{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T17:07:10Z","timestamp":1783012030748,"version":"3.54.6"},"reference-count":28,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,11,13]],"date-time":"2024-11-13T00:00:00Z","timestamp":1731456000000},"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":["European J of Haematology"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To evaluate the tolerability of crovalimab versus eculizumab in C5 inhibitor (C5i)\u2010naive and \u2010experienced patients with PNH from COMMODORE 2, 3 and 1 (NCT04434092, NCT04654468 and NCT04432584).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Pooled safety data were assessed in the total crovalimab and eculizumab populations and by C5i\u2010naive versus C5i\u2010switched status in patients receiving crovalimab. Analyses include 6.5\u2009months of additional follow\u2010up from the COMMODORE 2 and 1 primary analyses.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>COMMODORE safety data (crovalimab, 393 patients [naive, 192 patients; switched, 201 patients]; eculizumab, 111 patients) were analysed. The total patient years (PY) were 503.9 and 51.1 in the total crovalimab and eculizumab populations, respectively, with 471 and 581 adverse events (AEs) per 100 PY. Serious infection rates were 8.9 and 13.7 AEs per 100 PY, respectively; no meningococcal infections were reported. Fatal AEs occurred in eight (2%) patients receiving crovalimab (naive, six patients; switched, two patients) and one (1%) receiving eculizumab, all treatment unrelated. In C5i\u2010switched patients, 39 (19%) had transient immune complex reactions (risk when switching between C5i and crovalimab); the majority were Grades 1\u20132 arthralgia and rash, and 16 (8%) had Grade 3 events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Crovalimab's safety profile was consistent with eculizumab's and was generally comparable between C5i\u2010naive and C5i\u2010switched patients.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ejh.14339","type":"journal-article","created":{"date-parts":[[2024,11,13]],"date-time":"2024-11-13T11:59:17Z","timestamp":1731499157000},"page":"373-382","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Safety of Crovalimab Versus Eculizumab in Patients With Paroxysmal Nocturnal Haemoglobinuria (<scp>PNH<\/scp>): Pooled Results From the Phase 3 <scp>COMMODORE<\/scp> Studies"],"prefix":"10.1111","volume":"114","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4414-7699","authenticated-orcid":false,"given":"Alexander","family":"R\u00f6th","sequence":"first","affiliation":[{"name":"Department of Hematology and Stem Cell Transplantation West German Cancer Center, University Hospital Essen, University of Duisburg\u2010Essen  Essen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9928-9224","authenticated-orcid":false,"given":"Rong","family":"Fu","sequence":"additional","affiliation":[{"name":"Department of Hematology Tianjin Medical University General Hospital  Tianjin People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3944-5897","authenticated-orcid":false,"given":"Guangsheng","family":"He","sequence":"additional","affiliation":[{"name":"Department of Hematology The First Affiliated Hospital of Nanjing Medical University  Nanjing People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hazzaa","family":"Alzahrani","sequence":"additional","affiliation":[{"name":"King Faisal Specialist Hospital &amp; Research Centre  Riyadh Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheng\u2010Chieh","family":"Chou","sequence":"additional","affiliation":[{"name":"Division of Hematology, Department of Internal Medicine National Taiwan University Hospital  Taipei Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yosr","family":"Hicheri","sequence":"additional","affiliation":[{"name":"Department of Hematology Institut Paoli\u2010Calmettes  Marseille France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maciej","family":"Ka\u017amierczak","sequence":"additional","affiliation":[{"name":"Department of Hematology and Bone Marrow Transplantation Poznan University of Medical Sciences  Pozna\u0144 Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Viviane Lacorte","family":"Recova","sequence":"additional","affiliation":[{"name":"Chronos Clinical Research  Bras\u00edlia\u2010DF Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michihiro","family":"Uchiyama","sequence":"additional","affiliation":[{"name":"Department of Hematology Suwa Red Cross Hospital  Nagano Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana\u2010Maria","family":"Vladareanu","sequence":"additional","affiliation":[{"name":"Department of Hematology Bucharest Emergency University Hospital  Bucharest Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leigh","family":"Beveridge","sequence":"additional","affiliation":[{"name":"Genentech, Inc.  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