<p>Patient Reported Ease-of-Use with a Disposable Autoinjector in Individuals with Migraine</p>

Abstract

Purpose: Erenumab-aooe (erenumab, Aimovig ®)-a fully human monoclonal antibody that inhibits the calcitonin gene-related peptide (CGRP) receptor-is approved for the prevention of migraine in adults in a number of countries. The approved monthly dosage of erenumab (70 and/or 140 mg, depending on the country) is available as a single, prefilled autoinjector for subcutaneous administration in most countries where it is approved. This study evaluated the patient-reported ease-of-use, ability to learn self-injection, confidence in performing a simulated self-injection, and ergonomics of a prefilled autoinjector device for erenumab (SureClick ® autoinjector) in individuals in the US with migraine. Patients and Methods: Participants with migraine headaches, all of whom were naïve to the use of an autoinjector for migraine or another condition and CGRP therapy, were recruited from three US-based headache centers. Each participant received a supervised demonstration of the autoinjector during a 30-minute one-on-one session using a standard protocol-driven script. Participants then practiced a simulated injection into an artificial tissue pad using the autoinjector and were asked to rate their agreement with 19 statements about the device on a 5-point Likert scale (1 = completely disagree, 2 = somewhat disagree, 3 = neutral, 4 = somewhat agree, 5 = completely agree). Results: Participants who completed the study and provided responses (n = 204) were between 21 and 85 years of age, inclusive, and 73% were female. More than 90% of the participants completely or somewhat agreed with 16/19 statements relating to the device, including ease-of-use, ability to self-inject, and confidence in using the device, with an average rating of >4.5 on the 5-point Likert scale. Participants rated the size of the device and the compactness of the device as 4.23/5 and 4.26/5, respectively. Conclusion: The erenumab-prefilled disposable autoinjector was consistently highly rated across categories by individuals with migraine, with an average rating of >4.5 on the 5-point Likert scale; results were consistent across the three study centers.

Formative and Validation Human Factors studies of a new disposable autoinjector for subcutaneous delivery of chronic disease therapies

“…A number of treatments for chronic inflammatory diseases are delivered subcutaneously via prefilled syringes or autoinjection devices [1][2][3][4]. Contrary to intravenous infusions, subcutaneous injections provide the convenience of selfadministration, which enhances patient experience, decreases treatment burden, and lowers costs for both patients and healthcare systems [5][6][7][8][9][10][11][12].…”