancy: A composite evaluation of pregnancy outcomes"],"prefix":"10.2500","volume":"47","author":[{"given":"Frank L.","family":"Ventura","sequence":"first","affiliation":[{"name":"From the Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven B.","family":"Clayton","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Wake Forest University School of Medicine, Winston-Salem, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1355","reference":[{"key":"B1","doi-asserted-by":"crossref","first-page":"211","DOI":"10.1038\/s41423-025-01261-2","article-title":"Type 2 immunity in allergic diseases","volume":"22","author":"Ogulur","year":"2025","journal-title":"Cell Mol Immunol"},{"key":"B2","doi-asserted-by":"crossref","first-page":"425","DOI":"10.1080\/1744666X.2017.1298443","article-title":"Commonality of the IL-4\/IL-13 pathway in atopic diseases","volume":"13","author":"Gandhi","year":"2017","journal-title":"Expert Rev Clin Immunol"},{"key":"B3","doi-asserted-by":"crossref","first-page":"5","DOI":"10.1111\/cea.13491","article-title":"Mechanisms of dupilumab","volume":"50","author":"Harb","year":"2020","journal-title":"Clin Exp Allergy"},{"key":"B4","doi-asserted-by":"crossref","first-page":"1115","DOI":"10.1007\/s40265-017-0768-3","article-title":"Dupilumab: first global approval","volume":"77","author":"Shirley","year":"2017","journal-title":"Drugs"},{"key":"B5","doi-asserted-by":"crossref","first-page":"97","DOI":"10.18176\/jiaci.0682","article-title":"Dupilumab: a review of present indications and off-label uses","volume":"32","author":"Mu\u00f1oz-Bellido","year":"2022","journal-title":"J Investig Allergol Clin Immunol"},{"key":"B6","article-title":"Dupixent","year":"Updated September 30, 2025"},{"key":"B7","doi-asserted-by":"crossref","first-page":"1185","DOI":"10.1016\/j.jaci.2022.01.010","article-title":"Atopic dermatitis and pregnancy","volume":"149","author":"Balakirski","year":"2022","journal-title":"J Allergy Clin Immunol"},{"key":"B8","year":"2025"},{"key":"B9","article-title":"Asthma management and prevention for adults, adolescents and children 6\u201311 years (2024). A summary guide for healthcare providers","year":"2024"},{"key":"B10","doi-asserted-by":"crossref","first-page":"226","DOI":"10.1016\/j.yrtph.2009.02.001","article-title":"A comparison of effects on reproduction and neonatal development in cynomolgus monkeys given human soluble IL-4R and mice given murine soluble IL-4R","volume":"53","author":"Carlock","year":"2009","journal-title":"Regul Toxicol Pharmacol"},{"key":"B11","doi-asserted-by":"crossref","first-page":"1644","DOI":"10.1111\/jdv.15709","article-title":"European Task Force on atopic dermatitis position paper: treatment of parental atopic dermatitis during preconception, pregnancy and lactation period","volume":"33","author":"Vestergaard","year":"2019","journal-title":"J Eur Acad Dermatol Venereol"},{"key":"B12","doi-asserted-by":"crossref","first-page":"583","DOI":"10.1016\/S0140-6736(24)02519-4","article-title":"Atopic dermatitis","volume":"405","author":"Guttman-Yassky","year":"2025","journal-title":"Lancet"},{"key":"B13","volume-title":"MotherToBaby | Fact Sheets [Internet]","year":"2024"},{"key":"B14","doi-asserted-by":"crossref","first-page":"adv41307","DOI":"10.2340\/actadv.v105.41307","article-title":"Safety of dupilumab therapy for atopic dermatitis during pregnancy: a systematic review and meta-analysis","volume":"105","author":"S\u00e1nchez-Garc\u00eda","year":"2025","journal-title":"Acta Derm Venereol"},{"key":"B15","first-page":"5448","article-title":"Safety profile of dupilumab during pregnancy: a data mining and disproportionality analysis of over 37,000 reports from the WHO individual case safety reporting database (VigiBase\u2122)","volume":"25","author":"Khamisy-Farah","year":"2021","journal-title":"Eur Rev Med Pharmacol Sci"},{"key":"B16","doi-asserted-by":"crossref","first-page":"51","DOI":"10.1177\/12034754241290806","article-title":"Maternal, fetal, and labour outcomes of dupilumab use for atopic dermatitis during pregnancy: a systematic review","volume":"29","author":"Chopra","year":"2025","journal-title":"J Cutan Med Surg"},{"key":"B17","doi-asserted-by":"crossref","first-page":"1799","DOI":"10.1111\/jdv.19794","article-title":"Association between maternal dupilumab exposure and pregnancy outcomes in patients with moderate-to-severe atopic dermatitis: a nationwide retrospective cohort study","volume":"38","author":"Avallone","year":"2024","journal-title":"J Eur Acad Dermatol Venereol"},{"key":"B18","doi-asserted-by":"crossref","first-page":"1658","DOI":"10.1016\/S0140-6736(21)00682-6","article-title":"Miscarriage matters: the epidemiological, physical, psychological, and economic costs of early pregnancy loss","volume":"397","author":"Quenby","year":"2021","journal-title":"Lancet"},{"key":"B19","doi-asserted-by":"crossref","first-page":"3149","DOI":"10.1016\/j.jaip.2022.08.013","article-title":"Safety of biologics for atopic diseases during pregnancy","volume":"10","author":"Shakuntulla","year":"2022","journal-title":"J Allergy Clin Immunol Pract"},{"key":"B20","doi-asserted-by":"crossref","first-page":"1928","DOI":"10.1016\/j.jaip.2020.01.016","article-title":"Perinatal outcomes associated with maternal asthma and its severity and control during pregnancy","volume":"8","author":"Yland","year":"2020","journal-title":"J Allergy Clin Immunol Pract"}],"container-title":["Allergy and Asthma Proceedings"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ingentaconnect.com\/content\/ocean\/aap\/2026\/00000047\/00000004\/art00011","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T04:36:37Z","timestamp":1782880597000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ingentaconnect.com\/content\/10.2500\/aap.2026.47.260026"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,1]]},"references-count":20,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2026,7,1]]}},"alternative-id":["1088-5412(20260701)47:4L.291;1-"],"URL":"https:\/\/doi.org\/10.2500\/aap.2026.47.260026","relation":{},"ISSN":["1088-5412"],"issn-type":[{"value":"1088-5412","type":"print"}],"subject":[],"published":{"date-parts":[[2026,7,1]]}}}