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Rituximab (RTX) is an effective second-line treatment. Low-dose RTX has shown similar efficacy to standard dose, but the optimal dosage remains uncertain.\u00a0This multicentre, prospective, open-label, randomised controlled trial aimed to compare the long-term efficacy (5-year follow-up) and 1-year safety of two low-dose RTX regimens in Chinese adult patients with glucocorticoid-resistant\/dependent or relapsed ITP. Patients (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009104) were randomised 1:1 to group A (RTX 100\u00a0mg weekly for 4 weeks) or group B (RTX 375 mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    once). The primary outcome was overall response (OR) at 3 months after RTX initiation. Response was followed up until disease relapse or for 5 years.\u00a0Forty-nine patients in Group A and 51 patients in Group B completed the intervention. At 3 months after RTX initiation, 32 patients in group A (65.3%) and 33 patients in group B (64.7%) achieved OR, and the complete response rate was 42.9% (21\/49) in group A and 39.2% (20\/51) in group B. The sustained response rates at 6 months, 1, 2, and 5 years were 59.2%, 42.9%, 28.6%, and 20.4% in group A and 58.8%, 43.1%, 33.3%, and 17.6% in group B. These variables were not statistically different between two groups. The most common adverse events were upper respiratory tract and pulmonary infections.\u00a0RTX 375mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    once showed similar long-term efficacy compared to RTX 100\u00a0mg weekly for 4 weeks, with a comparable 1-year safety profile; both being well tolerated. The single-dose regimen may be preferable due to greater patient convenience and reduced economic burden.\n                  <\/jats:p>\n                  <jats:p>Trial registration<\/jats:p>\n                  <jats:p>ClinicalTrials.gov Identifier- NCT01719692 (Registration date: October 26, 2012).<\/jats:p>","DOI":"10.1007\/s00277-026-06908-2","type":"journal-article","created":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T01:11:14Z","timestamp":1772068274000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Long-term efficacy and safety of low-dose rituximab in immune thrombocytopenia: a multicentre, prospective, open-label, randomised controlled trial"],"prefix":"10.1007","volume":"105","author":[{"given":"Yunfei","family":"Chen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiaying","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiawen","family":"Dai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ting","family":"Sun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zijian","family":"Qiao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maosheng","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hu","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zeping","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaofan","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rongfeng","family":"Fu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Feng","family":"Xue","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mankai","family":"Ju","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huan","family":"Dong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xinyue","family":"Dai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenjing","family":"Gu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renchi","family":"Yang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lei","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,2,26]]},"reference":[{"issue":"Suppl 1","key":"6908_CR1","doi-asserted-by":"publisher","first-page":"17","DOI":"10.1111\/vcp.12774","volume":"48","author":"DN LeVine","year":"2019","unstructured":"LeVine DN, Brooks MB (2019) Immune thrombocytopenia (ITP): pathophysiology update and diagnostic dilemmas. 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