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Methotrexate (MTX) is commonly used to prevent aGVHD but can lead to complications like delayed haematological recovery and oral mucositis (OM). This study investigates the efficacy of anti\u2010CD25 monoclonal antibody (mAb) as a potential MTX alternative. Participants were divided into two cohorts: a single\u2010dose group (25\u2009mg\/day anti\u2010CD25 mAb with MTX) and a double\u2010dose group (50\u2009mg\/day anti\u2010CD25 mAb without MTX). The primary end\u2010point was the cumulative incidence (CI) of severe aGVHD by day 100. The double\u2010dose cohort demonstrated a significantly lower CI of total aGVHD (23.53% vs. 42.11%, <jats:italic>p<\/jats:italic>\u2009=\u20090.009) and grade 3\u20134 aGVHD (7.35% vs. 18.42%, <jats:italic>p<\/jats:italic>\u2009=\u20090.047). After inverse probability of treatment weighting adjustment, the adjusted HR of double\u2010dose compared with single\u2010dose cohort for total aGVHD was 0.47 (95% CI 0.26\u20130.86; <jats:italic>p<\/jats:italic>\u2009=\u20090.015), 0.42(95% CI 0.15\u20131.22; <jats:italic>p<\/jats:italic>\u2009=\u20090.110) for grade III\u2013IV aGVHD, 0.45 (95% CI 0.26\u20130.77; <jats:italic>p<\/jats:italic>\u2009=\u20090.004) for total cGVHD and 0.36 (95% CI 0.18\u20130.72; <jats:italic>p<\/jats:italic>\u2009=\u20090.004) for the moderate to severe cGVHD. Additionally, this double\u2010dose regimen significantly reduced the incidence of oral mucositis and demonstrated lower rates of infections and haemorrhagic cystitis. These findings suggest that a double\u2010dose anti\u2010CD25 mAb regimen without MTX is a promising strategy for aGVHD prophylaxis in haplo\u2010HSCT (ChiCTR2200060184).<\/jats:p>","DOI":"10.1111\/bjh.19958","type":"journal-article","created":{"date-parts":[[2024,12,23]],"date-time":"2024-12-23T00:29:16Z","timestamp":1734913756000},"page":"615-627","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Humanized anti\u2010<scp>CD25<\/scp> monoclonal antibody replaces methotrexate as acute graft\u2010versus\u2010host disease prophylaxis in haploidentical allogeneic haematopoietic stem cell transplantation"],"prefix":"10.1111","volume":"206","author":[{"given":"Ao","family":"Zhang","sequence":"first","affiliation":[{"name":"Institute of Hematology, Union Hospital, Tongji Medicine College Huazhong University of Science and Technology  Wuhan 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