Recaticimab may offer a solution for uncontrolled hypercholesterolaemia

Recaticimab demonstrated to be a promising add-on therapy for patients with hypercholesterolaemia and mixed hyperlipidaemia who were inadequately controlled on statins. The drug allowed for infrequent dosing and no substantial safety issues emerged in the REMAIN-2 study.

“Although anti-PCSK9 antibodies are efficacious as add-on therapy for patients with non-familial hypercholesterolaemia (non-FH) and mixed hyperlipidaemia, adherence in the real world is compromised due to frequent dosing,” explained Dr Xin Du (Beijing Anzhen Hospital, China) [1–3]. “Recaticimab is a long-acting anti-PCSK9 antibody, designed to overcome this matter” [3]. This new PCK9 inhibitor can be injected every 1 to 3 months.

The randomised, double-blind, placebo-controlled, phase 3 REMAIN-2 study (NCT04885218) randomised 692 participants with hypercholesterolemia and mixed hyperlipidaemia who were not known to have FH 2:1 to one of three recaticimab arms (150 mg every 4 weeks, 300 mg every 8 weeks, or 450 mg every 12 weeks, subcutaneously administered) or a matched placebo. The primary endpoint was the percentage change in LDL cholesterol from baseline to week 24.

At week 24, recaticimab reduced LDL cholesterol by 53.4–62.2% compared with placebo, irrespective of dose level (P<0.0001 for all dose levels). These reductions were sustained through week 48. “LDL-cholesterol control goals were achieved by 85.8–94.5% of the participants treated with recaticimab and by 9.8–33.3% of the participants on placebo,” added Dr Du.

Furthermore, recaticimab outperformed placebo in reducing other lipid parameters, such as non-HDL-cholesterol, ApoB, and Lp(a). According to Dr Du, the incidence and severity of treatment-related adverse events were comparable across treatment groups. Increased alanine transaminase (ALT), increased blood creatine phosphokinase (CPK), and hyperuricaemia were the most common adverse events in both groups.

Prof. Stephen Nicholls (Monash University, Australia), a discussant of the trial, commented that longer studies are required to determine whether this agent can evoke durable reductions in LDL-cholesterol and cardiovascular adverse events cost-effectively.

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   1. Blom DJ, et al. N Engl J Med 2014:370(19):1809–1819.
   2. Robinson JG, et al. N Engl J Med 2015;372(16):1489–1499.
   3. Du X, et al. Recaticimab add-on therapy in patients with non-familial hypercholesterolaemia and mixed hyperlipidemia (REMAIN-2): a multicenter, randomized, double-blind, placebo-controlled phase 3 trial. LB06, AHA Scientific Sessions 2023, 11–13 November, Philadelphia, USA.

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Posted on 29 January, 202429 January, 2024