{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T19:48:24Z","timestamp":1789069704722,"version":"build-2803163510"},"reference-count":23,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2024,6,17]],"date-time":"2024-06-17T00:00:00Z","timestamp":1718582400000},"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":["American J Hematol"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Crovalimab is a novel C5 complement inhibitor that enables rapid and sustained C5 inhibition with subcutaneous, low\u2010volume self\u2010administration every 4\u2009weeks. COMMODORE 2 (NCT04434092) is a global, randomized, open\u2010label, multicenter, phase 3 trial evaluating the non\u2010inferiority of crovalimab versus eculizumab in patients with paroxysmal nocturnal hemoglobinuria not previously treated with C5 inhibition. C5 inhibitor\u2010naive patients with lactate dehydrogenase (LDH) \u22652\u2009\u00d7\u2009upper limit of normal (ULN) were randomized 2:1 to crovalimab or eculizumab. Co\u2010primary efficacy endpoints were proportion of patients with hemolysis control (centrally assessed LDH \u22641.5\u2009\u00d7\u2009ULN) and proportion with transfusion avoidance. Secondary efficacy endpoints were proportions of patients with breakthrough hemolysis, stabilized hemoglobin, and change in FACIT\u2010Fatigue score. The primary treatment period was 24\u2009weeks. Two hundred and four patients were randomized (135 crovalimab; 69 eculizumab). Crovalimab was non\u2010inferior to eculizumab in the co\u2010primary endpoints of hemolysis control (79.3% vs. 79.0%; odds ratio, 1.0 [95% CI, 0.6, 1.8]) and transfusion avoidance (65.7% vs. 68.1%; weighted difference, \u22122.8 [\u221215.7, 11.1]), and in the secondary efficacy endpoints of breakthrough hemolysis (10.4% vs. 14.5%; weighted difference, \u22123.9 [\u221214.8, 5.3]) and hemoglobin stabilization (63.4% vs. 60.9%; weighted difference, 2.2 [\u221211.4, 16.3]). A clinically meaningful improvement in FACIT\u2010Fatigue score occurred in both arms. Complete terminal complement activity inhibition was generally maintained with crovalimab. The safety profiles of crovalimab and eculizumab were similar with no meningococcal infections. Most patients who switched from eculizumab to crovalimab after the primary treatment period preferred crovalimab. These data demonstrate the positive benefit\u2013risk profile of crovalimab.<\/jats:p>","DOI":"10.1002\/ajh.27412","type":"journal-article","created":{"date-parts":[[2024,6,17]],"date-time":"2024-06-17T10:34:30Z","timestamp":1718620470000},"page":"1768-1777","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":51,"title":["Phase 3 randomized <scp>COMMODORE<\/scp> 2 trial: Crovalimab versus eculizumab in patients with <scp>paroxysmal nocturnal hemoglobinuria<\/scp> naive to complement inhibition"],"prefix":"10.1002","volume":"99","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 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