{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:39:51Z","timestamp":1787013591466,"version":"build-2736575974"},"reference-count":28,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2023,8,14]],"date-time":"2023-08-14T00:00:00Z","timestamp":1691971200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008373","name":"Takeda Pharmaceutical Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008373","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":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The safety and efficacy of lanadelumab for the prevention of hereditary angioedema (HAE) attacks have not been studied in Japanese patients. We report outcomes from a phase 3, multicenter, open\u2010label study (NCT04180163) of lanadelumab in Japanese patients with HAE. Japanese patients with HAE aged \u226512\u2009years with \u22651 investigator\u2010confirmed HAE attack during the 4\u2010week run\u2010in baseline period were enrolled into the study and received lanadelumab 300\u2009mg every 2\u2009weeks subcutaneously for 52\u2009weeks. Dosing could be reduced to 300\u2009mg every 4\u2009weeks during the second 26\u2010week treatment period if patients had well\u2010controlled symptoms (e.g., attack\u2010free) for 6\u2009months. The primary efficacy endpoint was no investigator\u2010confirmed HAE attacks (attack\u2010free status) during days 0\u2013182. Other outcomes included the rate of investigator\u2010confirmed HAE attacks per month (28\u2009days) and lanadelumab safety. Twelve patients (mean\u2009\u00b1\u2009SD age 41.9 \u00b1\u200912.4\u2009years) were enrolled. During the first 26\u2009weeks (days 0\u2013182), five (41.7%) patients were attack\u2010free. The mean\u2009\u00b1\u2009SD HAE attack rate per month decreased by 74.0%, from 3.8\u2009\u00b1\u20092.4 during baseline to 1.2\u2009\u00b1\u20092.6 during the overall 52\u2010week treatment period. There were no deaths or discontinuations due to treatment\u2010emergent adverse events (TEAEs), no severe or serious TEAEs related to lanadelumab, and no positive anti\u2010drug antibody results. The most frequent TEAEs were injection\u2010site reactions (37 events in six patients). Most of the injection\u2010site reaction adverse events were mild in severity. Results of this study support the findings from two global phase 3 studies for lanadelumab use as prophylactic therapy in Japanese patients with HAE.<\/jats:p>","DOI":"10.1111\/1346-8138.16909","type":"journal-article","created":{"date-parts":[[2023,8,14]],"date-time":"2023-08-14T03:29:28Z","timestamp":1691983768000},"page":"1381-1391","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Efficacy and safety of lanadelumab in Japanese patients with hereditary angioedema: A phase 3 multicenter, open\u2010label study"],"prefix":"10.1111","volume":"50","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1569-6034","authenticated-orcid":false,"given":"Michihiro","family":"Hide","sequence":"first","affiliation":[{"name":"Department of Dermatology Hiroshima City Hiroshima Citizens Hospital  Hiroshima Japan"},{"name":"Department of Dermatology Hiroshima University  Hiroshima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isao","family":"Ohsawa","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Internal Medicine Saiyu Soka Hospital  Soka Japan"},{"name":"Department of Nephrology Juntendo University Faculty of Medicine  Bunkyo\u2010ku Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Nurse","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.  Lexington Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ming","family":"Yu","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.  Lexington Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the SHP643\u2010302 Trial Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,8,14]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12016-016-8561-8"},{"key":"e_1_2_9_3_1","first-page":"S292","article-title":"Severity of hereditary angioedema, prevalence, and diagnostic considerations","volume":"24","author":"Bernstein JA","year":"2018","journal-title":"Am J Manag Care"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13223-019-0376-8"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.15214"},{"key":"e_1_2_9_6_1","volume-title":"Statistical Handbook of Japan 2022","author":"Statistics Bureau","year":"2022"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.2169\/internalmedicine.8624-16"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1808012"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12016-016-8575-2"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaip.2020.08.046"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.alit.2020.07.008"},{"key":"e_1_2_9_12_1","unstructured":"Pharmaceuticals and Medical Devices Agency.New drugs approved in FY2020. 2021. 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Takhzyro\u00ae(lanadelumab injection).2021.Available from:https:\/\/www.takeda.com\/496674\/siteassets\/en\u2010ca\/home\/what\u2010we\u2010do\/our\u2010medicines\/product\u2010monographs\/takhzyro\/takhzyro\u2010pm\u2010en.pdf"},{"key":"e_1_2_9_18_1","unstructured":"Takeda Pharmaceuticals International AG.Summary of product characteristics. Takhzyro (INN\u2010lanadelumab).2022.Available from:https:\/\/www.ema.europa.eu\/en\/documents\/product\u2010information\/takhzyro\u2010epar\u2010product\u2010information_en.pdf"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1097\/MAJ.0b013e31822bdb65"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.15034"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.2332\/allergolint.14-OA-0700"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.5152\/balkanmedj.2021.20060"},{"key":"e_1_2_9_23_1","unstructured":"Pharmaceuticals and Medical Devices Agency.New drugs approved in FY 2021.2022. 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