Antidrug Antibodies in Patients Treated with Alirocumab
Open accessAbstract
In 10 clinical trials involving 4747 patients, among those who received the PCSK9 inhibitor alirocumab, antidrug antibodies developed in 5.1%, although no significant effect was seen on the reduction in LDL cholesterol levels.
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Antidrug antibodies have been shown not to influence the lipid-lowering efficacy of alirocumab.
“and have been shown not to influence the lipid-lowering efficacy of alirocumab. 22”
From Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (2018) · cites this paper as [22]
The correspondence reports that substantial LDL-cholesterol reductions were maintained regardless of antidrug-antibody status, supporting the claim's main point. But it also notes nominally significant differences at some time points and says the findings are limited by the small number of patients who developed antibodies. It therefore does not establish that antibodies had no influence on efficacy. (LLM, conf=0.87)
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References 4 · Cited by 90
- Authors
- Roth, E. M., Goldberg, A. C., Catapano, A. L., Torri, A., Yancopoulos, G. D., Stahl, N., Brunet, A., Lecorps, G., & Colhoun, H. M.
- Affiliations
- Sterling Research Group (US)
- Washington University in St. Louis (US)
- University of Milan (IT)
- Regeneron (United States) (US)
- Sanofi (United States) (US)
- Sanofi (France) (FR)
- University of Edinburgh (GB)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2017-04-20
- Volume
- 376
- Issue
- 16
- Pages
- 1589-1590
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2596887658
- Semantic Scholar
- 88191090dd5b1eb6f58b738b209af2db7ad162fe
- Cited by
- 90
- References
- 4
- Citations by year
- 2026: 2 · 2025: 9 · 2024: 4 · 2023: 7 · 2022: 6 · 2021: 3 · 2020: 12 · 2019: 12 · 2018: 19 · 2017: 15 · 2013: 1
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- other-oa
- Locations
- New England Journal of Medicine (publishedVersion, other-oa)
- PubMed (publishedVersion)
- Archivio Istituzionale della Ricerca (Universita Degli Studi Di Milano) (submittedVersion, other-oa)
- Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Keywords
- alirocumab, antidrug antibodies, PCSK9 inhibitors, LDL cholesterol lowering, PCSK9, drug safety, hypercholesterolemia treatment
- MeSH terms
- Antibodies, Antibodies, Monoclonal, Anticholesteremic Agents, Humans
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