Patient Experience and Improvement Opportunities in Self-Administered, Large-Volume Subcutaneous Infusions at Home.

Purpose: Subcutaneous (SC) administration is largely established as the preferred route to deliver biotherapeutics. Although the majority of approved SC products are limited to dose volumes ≤2.25 mL, there has been increasing industry focus on large-volume SC (LVSC) development. To date, however, there are few LVSC biotherapeutics available for self-administration, and subcutaneous immunoglobulin (SCIg) remains the most established example. As a result, there is limited published literature on real-world practices with LVSC therapies to inform user needs and preferences for delivery device design attributes. Patients and Methods: This was a remote ethnography study of patients self-administering SCIg at home for treatment of primary immunodeficiency diseases (PIDD). Participants passively video recorded their preparation and infusion processes, took photos, and provided open responses to illustrate their overall experiences with their disease, infusions, and delivery devices. Qualitative data were compiled, analyzed, and grouped into themes and subthemes that represented participant responses and sentiments. Results: A total of 11 patients completed the remote study, all of whom were diagnosed with PIDD. Enrolled participants were currently infusing SCIg with one of five delivery devices and most also had previous experience with another delivery device. Emerging themes included universal preference for SC administration and pain points associated with managing medication/supply orders, storing medications/supplies, troubleshooting device issues, performing burdensome medication preparations, priming tubing/needles, inserting/securing needles, programming devices, adapting to device volume constraints, and loading reservoirs or tubing into delivery devices. Conclusion: Although patients prefer LVSC administration at home compared to the alternatives, the current SCIg use process presents a variety of challenges. While not all of these factors will apply to every LVSC scenario, these insights, along with their corresponding implications for device design, provide a framework to inform user needs for LVSC self-administration, anticipate obstacles during development of new LVSC therapies, and improve existing delivery devices.