Long-Term Reduction in Lipoprotein (a) With the PCSK9 Monoclonal Antibody Evolocumab (AMG 145): A Pooled Analysis of 3278 Patients in Phase 2, 3, and Open Label Extension Studies

Introduction: Lipoprotein (a) {Lp(a)}, a pro-atherogenic lipoprotein related to low-density lipoprotein, is independently associated with cardiovascular disease risk. Current therapeutic options to reduce Lp(a are limited. We assessed the long-term effect of evolocumab (AMG 145), a fully human monoclonal antibody to PCSK9 on Lp(a) from a pooled analysis of phase 2, 3, and open label studies. Methods: Data from 3278 patients were analyzed. These patients completed a 12 week parent phase 2 or 3 evolocumab study and were followed for an additional 52 weeks after being re-randomized 2:1 to evolocumab + standard of care (SoC) vs SoC only, in the extension phase. Parent study results for the control patients and patients receiving evolocumab 140 mg Q2W or 420 mg QM subcutaneously were reported. In the extension phase, all participating parent study patients received either 140 mg Q2W or 420 mg QM, and the results for these two doses were combined. Lp(a) was measured by the same standardized isoform-independent ...