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作者

Yihong Sun, Qiang Lv, Yuhan Guo, Zhifang Wang, Rongjie Huang, Xiaohong Gao, Yajun Han, Zhuhua Yao, Mingqi Zheng, Suxin Luo, Yue Li, Xiang Gu, Yumin Zhang, Junkui Wang, Lang Hong, Xueping Ma, Guohai Su, Jianlong Sheng, Chunlin Lai, Aidong Shen, Mian Wang, WeiHua Zhang, Shaorong Wu, Zeqi Zheng, Juxiang Li, Tingyan Zhong, Ying Wang, Liu He, Xin Du, Chang-Sheng Ma

作者单位

Affiliations ¹ Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. ² Jiangsu Hengrui Pharmaceuticals, Co Ltd, Shanghai, China. ³ Department of Cardiology, Xinxiang Central Hospital, Xinxiang, China. ⁴ Department of Cardiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China. ⁵ Department of Cardiology, Beijing Pinggu Hospital, Beijing, China. ⁶ Department of Geriatric Cardiology, Inner Mongolia Autonomous Region People's Hospital, Hohhot, China. ⁷ Department of Cardiology, Tianjin Union Medical Center, Tianjin, China. ⁸ Department of Cardiology, The First Hospital of Hebei Medical University, Shijiazhuang, China. ⁹ Department of Cardiology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. ¹⁰ Department of Cardiology, The First Affiliated Hospital of Harbin Medical University, Harbin, China. ¹¹ Department of Cardiology, Northern Jiangsu People's Hospital, Yangzhou, China. ¹² Department of Cardiology, The Third Hospital of Changsha, Changsha, China. ¹³ Department of Cardiology, Shaanxi Provincial People's Hospital, Xi'an, China. ¹⁴ Department of Cardiology, The Jiangxi Provincial People's Hospital, Nanchang, China. ¹⁵ Department of Cardiology, General Hospital of Ningxia Medical University, Yinchuan, China. ¹⁶ Department of Cardiology, Jinan Central Hospital/Central Hospital Affiliated to Shandong First Medical University, Jinan, China. ¹⁷ Department of Cardiology, The Second Hospital of Anhui Medical University, Hefei, China. ¹⁸ Department of Cardiology, Shanxi Provincial People's Hospital, Taiyuan, China. ¹⁹ Department of Cardiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China. ²⁰ Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China. ²¹ Department of Cardiology, First Bethune Hospital of Jilin University, Changchun, China. ²² Department of Cardiology, The First Affiliated Hospital of Jinan University, Guangzhou, China. ²³ Department of Cardiology, The First Affiliated Hospital of Nanchang University, Nanchang, China. ²⁴ Department of Cardiology, The Second Affiliated Hospital of Nanchang University, Nanchang, China. ²⁵ Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. Electronic address: chshma@vip.sina.com.

刊名

Journal of the American College of Cardiology

年份

2024

卷号

Vol.84 No.20

页码

2037-2047

ISSN

1558-3597

关键词

LDL PCSK9 cholesterol lipoproteins nonfamilial hypercholesterolemia recaticimab.

摘要

Background: Currently available antiproprotein convertase subtilisin/kexin type 9 monoclonal antibodies can effectively decrease low-density lipoprotein cholesterol levels, but require frequent dosing. Recaticimab is a novel humanized monoclonal antibody against proprotein convertase subtilisin/kexin type 9. In a phase 1b/2 trial, recaticimab as add-on to stable statins showed robust LDL-C reduction with a dosing interval up to every 12 weeks in patients with hypercholesterolemia. Objectives: ...更多

Background: Currently available antiproprotein convertase subtilisin/kexin type 9 monoclonal antibodies can effectively decrease low-density lipoprotein cholesterol levels, but require frequent dosing. Recaticimab is a novel humanized monoclonal antibody against proprotein convertase subtilisin/kexin type 9. In a phase 1b/2 trial, recaticimab as add-on to stable statins showed robust LDL-C reduction with a dosing interval up to every 12 weeks in patients with hypercholesterolemia. Objectives: REMAIN-2 aimed to assess the efficacy and safety of 48-week treatment with recaticimab as add-on therapy to statins in nonfamilial hypercholesterolemia. Methods: REMAIN-2 was a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial. During the run-in period, patients received stable moderate or high-intensity statin, with or without cholesterol absorption inhibitors or fenofibrate, for ≥4 weeks. Patients with an LDL-C of ≥1.8 mmol/L or ≥2.6 mmol/L were then randomized to receive recaticimab 150 mg every 4 weeks , 300 mg every 8 weeks , or 450 mg Q12W, or matching placebo injections for 48 weeks. The primary efficacy endpoint was percentage change from baseline to week 24 in LDL-C level. Results: A total of 689 randomly assigned patients received treatment . Percentage change in LDL-C from baseline to week 24 was significantly more pronounced with recaticimab vs placebo , with least-squares mean differences of -62.2% , -59.7% , and -53.4% for the 150 mg Q4W, 300 mg Q8W, and 450 mg Q12W regimens, respectively. The decreases in LDL-C with recaticimab were maintained through week 48. Secondary lipid variables, including non-high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein also favored the recaticimab groups. During the treatment period, the incidence of treatment-related adverse events and serious treatment-related adverse events was similarly low in both the recaticimab and placebo groups. Conclusions: Recaticimab as add-on to stable statin therapy significantly decreased LDL-C levels at week 24 and sustained the decreases through week 48, providing a novel therapeutic alternative with a dosing interval of up to every 12 weeks in patients with nonfamilial hypercholesterolemia.收起

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