Samsung Bioepis' SB4 Performs Well in RA, axSpA Transition Study

July 15, 2020
Tony Hagen

Tony Hagen is senior managing editor for The Center for Biosimilars®.

The transition from reference to biosimilar etanercept was safe and effective in patients with stable rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA), according to updated findings from the BENEFIT study.

The transition from reference to biosimilar etanercept was safe and effective in patients with stable rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA), according to updated findings from the BENEFIT study, based on observed declines in disease activity.

Investigators evaluated clinical records of adult patients in France, Germany, Italy, and Spain. The real-world study employed Samsung Bioepis’ etanercept biosimilar, SB4, which is approved in multiple markets and distributed under the names Benepali, Brenzys, and Eticovo. It received FDA approval in 2019 but is not expected to come to market until 2029.

The investigators enrolled 358 patients with RA and 199 patients with axSpA. They used the Disease Activity Score 28 (DAS28) to measure changes in RA and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for axSpA.

DAS28 assigns a score from 1 to 10 based on tenderness and swelling in 28 bodily joints, with higher scores being more disease severity. In the study, the mean individual DAS28 change following transition from reference (Enbrel) was —0.02 (95% CI, –0.11 to 0.08) at 3 months and 0.01 (95% CI, –0.09 to 0.11) at 6 months.

BASDAI assigns a score of 1 to 10 based on fatigue, spinal pain, joint pain and swelling, tenderness, and stiffness. Among patients with axSpA, the 3- and 6-month values for BASDAI were —0.01 (95% CI, –0.24 to 0.21) and –0.11 (95% CI, –0.31 to 0.10), respectively.

Among patients with RA, 19 (5.3%) experienced adverse events and 5 (1.4%), serious adverse events (SAEs). The respective numbers for patients in the axSpA cohort were 12 (6%) and 2 (1%). Investigators said an SAE of pneumonia in the RA cohort was considered SB4 related.

At 6 months, 90.8% of patients remained on SB4, compared with 92.4% in the axSpA group.

The updated findings correlate with data reported from BENEFIT last year at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology.

Reference

Selmi C, Krüger K, Cantagrel A, et al. BENEFIT: real-world effectiveness of SB4 after transition from reference etanercept in rheumatoid arthritis and axial spondyloarthritis. Clin Exp Rheumatol. Published online Jun 30, 2020. https://pubmed.ncbi.nlm.nih.gov/32662409/

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