Enhancement of an Auto-Injector Device for Self-Administration of Etanercept in Patients With Rheumatoid Arthritis Confers Emotional and Functional Benefits

Abstract

Introduction: Etanercept is effective in the management of rheumatoid arthritis (RA) and can be self-administered via an auto-injector. While these devices are generally well accepted, some patients are not comfortable with the process of self-administration; this has been cited as a reason for discontinuation of biologic treatment. Alternative routes of administration (e.g., infusion) are more resource intensive. The aim of this analysis was to explore the attributes of auto-injection devices that impact patient confidence and ability to self-administer. Methods: Patients with RA (n = 168) and healthcare providers (n = 82) in Belgium, Germany, Japan, Spain, and the UK were interviewed (n = 250 overall). Mock injection procedures were carried out using an auto-injector device with the addition of a sleeve with a wider rubber grip. Importance of and performance of the device against a range attributes were captured using a Likert scale (1-7). Disease severity was captured using the Cochin hand function scale. Results: Device attributes reported by patients to be most important were 'use without assistance' 'ease of administration', 'ease of operation', and 'ease of grip'. The device with additional sleeve performed strongly against these attributes, scoring 6.9 (out of 7), 6.8, 6.8, and 6.6, respectively with no difference observed between countries. Nurses and physicians reported similar responses. Qualitatively, patients reported that stability and grip provided a sense of control and reduced anxiety. Similar overall 'ease of operation' was reported between patients with mild (n = 89) or moderate/severe (n = 71) disease (score 6.4 vs. 6.5, respectively). Conclusions: The auto-injector plus sleeve performed strongly against key attributes even in patients with moderate/severe RA and patients with reduced grip strength. The robust grip improved patient confidence and reduced injection-related anxiety. This may be beneficial in patients who are anxious about self-administration, those new to self-administration, and potentially in patients with reduced hand dexterity as a result of either advanced disease or a painful day.

Usability Study of PF-06410293, an Adalimumab Biosimilar, by Prefilled Pen: Open-Label, Single-Arm, Sub-Study of a Phase 3 Trial in Patients with Rheumatoid Arthritis

“…Autoinjector devices have also been developed for other boDMARDs, including etanercept and sarilumab [ 21 , 25 , 26 ]. The use of these pen devices compares favorably with delivery by PFS (based on patient surveys) [ 21 , 25 , 26 ].…”

“…Autoinjector devices have also been developed for other boDMARDs, including etanercept and sarilumab [ 21 , 25 , 26 ]. The use of these pen devices compares favorably with delivery by PFS (based on patient surveys) [ 21 , 25 , 26 ]. The experiences and preferences (PFS or PFP device) of patients with RA and other chronic autoimmune conditions is largely based on subjective surveys, and device changes for boDMARDs and bsDMARDs are often based on patient/healthcare professional preference studies [ 19 , 20 , 22 , 29 – 34 ].…”

“…To provide patients with a more convenient administration, prefilled pen (PFP) devices have been developed for several boDMARDs and bsDMARDs [ 19 – 26 ]. In 2006, a new presentation of ADL as a single-use, disposable PFP was approved by the FDA [ 27 ].…”

Technische Alltagshilfen in der Rheumatologie – Was ist sinnvoll, was ist bewiesen, welche Perspektiven gibt es?

“…Die Adhärenz der Patienten kann erheblich darunter leiden. Es wurden automatische Injektionsgeräte entwickelt, um die Anwendung für die Patienten zu erleichtern 42 . In vielen Studien wurde die Wirksamkeit von Hilfsmitteln zur Medikamentenapplikation untersucht und es existieren aktuell verschiedene Variationen von Injektionshilfen bei den unterschiedlichen Medikamenten ( Abb.…”

“…Die wichtigsten Attribute, die durch die Studie herausgearbeitet werden konnten, waren „leichte Bedienbarkeit ohne Hilfestellung“, „leichte Anwendung“ und „leichte Bedienbarkeit insgesamt“. So war ein zusätzlicher Griff für ein automatisches Injektionsgerät zur Verbesserung der Greifbarkeit und Stabilität eine große Hilfe für die Patienten 42 . In einer anderen Patientenpräferenzstudie waren die wichtigsten Attribute „gute Griffigkeit“ und „Leichtigkeit der Selbstinjektion“ 43 .…”