{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T22:59:44Z","timestamp":1789685984669,"version":"4.0.1"},"reference-count":33,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2025,7,3]],"date-time":"2025-07-03T00:00:00Z","timestamp":1751500800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,7,3]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:p>Dupilumab, the first biologic approved for eosinophilic esophagitis treatment (EoE-tx) in 2022, demonstrated favorable safety in phase-III clinical trials. However, real-world dupilumab-associated adverse reactions (DARs) for EoE-tx are unknown. This study aims to evaluate DAR for EoE-tx using the FDA Adverse Event Reporting System. FDA Adverse Event Reporting System was queried for DAR between 2022Q1 and 2023Q4. Individual DARs (iDARs) were categorized and compared between treatment groups: EoE, asthma, atopic dermatitis, and chronic rhinosinusitis with nasal polyps. Logistic regression was used to predict serious DAR and outcomes, and zero-truncated negative binomial regression was used to predict the number of iDAR. There were 51,000 DAR observations; 1459 for EoE-tx with 103 (7.1%) serious reactions and 44 (3.0%) serious outcomes including 3 deaths. For EoE-tx, the mean iDAR was 3.68 [3.51, 3.85], and the iDAR incidence rate ratio among men receiving EoE-tx was 0.73 [0.65, 0.83]. EoE-tx average iDAR primarily included general (0.75 [0.70, 0.80]), injection-site (0.69 [0.63, 0.74]), dermatologic (0.51 [0.46, 0.55]), and gastrointestinal (0.24 [0.21, 0.27]) reactions. Adults \u226550\u00a0years had 1.97 [1.28, 2.99] higher odds for serious DAR compared to younger adults in EoE-tx. Overall, dupilumab demonstrated a favorable safety profile across all indications, with low rates of serious adverse events. For EoE-tx specifically, higher total iDAR rates were observed, driven largely by increased injection-site and gastrointestinal reactions compared to other indications. Additionally, women exhibited higher iDAR rates than men across all indications.<\/jats:p>","DOI":"10.1093\/dote\/doaf055","type":"journal-article","created":{"date-parts":[[2025,7,1]],"date-time":"2025-07-01T07:44:57Z","timestamp":1751355897000},"source":"Crossref","is-referenced-by-count":4,"title":["Dupilumab adverse reactions in eosinophilic esophagitis treatment: a Food and Drug Administration Adverse Event Reporting System database analysis"],"prefix":"10.1093","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-7807-9114","authenticated-orcid":false,"given":"Kasey","family":"Bowyer","sequence":"first","affiliation":[{"name":"Kaiser Permanente Bernard J. Tyson School of Medicine, Kaiser Permanente , Pasadena, CA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Austin R","family":"Swisher","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2014Head and Neck Surgery, Mayo Clinic Arizona , Scottsdale, AZ ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nancy","family":"Jiang","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2014Head and Neck Surgery, Kaiser Permanente , Oakland, CA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Liang","sequence":"additional","affiliation":[{"name":"Kaiser Permanente Bernard J. Tyson School of Medicine, Kaiser Permanente , Pasadena, CA ,","place":["USA"]},{"name":"Department of Otolaryngology\u2014Head and Neck Surgery, Kaiser Permanente , Oakland, CA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,7,15]]},"reference":[{"key":"2025071505414502200_ref1","doi-asserted-by":"crossref","first-page":"319","DOI":"10.1053\/j.gastro.2017.06.067","article-title":"Epidemiology and natural history of eosinophilic esophagitis","volume":"154","author":"Dellon","year":"2018","journal-title":"Gastroenterology"},{"key":"2025071505414502200_ref2","doi-asserted-by":"crossref","first-page":"1316","DOI":"10.1053\/j.gastro.2008.02.016","article-title":"Eosinophilic esophagitis: a prevalent disease in the United States that affects all age 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