Background/Purpose: Background: Biosimilar TNFα inhibitors have only become available in the last few years. Etanercept bisosimilar SB-4 Benepali® has been launched in March 2016 in Germany. Although controlles studies have shown equivalent efficacy and safety compared to the originator, so far only limited data about using biosimilar agents in the daily clinical settiing are availalbe.
Purpose: 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 switch to etanercept biosimilar SB4 from etanercept reference product (Enbrel®) in RA, SpA and PsA patients. Mean disease activity will be assessed during the 12 months treatment periods.

Methods: Prospective and retrospective non-interventional study
Number of included patients: n=40 (RA:14, SpA: 8, PsA:4)
Switch patients: n=14 (RA: 8, SpA: 4, PsA: 2)
All patients re3ceived commervially available BioETA SB4 50 mg sc. per weel. Controlled treatment Phase: Data have been collected prior to BioETA therapy and during aq treatment period of 12 months. At Baseline and after 3, 6, and 12 months clinical disease activity scores (DAS28, Haq, BASDAI, BASFI and BASMI, PASI) and lab tests (CRP, ESR) were performed. Also safety data were acquired.

Results: 40 patients (m= 19, f= 21) were included in this IIT. Average  diease duration prior to study entry was 5.9 years (RA); 10.1 (AS), 8.1 (PsA) in therapy naive patients and 8.2 years (RA), 15.2 (AS) and 6.1. (PsA) respectively in switchers.
Clinical disease activity indices (DAS28) improved in ETA-naive RA 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 from 5.9 to 3.2, BASMI from 4.8 to 4.2. ETA naive PsA patients showed improvement of skin (PASI 23.1 to 10.1) and musculoskeletal (Haq 2.1 versus 1.2). CRP and ESR rates improved accordingly.
In switched patients, no significant changes in clinical disease activity scorea as well as lab test results were observed.
Regarsding safety aspects, one patient had to stop ETA- Biosimilar therapy due to side effects (developed psoriatic skin lesions).

Conclusion: The result of the observational study confirm the effectiveness and safety of BioETA SB4 (Benepali) in all real-life Setting, which has previously been investigated in controlled studies in ETA naive patients as well as in patients being switched from Enbrel (R)
to SB4. These data may support decision making by prescribers as well as on patients’ acceptance towards their choice for BioETA.

« Back to 2019 ACR/ARP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/in-the-real-world-clinical-setting-etanercept-biosimilar-sb4benepail-demonstrates-equivalent-safety-and-effectiveness-in-biological-naive-as-well-as-with-enbrel-pretreated-raspa-and-ps/