AB1468-HPR

SATISFACTION WITH THE BDMARD ETANERCEPT BIOSIMILAR (SB4) PRE-FILLED PEN AMONG RHEUMATOID ARTHRITIS AND SPONDYLOARTHROPATHY PATIENTS; A GERMAN OBSERVATIONAL STUDY

U. Müller-Ladner1,*, S. Zinke2, P. M. Aries3, C. Maucksch4

1Abteilung für Rheumatologie und Klinische Immunologie, Kerckhoff-Klinik GmbH, Bad Nauheim, 2Rheumapraxis Zinke, Berlin, 3Rheumatologie im Struenseehaus, Hamburg, 4Biogen GmbH, Ismaning, Germany

 

Background: The TNFα inhibitor etanercept was the first targeted biological disease modifying anti-rheumatic drug (bDMARD) approved for treatment of RA; the first etanercept biosimilar (SB4) was authorised in the EU in January 2016. Various administration devices have been developed for convenient subcutaneous self-injection of bDMARDs including pre-filled pens.

Objectives: This study aims to document general patient satisfaction in day-to-day use of the SB4 pre-filled pen. Patients’ experience regarding handling, convenience, other features and the associated training on self-injection is also evaluated.

Methods: This non-interventional, cross-sectional study is enrolling patients who are treated according to usual medical practice. Patients had experience with the SB4 pre-filled pen in accordance with the prescribing information for at least 3 months prior to completing the onetime standardized patient questionnaire. This study started in August 2017, is ongoing and plans to enrol 500 patients in total from 50 centres across Germany. Subgroup analyses by previous therapy, modality of administration and by indication group are pre-planned.

Results: By November 2017, completed surveys from 142 patients were available for interim analysis. Mean age was 55 years, 61% were female and the median duration of the disease was 6 years. The indications were rheumatoid arthritis in 63% (median disease activity score DAS28: 2.4), psoriatic arthritis in 19% (median DAS28: 2.5) and axial spondyloarthritis in 18% of patients (median BASDAI: 3.0). 68% of patients were new to bDMARD therapy. Previous therapies included conventional synthetic DMARDs (67% of patients), steroids (49%), non-steroidal anti-inflammatory drugs (43%) and bDMARDs (32%). Patient satisfaction response rates are shown in Table 1.

Table 1: Patient-assessed satisfaction with SB4-pre-filled pen by previous treatment (Full Analysis Set)

 

New to

bDMARD

(N=96)

Switch from

syringe

(N=22)

Switch from

pen

(N=21)

Switch from

intravenous

bDMARD therapy

(N=2)

Total*

(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 the training pen**:

(very) satisfied

81/85 (95%)

20/21 (95%)

16/19 (84%)

2/2 (100%)

120/128 (94%)

*Missing responses are not included in calculations; total includes one patient with unknown previous therapy.
**Number of (very) satisfied patients / total number of patients who received injection training

Conclusions: High level of patient general satisfaction as well as satisfaction with the ease of use were reported with the etanercept biosimilar (SB4) pre-filled pen for patients who were new to bDMARDs or who had switched from other bDMARDs.

Acknowledgements: Biogen GmbH funded this study. Authors had full editorial control and provided final approval of all content.

Disclosure of Interest: U. Müller-Ladner Consultant for: Biogen, Speakers bureau: Biogen, S. Zinke Consultant for: Biogen, P. Aries Consultant for: Biogen, C. Maucksch Shareholder of: Biogen, Employee of: Biogen

DOI: 10.1136/annrheumdis-2018-eular.1426