{"id":"87abcbe3a810","type":"article","url":"https://hartvaat.nl/2024/11/12/recaticimab-als-toevoeging-aan-statines-fase-3-remain-2/","title":"Recaticimab als toevoeging aan statines: fase 3 REMAIN-2","title_en":"Recaticimab as Add-On Therapy to Statins for Nonfamilial Hypercholesterolemia: The Randomized, Phase 3 REMAIN-2 Trial.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["ezetimibe","lipidenverlaging","niet-statine-therapie","soul-trial","statines"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.09.012","source_url":"https://doi.org/10.1016/j.jacc.2024.09.012","authors":["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"],"significance":7,"published":"2024-11-12","source_date":"2024-11-12","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/lipiden/ezetimib/"],"congress":"","summary_en":"The REMAIN-2 trial showed that recaticimab added to statin therapy provides additional LDL cholesterol lowering in patients not reaching goals on statins alone, confirming the efficacy of this new PCSK9 antibody in combination therapy.","created":"2026-07-03T10:31:18Z","updated":"2026-07-03T13:30:19Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Fase 3 trial van recaticimab plus statine toonde additionele LDL-verlaging bij patiënten met onvoldoende respons op statine monotherapie. Het antilichaam is een effectieve add-on therapie.","abstract_original":"BACKGROUND: Currently available antiproprotein convertase subtilisin/kexin type 9 monoclonal antibodies can effectively decrease low-density lipoprotein cholesterol (LDL-C) 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 (Q12W) in patients with hypercholesterolemia. OBJECTIVES: REMAIN-2 (REcaticiMab Add-on therapy In patients with Nonfamilial hypercholesterolemia) 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 (ezetimibe) or fenofibrate, for ≥4 weeks. Patients with an LDL-C of ≥1.8 mmol/L (if with atherosclerotic cardiovascular disease [ASCVD]) or ≥2.6 mmol/L (if without ASCVD) were then randomized (2:2:2:1:1:1) to receive recaticimab 150 mg every 4 weeks (Q4W), 300 mg every 8 weeks (Q8W), or 450 mg Q12W, or matching placebo injections (Q4W, Q8W, or Q12W) 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 (mean age, 55.8 years; male, 64.4%; ASCVD history, 69.5%; concomitant ezetimibe, 11.2%; mean baseline LDL-C, 2.8 mmol/L). Percentage change in LDL-C from baseline to week 24 was significantly more pronounced with recaticimab vs placebo (P < 0.0001), with least-squares mean differences of -62.2% (95% CI: -67.0% to -57.4%), -59.7% (95% CI: -65.0% to -54.4%), and -53.4% (95% CI: -58.7% to -48.2%) 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(a) also favored the recaticimab groups. During the treatment period, the incidence of treatment-related adverse events (28.5% vs 26.6%) and serious treatment-related adverse events (0.4% vs 0.4%) 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."}