{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,5]],"date-time":"2026-08-05T03:07:39Z","timestamp":1785899259915,"version":"3.56.0"},"reference-count":17,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2025,1,28]],"date-time":"2025-01-28T00:00:00Z","timestamp":1738022400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,1,28]],"date-time":"2025-01-28T00:00:00Z","timestamp":1738022400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100016288","name":"Kissei","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100016288","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Hematol"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:p>Fostamatinib had superior efficacy to a placebo and acceptable safety profiles for at least 1 year in a phase 3 study of Japanese patients with primary immune thrombocytopenia. Here, we report the 3-year safety and efficacy of fostamatinib in that study. Data from 33 patients who received at least one dose of fostamatinib were analyzed. A platelet response\u2009&gt;\u200950,000\/\u00b5L (at two consecutive visits at least 28\u00a0days apart while receiving fostamatinib) was achieved in 16 patients (48%). The median total duration of a platelet response\u2009&gt;\u200950,000\/\u00b5L was 589 (range: 106\u20131003)\u00a0days. Gastrointestinal disorders, such as diarrhea, hypertension, and hepatic enzyme elevation, were the most common fostamatinib-related adverse events. Most events occurred within 12\u00a0weeks of treatment. No thromboembolisms, treatment-related infections, or moderate or severe treatment-related bleeding events were observed. In summary, this extension study of a clinical trial found a sustained platelet response without new safety signals during 3-year treatment with fostamatinib.<\/jats:p>","DOI":"10.1007\/s12185-025-03924-2","type":"journal-article","created":{"date-parts":[[2025,1,28]],"date-time":"2025-01-28T15:55:29Z","timestamp":1738079729000},"page":"356-362","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Long-term safety and efficacy of fostamatinib in Japanese patients with primary immune thrombocytopenia"],"prefix":"10.1007","volume":"121","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8352-6136","authenticated-orcid":false,"given":"Masataka","family":"Kuwana","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7645-0989","authenticated-orcid":false,"given":"Yoshiaki","family":"Tomiyama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,1,28]]},"reference":[{"key":"3924_CR1","doi-asserted-by":"publisher","first-page":"2027","DOI":"10.1182\/blood-2018-11-852491","volume":"133","author":"NT Connell","year":"2019","unstructured":"Connell NT, Berliner N. Fostamatinib for the treatment of chronic immune thrombocytopenia. Blood. 2019;133:2027\u201330.","journal-title":"Blood"},{"key":"3924_CR2","doi-asserted-by":"publisher","first-page":"9","DOI":"10.2217\/imt-2017-0097","volume":"10","author":"A Newland","year":"2018","unstructured":"Newland A, Lee E-J, Mcdonald V, Bussel JB. Fostamatinib for persistent\/chronic adult immune thrombocytopenia. Immunotherapy. 2018;10:9\u201325.","journal-title":"Immunotherapy"},{"key":"3924_CR3","doi-asserted-by":"publisher","first-page":"1532","DOI":"10.4049\/jimmunol.1000983","volume":"185","author":"L Colonna","year":"2010","unstructured":"Colonna L, Catalano G, Chew C, D\u2019Agati V, Thomas JW, Wong FS, et al. Therapeutic targeting of Syk in autoimmune diabetes. 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Am J Hematol. 2024;99:E55\u20139.","journal-title":"Am J Hematol"},{"issue":"5","key":"3924_CR6","doi-asserted-by":"publisher","first-page":"546","DOI":"10.1002\/ajh.25444","volume":"94","author":"JB Bussel","year":"2019","unstructured":"Bussel JB, Arnold DM, Boxer MA, et al. Long-term fostamatinib treatment of adults with immune thrombocytopenia during the phase 3 clinical trial program. Am J Hematol. 2019;94(5):546\u201353.","journal-title":"Am J Hematol"},{"key":"3924_CR7","doi-asserted-by":"publisher","first-page":"3780","DOI":"10.1182\/bloodadvances.2019000812","volume":"3","author":"D Provan","year":"2019","unstructured":"Provan D, Arnold DM, Bussel JB, Chong BH, Cooper N, Gernsheimer T, et al. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Adv. 2019;3:3780\u2013817.","journal-title":"Blood Adv"},{"key":"3924_CR8","doi-asserted-by":"publisher","DOI":"10.1016\/j.ebiom.2022.103820","volume":"76","author":"D Provan","year":"2022","unstructured":"Provan D, Semple JW. Recent advances in the mechanisms and treatment of immune thrombocytopenia. EBioMedicine. 2022;76: 103820.","journal-title":"EBioMedicine"},{"key":"3924_CR9","doi-asserted-by":"publisher","first-page":"204062072110108","DOI":"10.1177\/20406207211010875","volume":"12","author":"N Cooper","year":"2021","unstructured":"Cooper N, Altomare I, Thomas MR, Nicolson PLR, Watson SP, Markovtsov V, et al. Assessment of thrombotic risk during long-term treatment of immune thrombocytopenia with fostamatinib. 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Arterioscler Thromb Vasc Biol. 2016;36:1247\u201353.","journal-title":"Arterioscler Thromb Vasc Biol"}],"container-title":["International Journal of Hematology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12185-025-03924-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s12185-025-03924-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12185-025-03924-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,25]],"date-time":"2025-02-25T12:42:38Z","timestamp":1740487358000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s12185-025-03924-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1,28]]},"references-count":17,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2025,3]]}},"alternative-id":["3924"],"URL":"https:\/\/doi.org\/10.1007\/s12185-025-03924-2","relation":{},"ISSN":["0925-5710","1865-3774"],"issn-type":[{"value":"0925-5710","type":"print"},{"value":"1865-3774","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,1,28]]},"assertion":[{"value":"30 October 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"14 January 2025","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"15 January 2025","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"28 January 2025","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Masataka Kuwana has received grants or contracts from Boehringer Ingelheim International GmbH and Ono Pharmaceutical Co., Ltd.; royalties or licenses from Medical & Biological Laboratories Co., Ltd.; consulting fees from Kissei Pharmaceutical Co., Ltd., Boehringer Ingelheim International GmbH, and Mochida Pharmaceutical Co., Ltd., Glaxo Smith Kline K.K., Astra Zeneca K.K., Mitsubishi Tanabe Pharma Corporation, Janssen Pharmaceutical K.K., Biogen Japan Ltd., and Novartis Pharma K.K.; payment or honoraria for lectures, presentations, speaker bureaus, manuscript writing, or educational events from Boehringer Ingelheim International GmbH, Astellas Pharma Inc., and Asahi Kasei Pharma Corporation; and participated on a Data Safety Monitoring Board or Advisory Board at Argenx. Yoshiaki Tomiyama has received support for the present manuscript (e.g., funding, provision of study materials, medical writing, and article processing charges) from Kissei Pharmaceutical Co., Ltd.; consulting fees from Kissei Pharmaceutical Co., Ltd., Novartis Pharma K.K., Swedish Orphan Biovitrum AB, Takeda Pharmaceutical, Argenx and Megakaryon Corporation; payment or honoraria for lectures, presentations, speaker bureaus, manuscript writing, or educational events from Kissei Pharmaceutical Co., Ltd., Novartis Pharma K.K., Kyowa Kirin Co., Ltd., and UCB Japan Co. Ltd.; payment for expert testimony from Swedish Orphan Biovitrum AB and Sanofi; and participation on a Data Safety Monitoring Board or Advisory Board at Novartis Pharma K.K..","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"This study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. This study was approved by the institutional review board of each participating institution. All patients gave written informed consent before any study procedures were undertaken and again before participating in the washout period and period III.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}