Observational Study Finds High Patient Satisfaction With Prefilled Biosimilar SB4 Pen

A survey of German patients who used a prefilled pen for subcutaneous delivery of biosimilar etanercept SB4 has reported a very high level of patient satisfaction with the product following an interim analysis.
Jackie Syrop
July 06, 2018
A survey of German patients who used a prefilled pen for subcutaneous delivery of biosimilar etanercept SB4 has reported a very high level of patient satisfaction with the product following an interim analysis. Ulf Muller-Ladner, MD, and colleagues presented the results of this study at the annual European Congress of Rheumatology, held June 13-16, 2018, in Amsterdam.1

All patients in this observational study were new to biologic disease-modifying anti-rheumatic (bDMARD) medications or had switched from other biologic DMARDs. SB4 was approved in the European Union in January 2016 as a biosimilar to innovator etanercept (Enbrel). Their ratings of the ease of use of the product were also high.

The ongoing noninterventional, cross-sectional study began in August 2017 and is enrolling patients treated according to usual medical practice. Prior to study enrollment and before they answer the study questionnaire, patients have at least 3 months’ experience with the SB4 prefilled pen in accordance with prescribing information. The study will enroll 500 patients in total from 50 centers across Germany. Subgroup analyses by previous therapy, modality of administration, and indication group are planned.

The present interim analysis is based on 142 patients who were available for evaluation by November 2017. Their indications were rheumatoid arthritis (63%), psoriatic arthritis (19%), and axial spondyloarthritis (18%). Mean patient age was 55 years, 61% were female, and median duration of disease was 6 years. Sixty-eight percent were new to bDMARD therapy. Previous therapies included conventional synthetic DMARDs (67% of patients), steroids (49%), nonsteroidal anti-inflammatory drugs (43%), and bDMARDs (32%); patients were new to bDMARDs, switched from syringe medication, switched from another prefilled pen, or were switched from intravenous (IV) bDMARD therapy. 

Self-assessed patient satisfaction response rates with the SB4 pre-filled pen were as follows (adapted from original):

Patient-Assessed Satisfaction With SB4 Prefilled Pen by Previous Treatment* 

New to bDMARD
(n = 96)
Switched from syringe
(n = 22)
Switched from pen
(n = 21)
Switched from IV bDMARD therapy
 (n = 2)
(n = 142)
General satisfaction: (very) satisfied 79 (82%) 19 (86%) 17 (81%) 2 (100%) 118 (83%)
Ease of execution:
(very) simple
90 (94%) 18 (82%) 17 (81%) 2 (100%) 128 (90%)
Satisfaction with training on injection with training pen: (very satisfied)** 81/85 (95%) 20/21 (95%) 16/19 (84%) 2/2 (100%) 120/128 (94%)
*Full analysis set. (Missing responses are not included in calculations; total includes 1 patients with unknown previous therapy.)
**Number of (very) satisfied patients/total number of patients who received injection training.
bDMARD indicates biologic disease-modifying anti-rheumatic drug.

The researchers conclude that general patient satisfaction in day-to-day use of the SB4 pre-filled pen with respect to handling, convenience, and training on self-injection is high.

Biogen GmbH provided financial support for this study.

  1. Muller-Ladner U, Zinke S, Aries PM, Maucksch C. Satisfaction with the bDMARD etanercept biosimilar (SB4) pre-filled pen among rheumatoid arthritis and spondyloarthropathy patients: a German observational study. Presented at the European League Against Rheumatism’s Annual European Congress of Rheumatology, June 13-16, 2018; Amsterdam, Netherlands. Abstract AB1468-HPR. doi: 10.1136/annrheumdis-2018-eular.1426.



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