Cited by 369Lipoproteins and Cardiovascular HealthLipid metabolism and disordersCholesterol and Lipid Metabolism

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Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab

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Ridker, Paul M, Tardif, Jean-Claude, Amarenco, Pierre, Duggan, William, Glynn, Robert J., Jukema, J. Wouter, Kastelein, John J.P., Kim, Albert M., Koenig, Wolfgang, Nissen, Steven, Revkin, James, Rose, Lynda M., Santos, Raul D., Schwartz, Pamela F., Shear, Charles L., Yunis, Carla·2017·New England Journal of Medicine

DOI 10.1056/nejmoa1614062

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Abstract

BACKGROUND: Bococizumab, a humanized monoclonal antibody targeting proprotein convertase subtilisin-kexin type 9 (PCSK9), reduces levels of low-density lipoprotein (LDL) cholesterol. However, the variability and durability of this effect are uncertain. METHODS: We conducted six parallel, multinational lipid-lowering trials enrolling 4300 patients with hyperlipidemia who were randomly assigned to receive 150 mg of bococizumab or placebo subcutaneously every 2 weeks and who were followed for up to 12 months; 96% were receiving statin therapy at the time of enrollment. The patients were assessed for lipid changes over time, stratified according to the presence or absence of antidrug antibodies detected during the treatment period. RESULTS: At 12 weeks, patients who received bococizumab had a reduction of 54.2% in the LDL cholesterol level from baseline, as compared with an increase of 1.0% among those who received placebo (absolute between-group difference, -55.2 percentage points). Significant between-group differences were also observed in total cholesterol, non-high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein(a) (P<0.001 for all comparisons). However, high-titer antidrug antibodies developed in a substantial proportion of the patients who received bococizumab, which markedly diminished the magnitude and durability of the reduction in LDL cholesterol levels. In addition, among patients with no antidrug antibodies, there was wide variability in the reduction in LDL cholesterol levels at both 12 weeks and 52 weeks. Major cardiovascular events occurred in 57 patients (2.5%) who received bococizumab and in 55 (2.7%) who received placebo (hazard ratio, 0.96; 95% confidence interval, 0.66 to 1.39; P=0.83). The most common adverse event among patients who received bococizumab was injection-site reaction (12.7 per 100 person-years). CONCLUSIONS: In six multinational trials evaluating bococizumab, antidrug antibodies developed in a large proportion of the patients and significantly attenuated the lowering of LDL cholesterol levels. Wide variation in the relative reduction in cholesterol levels was also observed among patients in whom antidrug antibodies did not develop. (Funded by Pfizer; SPIRE ClinicalTrials.gov numbers, NCT01968954 , NCT01968967 , NCT01968980 , NCT02100514 , NCT02135029 , and NCT02458287 .).

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Authors: Ridker, P. M., Tardif, J.-C., Amarenco, P., Duggan, W., Glynn, R. J., Jukema, J. W., Kastelein, J. J. P., Kim, A. M., Koenig, W., Nissen, S., Revkin, J., Rose, L. M., Santos, R. D., Schwartz, P. F., Shear, C. L., & Yunis, C.
Affiliations: Brigham and Women's Hospital (US)
ORCID: Ridker, Paul M
Tardif, Jean-Claude
Amarenco, Pierre
Glynn, Robert J.
Jukema, J. Wouter
Kastelein, John J.P.
Kim, Albert M.
Nissen, Steven
Revkin, James
Rose, Lynda M.
Santos, Raul D.
Yunis, Carla
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2017-04-20
Volume: 376
Issue: 16
Pages: 1517-1526
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1614062
OpenAlex: W2596676407
Cited by: 369
References: 14
Citations by year: 2026: 18 · 2025: 32 · 2024: 25 · 2023: 31 · 2022: 33 · 2021: 27 · 2020: 46 · 2019: 50 · 2018: 56 · 2017: 51
FWCI: 56.82
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (publishedVersion, other-oa)
PubMed (publishedVersion)
Pure Amsterdam UMC (submittedVersion, other-oa)
Data Archiving and Networked Services (DANS) (submittedVersion)
Leiden Repository (Leiden University) (submittedVersion)
mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
Life Sciences › Biochemistry, Genetics and Molecular Biology › Biochemistry › Cholesterol and Lipid Metabolism
Keywords: bococizumab, PCSK9 inhibitors, antidrug antibodies, LDL cholesterol lowering, hyperlipidemia, statin therapy, apolipoprotein B, lipoprotein(a), cardiovascular events, injection site reactions, monoclonal antibody therapy, drug durability, treatment response heterogeneity, cardiovascular risk reduction
MeSH terms: Proprotein Convertase 9, PCSK9 Inhibitors, Antibodies, Anticholesteremic Agents, Female, Follow-Up Studies, Humans, Hypercholesterolemia, Injections, Subcutaneous, Lipids, Cholesterol, LDL, Male, Middle Aged, Treatment Outcome, Antibodies, Monoclonal, Humanized

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Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab

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