Real-World Data on SB4 Highlight Biosimilar Etanercept's Efficacy

Samsung Bioepis’ etanercept biosimilar, SB4, is approved in multiple regulatory territories under the names Benepali, Brenzys, and Eticovo. The biosimilar earned its first approval in the Republic of Korea in 2015, followed by approvals in the European Union, Canada, Australia, and other markets 2016, and the United States in 2019.

During this week’s European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology, multiple teams of researchers will present their findings on real-world evidence of the biosimilar’s efficacy and the feasibility of switching to SB4 from the reference etanercept, Enbrel.

BENEFIT Shows No Difference in Disease Scores After a Switch

Investigators from the BENEFIT study, a pan-European study that seeks to gather real-world evidence on switching to the biosimilar in routine clinical practice, will report their 6-month findings for 533 patients with rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA) who switched to the biosimilar.¹

A total of 347 patients with RA and 186 patients with axSpA were transitioned from reference etanercept to the biosimilar after a minimum of 6 months of treatment at clinics in 4 European countries. The patients were found, 6 months post-transition, to have no clinically significant difference in disease score after the switch; the mean individual change was 0.0 (95% CI, —0.1 to 0.1) and 0.0 (95% CI, –0.3 to 0.2) in the patients with RA and axSpA, respectively.

The study’s investigators concluded that patients who were stable on their therapy and switched to the biosimilar maintained clinical response at 6 months.

Nordic Study in Spondyloarthritis Shows Comparable 1-Year Retention

Next, researchers will discuss findings from a study conducted in Sweden, Denmark, Finland, Norway, and Iceland, which compared 1-year treatment retention in biologic naïve patients with spondyloarthritis (SpA) who started treatment with biosimilar versus reference etanercept.²

The study included data from 1015 patients who started treatment in 2014 to 2017. Among these patients, 493 started therapy with the reference product, and 522 started treatment with SB4. Baseline characteristics were similar in the 2 groups.

At 1 year, 66% (95%CI, 61%-70%) of those who were treated with the reference product remained on the drug, versus 73% (95%CI, 68%-78%) of those treated with the biosimilar.

In JIA, Switching to the Biosimilar Did Not Lead to LOE

Additionally, a team from Italy published findings from a review of charts of patients with juvenile idiopathic arthritis (JIA) that showed that a switch to biosimilar etanercept did not results in a loss of efficacy (LOE).³

The retrospective observational study included 14 patients with JIA—13 of whom were in remission and all of whom received previous methotrexate—who switched from the reference product to SB4 in 2018.

After the switch, say the investigators, there was no observed disease recurrence. C-reactive protein levels remained within normal values in all cases except 1. No new safety signals were observed, the authors note.

Comparable Efficacy for Reference and Biosimilar in RA

In a monocentric, case-control, prospective study, investigators from a single center in Italy, report that, in a real-world setting, the biosimilar and the reference are comparable in reducing disease activity score in a count of 28 joints (DAS28) with erythrocyte sedimentation rate (ESR).⁴

The study enrolled 75 patients with RA who started on either the biosimilar (n = 35) or the reference etanercept (n = 40). For 71.4% of patients in the biosimilar group and 80% in the reference group, etanercept was first-line biologic treatment.

Both groups had a significant reduction of DAS28-ESR values and Health Assessment Questionnaire scores at 4 months and at 12 months. When evaluating remission rate, defined as a DAS28-ESR score of less than 2.6, there was a significantly higher rate of remission at 4 months among those taking the reference (53.8%) versus those taking the biosimilar (26.7%, P = .0002). However, no differences were found in remission rate between the 2 arms at 12 months.

References

1. Krueger K, Selmi C, Cantagrel A, et al. BENEFIT study: a pan-European observational study to evaluate real-world effectiveness of SB4 following transition from originator etanercept (ETN) in patients with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA). Presented at: The European League Against Rheumatism European Congress of Rheumatology 2019; June 12-15, 2019; Madrid, Spain. Abstract FRI0103.

2. Glintborg B, Lindström U, Giuseppe DDI, et al. Similar one-year treatment retention of originator and biosimilar etanercept. Results of a Nordic collaboration including 1015 patients with spondyloarthritis. Presented at: The European League Against Rheumatism European Congress of Rheumatology 2019; June 12-15, 2019; Madrid, Spain. Abstract: OP0236.

3. Marinelli M, Marino A, Simonini G, Cimaz R, Giani T. Use of etanercept biosimilar in JIA: preliminary experience using real world data. Presented at: The European League Against Rheumatism European Congress of Rheumatology 2019; June 12-15, 2019; Madrid, Spain. Abstract AB1014.

4. Luccetti R, Ceccarelli F, Perrione C, et al. Biosimilar etanercept versus originator: results from a longitudinal prospective monocentric study. Presented at: The European League Against Rheumatism European Congress of Rheumatology 2019; June 12-15, 2019; Madrid, Spain. Abstract AB0389.