{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T16:54:23Z","timestamp":1790787263936,"version":"4.1.0"},"reference-count":31,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2023,10,18]],"date-time":"2023-10-18T00:00:00Z","timestamp":1697587200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100012166","name":"National Key Research and Development Program of China","doi-asserted-by":"publisher","award":["2019YFA0110802"],"award-info":[{"award-number":["2019YFA0110802"]}],"id":[{"id":"10.13039\/501100012166","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["81970121"],"award-info":[{"award-number":["81970121"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["82270152"],"award-info":[{"award-number":["82270152"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["American J Hematol"],"published-print":{"date-parts":[[2024,1]]},"abstract":"Abstract<\/jats:title>\n \n Acquired hemophilia A (AHA) is a rare but serious bleeding disorder. Randomized controlled trial (RCT) comparing the efficacy of immunosuppression therapy for AHA lacks. We conducted the first multicenter RCT aiming to establish whether the single\u2010dose rituximab combination regimen was noninferior to the cyclophosphamide combination regimen. From 2017 to 2022, 63 patients with newly diagnosed AHA from five centers were randomly assigned 1:1 to receive glucocorticoid (methylprednisolone 0.8\u2009mg\/kg per day for the first 3\u2009weeks and then tapered) plus single\u2010dose rituximab (375\u2009mg\/m\n 2<\/jats:sup>\n ;\n n<\/jats:italic>\n \u2009=\u200931) or plus cyclophosphamide (2\u2009mg\/kg per day until inhibitor becomes negative, for a maximum of 5\u2009weeks;\n n<\/jats:italic>\n \u2009=\u200932). The primary outcome was complete remission (CR, defined as FVIII activity \u226550\u2009IU\/dL, FVIII inhibitor undetectable, immunosuppression tapered and no bleeding for 24\u2009h without bypassing agents) rate measured within 8\u2009weeks. The noninferiority margin was an absolute difference of 20%. Twenty\u2010four (77.4%) patients in the rituximab group and 22 (68.8%) patients in the cyclophosphamide group achieved CR, which showed the noninferiority of the single\u2010dose rituximab\u2010based regimen (absolute difference = \u22128.67%, lower limit of the 95% confidence interval\u2009=\u2009\u221213.11%; Pnoninferiority\u2009= 0.005). No difference was found in the incidence of treatment\u2010related adverse events. Single\u2010dose rituximab plus glucocorticoid regimen showed similar efficacy and safety, without a reported risk of secondary malignancies or reproductive toxicity seen in cyclophosphamide, it might be recommended as a first\u2010line therapy for AHA, especially in China where there is a young age trend in AHA patients. This trial was registered at\n ClinicalTrials.gov<\/jats:ext-link>\n as #NCT03384277.\n <\/jats:p>","DOI":"10.1002\/ajh.27128","type":"journal-article","created":{"date-parts":[[2023,10,18]],"date-time":"2023-10-18T13:24:58Z","timestamp":1697635498000},"page":"28-37","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Single\u2010dose rituximab plus glucocorticoid versus cyclophosphamide plus glucocorticoid in patients with newly diagnosed acquired hemophilia A: A multicenter, open\u2010label, randomized noninferiority trial"],"prefix":"10.1002","volume":"99","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-4729-1573","authenticated-orcid":false,"given":"PanJing","family":"Wang","sequence":"first","affiliation":[{"name":"State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rongfu","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Hematology Affiliated Drum Tower Hospital of Nanjing University Medical School Nanjing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5947-3924","authenticated-orcid":false,"given":"Feng","family":"Xue","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hu","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Hematology The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Hemostasis and Thrombosis Diagnostic Engineering Research Center of Henan Province Zhengzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Bai","sequence":"additional","affiliation":[{"name":"Department of Hematology The Second Hospital of Tianjin Medical University Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xianghua","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Hematology Shandong Provincial Hospital Affiliated to Shandong First Medical University Jinan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yueshen","family":"Ma","sequence":"additional","affiliation":[{"name":"Office of Biostatistics, Center for Information and Resources of State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhen","family":"Song","sequence":"additional","affiliation":[{"name":"Center for Information and Resources of State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7309-8545","authenticated-orcid":false,"given":"Yunfei","family":"Chen","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9911-4491","authenticated-orcid":false,"given":"Xiaofan","family":"Liu","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rongfeng","family":"Fu","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ting","family":"Sun","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of 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for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1783-711X","authenticated-orcid":false,"given":"Huan","family":"Dong","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renchi","family":"Yang","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood 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