{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T14:01:16Z","timestamp":1790863276704,"version":"4.1.0"},"reference-count":31,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2022,12,5]],"date-time":"2022-12-05T00:00:00Z","timestamp":1670198400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Br J Haematol"],"published-print":{"date-parts":[[2023,3]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>Fostamatinib, a spleen tyrosine kinase inhibitor, has been approved for the treatment of chronic primary immune thrombocytopenia (ITP) in the United States, Canada and some European countries. We conducted a phase 3, placebo\u2010controlled, double\u2010blind, parallel\u2010group study to evaluate the efficacy and safety of fostamatinib in Japanese patients with primary ITP. Thirty\u2010four patients were randomised to fostamatinib (<jats:italic>n<\/jats:italic>\u00a0=\u200922) or placebo (<jats:italic>n<\/jats:italic>\u00a0=\u200912) at 100\u2013150\u2009mg twice a day for 24\u2009weeks. Stable responses (platelet \u226550\u2009000\/\u03bcl at \u22654 of the 6 visits from weeks 14 to 24) were observed in eight (36%) patients on fostamatinib and in none of the patients on placebo (<jats:italic>p<\/jats:italic>\u00a0=\u20090.030). Overall responses (platelet \u226550\u2009000\/\u03bcl at \u22651 of the 6 visits from weeks 2 to 12) were seen in 10 (45%) patients on fostamatinib and in none of the patients on placebo (<jats:italic>p<\/jats:italic>\u00a0=\u20090.006). Patients on fostamatinib required rescue medication less often and experienced fewer bleeding symptoms than patients on placebo. Adverse events observed were mild or moderate and were manageable. No new safety signals were identified in Japanese patients with ITP.<\/jats:p>","DOI":"10.1111\/bjh.18582","type":"journal-article","created":{"date-parts":[[2022,12,6]],"date-time":"2022-12-06T02:44:52Z","timestamp":1670294692000},"page":"802-811","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":31,"title":["Fostamatinib for the treatment of Japanese patients with primary immune thrombocytopenia: A phase 3, placebo\u2010controlled, double\u2010blind, parallel\u2010group study"],"prefix":"10.1111","volume":"200","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8352-6136","authenticated-orcid":false,"given":"Masataka","family":"Kuwana","sequence":"first","affiliation":[{"name":"Department of Allergy and Rheumatology Nippon Medical School Graduate School of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5419-9156","authenticated-orcid":false,"given":"Tomoki","family":"Ito","sequence":"additional","affiliation":[{"name":"First Department of Internal Medicine Kansai Medical University  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1836-0464","authenticated-orcid":false,"given":"Shugo","family":"Kowata","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology Department of Internal Medicine, Iwate Medical University  Iwate Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshihiro","family":"Hatta","sequence":"additional","affiliation":[{"name":"Department of Hematology and Rheumatology Nihon University School of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9996-6459","authenticated-orcid":false,"given":"Katsumichi","family":"Fujimaki","sequence":"additional","affiliation":[{"name":"Department of Hematology Fujisawa City Hospital  Kanagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kensuke","family":"Naito","sequence":"additional","affiliation":[{"name":"Department of Hematology Hamamatsu Medical Center  Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shingo","family":"Kurahashi","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology Toyohashi Municipal Hospital  Aichi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0303-464X","authenticated-orcid":false,"given":"Toshiya","family":"Kagoo","sequence":"additional","affiliation":[{"name":"Division of Hematology, Department of Internal Medicine National Hospital Organization Tokyo Medical Center  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuki","family":"Tanimoto","sequence":"additional","affiliation":[{"name":"Hematology and Oncology Division Japanese Red Cross Fukuoka Hospital  Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"So","family":"Saotome","sequence":"additional","affiliation":[{"name":"Kissei Pharmaceutical Co., Ltd.  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