Evolocumab lowers LDL-C safely and effectively when self-administered in the at-home setting

Ricardo Dent, Raju Joshi, C Stephen Djedjos, Jason Legg, Mary Elliott, Michelle Geller, Dawn Meyer, Ransi Somaratne, Chris Recknor, Robert Weiss, Ricardo Dent, Raju Joshi, C Stephen Djedjos, Jason Legg, Mary Elliott, Michelle Geller, Dawn Meyer, Ransi Somaratne, Chris Recknor, Robert Weiss

Abstract

Evolocumab has been shown to consistently reduce low-density lipoprotein cholesterol (LDL-C) across populations. The phase 3 studies included administration in the home-use and in-clinic settings but did not specifically evaluate the feasibility of home-use administration. Two clinical studies enrolled patients with hypercholesterolemia or mixed dyslipidemia on statin therapy and with/without ezetimibe received evolocumab in the home-use setting. Patients were randomized to self-administer evolocumab using one of two injection devices biweekly over 6 weeks (autoinjector or prefilled syringe; n = 149; ClinicalTrials.gov, NCT01849497) or monthly over 12 weeks (autoinjector or automated minidoser; n = 164; NCT01879319). The first self-administration occurred in the in-clinic setting, and two more were performed in the at-home setting. Patients were successful in self-administering evolocumab in the home-use setting in approximately 95 % of attempts and experienced LDL-C reductions from baseline to week 6 or the mean of weeks 10 and 12 of approximately 65 %. Rates of successful self-administration and LDL-C reduction were similar across dosing schedules and study devices. Adverse events were similar between randomized groups and generally mild in severity. In two clinical studies, therefore, patients were able to successfully self-administer evolocumab in both the in-clinic and at-home settings regardless of which dosing schedule or device they used.

Keywords: Evolocumab; Home-use; In-clinic; PCSK9 inhibition; Self-administration.

Figures

Fig. 1
Fig. 1
Proportion of successful home administrations in a overall population and b prespecified subgroups. Q2W biweekly (140 mg), QM monthly (420 mg), T-1 THOMAS-1, T-2 THOMAS-2
Fig. 2
Fig. 2
Change in LDL-C from baseline to 6 weeks in THOMAS-1 and to the mean of weeks 10 and 12 in THOMAS-2. LDL-C was based on calculated values unless calculated LDL-C was 400 mg/dL, in which case the ultracentrifugation LDL-C value from the same blood sample was used instead, if available. AI autoinjector, AMD automated minidoser, LDL-C low-density lipoprotein cholesterol, PFS prefilled syringe, Q2W biweekly (140 mg), QM monthly (420 mg), SE standard error, T-1 THOMAS-1, T-2 THOMAS-2

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