Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment

Phase 3 Completed 39 enrolled Amgen

RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled low-density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future apheresis.

Timeline

Start: 2015-12-21
Primary completion: 2016-09-01
Completion: 2017-01-20

Outcome

Met primary endpoint

registry NUMBER Apheresis: 10.0 (2.8 to 30.1) percentage of participants NUMBER Evolocumab: 84.2 (62.4 to 94.5) percentage of participants NCT02585895 ↗

registry analysis (unspecified test); Apheresis vs Evolocumab; p < 0.0001; Treatment Difference 74.2 (95% CI 44.6 to 86.8); Cochran-Mantel-Haenszel NCT02585895 ↗

release “The study met its primary endpoint, demonstrating that treatment with Repatha significantly reduced the need for LDL-C apheresis in adult patients” amgen.com ↗

Publications

Background Baum SJ, Sampietro T, Datta D, Moriarty PM, Knusel B, Schneider J, Somaratne R, Kurtz C, Hohenstein B. Effect of evolocumab on lipoprotein apheresis requirement and lipid levels: Results of the randomized, controlled, open-label DE LAVAL study. J Clin Lipidol. 2019 Nov-Dec;13(6):901-909.e3. doi: 10.1016/j.jacl.2019.10.003. Epub 2019 Oct 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Evolocumab	Monoclonal antibody	140 mg	Subcutaneous