Abstract 14270: The Effect of Evinacumab on Apheresis Eligibility in Patients With Homozygous Familial Hypercholesterolemia
| Autor: | Daniel Gaudet, Frederick J. Raal, Robert Pordy, Nagwa Khilla, Robert S. Rosenson, Poulabi Banerjee, Yi Zhang, Laurens F. Reeskamp, John J.P. Kastelein, Jennifer McGinniss, Shazia Ali, Paolo Rubba, G. Kees Hovingh, Kuo-Chen Chan |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Lipid disorder business.industry medicine.drug_class Evinacumab Familial hypercholesterolemia medicine.disease Monoclonal antibody Gastroenterology Clinical trial Apheresis Physiology (medical) Internal medicine Medicine In patient Cardiology and Cardiovascular Medicine business Lipoprotein cholesterol |
| Zdroj: | Circulation. 142 |
| ISSN: | 1524-4539 0009-7322 |
| DOI: | 10.1161/circ.142.suppl_3.14270 |
| Popis: | Background: Homozygous familial hypercholesterolemia (HoFH) is a rare genetic lipid disorder characterized by elevated low-density lipoprotein cholesterol (LDL-C) levels and premature atherosclerotic cardiovascular disease. Evinacumab, a fully human monoclonal antibody against angiopoietin-like protein 3, has demonstrated approximately 50% reductions in LDL-C in HoFH patients when added to maximally tolerated lipid-lowering therapies. Objective: In this post-hoc analysis, we assessed the effect of evinacumab on the eligibility for apheresis using predefined US and EU apheresis criteria. Methods: This was a double-blind, placebo-controlled, 24-week phase 3 trial (NCT03399786) that randomized patients 2:1 to evinacumab 15 mg/kg intravenously every 4 weeks (Q4W; n=43) or placebo (n=22). We assessed the proportion of patients who met per protocol US apheresis criteria (LDL-C ≥300 mg/dL), newer US criteria for FH (LDL-C ≥300 mg/dL or LDL-C ≥160 mg/dL with coronary heart disease or peripheral artery disease) and per protocol EU apheresis criteria (LDL-C >160 mg/dL [primary prevention] or >120 mg/dL [secondary prevention]) at baseline and week 24. Results: Under the newer US criteria (2018), 62.8% (n=27) of evinacumab-treated patients and 54.5% (n=12) placebo-treated patients qualified for apheresis at baseline (Table). Following 24 weeks of treatment, 48.8% of all evinacumab versus 9.1% of all placebo patients no longer qualified for apheresis. Similar results were observed using EU apheresis criteria, where 46.5% of evinacumab-treated patients shifted from qualifying for apheresis at baseline to not qualifying at week 24, compared with 4.5% of placebo-treated patients. The majority of evinacumab (65.1%) and placebo (68.2%) patients did not qualify for per protocol US apheresis at baseline, however a shift of 27.9% and 9.1% was observed, respectively. Conclusions: Evinacumab has the potential to reduce the need for apheresis in patients with HoFH. |
| Databáze: | OpenAIRE |
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