Effect of Evolocumab on Lipoprotein Apheresis Requirement and Lipid Levels: Results of the Randomized, Controlled, Open-Label DE LAVAL Study

Abstract Background Lipoprotein apheresis (LA) can effectively lower lipoproteins but is an invasive procedure. Objective To evaluate whether evolocumab can reduce LA requirement in patients undergoing chronic LA. Methods Patients on regular weekly or every-2-week (Q2W) LA and moderate-to-high-intensity statin (if tolerated) with pre-LA low-density lipoprotein-cholesterol (LDL-C) levels ≥2.6 mmol/L (100 mg/dL) to ≤4.9 mmol/L (190 mg/dL) were randomized to continue the same LA frequency, or discontinue LA and receive evolocumab 140 mg Q2W subcutaneously for 6 weeks. At week 6, all patients received only open-label evolocumab for 18 weeks. The primary endpoint was LA avoidance at the end of 6 weeks based on achieving pre-LA LDL-C Results Thirty-nine patients (mean [SD] age 62 [10] years, 59% male, 82% with familial hypercholesterolemia) were randomized (evolocumab, n=19; LA, n=20). At the end of 6 weeks, more patients receiving evolocumab avoided LA than those receiving LA (84% vs 10%; treatment difference, 74% [95% CI: 45, 87]; P Conclusion Evolocumab treatment significantly reduced LA requirement in patients undergoing chronic LA. Additionally, >50% of patients achieved LDL-C