Results of a human factors experiment of the usability and patient acceptance of a new autoinjector in patients with rheumatoid arthritis

Abstract

PurposeThis study evaluated the human factors affecting the ease of use of a disposable autoinjector developed for subcutaneous self-injections performed by patients with chronic diseases.Materials and methodsThis was a randomized, single-center study conducted with 65 patients with rheumatoid arthritis. Patients performed six simulated injections. Assessments of patient device acceptance and device usability were made by patient reports and independent observations of compliance with the device instruction for use (IFU) following single injections and repeated injections.ResultsA total of 390 simulated injections were performed. Patient device acceptance was high; more than 90% of patients found each of the tested criteria to be acceptable (>80% was required for statistical significance; P<0.016). Perceived ease of use and simplicity of the three-step process resulted in high acceptance scores: mean scores (± standard deviation) were 8.71 (±1.18) and 8.05 (±0.37), respectively, on a 0–10-point scale. Patients also expressed their acceptance with the ease and usefulness of the detection of the remaining drug in the autoinjector. In addition, 80% of patients declared that they would recommend the device to someone else. Globally, the human factors tested (age, sex, hand disability [Cochin score], extent of previous experience with self-injection [ie, expert or naïve]) had no impact on IFU device compliance. In particular, the lack of a Cochin score interaction indicated that the degree of hand disability is not a predictive factor of poor self-injection capability with this autoinjector.ConclusionThis study demonstrated a high level of patient acceptance for self-injection with this autoinjector among patients with rheumatoid arthritis. In particular, patients with severe hand disability were able to successfully comply with device IFU.

Absolute Bioavailability and Pharmacokinetic Comparability of Sirukumab Following Subcutaneous Administration by a Prefilled Syringe or an Autoinjector

“…These results mirror those observed with another biologic agent, golimumab, when administered SC by standard needle and syringe or a similar autoinjector device to that used in the current study . The use of autoinjectors among patients with RA, including those with severe hand disability, is associated with a high level of acceptance and increased treatment compliance . Thus, data from the current pharmacokinetic study suggest the potential for switching from the existing PFS‐U presentation that was used in the phase 3 efficacy studies to the PFS‐AI device for administration of sirukumab.…”

“…11 The use of autoinjectors among patients with RA, including those with severe hand disability, is associated with a high level of acceptance and increased treatment compliance. 12 Thus, data from the current pharmacokinetic study suggest the potential for switching from the existing PFS-U presentation that was used in the phase 3 efficacy studies to the PFS-AI device for administration of sirukumab.…”

Usability of mepolizumab single-use prefilled autoinjector for patient self-administration

“…One limitation of this study was the small proportion of adolescent (7%) and older patients (!65 years, 16%) in the study population. Further information on the usability of the AI device in these populations would be beneficial; however, other studies have shown that high injection success rates were achieved with AI devices across a variety of participant demographics and disease characteristics (19)(20)(21). A further study limitation was the potential for patient selection bias given that only patients who were willing to selfadminister mepolizumab at home participated.…”

Patient Perceptions and Preferences of Two Etanercept Autoinjectors for Rheumatoid Arthritis: Findings from a Patient Survey in Europe

“…Altogether, the attributes of the Benepali autoinjector that patients most preferred, which were in alignment with results from the nurse survey [17], can be described as those that make the handling process easier for the patient, suggesting that both patients and nurses in Europe consider the Benepali autoinjector to be easier to handle than the Enbrel MYCLIC autoinjector. This is of paramount importance, as many patients with RA suffer from compromised dexterity, which can affect the ability to perform the steps required [20]. …”