Good acceptance by patients and prescribers of self-injectable PCSK9 antibody
Patient and Physician Perspectives on Mode of Administration of the PCSK9 Monoclonal Antibody Alirocumab, an Injectable Medication to Lower LDL-C Levels
Roth EM, Bujas-Bobanovic M, Louie MJ, Cariou B
Clin Ther. 2015 Aug 13. pii: S0149-2918(15)00936-4. doi: 10.1016/j.clinthera.2015.07.008
BackgroundAlirocumab, a monoclonal antibody directed against PCSK9, has been shown to effectively reduce LDL-c levels [1-4]. Alirocumab is administered as either monotherapy or with background statin therapy and/or other lipid-lowering therapies, via subcutaneous injection. In phase III trials two delivery devices have been used: a prefilled syringe  and a prefilled pen (or autoinjector), using a 1-mL injection volume for doses of 75 or 150 mg [1,2,4].
Patients and physicians will have little experience with injectable lipid-lowering drugs. This study was set up to assess patient and physician perceptions of the ease of use and acceptance of those devices. 200 physicians (99 primary care physicians [PCP]) and 200 patients from 6 countries were interviewed via a self-administered questionnaire. Participants were randomly assigned to interact with either the pen or the syringe.
- Physicians agreed to 83% to 100% of positively formulated statements about device operation and ease of use, regarding both devices.
- After instruction and testing of the devices on a prosthetic pad, physicians estimated that 66% (pen) and 58% (syringe) of patients would be willing to use the device to self-inject alirocumab, representing relative increases from before testing of 22% and 16% respectively.
- Specialist estimates of acceptance by patients were higher than PCP estimates (pen: 60 vs. 47% before and 72 vs. 61% after testing, syringe: 57 vs. 61% before and 63 vs 54% after).
- Patient acceptance was also high for both devices, with 86% to 100% agreeing with statements about device operation and ease of use.
- After instruction and testing, 72% (pen) and 63% (syringe) of patients were willing to self-inject the drug if their physician recommended it, representing relative increases of 26% and 11% from before testing.
- After testing the devices, 74% (pen) and 66% (syringe) of patients indicated that they would be confident in self-injecting at home.
ConclusionThis study shows that both physicians’ and patients’ acceptance of alirocumab injection via either a pen or a syringe was positive. While the majority of patients did not have experience with injectable medication, the devices were considered easy to use. The willingness of patients to self-inject or of physicians to prescribe was higher with the pen than with the syringe. Instructions on and testing of the devices increased the acceptance of the devices. Thus, it appears that in clinical practice, using prefilled pen or syringe devices do not discourage most physicians from prescribing and patients from self-administering this drug.
Find this article online at Clinical Therapeutics
1. Cannon CP ,Cariou B,Blom D,et al. Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated doses of statins: the ODYSSEY COMBO II randomized controlled trial. Eur Heart J. 2015 1186–1194.
2. Kereiakes DJ, Robinson JG, Cannon CP,et al. Efficacy and safety of the PCSK9 inhibitor alirocumab among high cardiovascular risk patients on maximally tolerated statin therapy: the ODYSSEY COMBO I study. Am HeartJ. 2015; 169:906–915e13.
3. Robinson JG, Farnier M, Krempf M, et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015;372:1489–1499.
4. Roth EM, Taskinen MR, Ginsberg HN, et al. Monotherapy with thePCSK9inhibitoralirocumabversusezetimibein patients withhypercholesterolemia:resultsofa24week, double-blind, randomizedPhase3trial. Int JCardiol. 2014;176:55–61.