Abstract
Background: The etanercept biosimilar SB4 is a TNF inhibitor authorised for use as a targeted Biological Disease-Modifying Anti-Rheumatic Drug (bDMARD). Various administration devices have been developed for subcutaneous self-injection of bDMARDs. Objective: This study surveyed patient satisfaction with their experience of using the SB4 pre-filled pen device. Methods: This non-interventional, cross-sectional, multi-centre study enrolled adult rheumatoid arthritis and spondyloarthropathy patients who had been treated for at least three months with the SB4 pre-filled pen. Based on a standardized questionnaire, patients rated general satisfaction, handling, user-friendliness, physical characteristics, and training material received. A total of 492 eligible patients completed questionnaires at 43 centres across Germany between August 2017 and June 2018. Data were analysed descriptively. Pre-defined subgroup analyses by previous therapy and by indication were performed. Results: Overall, 87% (95% CI 83% - 90%) of patients reported being ‘satisfied’ or ‘very satisfied’ with the pen. 89% of patients reported that the pen was ‘simple’ or ‘very simple’ to use. Most patients (87%) self-injected. 93% of patients who received training on the use of the pen were ‘satisfied’ or ‘very satisfied’ with the training provided. In this cross-sectional study, 12 patients reported an Adverse Event (AE) and one patient reported a treatment-related AE (nausea). Conclusion: The results demonstrated a high level of general satisfaction among patients using the SB4 pre-filled pen as well as satisfaction with ease of use for patients who were either naïve to bDMARDs or who had switched to SB4 from other bDMARDs.
Highlights
IntroductionThe administration route of most Biological Disease-Modifying Anti-Rheumatic Drug (bDMARD) is subcutaneous injection, for which a variety of product-specific administration devices are available
The results demonstrated a high level of general satisfaction among patients using the SB4 pre-filled pen as well as satisfaction with ease of use for patients who were either naïve to Biological Disease-Modifying Anti-Rheumatic Drug (bDMARD) or who had switched to SB4 from other bDMARDs
This study aimed to ascertain satisfaction with the day-today use of the SB4 pre-filled pen in patients with Rheumatoid Arthritis (RA) or Spondyloarthropathy (SpA). It investigated whether differences in satisfaction exist between subgroups of patients who were either naïve to the use of bDMARDs, were switching from a pre-filled syringe or were switching from another bDMARD pre-filled pen
Summary
The administration route of most bDMARDs is subcutaneous injection, for which a variety of product-specific administration devices are available. These devices were developed to enable safe and comfortable self-injection, which is an important aspect of patient compliance [3]. This study aimed to ascertain satisfaction with the day-today use of the SB4 pre-filled pen in patients with Rheumatoid Arthritis (RA) or Spondyloarthropathy (SpA). It investigated whether differences in satisfaction exist between subgroups of patients who were either naïve to the use of bDMARDs, were switching from a pre-filled syringe or were switching from another bDMARD pre-filled pen. Various administration devices have been developed for subcutaneous self-injection of bDMARDs
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