Safety and Efficacy of Recaticimab in Dyslipidemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Abstract

Dyslipidemia is an established risk factor for atherosclerotic cardiovascular disease (ASCVD). Recaticimab is a novel humanized monoclonal antibody that specifically targets proprotein convertase subtilisin/kexin type 9 (PCSK9). It has shown promising results in reducing low-density lipoprotein cholesterol (LDL-C) levels. Here, we aim to further investigate the safety and efficacy of recaticimab in patients with dyslipidemia. We comprehensively searched PubMed, Scopus, Web of Science, and Cochrane Library databases to identify all randomized controlled trials (RCTs) comparing recaticimab with placebo. Eligible RCTs were selected, and their data were extracted and analyzed using the RevMan software. Four studies involving 1657 patients were included in this meta-analysis. In terms of efficacy outcomes, compared with the placebo group, recaticimab significantly decreased levels of LDL-C, non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), triglyceride (TG), and lipoprotein(a) [Lp(a)], with the following values, respectively: (mean difference (MD): -52.62, 95% confidence interval (CI) [-57.25, -47.99], p < 0.00001); (MD: -47.03, 95% CI [-48.96, -45.11], p < 0.00001); (MD: -44.33, 95% CI [-46.08, -42.58], p < 0.00001); (MD: -8.83, 95% CI [-13.03, -4.63], p < 0.0001); and (MD: -29.21, 95% CI [-32.10, -26.31], p < 0.00001). In terms of safety outcomes, there was no significant difference between recaticimab and placebo groups in the incidence of any adverse events (odds ratio (OR): 1.16, 95% CI [0.90, 1.51], p = 0.26), serious adverse events, upper respiratory tract infections, or elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma-glutamyl transferase (GGT). However, recaticimab was associated with higher odds of injection site reactions compared with placebo (OR: 2.65, 95% CI [1.24, 5.67], p = 0.01). Recaticimab significantly reduced LDL-C levels and was associated with a manageable safety profile, even with dosing intervals of up to 12 weeks. Further studies should be conducted globally in larger and more diverse patient populations.