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Patient-reported outcomes in patients with paroxysmal nocturnal hemoglobinuria treated with crovalimab and approved C5 inhibitors in the phase III COMMODORE 2 and 1 studies.

作者信息

Panse Jens, Han Bing, Cermak Jaroslav, Gonzalez Fernandez Fernando Ataulfo, Gotoh Akihiko, Kulasekararaj Austin G, Kyselova Olena, Sahin Fahri, Scheinberg Phillip, Schrezenmeier Hubert, Straetmans Nicole, Ueda Yasutaka, Chang Alice C, Gentile Brittany, Stefani Jennifer, Uguen Marianne, Röth Alexander

机构信息

Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen, Germany.

Centre for Integrated Oncology (CIO), Aachen, Bonn, Cologne, Düsseldorf (ABCD), Germany.

出版信息

Ann Hematol. 2025 Jun 14. doi: 10.1007/s00277-025-06449-0.

DOI:10.1007/s00277-025-06449-0
PMID:40515823
Abstract
摘要

相似文献

1
Patient-reported outcomes in patients with paroxysmal nocturnal hemoglobinuria treated with crovalimab and approved C5 inhibitors in the phase III COMMODORE 2 and 1 studies.在III期COMMODORE 2和1研究中,接受crovalimab和已获批的C5抑制剂治疗的阵发性夜间血红蛋白尿患者的患者报告结局。
Ann Hematol. 2025 Jun 14. doi: 10.1007/s00277-025-06449-0.
2
Crovalimab: A Novel Approach in the Management of Paroxysmal Nocturnal Hemoglobinuria.克罗伐利单抗:阵发性夜间血红蛋白尿治疗的新方法。
Health Sci Rep. 2025 Jul 13;8(7):e70986. doi: 10.1002/hsr2.70986. eCollection 2025 Jul.
3
Phase 3 randomized COMMODORE 1 trial: Crovalimab versus eculizumab in complement inhibitor-experienced patients with paroxysmal nocturnal hemoglobinuria.第 3 阶段随机化 COMMODORE 1 试验:在补体抑制剂经治的阵发性睡眠性血红蛋白尿症患者中,crovalimab 对比依库珠单抗。
Am J Hematol. 2024 Sep;99(9):1757-1767. doi: 10.1002/ajh.27413. Epub 2024 Jun 25.
4
Breakthrough hemolysis in paroxysmal nocturnal hemoglobinuria throughout clinical trials: from definition to clinical practice.阵发性夜间血红蛋白尿症在整个临床试验中的突破性溶血:从定义到临床实践
Blood. 2025 Jul 24;146(4):411-421. doi: 10.1182/blood.2024027574.
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Navigating the paroxysmal nocturnal hemoglobinuria (PNH) landscape.探索阵发性夜间血红蛋白尿(PNH)的全貌。
Clin Adv Hematol Oncol. 2025 Jun;23 Suppl 8(4):1-19.
6
Ravulizumab demonstrates long-term efficacy, safety and favorable patient survival in patients with paroxysmal nocturnal hemoglobinuria.ravulizumab在阵发性夜间血红蛋白尿患者中显示出长期疗效、安全性及良好的患者生存率。
Ann Hematol. 2025 Jan;104(1):81-94. doi: 10.1007/s00277-025-06193-5. Epub 2025 Jan 22.
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Phase 3 randomized COMMODORE 2 trial: Crovalimab versus eculizumab in patients with paroxysmal nocturnal hemoglobinuria naive to complement inhibition.三期随机 COMMODORE 2 试验:初治补体抑制的阵发性睡眠性血红蛋白尿症患者中 Crovalimab 与依库珠单抗的比较。
Am J Hematol. 2024 Sep;99(9):1768-1777. doi: 10.1002/ajh.27412. Epub 2024 Jun 17.
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Immunotherapy. 2024;16(20-22):1185-1196. doi: 10.1080/1750743X.2024.2433410. Epub 2024 Dec 2.
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Two Cases of Crovalimab-Induced Platelet Recovery in Bone Marrow Failure-Associated Paroxysmal Nocturnal Hemoglobinuria (PNH).两例骨髓衰竭相关阵发性睡眠性血红蛋白尿(PNH)患者使用克罗瓦利单抗后血小板恢复的病例
Cureus. 2025 May 19;17(5):e84380. doi: 10.7759/cureus.84380. eCollection 2025 May.
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Pharmacokinetic characterization and exposure-response relationship of crovalimab in the COMMODORE 1, 2 and 3 and COMPOSER trials of patients with paroxysmal nocturnal haemoglobinuria.在阵发性夜间血红蛋白尿症患者的COMMODORE 1、2和3以及COMPOSER试验中,crovalimab的药代动力学特征及暴露-反应关系
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本文引用的文献

1
Patient-reported improvements in paroxysmal nocturnal hemoglobinuria treated with iptacopan from 2 phase 3 studies.来自2项3期研究的患者报告显示,接受iptacopan治疗的阵发性夜间血红蛋白尿症有改善。
Blood Adv. 2025 Apr 22;9(8):1816-1826. doi: 10.1182/bloodadvances.2024014652.
2
Long-term efficacy and safety of danicopan as add-on therapy to ravulizumab or eculizumab in PNH with significant EVH.达尼考潘作为ravulizumab或依库珠单抗的附加疗法用于具有显著血管外溶血(EVH)的阵发性睡眠性血红蛋白尿(PNH)的长期疗效和安全性。
Blood. 2025 Feb 20;145(8):811-822. doi: 10.1182/blood.2024026299.
3
Phase 3 randomized COMMODORE 1 trial: Crovalimab versus eculizumab in complement inhibitor-experienced patients with paroxysmal nocturnal hemoglobinuria.
第 3 阶段随机化 COMMODORE 1 试验:在补体抑制剂经治的阵发性睡眠性血红蛋白尿症患者中,crovalimab 对比依库珠单抗。
Am J Hematol. 2024 Sep;99(9):1757-1767. doi: 10.1002/ajh.27413. Epub 2024 Jun 25.
4
Phase 3 randomized COMMODORE 2 trial: Crovalimab versus eculizumab in patients with paroxysmal nocturnal hemoglobinuria naive to complement inhibition.三期随机 COMMODORE 2 试验:初治补体抑制的阵发性睡眠性血红蛋白尿症患者中 Crovalimab 与依库珠单抗的比较。
Am J Hematol. 2024 Sep;99(9):1768-1777. doi: 10.1002/ajh.27412. Epub 2024 Jun 17.
5
Treatment outcomes of complement protein C5 inhibition in 509 UK patients with paroxysmal nocturnal hemoglobinuria.509 例阵发性睡眠性血红蛋白尿症英国患者中补体蛋白 C5 抑制的治疗结果。
Blood. 2024 Mar 21;143(12):1157-1166. doi: 10.1182/blood.2023021762.
6
Clinically important change for the FACIT-Fatigue scale in paroxysmal nocturnal hemoglobinuria: a derivation from international PNH registry patient data.FACIT-Fatigue 量表在阵发性睡眠性血红蛋白尿症中的临床重要变化:来自国际 PNH 登记患者数据的推导。
J Patient Rep Outcomes. 2023 Jul 5;7(1):63. doi: 10.1186/s41687-023-00609-4.
7
Assessing the impact of open-label designs in patient-reported outcomes: investigation in oncology clinical trials.评估开放标签设计对患者报告结局的影响:肿瘤学临床试验的研究。
JNCI Cancer Spectr. 2023 Mar 1;7(2). doi: 10.1093/jncics/pkad002.
8
The burden of illness of patients with paroxysmal nocturnal haemoglobinuria receiving C5 inhibitors in France, Germany and the United Kingdom: Patient-reported insights on symptoms and quality of life.法国、德国和英国阵发性睡眠性血红蛋白尿症患者接受 C5 抑制剂治疗的疾病负担:症状和生活质量的患者报告见解。
Eur J Haematol. 2022 Oct;109(4):351-363. doi: 10.1111/ejh.13816. Epub 2022 Jul 7.
9
Crovalimab for treatment of patients with paroxysmal nocturnal haemoglobinuria and complement C5 polymorphism: Subanalysis of the phase 1/2 COMPOSER study.克罗伐利单抗治疗阵发性夜间血红蛋白尿和补体C5多态性患者:1/2期COMPOSER研究的亚分析
Br J Haematol. 2022 Aug;198(3):e46-e50. doi: 10.1111/bjh.18274. Epub 2022 May 24.
10
Long-term safety and efficacy of ravulizumab in patients with paroxysmal nocturnal hemoglobinuria: 2-year results from two pivotal phase 3 studies.阵发性睡眠性血红蛋白尿症患者使用 ravulizumab 的长期安全性和疗效:两项关键性 3 期研究的 2 年结果。
Eur J Haematol. 2022 Sep;109(3):205-214. doi: 10.1111/ejh.13783. Epub 2022 Jun 16.