{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T06:35:12Z","timestamp":1773038112402,"version":"3.50.1"},"reference-count":45,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2021,12,16]],"date-time":"2021-12-16T00:00:00Z","timestamp":1639612800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2021,12,16]],"date-time":"2021-12-16T00:00:00Z","timestamp":1639612800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Laryngoscope"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Dupilumab was the first biologic approved to treat chronic rhinosinusitis with nasal polyps (CRSwNP). While the risk of adverse events in phase\u2010III clinical trials was low, dupilumab\u2010associated adverse reactions (DAR) with real\u2010world use is unknown and potentially under\u2010reported. We aimed to evaluate DAR for CRSwNP treatment (CRSwNP\u2010tx) using the FDA Adverse Event Reporting System (FAERS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Design<\/jats:title>\n                    <jats:p>Retrospective database study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>FAERS was queried for DAR from 2019Q1 to 2021Q2. Individual DAR (iDAR) were categorized and quantitatively compared between treatment groups (CRSwNP, asthma, atopic dermatitis). Zero\u2010truncated Poisson regression was modeled to predict the number of iDAR, and logistic regression was modeled to predict serious DARs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      There were 15,411 DAR observations; 911 for CRSwNP\u2010tx, of which 121 (13.3%) had serious reactions and 3 died. Common CRSwNP\u2010tx iDAR were dermatologic (13.9%), generalized (13.3%), and injection\u2010site (10.8%) symptoms. The number of CRSwNP\u2010tx iDAR was 2.99 [2.81, 3.17], compared to 3.44 [3.32, 3.56] for asthma and 3.18 [3.13, 3.24] for atopic dermatitis (Kruskal\u2010Wallis test,\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0&lt;\u2009.001). For CRSwNP\u2010tx, iDAR reported\u2010risk\u2010ratio was 0.84 [0.77, 0.92] among men and 1.12 [1.04, 1.22] among older adults (&gt;50). Serious DAR reported\u2010odds\u2010ratio was 1.37 [0.91, 2.04] among men and 1.39 [0.93, 2.08] among older adults.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>While there are limitations with FAERS, this analysis suggests CRSwNP\u2010tx is associated with fewer iDAR compared with other treatment indications. More iDAR are experienced among women and older adults, but men tend to have more serious DAR.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Level of Evidence<\/jats:title>\n                    <jats:p>\n                      3\n                      <jats:italic>Laryngoscope<\/jats:italic>\n                      , 132:2307\u20132313, 2022\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/lary.29992","type":"journal-article","created":{"date-parts":[[2021,12,17]],"date-time":"2021-12-17T02:27:21Z","timestamp":1639708041000},"page":"2307-2313","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["Dupilumab Adverse Events in Nasal Polyp Treatment: Analysis of\n                    <scp>FDA<\/scp>\n                    Adverse Event Reporting System"],"prefix":"10.1002","volume":"132","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9427-1914","authenticated-orcid":false,"given":"Austin R.","family":"Swisher","sequence":"first","affiliation":[{"name":"University of California Riverside School of Medicine  Riverside California U.S.A."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3113-2685","authenticated-orcid":false,"given":"Rijul S.","family":"Kshirsagar","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology\u2010Head and Neck Surgery University of Pennsylvania  Philadelphia Pennsylvania U.S.A."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nithin D.","family":"Adappa","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology\u2010Head and Neck Surgery University of Pennsylvania  Philadelphia Pennsylvania U.S.A."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonathan","family":"Liang","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2010Head and Neck Surgery Kaiser Permanente  Oakland California U.S.A."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,12,16]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-020-01298-9"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.alit.2020.01.002"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0140-6736(19)31881-1"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.4193\/Rhino12.000"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.23979"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2015.12.1324"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11882-020-00910-y"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1177\/0145561320964653"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaip.2016.04.012"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaip.2020.09.063"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaip.2020.02.023"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.13984"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2015.19330"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.4193\/Rhin18.282"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S243053"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.2147\/JAA.S258438"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.2217\/imt-2019-0191"},{"key":"e_1_2_6_19_1","unstructured":"Food and Drug Administration USA.Questions and answers on FDA's Adverse Event Reporting System (FAERS).2018.https:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/Surveillance\/AdverseDrugEffects\/default.htm. 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