Abstract

Therapy based on monoclonal antibodies (mAbs) might induce unwanted immunogenicity, which may lead to minor problems, such as injection-site reactions or flu-like symptoms, or to more serious problems, such as anaphylaxis or loss of drug efficacy. Two recent manufacturer-supported reports describe antidrug-antibody formation in patients exposed to mAb-based proprotein convertase subtilisin–kexin type 9 (PCSK9) therapies. Ridker and colleagues reported data from six studies on approximately 4000 patients randomized to the experimental PCSK9 inhibitor bococizumab (a “humanized” …

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