{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T19:31:43Z","timestamp":1785871903993,"version":"3.56.0"},"reference-count":20,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,3,21]],"date-time":"2025-03-21T00:00:00Z","timestamp":1742515200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["eJHaem"],"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>SB12 demonstrated equivalence to reference eculizumab (ECU) in complement inhibitor\u2010na\u00efve patients with paroxysmal nocturnal hemoglobinuria (PNH) in the previous randomized, double\u2010blind, multi\u2010national, crossover, Phase III study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The scope of this post\u2010hoc study was subgroup analysis by race to compare the efficacy and safety of SB12 and ECU in PNH patients in the Asian and Non\u2010Asian subgroups of the Phase III study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Results including lactate dehydrogenase (LDH), number of units of packed red blood cells and safety as primary and secondary endpoints demonstrated comparable efficacy and safety of SB12 and ECU in Asian and Non\u2010Asian PNH patients, in line with the study results in the overall population. In addition, transfusion avoidance (68.1% for SB12 vs. 72.9% for ECU, <jats:italic>p<\/jats:italic>\u2010value of 0.4492) and hemoglobin stabilization (SB12\u2013ECU: 6.3%, 95% confidence interval [CI] [\u201021.5, 34.1] and SB12\u2013ECU: 2.5%, 95% CI [\u201024.8, 29.8] using stringent criteria) as post\u2010hoc endpoints were not substantially different between SB12 and ECU treatment groups in the overall population as well as in Asians and Non\u2010Asians.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In conclusion, this subgroup analysis by race (Asians and Non\u2010Asians) supports comparable efficacy and safety between SB12 and reference eculizumab in global PNH patients including no difference in transfusion avoidance effect.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jha2.70020","type":"journal-article","created":{"date-parts":[[2025,3,23]],"date-time":"2025-03-23T12:40:54Z","timestamp":1742733654000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["EPYSQLI (SB12; Biosimilar to Reference Eculizumab) in Asian and Non\u2010Asian Patients With Paroxysmal Nocturnal Hemoglobinuria: Subgroup Analysis of a Global Phase III Randomized Controlled Trial"],"prefix":"10.1002","volume":"6","author":[{"given":"Jun Ho","family":"Jang","sequence":"first","affiliation":[{"name":"Department of Hematology\u2010Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ciprian","family":"Tomuleasa","sequence":"additional","affiliation":[{"name":"Department of Hematology Iuliu Hatieganu University of Medicine and Pharmacy  Cluj\u2010Napoca Romania"},{"name":"Department of Hematology Ion Chiricuta Clinical Cancer Center  Cluj\u2010Napoca Romania"},{"name":"Medfuture Research Center for Advanced Medicine Iuliu Hatieganu University of Medicine and Pharmacy  Cluj\u2010Napoca Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanna","family":"Oliynyk","sequence":"additional","affiliation":[{"name":"Department of Hematology Vinnytsia M I Pyrohov Regional Clinical Hospital  Vinnytsia Ukraine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Theerin","family":"Lanamtieng","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Division of Hematology Srinagarind Hospital, Faculty of Medicine, Khon Kaen, University  Khon Kaen Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jihye","family":"Park","sequence":"additional","affiliation":[{"name":"Samsung Bioepis Co., Ltd.  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