{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,12]],"date-time":"2026-06-12T06:17:21Z","timestamp":1781245041800,"version":"3.54.1"},"reference-count":20,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2021,1,3]],"date-time":"2021-01-03T00:00:00Z","timestamp":1609632000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["European J of Haematology"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Ravulizumab every 8\u00a0weeks showed non\u2010inferiority to eculizumab every 2\u00a0weeks in a 26\u2010week, phase 3, randomized controlled trial in adults with paroxysmal nocturnal hemoglobinuria (PNH) who were clinically stable on eculizumab (NCT03056040). We report results from the first 26\u00a0weeks of the extension period in which patients continued ravulizumab (n\u00a0=\u00a096) or switched from eculizumab to ravulizumab (n\u00a0=\u00a095). At week 52, mean (SD) lactate dehydrogenase levels increased 8.8% (29%) with ravulizumab\u2010ravulizumab and 5.8% (27%) with eculizumab\u2010ravulizumab from primary evaluation period baseline. During the extension period, four patients (ravulizumab\u2010ravulizumab, n\u00a0=\u00a03; eculizumab\u2010ravulizumab, n\u00a0=\u00a01) experienced breakthrough hemolysis, but none associated with serum free C5\u00a0\u2265\u00a00.5\u00a0\u03bcg\/mL. Mean Functional Assessment of Chronic Illness Therapy (FACIT)\u2010Fatigue scores remained stable through week 52. During the extension period, proportions of patients avoiding transfusion remained stable (ravulizumab\u2010ravulizumab, 86.5%; eculizumab\u2010ravulizumab, 83.2%); 81.2% and 81.1%, respectively, had stabilized hemoglobin. All patients maintained serum free C5 levels\u00a0&lt;\u00a00.5\u00a0\u03bcg\/mL. Adverse events were generally similar between groups, and rates were lower in the extension period. Adults with PNH on stable eculizumab therapy who received ravulizumab over 52\u00a0weeks experienced durable efficacy, with consistent efficacy in patients who received eculizumab during the primary evaluation period and then switched to ravulizumab. Ravulizumab was well tolerated.<\/jats:p>","DOI":"10.1111\/ejh.13564","type":"journal-article","created":{"date-parts":[[2020,12,11]],"date-time":"2020-12-11T03:22:30Z","timestamp":1607656950000},"page":"389-397","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":35,"title":["One\u2010year outcomes from a phase 3 randomized trial of ravulizumab in adults with paroxysmal nocturnal hemoglobinuria who received prior eculizumab"],"prefix":"10.1111","volume":"106","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3180-3570","authenticated-orcid":false,"given":"Austin G.","family":"Kulasekararaj","sequence":"first","affiliation":[{"name":"Department of Haematological Medicine King\u2019s College Hospital National Institute of Health Research\/Wellcome King\u2019s Clinical Research Facility and King\u2019s College London London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anita","family":"Hill","sequence":"additional","affiliation":[{"name":"Department of Haematology Leeds Teaching Hospitals Leeds UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saskia","family":"Langemeijer","sequence":"additional","affiliation":[{"name":"Radboudumc Nijmegen the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Wells","sequence":"additional","affiliation":[{"name":"Sunnybrook Health Sciences Centre Toronto ON Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F. Ata\u00falfo","family":"Gonz\u00e1lez Fern\u00e1ndez","sequence":"additional","affiliation":[{"name":"Department of Hematology Hospital Clinico Universitario San Carlos The Cl\u0131nic Institute of Haematological and Oncological Diseases Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Gaya","sequence":"additional","affiliation":[{"name":"Department of Hematology Hospital Clinic de Barcelona Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emilio","family":"Ojeda Gutierrez","sequence":"additional","affiliation":[{"name":"Hospital Universitario Puerta de Hierro Majadahonda Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline I.","family":"Piatek","sequence":"additional","affiliation":[{"name":"Jane Anne Nohl Division of Hematology Keck School of Medicine University of Southern California Los Angeles CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lindsay","family":"Mitchell","sequence":"additional","affiliation":[{"name":"Monklands Hospital Airdrie Scotland UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kensuke","family":"Usuki","sequence":"additional","affiliation":[{"name":"NTT Medical Center Tokyo Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto","family":"Bosi","sequence":"additional","affiliation":[{"name":"Department of Experimental and Clinical Medicine University of Florence Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert A.","family":"Brodsky","sequence":"additional","affiliation":[{"name":"The John Hopkins University School of Medicine Baltimore MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masayo","family":"Ogawa","sequence":"additional","affiliation":[{"name":"Alexion Pharmaceuticals, Inc. 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