Safety of Crovalimab Versus Eculizumab in Patients With Paroxysmal Nocturnal Haemoglobinuria (PNH): Pooled Results From the Phase 3 COMMODORE Studies.

IF 2.3 3区 医学 Q2 HEMATOLOGY
Alexander Röth, Rong Fu, Guangsheng He, Hazzaa Alzahrani, Sheng-Chieh Chou, Yosr Hicheri, Maciej Kaźmierczak, Viviane Lacorte Recova, Michihiro Uchiyama, Ana-Maria Vladareanu, Leigh Beveridge, Simon Buatois, Muriel Buri, Nicolo Compagno, Dayu Shi, Nadiesh Balachandran, Sasha Sreckovic, Phillip Scheinberg
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引用次数: 0

Abstract

Objectives: To evaluate the tolerability of crovalimab versus eculizumab in C5 inhibitor (C5i)-naive and -experienced patients with PNH from COMMODORE 2, 3 and 1 (NCT04434092, NCT04654468 and NCT04432584).

Methods: Pooled safety data were assessed in the total crovalimab and eculizumab populations and by C5i-naive versus C5i-switched status in patients receiving crovalimab. Analyses include 6.5 months of additional follow-up from the COMMODORE 2 and 1 primary analyses.

Results: 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-switched patients, 39 (19%) had transient immune complex reactions (risk when switching between C5i and crovalimab); the majority were Grades 1-2 arthralgia and rash, and 16 (8%) had Grade 3 events.

Conclusions: Crovalimab's safety profile was consistent with eculizumab's and was generally comparable between C5i-naive and C5i-switched patients.

Crovalimab与Eculizumab对阵发性夜间血红蛋白尿症(PNH)患者的安全性对比:COMMODORE 3 期研究的汇总结果。
目的评估来自COMMODORE 2、3和1(NCT04434092、NCT04654468和NCT04432584)的C5抑制剂(C5i)无反应和有反应的PNH患者使用巴伐利单抗和依库珠单抗的耐受性:方法:评估了全部巴伐利单抗和依库珠单抗患者的汇总安全性数据,以及接受巴伐利单抗治疗患者的C5i-naive与C5i-switched状态。分析包括 COMMODORE 2 和 1 主要分析的 6.5 个月额外随访:分析了 COMMODORE 的安全性数据(393 例患者接受了巴伐利单抗治疗[192 例患者为天真患者;201 例患者为转换患者];111 例患者接受了依库珠单抗治疗)。总的患者年数(PY)分别为 503.9 年和 51.1 年,每 100 年分别发生 471 起和 581 起不良事件(AE)。严重感染率分别为每百人 8.9 例和 13.7 例;未报告脑膜炎球菌感染。8例(2%)接受巴伐利单抗治疗的患者(6例为天真患者,2例为转换患者)和1例(1%)接受依库珠单抗治疗的患者发生了致命的AE,所有这些患者均与治疗无关。在C5i换药患者中,39人(19%)出现了一过性免疫复合物反应(在C5i和巴珠单抗之间切换时的风险);大多数为1-2级关节痛和皮疹,16人(8%)出现了3级事件:结论:Crovalimab的安全性与依库珠单抗一致,C5i免疫患者与C5i转换患者的安全性基本相当。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
5.50
自引率
0.00%
发文量
168
审稿时长
4-8 weeks
期刊介绍: European Journal of Haematology is an international journal for communication of basic and clinical research in haematology. The journal welcomes manuscripts on molecular, cellular and clinical research on diseases of the blood, vascular and lymphatic tissue, and on basic molecular and cellular research related to normal development and function of the blood, vascular and lymphatic tissue. The journal also welcomes reviews on clinical haematology and basic research, case reports, and clinical pictures.
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