{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T19:46:43Z","timestamp":1790192803976,"version":"4.1.0"},"reference-count":27,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2022,12,20]],"date-time":"2022-12-20T00:00:00Z","timestamp":1671494400000},"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":[[2023,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Treatment of paroxysmal nocturnal haemoglobinuria (PNH) includes the monoclonal antibody eculizumab. This randomised, double\u2010blind, multi\u2010national cross\u2010over Phase III study in PNH patients aimed to demonstrate the equivalence of the proposed eculizumab biosimilar SB12 and reference eculizumab (Soliris, ECU). PNH patients with lactate dehydrogenase (LDH) \u22651\u00b75\u00d7 upper limit of normal were randomised into treatment sequences SB12\u2010ECU or ECU\u2010SB12. Four weekly infusions of 600\u00a0mg eculizumab were followed by fortnightly infusions of 900\u00a0mg until week 50 (ECU\/SB12 cross\u2010over at week 26). Primary endpoints were LDH at week 26 and the time\u2010adjusted area under the effect curve (AUEC) of LDH over weeks 14\u201226 and 40\u201252. Among 46 patients (92%) who completed the study, the least squares mean (LSM) difference in LDH at week 26 (34\u00b748; 95% confidence interval [CI] \u221247\u00b766\u2012116\u00b762\u00a0U\/l) and geometric LSM ratio of time\u2010adjusted AUEC of LDH (1\u00b708; 90% CI 0\u00b795\u20121\u00b723) were within pre\u2010defined equivalence margins. Mean numbers of transfused red blood cell units, other secondary endpoints, pharmacokinetics, and pharmacodynamics were comparable. No patients developed anti\u2010drug antibodies. Treatment\u2010emergent adverse events were reported in 72% and 68% of patients in the SB12 and ECU treatment groups, respectively. The results demonstrate equivalence of SB12 to ECU and support SB12\u2010use in PNH patients.<\/jats:p>","DOI":"10.1002\/jha2.632","type":"journal-article","created":{"date-parts":[[2022,12,20]],"date-time":"2022-12-20T14:44:15Z","timestamp":1671547455000},"page":"26-36","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["A phase III, randomised, double\u2010blind, multi\u2010national clinical trial comparing SB12 (proposed eculizumab biosimilar) and reference eculizumab in patients with paroxysmal nocturnal haemoglobinuria"],"prefix":"10.1002","volume":"4","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7423-4676","authenticated-orcid":false,"given":"Jun Ho","family":"Jang","sequence":"first","affiliation":[{"name":"Samsung Medical Center Sungkyunkwan University School of Medicine  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberta Demichelis","family":"Gomez","sequence":"additional","affiliation":[{"name":"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran  Mexico City Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3706-3166","authenticated-orcid":false,"given":"Horia","family":"Bumbea","sequence":"additional","affiliation":[{"name":"Bucharest Emergency University Hospital  Bucharest Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Larysa","family":"Nogaieva","sequence":"additional","affiliation":[{"name":"Cherkasy Regional Oncology Dispensary of Cherkasy Oblast Council  Cherkasy Ukraine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lily Lee Lee","family":"Wong","sequence":"additional","affiliation":[{"name":"Queen Elizabeth Hospital  Kota Kinabalu Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Soo Min","family":"Lim","sequence":"additional","affiliation":[{"name":"Sultanah Aminah Hospital  Johor Bahru Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Younsoo","family":"Kim","sequence":"additional","affiliation":[{"name":"Samsung Bioepis  Incheon Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jihye","family":"Park","sequence":"additional","affiliation":[{"name":"Samsung Bioepis  Incheon Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,12,20]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2141.2004.04992.x"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.md.0000126763.68170.46"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199511093331904"},{"key":"e_1_2_9_5_1","first-page":"2","article-title":"Paroxysmal nocturnal hemoglobinuria: pathogenesis, testing, and diagnosis","volume":"11","author":"Sharma VR","year":"2013","journal-title":"Clin Adv Hematol Oncol"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2005-04-1717"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1097\/00005792-196609000-00001"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1080\/14728214.2022.2031973"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2005-02-0564"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa061648"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2007-06-094136"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.2147\/TCRM.S96720"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2021-148197"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.5414\/CP204176"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2013.281053"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V118.21.3166.3166"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/imj.13523"},{"key":"e_1_2_9_18_1","unstructured":"Medical Dictionary for Regulatory Activities.What's new: MedDRA version 21.0.2018. 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