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Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab.

Paul M Ridker1, Jean-Claude Tardif1, Pierre Amarenco1

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The New England Journal of Medicine
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Bococizumab effectively lowered LDL cholesterol, but antidrug antibodies diminished its effect and durability. Wide variability in cholesterol reduction was observed even without antibodies.

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Area of Science:

  • Cardiology
  • Pharmacology
  • Immunology

Background:

  • Bococizumab is a monoclonal antibody targeting PCSK9, aiming to reduce LDL cholesterol.
  • The long-term efficacy and variability of bococizumab's lipid-lowering effects require further investigation.

Purpose of the Study:

  • To evaluate the efficacy, variability, and durability of bococizumab in reducing LDL cholesterol levels.
  • To assess the impact of antidrug antibodies on bococizumab's lipid-lowering effects and cardiovascular outcomes.

Main Methods:

  • Six multinational clinical trials involving 4300 hyperlipidemia patients receiving bococizumab or placebo.
  • Lipid changes were monitored over 12 months, with stratification based on antidrug antibody presence.

Main Results:

  • Bococizumab significantly reduced LDL cholesterol by 54.2% at 12 weeks compared to placebo.
  • High-titer antidrug antibodies developed in a substantial proportion, diminishing LDL cholesterol reduction.
  • Significant variability in LDL cholesterol reduction was noted, even in patients without antidrug antibodies.

Conclusions:

  • Antidrug antibodies significantly attenuated bococizumab's LDL cholesterol-lowering efficacy and durability.
  • Wide variability in cholesterol reduction was observed, irrespective of antibody development.
  • Bococizumab showed no significant difference in major cardiovascular events compared to placebo.