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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” mAb) or placebo. At 12 months, LDL cholesterol was significantly reduced with bococizumab (mean, −40%), but 48% of bococizumab patients had high-titer antidrug antibodi…