{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T06:50:50Z","timestamp":1789541450877,"version":"build-2803163510"},"reference-count":26,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2020,11,23]],"date-time":"2020-11-23T00:00:00Z","timestamp":1606089600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009857","name":"Regeneron Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009857","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100013995","name":"Sanofi Genzyme","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100013995","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Laryngoscope"],"published-print":{"date-parts":[[2021,6]]},"abstract":"\n Objectives\/Hypothesis<\/jats:title>\n Dupilumab, which blocks the shared receptor component for interleukin\u20104 and interleukin\u201013, reduced polyp size, sinus opacification, and symptom severity, and was well tolerated in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in the SINUS\u201052 study (NCT02898454). We assessed dupilumab in patients enrolled at Japanese centers.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n Patients on a background of mometasone furoate nasal spray, received dupilumab 300\u2009mg every 2\u2009weeks (q2w) for 52\u2009weeks (Arm A); dupilumab 300\u2009mg q2w for 24\u2009weeks, followed by every 4\u2009weeks (q4w) for 28\u2009weeks (Arm B); or placebo (Arm C). Co\u2010primary endpoints were week 24 nasal polyp score (NPS), nasal congestion (NC) score, and sinus Lund\u2013Mackay CT (LMK\u2010CT) scores. Symptoms, sense of smell, health\u2010related quality of life, and safety were assessed during the 52\u2010week treatment period.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Of 49 patients enrolled in Japan, 45 completed the study. Week 24 least squares (LS) mean improvement versus placebo were as follows: NPS (Arm A: \u22123.1,\n P<\/jats:italic>\n \u2009<\u2009.0001; Arm B: \u22122.1,\n P<\/jats:italic>\n = .0011); NC score (Arm A: \u22121.2,\n P<\/jats:italic>\n \u2009<\u2009.0001; Arm B: \u22120.9,\n P<\/jats:italic>\n \u2009<\u2009.0001); and LMK\u2010CT (Arm A: \u22125.1,\n P<\/jats:italic>\n = .0005; Arm B: \u22122.8,\n P<\/jats:italic>\n = .0425). The most common treatment\u2010emergent adverse event in dupilumab and placebo\u2010treated patients was nasopharyngitis.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n Dupilumab provided rapid, significant, and clinically meaningful improvements for patients with CRSwNP in Japan. Dupilumab was well tolerated, and safety and efficacy were consistent with the overall study population.<\/jats:p>\n <\/jats:sec>\n \n Level of Evidence<\/jats:title>\n \n 2\n Laryngoscope<\/jats:italic>\n , 131:E1770\u2013E1777, 2021\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/lary.29230","type":"journal-article","created":{"date-parts":[[2020,11,23]],"date-time":"2020-11-23T21:43:13Z","timestamp":1606167793000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":60,"title":["The Effect of Dupilumab on Intractable Chronic Rhinosinusitis with Nasal Polyps in Japan"],"prefix":"10.1002","volume":"131","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9460-7377","authenticated-orcid":false,"given":"Shigeharu","family":"Fujieda","sequence":"first","affiliation":[{"name":"University of Fukui Fukui Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shoji","family":"Matsune","sequence":"additional","affiliation":[{"name":"Nippon Medical School, Musashi Kosugi Hospital Kanagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9853-2501","authenticated-orcid":false,"given":"Sachio","family":"Takeno","sequence":"additional","affiliation":[{"name":"Graduate School of Biomedical and Health Sciences, Hiroshima University Hiroshima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikiya","family":"Asako","sequence":"additional","affiliation":[{"name":"Kansai Medical University Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Makiko","family":"Takeuchi","sequence":"additional","affiliation":[{"name":"Sanofi K.K Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyuki","family":"Fujita","sequence":"additional","affiliation":[{"name":"Sanofi K.K Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshinori","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Sanofi K.K Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikhil","family":"Amin","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc Tarrytown New York U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yamo","family":"Deniz","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc Tarrytown New York U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Rowe","sequence":"additional","affiliation":[{"name":"Sanofi Bridgewater New Jersey U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leda","family":"Mannent","sequence":"additional","affiliation":[{"name":"Sanofi Chilly\u2010Mazarin France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,11,23]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.2500\/ajra.2016.30.4297"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.12644"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.anai.2014.07.025"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1177\/0003489415576181"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.23259"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.26391"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.2500\/ajr.2007.21.3108"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.2500\/ajra.2017.31.4402"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.23979"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40463-017-0214-2"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1177\/194589240401800307"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.4193\/Rhino10.261"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.alit.2019.07.002"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaip.2016.12.027"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.2500\/ajra.2014.28.4076"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.1324022111"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.1323896111"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1080\/1744666X.2017.1298443"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)31881-1"},{"key":"e_1_2_6_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.alit.2020.01.002"},{"key":"e_1_2_6_22_1","unstructured":"DUPIXENT\u00ae (dupilumab).Japan PMDA. 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