RECATICIMAB significantly reduced LDL-C levels as an add-on to stable statin therapy, with effects sustained over 48 weeks and dosing intervals of up to 12 weeks.
The REMAIN-2 trial investigated the efficacy and safety of recaticimab, a humanised monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9, in patients with nonfamilial hypercholesterolemia . Current monoclonal antibody therapies for lowering LDL-C require frequent dosing, highlighting a need for alternatives with longer intervals. Recaticimab offers potential advantages, combining robust LDL-C reduction with dosing intervals extending to every 12 weeks.
This multicentre, randomised, double-blind, placebo-controlled phase 3 study enrolled 689 patients aged 55.8 years on average, 64.4% of whom were male. Participants had either a history of atherosclerotic cardiovascular disease (69.5%) or other risk factors and were on stable moderate or high-intensity statin therapy, with or without additional lipid-lowering agents. Eligible patients were randomised to receive recaticimab (150 mg every 4 weeks, 300 mg every 8 weeks, or 450 mg every 12 weeks) or matching placebo for 48 weeks. The primary endpoint was the percentage change in LDL-C from baseline to week 24.
Recaticimab led to significant LDL-C reductions compared to placebo (P < 0.0001), with least-squares mean differences of −62.2%, −59.7%, and −53.4% for the Q4W, Q8W, and Q12W regimens, respectively. These reductions were maintained through week 48, and additional lipid variables, such as non-HDL cholesterol, apolipoprotein B, and lipoprotein(a), also improved. The rates of treatment-related adverse events were low and comparable between the recaticimab and placebo groups (28.5% vs 26.6% overall).
Recaticimab represents a promising addition to lipid-lowering therapies, delivering significant LDL-C reductions with an extended dosing interval, addressing a notable gap in treatment convenience and adherence. Its safety profile aligns closely with placebo, underscoring its potential in routine clinical practice. Future research should explore its long-term cardiovascular outcomes and potential in broader patient populations.
Reference
Sun Y et al. Recaticimab as add-on therapy to statins for nonfamilial hypercholesterolemia: the randomized, phase 3 REMAIN-2 trial. JACC. 2024;84(20):203747.
