{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,20]],"date-time":"2026-09-20T06:00:27Z","timestamp":1789884027828,"version":"4.0.1"},"reference-count":17,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2016,6,29]],"date-time":"2016-06-29T00:00:00Z","timestamp":1467158400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100004095","name":"Kyowa Hakko Kirin","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004095","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2016,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Brodalumab (<jats:styled-content style=\"fixed-case\">KHK<\/jats:styled-content>4827) is a human anti\u2010interleukin\u201017\u2010receptor A monoclonal antibody. In Japanese patients with moderate\u2010to\u2010severe plaque psoriasis, brodalumab showed rapid and robust efficacy and a favourable safety profile in a 12\u2010week, phase 2, double\u2010blind, randomized controlled trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To evaluate the long\u2010term safety and efficacy of brodalumab, an extension of a phase 2 trial of Japanese patients with moderate\u2010to\u2010severe psoriasis was performed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients received open\u2010label brodalumab 210 or 140 mg subcutaneously every 2 weeks for 52 weeks. Efficacy was measured using the Psoriasis Area and Severity Index (<jats:styled-content style=\"fixed-case\">PASI<\/jats:styled-content>) score and the static physician global assessment (<jats:styled-content style=\"fixed-case\">sPGA<\/jats:styled-content>) instrument. The endpoint of psoriatic arthritis was 20% improvement in American College of Rheumatology response criteria (<jats:styled-content style=\"fixed-case\">ACR<\/jats:styled-content> 20). The patients were also monitored for treatment\u2010emergent adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s), including serious <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s (<jats:styled-content style=\"fixed-case\">SAE<\/jats:styled-content>s).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 145 patients, 133 completed the study. The percentage of patients with \u226575% reduction of <jats:styled-content style=\"fixed-case\">PASI<\/jats:styled-content> scores (<jats:styled-content style=\"fixed-case\">PASI<\/jats:styled-content> 75), \u226590% (<jats:styled-content style=\"fixed-case\">PASI<\/jats:styled-content> 90) and 100% (<jats:styled-content style=\"fixed-case\">PASI<\/jats:styled-content> 100) at Week 52 (the last observation carried forward) were 94.4%, 87.5% and 55.6%, respectively, in the 210\u2010mg group, and the corresponding values in the 140\u2010mg group were 78.1%, 71.2% and 43.8%. At Week 52, 75.0% patients in 210\u2010mg group achieved <jats:styled-content style=\"fixed-case\">ACR<\/jats:styled-content> 20, compared with 37.5% patients in 140\u2010mg group. The most commonly reported <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s were nasopharyngitis (35.2%), upper respiratory tract inflammation (10.3%) and contact dermatitis (9.7%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Brodalumab showed a sustained clinical response and an acceptable safety profile through 52 weeks in Japanese patients with moderate\u2010to\u2010severe plaque psoriasis in this open\u2010label extension study.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdv.13785","type":"journal-article","created":{"date-parts":[[2016,6,30]],"date-time":"2016-06-30T03:43:14Z","timestamp":1467258194000},"page":"1957-1960","source":"Crossref","is-referenced-by-count":39,"title":["Long\u2010term clinical safety and efficacy of brodalumab in the treatment of Japanese patients with moderate\u2010to\u2010severe plaque psoriasis"],"prefix":"10.1111","volume":"30","author":[{"given":"Y.","family":"Umezawa","sequence":"first","affiliation":[{"name":"Department of Dermatology The Jikei University School of Medicine Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H.","family":"Nakagawa","sequence":"additional","affiliation":[{"name":"Department of Dermatology The Jikei University School of Medicine Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H.","family":"Niiro","sequence":"additional","affiliation":[{"name":"Clinical Education Center Kyushu University Hospital Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Ootaki","sequence":"additional","affiliation":[{"name":"Kyowa Hakko Kirin Co., Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the Japanese Brodalumab Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2016,6,29]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1087-0024.2003.09102.x"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0733-8635(05)70376-4"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaut.2009.12.001"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen\u20102014\u2010006450"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2008.02.039"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2010.11.055"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.jid.5701213"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra0707449"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.180.11.7423"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1109017"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1503824"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdermsci.2015.10.009"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.11465"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2230.1994.tb01167.x"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/00005650-199206000-00002"},{"key":"e_1_2_6_17_1","first-page":"1583","article-title":"Development of the Japanese version of the Psoriasis Disability Index (PDI), the Psoriasis Specific QOL Index: results of the validation study","volume":"116","author":"Osamu F","year":"2006","journal-title":"Jpn J Dermatol"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2133.2007.07817.x"}],"container-title":["Journal of the European Academy of Dermatology and Venereology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fjdv.13785","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fjdv.13785","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jdv.13785","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,24]],"date-time":"2023-09-24T16:27:00Z","timestamp":1695572820000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jdv.13785"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,6,29]]},"references-count":17,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2016,11]]}},"alternative-id":["10.1111\/jdv.13785"],"URL":"https:\/\/doi.org\/10.1111\/jdv.13785","archive":["Portico"],"relation":{},"ISSN":["0926-9959","1468-3083"],"issn-type":[{"value":"0926-9959","type":"print"},{"value":"1468-3083","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,6,29]]}}}