{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:11:44Z","timestamp":1787015504969,"version":"build-2736575974"},"reference-count":34,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,11,15]],"date-time":"2025-11-15T00:00:00Z","timestamp":1763164800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,11,15]],"date-time":"2025-11-15T00:00:00Z","timestamp":1763164800000},"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":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The efficacy and safety of brodalumab in Japanese patients with palmoplantar pustulosis (PPP) were demonstrated during the 16\u2010week double\u2010blind phase of a randomized controlled trial. However, long\u2010term data are unavailable.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To assess the efficacy and safety of brodalumab 210\u2009mg administered subcutaneously (SC) repeatedly until Week 68 in PPP patients with moderate or severe pustules\/vesicles in an open\u2010label extension study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      In a multicentre, Phase 3, randomized, double\u2010blind, placebo\u2010controlled trial, Japanese adults having a diagnosis of\n                      <jats:styled-content style=\"fixed-case\">PPP<\/jats:styled-content>\n                      for \u226524\u2009weeks,\n                      <jats:styled-content style=\"fixed-case\">PPP<\/jats:styled-content>\n                      Area Severity Index (\n                      <jats:styled-content style=\"fixed-case\">PPPASI<\/jats:styled-content>\n                      ) of \u226512,\n                      <jats:styled-content style=\"fixed-case\">PPPASI<\/jats:styled-content>\n                      subscore of pustules\/vesicles of \u22652 and inadequate response to therapy were included. Patients completing the double\u2010blind phase with brodalumab 210\u2009mg or placebo (1:1)\n                      <jats:styled-content style=\"fixed-case\">SC<\/jats:styled-content>\n                      once every 2\u2009weeks (\n                      <jats:styled-content style=\"fixed-case\">Q2W<\/jats:styled-content>\n                      ) for 16\u2009weeks were invited to enter the open\u2010label extension to receive brodalumab for the subsequent 52\u2009weeks.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      By Week 68, 35 patients in the brodalumab group and 43 patients in the placebo\u2010to\u2010brodalumab group completed the study, with discontinuations (28 and 20 patients, respectively) primarily due to patient withdrawal. At Week 68, the mean\u2009\u00b1\u2009\n                      <jats:styled-content style=\"fixed-case\">SD<\/jats:styled-content>\n                      improvement of the\n                      <jats:styled-content style=\"fixed-case\">PPPASI<\/jats:styled-content>\n                      total score from baseline was 23.83\u2009\u00b1\u200912.28 and 22.37\u2009\u00b1\u200913.09 in the brodalumab and placebo\u2010to\u2010brodalumab groups, respectively. Continued improvement or trend for improvement was seen in the secondary endpoints such as\n                      <jats:styled-content style=\"fixed-case\">PPPASI<\/jats:styled-content>\n                      50\/75\/90 responses and Dermatology Life Quality Index. The incidence of adverse events was 849.3\/100 person\u2010years. Otitis externa had the highest incidence (44.0\/100 person\u2010years; Grade 1 or 2 only). Infection\u2010related events were frequent but controllable.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Brodalumab SC 210\u2009mg Q2W administered for 68\u2009weeks showed a long\u2010term benefit to both dermatological and quality of life indices in these patients. It is expected to be used in appropriate patients, considering both safety risks and efficacy benefits.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jdv.70156","type":"journal-article","created":{"date-parts":[[2025,11,15]],"date-time":"2025-11-15T11:16:08Z","timestamp":1763205368000},"page":"887-899","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Efficacy and safety of brodalumab in palmoplantar pustulosis: A 68\u2010week randomized Phase 3 trial"],"prefix":"10.1111","volume":"40","author":[{"given":"Masamoto","family":"Murakami","sequence":"first","affiliation":[{"name":"Department of Anatomy, Histochemistry and Cell Biology Faculty of Medicine, University of Miyazaki  Miyazaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9526-1259","authenticated-orcid":false,"given":"Yukari","family":"Okubo","sequence":"additional","affiliation":[{"name":"Department of Dermatology Tokyo Medical University  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satomi","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Department of Dermatology Seibo International Catholic Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natsuko","family":"Kikuta","sequence":"additional","affiliation":[{"name":"Kyowa Kirin Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiumi","family":"Ouchi","sequence":"additional","affiliation":[{"name":"Kyowa Kirin Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-4364-1399","authenticated-orcid":false,"given":"Kenta","family":"Shishido","sequence":"additional","affiliation":[{"name":"Kyowa Kirin Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadashi","family":"Terui","sequence":"additional","affiliation":[{"name":"Division of Dermatological Science, Department of Dermatology Nihon University School of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,11,15]]},"reference":[{"issue":"1","key":"e_1_2_13_2_1","article-title":"Interventions for chronic palmoplantar pustulosis","volume":"1","author":"Obeid G","year":"2020","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdermsci.2020.03.003"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.12272"},{"key":"e_1_2_13_5_1","first-page":"135","article-title":"Guselkumab for the treatment of palmoplantar pustulosis: a Japanese perspective","volume":"13","author":"Yamamoto T","year":"2021","journal-title":"Clin Pharm"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0625.2010.01224.x"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0625.2011.01325.x"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2133.2010.09819.x"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.12203"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2014-006450"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40261-018-00745-6"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40257-020-00503-5"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.13064"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.3109\/09546634.2015.1052036"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0232738"},{"key":"e_1_2_13_16_1","unstructured":"Media Center Kyowa Kirin Co. Ltd.Kyowa Kirin received partial change approval of LUMICEF\u00ae for palmoplantar pustulosis in Japan.2023. News release [cited 2024 Mar 29]. Available from:https:\/\/www.kyowakirin.com\/media_center\/news_releases\/2023\/e20230823_01.html"},{"key":"e_1_2_13_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-016-0634-8"},{"key":"e_1_2_13_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13555-022-00746-6"},{"key":"e_1_2_13_19_1","unstructured":"Kyowa Kirin.Kyowa Kirin announces partial change approval of LUMICEF\u00ae for the treatment of ankylosing spondylitis and non\u2010radiographic axial spondyloarthritis in Japan.2020. News Release [cited 2024 Sep 20]. Available from:https:\/\/www.kyowakirin.com\/media_center\/news_releases\/2020\/e20201127_01.html"},{"key":"e_1_2_13_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40257-024-00876-x"},{"key":"e_1_2_13_21_1","doi-asserted-by":"publisher","DOI":"10.3310\/mxpk2427"},{"key":"e_1_2_13_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.16132"},{"key":"e_1_2_13_23_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamadermatol.2019.1394"},{"issue":"2","key":"e_1_2_13_24_1","first-page":"1","article-title":"Brodalumab: a review of safety","volume":"23","author":"Rusta\u2010Sallehy S","year":"2018","journal-title":"Skin Therapy Lett"},{"key":"e_1_2_13_25_1","doi-asserted-by":"publisher","DOI":"10.2340\/00015555-1552"},{"key":"e_1_2_13_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.medcli.2018.06.011"},{"key":"e_1_2_13_27_1","doi-asserted-by":"publisher","DOI":"10.1177\/2050313X20940430"},{"key":"e_1_2_13_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdcr.2023.05.002"},{"key":"e_1_2_13_29_1","doi-asserted-by":"publisher","DOI":"10.4103\/ds.ds_40_20"},{"key":"e_1_2_13_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdcr.2020.08.033"},{"key":"e_1_2_13_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdcr.2021.08.021"},{"key":"e_1_2_13_32_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.15714"},{"key":"e_1_2_13_33_1","doi-asserted-by":"publisher","DOI":"10.1111\/dth.13161"},{"key":"e_1_2_13_34_1","doi-asserted-by":"publisher","DOI":"10.1093\/ced\/llac117"},{"key":"e_1_2_13_35_1","doi-asserted-by":"publisher","DOI":"10.1111\/ajd.14266"}],"container-title":["Journal of the European Academy of Dermatology and Venereology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jdv.70156","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/jdv.70156","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jdv.70156","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T07:24:07Z","timestamp":1777533847000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jdv.70156"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,15]]},"references-count":34,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,5]]}},"alternative-id":["10.1111\/jdv.70156"],"URL":"https:\/\/doi.org\/10.1111\/jdv.70156","archive":["Portico"],"relation":{},"ISSN":["0926-9959","1468-3083"],"issn-type":[{"value":"0926-9959","type":"print"},{"value":"1468-3083","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11,15]]},"assertion":[{"value":"2024-12-23","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-09-24","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-15","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}