Evinacumab in Patients with Refractory Hypercholesterolemia
Open accessAbstract
BACKGROUND: Patients with refractory hypercholesterolemia, who have high low-density lipoprotein (LDL) cholesterol levels despite treatment with lipid-lowering therapies at maximum tolerated doses, have an increased risk of atherosclerosis. In such patients, the efficacy and safety of subcutaneous and intravenous evinacumab, a fully human monoclonal antibody against angiopoietin-like 3, are not known. METHODS: In this double-blind, placebo-controlled, phase 2 trial, we enrolled patients with or without heterozygous familial hypercholesterolemia who had refractory hypercholesterolemia, with a screening LDL cholesterol level of 70 mg per deciliter or higher with atherosclerosis or of 100 mg per deciliter or higher without atherosclerosis. Patients were randomly assigned to receive subcutaneous or intravenous evinacumab or placebo. The primary end point was the percent change from baseline in the LDL cholesterol level at week 16 with evinacumab as compared with placebo. RESULTS: In total, 272 patients were randomly assigned to the following groups: subcutaneous evinacumab at a dose of 450 mg weekly (40 patients), 300 mg weekly (43 patients), or 300 mg every 2 weeks (39 patients) or placebo (41 patients); or intravenous evinacumab at a dose of 15 mg per kilogram of body weight every 4 weeks (39 patients) or 5 mg per kilogram every 4 weeks (36 patients) or placebo (34 patients). At week 16, the differences in the least-squares mean change from baseline in the LDL cholesterol level between the groups assigned to receive subcutaneous evinacumab at a dose of 450 mg weekly, 300 mg weekly, and 300 mg every 2 weeks and the placebo group were -56.0, -52.9, and -38.5 percentage points, respectively (P<0.001 for all comparisons). The differences between the groups assigned to receive intravenous evinacumab at a dose of 15 mg per kilogram and 5 mg per kilogram and the placebo group were -50.5 percentage points (P<0.001) and -24.2 percentage points, respectively. The incidence of serious adverse events during the treatment period ranged from 3 to 16% across trial groups. CONCLUSIONS: In patients with refractory hypercholesterolemia, the use of evinacumab significantly reduced the LDL cholesterol level, by more than 50% at the maximum dose. (Funded by Regeneron Pharmaceuticals; ClinicalTrials.gov number, NCT03175367.).
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In a phase 2 trial of 272 patients with refractory hypercholesterinaemia, evinacumab at a dose of 450 mg per week reduced LDL-C levels by −56% compared with baseline.
“Another phase 2 trial studied evinacumab in 272 patients with refractory hypercholesterinaemia (either HeFH or established atherosclerosis). At a dose of 450 mg per week, evinacumab reduced LDL-C levels by − 56% compared with baseline [151].”
From Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention (2023) · cites this paper as [151]
The Trial Groups section (p. 4) reports 272 patients randomized in this phase 2 trial. The results table (p. 9) reports a 47.2% LDL-C reduction from baseline for the 450-mg-weekly group; 56.0 percentage points is the difference versus placebo, not the reduction from baseline. (LLM, conf=0.92)
Experimental — accuracy not yet measuredEvinacumab reduces ApoB levels by >40% in adults with refractory hypercholesterolemia or homozygous familial hypercholesterolemia when administered intravenously at 15 mg/kg.
“In comparison, evinacumab, a monoclonal antibody against ANGPTL3 that is thought to cause near-total suppression of ANGPTL3 activity, 7,14,15 reduces ApoB levels by >40% in adults with refractory hypercholesterolemia or homozygous familial hypercholesterolemia in its intravenous formulation administered at a dose of 15 mg/kg.14,15”
From Effect of Vupanorsen on Non–High-Density Lipoprotein Cholesterol Levels in Statin-Treated Patients With Elevated Cholesterol: TRANSLATE-TIMI 70 (2022) · cites this paper as [15]
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- Authors
- Rosenson, R. S., Burgess, L. J., Ebenbichler, C. F., Baum, S. J., Stroes, E. S. G., Ali, S., Khilla, N., Hamlin, R., Pordy, R., Dong, Y., Son, V., & Gaudet, D.
- Affiliations
- Innsbruck Medical University (AT)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2020-12-10
- Volume
- 383
- Issue
- 24
- Pages
- 2307-2319
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3098138308
- Semantic Scholar
- ac311c54adb72af58fcfc75c3ae055aadb835e6b
- Cited by
- 302
- References
- 41
- Citations by year
- 2026: 27 · 2025: 45 · 2024: 52 · 2023: 55 · 2022: 55 · 2021: 65 · 2020: 3
- FWCI
- 40.62
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- Regeneron Pharmaceuticals
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
- Keywords
- evinacumab, LDL cholesterol lowering, ANGPTL3, heterozygous familial hypercholesterolemia, atherosclerosis, subcutaneous administration, intravenous administration, monoclonal antibodies, lipid-lowering therapy, adverse events, dose comparison, treatment efficacy and safety, atherosclerotic cardiovascular disease
- MeSH terms
- Angiopoietin-like Proteins, Angiopoietin-Like Protein 3, Adult, Antibodies, Monoclonal, Anticholesteremic Agents, Double-Blind Method, Drug Administration Schedule, Drug Resistance, Female, Humans, Hyperlipoproteinemia Type II, Infusions, Intravenous, Injections, Subcutaneous, Cholesterol, LDL, Male, Middle Aged, Antibodies, Monoclonal, Humanized
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