Usability and Acceptability of the Abatacept Pre-Filled Autoinjector for the Subcutaneous Treatment of Rheumatoid Arthritis

Abstract

IntroductionThe purpose of the present study was to determine whether the abatacept autoinjector can be used by the intended population without patterns of preventable use errors, and is acceptable when assessed against key user needs.MethodsTwo independently conducted simulated-use studies, with no active drug administered, quantified use errors and evaluated the abatacept autoinjector and competitor devices on key attributes (comfort, control, ease of use, confidence of dose) and overall acceptability. Autoinjector preference was also assessed. Participants were patients with rheumatoid arthritis, caregivers, and healthcare professionals (HCPs). Participants were informed that a new rheumatoid arthritis autoinjector was being tested but were blinded to the intended drug and sponsor identity.ResultsIn the formative (pre-validation) study (n = 54), two high-priority use errors occurred, both of which resulted from protocol non-compliance rather than mental confusion or physical limitations. In the summative (validation) study (n = 99), one high-priority use error occurred; this was deemed a simulated-use study artifact as participant behavior was guided by actual experience associated with the feel of drug delivery into the skin rather than by protocol, so no mitigation steps were considered necessary. Across user groups, average scores were consistently high for the pre-defined key attributes. Overall acceptability scores (7-point scale) were significantly higher for the abatacept versus competitor autoinjectors—formative study: patients 6.7 vs 5.2 (P = 0.0001), caregivers 7.0 vs 4.6 (P = 0.0093), HCPs 6.8 vs 5.1 (P = 0.0020); summative study: patients 6.5 vs 5.9 (P = 0.0404), caregivers 6.8 vs 5.8 (P = 0.0047), HCPs 6.8 vs 5.1 (P = 0.0002). The abatacept autoinjector was preferred to competitor devices: patients 85.7% vs 14.3% (P = 0.00002), caregivers 84.2% vs 15.8% (P = 0.00443), HCPs 95.0% vs 5.0% (P = 0.00004). Positive experiences with the abatacept autoinjector were attributed to the rubberized grip, device size, visualization of dose progression, button ergonomics, and ease of use.ConclusionThe abatacept autoinjector demonstrated usability without patterns of preventable use errors, and with high acceptability ratings across all key attributes assessed. Preference over competitor autoinjectors was due to device ergonomics, visualization of dose progression, confidence of dose delivery, and overall ease of use.FundingBristol-Myers Squibb.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-016-0286-9) contains supplementary material, which is available to authorized users.

Toward a new age of patient centricity? The application of eye-tracking to the development of connected self-injection systems

“…Formative usability studies have proven indispensable tools to advance device development [32,33]. Traditionally, new product development has advanced in cycles of optimizing the user interface of pen systems and (re-) assessing patient preferences [34].…”

“…Traditionally, new product development has advanced in cycles of optimizing the user interface of pen systems and (re-) assessing patient preferences [34]. Specifically, users' self-reported ratings or responses to openended questions [18,21,35,36], interviews [37,38], or observations [39][40][41] have been established as standard methods to assess patient engagement with mechanical autoinjectors or dial-anddose insulin pens [33,[42][43][44]. However, two key challenges highlight the urgent need for new methodological approaches to study usability of digitally enhanced drug delivery systems.…”

Hold the device against the skin: the impact of injection duration on user’s force for handheld autoinjectors

“…Subcutaneous administration of drugs is driving changes in global health-care systems [1,2]. In particular, novel device designs enable patient-centered concepts to healthcare and allow users across chronic disease states to routinely self-inject drugs at home, thereby eliminating the need of going to a hospital or infusion center [3][4][5][6][7]. Still, the delivery of around 1 mL of drug has been treated as upper limit using handheld autoinjectors, as the list of recently approved drug products indicates (see Table 1).…”

Usability and Patient Preference Phase 3 Study of the Sarilumab Pen in Patients with Active Moderate-to-Severe Rheumatoid Arthritis

“…Patients with RA may need to administer biologic therapies via subcutaneous injections and may have difficulty manipulating syringes, as RA often affects the small joints of the hand, impairing dexterity [17]. Results from previous AUC 0-s area under the plasma concentration-time curve from 0 to the end of the dosing period, C max maximum observed drug concentration, DMARD disease-modifying antirheumatic drug, q2w every 2 weeks, SD standard deviation, t max time to C max a Data were excluded if a patient did not take the study drug or took the wrong dose at day 1 or 71 [13,18,19], such as syringes.…”