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Zanubrutinib is a highly selective next\u2010generation Bruton tyrosine kinase (BTK) inhibitor that may reduce autoantibody production and reduce macrophage Fc\u03b3 receptor\u2010mediated platelet destruction. In this single\u2010arm, phase II study, we aimed to assess the efficacy and safety of zanubrutinib in corticosteroid\u2010resistant or relapsed ITP. All patients received 80\u2009mg zanubrutinib once daily for 6\u2009weeks followed by a 20\u2010week safety follow\u2010up period. The primary endpoint was overall response (OR), defined as at least two consecutive platelet counts of at least 30\u2009\u00d7\u200910<jats:sup>9<\/jats:sup>\/L, at least a 2\u2010fold increase in the baseline count, the absence of bleeding, and no need for rescue therapy at 4\u2009weeks. The trial was registered with <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>, number NCT05279872. Between January 1, 2022 and October 30, 2022, 20 patients were enrolled. The median platelet count was 19 (10\u201325)\u2009\u00d7\u200910<jats:sup>9<\/jats:sup>\/L at the time of enrollment. Participants had received a median of 4 (3\u20136) different therapies for ITP. Eleven (55%, 95% CI: 31.5%\u201376.9%) patients achieved an OR to the intervention. Two (10%) patients achieved a complete response. At the 6\u2010month follow\u2010up, a sustained response was achieved in seven (35.0%, 95% CI: 15.4%\u201359.2%) patients. There were no grade 4 or worse adverse events or treatment\u2010related deaths. The most common adverse events were upper respiratory tract infection (in 25% of the patients). Zanubrutinib showed an encouraging response rate and tolerability, supporting its therapeutic potential for the treatment of ITP.<\/jats:p><jats:p><jats:bold>Trial Registration:<\/jats:bold> <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link> identifier: NCT05279872.<\/jats:p>","DOI":"10.1002\/ajh.27718","type":"journal-article","created":{"date-parts":[[2025,5,20]],"date-time":"2025-05-20T08:48:06Z","timestamp":1747730886000},"page":"1314-1322","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Efficacy and Safety of the Bruton's Tyrosine Kinase Inhibitor Zanubrutinib in Immune Thrombocytopenia"],"prefix":"10.1002","volume":"100","author":[{"given":"Qiu\u2010Sha","family":"Huang","sequence":"first","affiliation":[{"name":"Peking University People's Hospital Peking University Institute of Hematology  Beijing 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