Physicians' Academy for Cardiovascular Education

Antidrug antibodies against PCSK9 antibody did not affect efficacy and safety

Antidrug Antibodies in Patients Treated with Alirocumab

Letter to the editor

Literature - Roth EM, Goldberg AC, Catapano AL, et al. - NEJM 2017, Epub ahead of print

Background

Important positive outcome data of the FOURIER trial, in which the fully human PCSK9 antibody evolocumab had been used, have just been published [1]. On the other hand, clinical development of a second murine-derived PCSK9 antibody, bococizumab, had been discontinued due to immunogenicity [2]. Also alirocumab, another PCSK9 antibody but also fully human, provoked immunogenicity at very low rates in the ODYSSEY trials.

To assess the potential effect of antidrug antibodies against alirocumab on efficacy – in terms of LDL-lowering – and safety, antidrug antibody levels were evaluated in 4747 patients of 10 ODYSSEY trials and related to these parameters.

Main results

Conclusion

Although antidrug antibodies were present in some patients treated with alirocumab, this did not affect the magnitude and duration of LDL-lowering. However, it should be noted that the number of patients with immunogenicity was very small.

References

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Find this letter online at NEJM