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


RESULTS
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.


CONCLUSIONS
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.
The Sterling Research Group and University of Cincinnati, Cincinnati, Ohio. Electronic address: eroth@sterlingresearch.org.
Eli M
EM
Roth
Sanofi, Paris, France.
Maja
M
Bujas-Bobanovic
Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
Michael J
MJ
Louie
Department of Endocrinology, l'Institut du Thorax, Nantes University Hospital, Nantes, France.
Bertrand
B
Cariou
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D001291:Attitude of Health Personnel; D001294:Attitude to Health; D008078:Cholesterol, LDL / Q000097:blood; D016503:Drug Delivery Systems / Q000523:psychology*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D006938:Hyperlipoproteinemia Type II / Q000097:blood / Q000188:drug therapy; D007267:Injections; D008297:Male; D008875:Middle Aged; D012646:Self Administration / Q000523:psychology; D013594:Syringes
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; C571059:alirocumab
PCSK9; administration; alirocumab; devices; pen; syringe