Abstract 16180: The Adherence and LDL-C Lowering Effect of Inclisiran Among Patients Who Received Treatment at Outpatient Clinics

Abstract

Introduction: Inclisiran is a novel small interfering RNA (siRNA) indicated as an adjunct to diet and maximally tolerated statin to lower LDL-C among adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) in the US. It is administered subcutaneously initially, again at 3 months, and then every six months by an HCP. Subsequent doses may be administered within three months after the scheduled dose without restarting a new dose schedule. Metro Infusion Center (MIC) is one of the largest infusion centers across the US with over 200 centers in 38 states and has clinician oversight over each administration. Hypothesis: To describe the real-world adherence to inclisiran and changes in low-density lipoprotein cholesterol (LDL-C) levels associated with inclisiran use at MICs. Methods: Patient charts for those who initiated inclisiran from March 1, 2022 to November 31, 2022 were reviewed retrospectively. Demographics and clinical characteristics at initiation were collected and patients were followed until May 2023 for the current analysis. The study outcomes included the proportion of eligible patients who received the 2 nd or 3 rd dose and the percent change in LDL-C levels from baseline to the latest available data. Results: A total of 562 patients were included in the analysis from 107 different MICs in over 21 states. Mean (SD) age was 70.6 (9.6) years; 51% were female. The majority of patients (80%) were covered by Medicare. 492 (88%) had a history of ASCVD and 60 (11%) had HeFH. Mean (SD) baseline LDL-C was 147.6 (59.9) mg/dl. Of the 562 patients initiated inclisiran, 531 (95%) received their 2 nd dose, and 91% received the 2 nd dose within ±7 days of the schedule. There were 233 patients eligible to receive a 3 rd dose, 196 (84%) of them had received the 3 rd dose. Among 274 patients who had the LDL-C measured after inclisiran initiation, the average LDL-C reduction from baseline was 46.3%. On average, the first LDL-C measurement was taken at 3 months after receiving at least one dose of Inclisiran. Conclusions: These real-world data demonstrate high adherence to inclisiran with LDL-C reductions of 46.3% at 3 months. This finding was consistent with the ORION clinical development program.