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BENEFIT: real-world effectiveness of SB4 after transition from reference etanercept in rheumatoid arthritis and axial spondyloarthritis

1, 2, 3, 4, 5, 6, 7


  1. Rheumatology and Clinical Immunology, Humanitas Clinical and Research Center - IRCCS, Rozzano, and Department of Biomedical Sciences, Humanitas University, Milan, Italy.
  2. Medical Centre of Rheumatology, Munich, Germany.
  3. Centre of Rheumatology, CHU Pierre Paul Riquet, Toulouse, France.
  4. FEA Reumatología, Hospital Virgen del Puerto, Plasencia, Spain.
  5. Biogen International GmbH, Baar, Switzerland.
  6. Biogen International GmbH, Baar, Switzerland.
  7. Biogen Idec, Maidenhead, UK.

2021 Vol.39, N°2
PI 0365, PF 0371
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PMID: 32662409 [PubMed]

Received: 30/09/2019
Accepted : 27/04/2020
In Press: 30/06/2020
Published: 09/04/2021


The objective of this non-interventional study was to evaluate the effectiveness and safety of the etanercept biosimilar SB4 (BenepaliTM) following transition from reference etanercept in patients with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA).
Data were collected from clinical records of adult patients with stable RA or axSpA, in France, Germany, Italy and Spain. Key outcomes included the change from transition to 3 and 6 months in Disease Activity Score 28 (DAS28) for RA or Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for axSpA.
In total, 358 patients with RA and 199 patients with axSpA were enrolled. The mean individual change in disease score from transition was -0.02 (95% confidence interval [CI] -0.11, 0.08) at 3 months and 0.01 (95% CI -0.09, 0.11) at 6 months for DAS28, and -0.01 (95% CI -0.24, 0.21) at 3 months and -0.11 (95% CI -0.31, 0.10) at 6 months for BASDAI. In the RA cohort, 19 (5.3%) and 5 patients (1.4%) reported adverse events and serious adverse events (SAEs), respectively. In the axSpA cohort, 12 (6.0%) and 2 patients (1.0%) reported adverse events and SAEs, respectively. One SAE of pneumonia (RA cohort) was considered to be related to SB4 administration. At 6 months post-transition, the SB4 retention rate was 90.8% (95% CI 87.2%, 93.4%) in the RA cohort and 92.4% (95% CI 87.5%, 95.4%) in the axSpA cohort.
Transition from reference etanercept to SB4 is effective and safe in patients with stable RA and axSpA.

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