{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T11:06:08Z","timestamp":1777633568293,"version":"3.51.4"},"reference-count":38,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T00:00:00Z","timestamp":1777420800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100007723","name":"Takeda Pharmaceuticals U.S.A.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007723","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Immunol."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Lanadelumab is a plasma kallikrein inhibitor approved in many countries, including China, for the long-term prophylaxis of hereditary angioedema (HAE). The primary objective was safety evaluation of lanadelumab for HAE long-term prophylaxis in a Chinese patient population. Secondary objectives included efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity evaluations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This open-label, prospective, phase 3, post-approval commitment study included patients in China aged \u226512 years with HAE due to C1 inhibitor deficiency (HAE-C1INH) (NCT05460325). Eligible patients with \u22651 HAE attack in the 4-week run-in period received subcutaneous lanadelumab 300 mg every 2\u00a0weeks during days 0\u2013182 for 14 doses in total.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Twenty patients were enrolled (median age, 38 years; 7 male), and all completed the study. No treatment-emergent adverse events (TEAEs) were fatal, led to treatment discontinuation, or were of special interest. Fifteen (75%) patients reported \u22651 TEAE during the study, most commonly COVID-19 infection (50%). Nine (45%) patients reported treatment-related TEAEs, most frequently injection site pain (20%) and swelling (15%). Injection site reactions occurred in 25% of patients. Mean\u00a0\u00b1\u00a0SD monthly rate of investigator-confirmed attacks decreased by 99.1% during days 0\u2013182 versus run-in (0.04\u00a0\u00b1\u00a00.14 vs 2.50\u00a0\u00b1\u00a01.44). Eighteen (90%) patients were attack free during days 0\u2013182; 2 patients experienced a total of 4 mild and 1 moderate investigator-confirmed HAE attacks. Lanadelumab pharmacokinetics, pharmacodynamics, and immunogenicity in Chinese patients were consistent with other patient populations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>These findings in patients with HAE in China are consistent with the profile of lanadelumab established in patients from other regions, supporting its use as first-line long-term prophylaxis.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fimmu.2026.1750735","type":"journal-article","created":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T04:44:00Z","timestamp":1777437840000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Lanadelumab safety, efficacy, and pharmacokinetics in patients aged \u226512 with hereditary angioedema in China: an open-label, multicenter study"],"prefix":"10.3389","volume":"17","author":[{"given":"Yuxiang","family":"Zhi","sequence":"first","affiliation":[{"name":"Department of Allergy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences","place":["Beijing, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rongfei","family":"Zhu","sequence":"additional","affiliation":[{"name":"Department of Allergy, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology","place":["Wuhan, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuemei","family":"Sun","sequence":"additional","affiliation":[{"name":"Department of Allergy, Yantai Yuhuangding Hospital","place":["Yantai, Shandong, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"He","family":"Lai","sequence":"additional","affiliation":[{"name":"Department of Allergy, The Second Affiliated Hospital of Guangzhou Medical University","place":["Guangzhou, Guangdong, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hong","family":"Ren","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.","place":["Cambridge, MA, United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yi","family":"Wang","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.","place":["Cambridge, MA, United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lin","family":"Dong","sequence":"additional","affiliation":[{"name":"Takeda APAC Biopharmaceutical Research and Development Company Limited","place":["Shanghai, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2026,4,29]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1111\/all.15214","article-title":"The international WAO\/EAACI guideline for the management of hereditary angioedema-the 2021 revision and 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