gms | German Medical Science

47. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 33. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), 29. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

04.09. - 07.09.2019, Dresden

In the real world clinical setting Etanercept Biosimilar SB4 (Benepali) demonstrates equivalent safety and effectiveness in biologic naive as well as with Enbrel, pretreated patients with RA, SpA or PsA

Meeting Abstract

Suche in Medline nach

  • Herbert Kellner - Schwerpunktpraxis für Rheumatologie und Gastroenterologie, München

Deutsche Gesellschaft für Rheumatologie. Deutsche Gesellschaft für Orthopädische Rheumatologie. Gesellschaft für Kinder- und Jugendrheumatologie. 47. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 33. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), 29. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR). Dresden, 04.-07.09.2019. Düsseldorf: German Medical Science GMS Publishing House; 2019. DocRA.47

doi: 10.3205/19dgrh219, urn:nbn:de:0183-19dgrh2194

Veröffentlicht: 8. Oktober 2019

© 2019 Kellner.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.


Gliederung

Text

Background: Biosimilar TNFα inhibitors have only become available in the last few years. Etanercept biosimilar (SB4-Benepali®) has been laucheed in March 2016 in Germany. Although controlled studies have shown equivalent efficacy and safety compared to the originator, so far only limited data about using biosimilar agents in the daily setting are available.

Objectives and methods: Assessment of safety and effectiveness of etanercept biosimilar (BioETA) SB4 in the daily clinical setting.

Primary study endpoints:

1.
To assess the effectiveness of biosimilar SB4 in biologic naive RA, SpA, and PsA patients at baseline and 3, 6 and 12 months after SB4 initiation.
2.
To assess safety and effectiveness at Baseline and 3, 6 and 12 months post switsch to BioETA SB4 from etanercept reference product (Enbrel®) in RA, SpA and PsA patients . Disease activity pre- and post-switch will be compared in each individual patient.

Additional objectives: Safety maintenance will be assessed during the 12 months treatment periods.

Prospective and retrospective noninterventional observervational study.

Number included patients: n=40
Biologic naive n= 26 (RA:14, SpA: 8, PsA: 4)
Switch patients: n=14 (RA: 8, SpA: 4, PsA: 2)
All patients received commercially available BioETA SB4 50 mg sc per week.

Controlled treatment phase: Data have been collected prior to BioETA therapy and during a treatment period of 12 months. At Baseline and after 2, 6 and 12 months clinical disease acivity scores (BASDAI, BASFI, BASMI, PASI) and lab tests (CRP, ESR) were performed. Also safety data were quired.

Results: 40 patients (m=19, f=21) were included in this IIT. Avarage disease duration prior to study entry was 5,9 years (RA), 10,1 (SpA), 81,1 (PsA) in therapy naive patients and 8,2 years (RA), 15,2 (SpA) and 6,1 (PsA), respectively in switchers.

Clinical disease activity indices (DAS28) improved in ETA-naive RA patients from 5,5 to 3,4, Haq from 1,9 to 1,4 and FFbH from 50 to 90%. In ETA naive SpA patients the BASDAI decreased in ETA naive patients from 5,9 to 3,2, BASMI from 4,8 to 4,2. ETA naive PsA patients showed improvement of skin (PASI 23,1 to10,1) and muskuloskeletal (Haq 2,1 versus 1,2). CRP and ESR rates imroved accordingly.

In switched patients, no significant changes in clinical disease activity scores as well as lab test results were observed.

Regarding safety aspects, one patient had to stop Bio-ETA therapy due to side effects (developed psoriatic skin lesions).

Conclusion: The results of this observational study confirms the efficacy and safety of BioETA SB4 (Benepali®) been observed in controlled studies in ETA naive patients as well as in patients being switched from Enbrel to SB4. These data should have an impact on decision making by prescribers as well as on patients acceptance towards their choice for BioETA.