Patient and Physician Perspectives on Mode of Administration of the PCSK9 Monoclonal Antibody Alirocumab, an Injectable Medication to Lower LDL-C Levels

• Published in: Clinical therapeutics Vol. 37; no. 9; pp. 1945 - 1954.e6
• Main Authors: Roth, Eli M., MD, FACC, Bujas-Bobanovic, Maja, MD, MSc, Louie, Michael J., MD, MPH, MSc, Cariou, Bertrand, MD, PhD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-09-2015; Elsevier Limited; Elsevier
• Series: Equipe 5
• Subjects: administration; Adult; Age; Aged; alirocumab; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - therapeutic use; Attitude of Health Personnel; Attitude to Health; Cholesterol, LDL - blood; Clinical trials; Data collection; devices; Diabetes; Drug Delivery Systems - psychology; Drug dosages; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Hypercholesterolemia - blood; Hypercholesterolemia - drug therapy; Hyperlipoproteinemia Type II - blood; Hyperlipoproteinemia Type II - drug therapy; Injections; Internal Medicine; Life Sciences; Lipids; Male; Medical Education; Middle Aged; Patients; PCSK9; pen; Physicians; Prostheses; Self Administration - psychology; syringe; Syringes; United Kingdom > UK; United States > US; Germany; pen; syringe; alirocumab; PCSK9; devices; administration; Middle Aged; Antibodies; Male; Drug Delivery Systems; Self Administration; LDL; Female; Monoclonal; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Attitude of Health Personnel; Attitude to Health; Hyperlipoproteinemia Type II; Cholesterol; Injections; Hypercholesterolemia; Syringes; Aged; adult; humans
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/j.clinthera.2015.07.008

Abstract Purpose Clinical trials of the PCSK9 inhibitor alirocumab, an every 2 week injectable monoclonal antibody, have shown significant reductions in LDL-cholesterol. However, many patients requiring lipid-lowering therapy are not experienced with self-injected medication. This study assessed patient and physician perceptions of 2 alirocumab delivery devices. Methods 400 participants (200 physicians, 200 patients) were included from 6 countries. Physicians (99 primary care physicians [PCPs]; 101 specialists) had mean practice experience of 17.8 years and an average of 797 hypercholesterolemic patients. Participating patients had LDL-C levels above their goal and at least one of the following: familial hypercholesterolemia, statin intolerance, high cardiovascular risk, and/or diabetes. Mean patient age was 58.5 years, 51% were female, and 25.5% had injectable medication experience. Following device instruction and demonstration, participants tested either a pre-filled pen or pre-filled syringe, using both 75 and 150 mg doses of single-blinded placebo into a prosthetic pad. Data were collected by self-administered questionnaire. Findings Participant acceptance of both devices was positive, with 83-100% agreeing with ease-of-use statements. After testing, physicians estimated that 66% (pen) and 58% (syringe) of their patients would be willing to self-inject using the device (relative increases from pre-testing of 22% and 16%, respectively; both P <0.05). Specialist estimates were higher than PCP estimates: for the pen, 60% versus 47% (pre-testing), respectively, and 72% versus 61% (post-testing); for the syringe, 57% versus 43% (pre-testing), 63% versus 54% (post-testing; all P <0.05, specialist vs PCP). After testing, 72% (pen) and 63% (syringe) of patient-participants were very willing to self-inject (relative increases from pre-testing of 26% [ P <0.05] and 11%, respectively); 96% (pen) and 93% (syringe) were either very willing or somewhat willing to self-inject. The proportion of patients aged <60 years who were very willing to self-inject with either device was numerically (but not statistically) higher compared with those ≥60 years. Initially, patients with injectable medication experience were generally more willing to use the pen than injection-naive patients; after testing there was no difference between groups. No significant differences were observed in responses to the 2 different doses. Implications Responses from physicians and patients to pre-filled pen and syringe devices were positive. Devices were considered easy to operate, with most patients willing to use and accept self-injection. Patient willingness to self-inject increased after demonstration and testing. Results suggest that, in clinical practice, alirocumab administration by either pre-filled pen or syringe would not deter most physicians from prescribing or most patients from self-administering.