RESEARCH ARTICLE


Patient Satisfaction with the Etanercept Biosimilar SB4 Device, Among Rheumatoid Arthritis and Spondyloarthropathy Patients - A German Observational Study



Christof Maucksch1, Peer M. Aries2, Silke Zinke3, Ulf Müller-Ladner4, *
1 Biogen GmbH, Carl-Zeiss-Ring , Ismaning, Germany
2 Rheumatologie at Struenseehaus, Mörkenstraße, Hamburg, Germany
3 Rheumapraxis Zinke, Hauptstraße, Berlin, Germany
4 Kerckhoff-Klinik GmbH, Department for Rheumatology and Clinical Immunology, Benekestraße, Bad Nauheim, Germany


© 2020 Maucksch et al.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: (https://creativecommons.org/licenses/by/4.0/legalcode). This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

* Address correspondence to this author at the Kerckhoff-Klinik GmbH, Department for Rheumatology and Clinical Immunology, Benekestr. 2-8, 61231 Bad Nauheim, Germany; Tel: ??????????; E-mail: U.Mueller-Ladner@kerckhoff-klinik.de


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.

Keywords: Biological disease-modifying anti-rheumatic drug, Etanercept biosimilar, Patient satisfaction, Pre-filled pen, Rheumatoid arthritis, SB4 (Benepali®), Spondyloarthropathy, TNF inhibitor.