{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,24]],"date-time":"2026-06-24T03:44:14Z","timestamp":1782272654765,"version":"3.54.5"},"reference-count":23,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2020,4,10]],"date-time":"2020-04-10T00:00:00Z","timestamp":1586476800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"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":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Dermatology"],"published-print":{"date-parts":[[2020,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Brodalumab, an interleukin\u201017 receptor A inhibitor, demonstrated rapid and robust efficacy with a favorable safety profile in patients with moderate to severe plaque psoriasis. Here, we present data from a multicenter, open\u2010label extension study in patients with plaque psoriasis with\/without psoriatic arthritis who completed 64\u00a0weeks of treatment with brodalumab (140 or 210\u00a0mg, every 2\u00a0weeks [Q2W]). Patients were enrolled to evaluate the long\u2010term safety and efficacy of a modified dose of brodalumab. Eligible patients were switched to a reduced dose of brodalumab (140\u00a0mg every 4\u00a0weeks on day 1) in the extension study; the dose and dosing interval were modified sequentially at the physician\u2019s discretion (minimum 140\u00a0mg every 8\u00a0weeks and maximum 210\u00a0mg Q2W) until drug approval, after which all patients were switched to 210\u00a0mg Q2W for postmarketing surveillance. Of the 129 patients enrolled, 107 (82.9%) completed the 108\u2010week or more extension study. All patients had psoriasis that was well controlled with brodalumab treatment on day 1. Improvement in psoriasis\u2010related symptoms, evaluated with the Psoriasis Area and Severity Index, Psoriasis Scalp Severity Index, Dermatology Life Quality Index, Nail Psoriasis Severity Index, and American College of Rheumatology 20, 50 and 70, was maintained during the 108\u2010week extension study. Brodalumab treatment was well tolerated throughout, and no new safety signals were identified. The most commonly reported treatment\u2010related adverse event was nasopharyngitis, followed by influenza and oral candidiasis. No cases of serious candida infection or Crohn\u2019s disease were observed in this study. Serious treatment\u2010related adverse events, such as appendicitis, brain abscess, bacterial meningitis, colon cancer, immunoglobulin A nephropathy and tubulointerstitial nephritis, were reported in one patient each. No anti\u2010brodalumab\u2010binding antibodies or brodalumab\u2010neutralizing antibodies were detected in any patient throughout the extension study. Overall, the long\u2010term efficacy and safety of brodalumab were demonstrated over 108\u00a0weeks.<\/jats:p>","DOI":"10.1111\/1346-8138.15343","type":"journal-article","created":{"date-parts":[[2020,4,10]],"date-time":"2020-04-10T10:45:10Z","timestamp":1586515510000},"page":"569-577","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Long\u2010term safety of brodalumab in Japanese patients with plaque psoriasis: An open\u2010label extension study"],"prefix":"10.1111","volume":"47","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0297-6627","authenticated-orcid":false,"given":"Yukie","family":"Yamaguchi","sequence":"first","affiliation":[{"name":"Department of Environmental Immuno\u2010Dermatology Yokohama City University Graduate School of Medicine Yokohama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobumichi","family":"Takatsu","sequence":"additional","affiliation":[{"name":"Medical Affairs Department Kyowa Kirin Co., Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenji","family":"Ootaki","sequence":"additional","affiliation":[{"name":"R&amp;D Division Kyowa Kirin Co., Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hidemi","family":"Nakagawa","sequence":"additional","affiliation":[{"name":"Department of Dermatology The Jikei University School of Medicine Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,4,10]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-3083.2012.04531.x"},{"key":"e_1_2_7_3_1","first-page":"1","article-title":"Skin conditions and related need for medical care among persons 1\u201374 years. United States, 1971\u20131974","author":"Johnson MT","year":"1978","journal-title":"Vital Health Stat 11"},{"key":"e_1_2_7_4_1","unstructured":"WHO.int [homepage on the internet].Global report on PSORIASIS (WHO). 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Available from URL:https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/761032lbl.pdf."},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-016-0634-8"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdermsci.2015.10.009"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.13785"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.14702"},{"key":"e_1_2_7_13_1","unstructured":"Clinicaltrials.gov[homepage on the internet].A Phase 3 Clinical Study of KHK 4827 (NCT02052609). [Cited 2019 Dec 11]. Available from URL:https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02052609?term=NCT02052609&rank=1."},{"key":"e_1_2_7_14_1","unstructured":"Clinicaltrials.gov[homepage on the internet].A Phase 4 Clinical Study of Brodalumab. [Cited 2019 Dec 11]. 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