{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T20:33:17Z","timestamp":1789072397075,"version":"build-2803163510"},"reference-count":28,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2024,9,29]],"date-time":"2024-09-29T00:00:00Z","timestamp":1727568000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,9,29]],"date-time":"2024-09-29T00:00:00Z","timestamp":1727568000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Kyowa Kirin Co., Ltd."}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Hematol"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Idiopathic thrombocytopenic purpura (ITP), an autoimmune hematologic disorder characterized by severe platelet count reduction, can be treated with romiplostim. However, post-marketing safety and effectiveness data for romiplostim in Japan are scarce. This prospective, observational, post-marketing Specified Use-Results Survey evaluated the real-world safety and effectiveness of romiplostim for 2\u00a0years. All patients treated with romiplostim during the survey period were eligible. Of the 1622 patients in the safety analysis set, 94.08% (1526\/1622) had chronic ITP. The mean single dose of romiplostim was stable after 12\u00a0weeks and remained\u2009&lt;\u20096\u00a0\u03bcg\/kg in approximately 70% of patients until 104\u00a0weeks. Within 2\u00a0years, 14.92% of patients discontinued romiplostim because of adverse events, while 6.47% discontinued because of suspected adverse drug reactions. In contrast, 14.00% of patients discontinued romiplostim because of symptom improvement. Before romiplostim initiation, platelet count was\u2009&lt;\u20092.0\u2009\u00d7\u200910<jats:sup>4<\/jats:sup>\/\u00b5L in 60.54% of patients, and the mean platelet count was 2.84\u2009\u00b1\u20095.76\u2009\u00d7\u200910<jats:sup>4<\/jats:sup>\/\u00b5L. Platelet count was 9.19\u2009\u00b1\u200913.01\u2009\u00d7\u200910<jats:sup>4<\/jats:sup>\/\u00b5L after 4\u00a0weeks, and remained between 10.34\u2009\u00b1\u200910.72 and 12.38\u2009\u00b1\u200912.63\u2009\u00d7\u200910<jats:sup>4<\/jats:sup>\/\u00b5L from 8 to 104\u00a0weeks of treatment. No specific concerns were revealed regarding the safety and effectiveness of romiplostim in chronic ITP; the findings demonstrated a favorable risk\u2013benefit balance for romiplostim in this population. <jats:italic>Trial registration<\/jats:italic>: UMIN000047864 (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.umin.ac.jp\/ctr\">www.umin.ac.jp\/ctr<\/jats:ext-link>).<\/jats:p>","DOI":"10.1007\/s12185-024-03847-4","type":"journal-article","created":{"date-parts":[[2024,9,29]],"date-time":"2024-09-29T11:13:05Z","timestamp":1727608385000},"page":"665-674","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Long-term safety and effectiveness of romiplostim for chronic idiopathic thrombocytopenic purpura in real-world settings"],"prefix":"10.1007","volume":"120","clinical-trial-number":[{"clinical-trial-number":"umin000047864","registry":"10.18810\/umin-japan"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6563-3093","authenticated-orcid":false,"given":"Naoshi","family":"Obara","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shigeki","family":"Hatanaka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukie","family":"Tsuji","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Higashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,9,29]]},"reference":[{"key":"3847_CR1","doi-asserted-by":"publisher","first-page":"425","DOI":"10.1146\/annurev.med.56.082103.104644","volume":"56","author":"DB Cines","year":"2005","unstructured":"Cines DB, McMillan R. Management of adult idiopathic thrombocytopenic purpura. Annu Rev Med. 2005;56:425\u201342.","journal-title":"Annu Rev Med"},{"key":"3847_CR2","first-page":"273","volume":"57","author":"M Onis\u00e2i","year":"2019","unstructured":"Onis\u00e2i M, Vl\u0103d\u0103reanu AM, Sp\u00eenu A, G\u0103man M, Bumbea H. Idiopathic thrombocytopenic purpura (ITP)\u2013new era for an old disease. Rom J Intern Med. 2019;57:273\u201383.","journal-title":"Rom J Intern Med"},{"key":"3847_CR3","first-page":"482","volume":"34","author":"D Hubulashvili","year":"2009","unstructured":"Hubulashvili D, Marzella N. Romiplostim (Nplate), a treatment option for immune (idiopathic) thrombocytopenic purpura. P T. 2009;34:482\u20135.","journal-title":"P T"},{"key":"3847_CR4","unstructured":"Kyowa Kirin Co., Ltd. Romiplate for S.C. Injection 250 \u03bcg prescribing information. [Cited 2022 July 18]. 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Also, Naoshi Obara is an editor for International Journal of Hematology. Shigeki Hatanaka, Yukie Tsuji, and Koji Higashi are employees of Kyowa Kirin Co., Ltd., which funded this survey.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}