Article Text

Download PDFPDF

FRI0190 Clinical outcomes from a nationwide non-medical switch from originator to biosimilar etanercept in patients with inflammatory arthritis after 5 months follow-up. results from the danbio registry
  1. B Glintborg,
  2. IJ Sørensen,
  3. AG Loft,
  4. J Esbesen,
  5. H Lindegaard,
  6. DV Jensen,
  7. K Danebod,
  8. S Dieperink,
  9. O Hendricks,
  10. IMJ Hansen,
  11. A Linauskas,
  12. S Kristensen,
  13. LS Andersen,
  14. M Hossein,
  15. H Nordin,
  16. BL Andersen,
  17. S Chrysidis,
  18. JL Raun,
  19. N Manilo,
  20. J Grydehøj,
  21. EB Dalgaard,
  22. DD Pedersen,
  23. NS Krogh,
  24. ML Hetland
  1. The DANBIO registry and the Danish Departments of Rheumatology, Copenhagen, Denmark


Background In Denmark, biological drugs are provided free by the hospitals to the patients via a tax-based system. In 2015 a non-medical switch from originator infliximab to CT-P13 was conducted (1). According to national guidelines in April 2016, a non-medical switch from originator (ETA, Enbrel® 50 mg/week) to biosimilar etanercept (SB4, Benepali®) was dictated when SB4 was marketed, including patients with inflammatory rheumatic diseases treated in routine care.

Objectives To investigate 3 months' disease activity and 5 months' treatment withdrawal in ETA-treated patients (pts) with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthrits (SpA), who were switched to SB4 and monitored prospectively in the DANBIO registry.

Methods Pts with RA/PsA/SpA followed in DANBIO since start of first bDMARD were included. Disease activity at 3 months before switch (pre-switch), at the switch and after 3 months (post-switch) and changes over time (Δpre-switch and Δpost-switch) were calculated. Disease flare was defined as ΔDAS28≥1.2 (RA/PsA) or ΔASDAS≥1.3 (SpA). Factors associated with withdrawal (gender/age/diagnosis/bDMARD-treatment-no/comedication methotrexate/baseline CRP/patient's global score) were explored by multivariable Cox regression analysis.

Results In total, 1548 switch pts were identified (891 RA, 335 PsA, 322 SpA). 60% were women, age (median (IQR) 56 (44–65) yrs)). Prior ETA treatment duration was 5.2 (3.2–8.0) yrs. ETA was the first biological treatment in 49%, and the second in 33% of pts. Concomitant MTX was given in 60% (RA)/49% (PsA)/15% (SpA). Median follow-up time was 154 (110–178) days.

Disease activity remained largely unchanged 3 months prior to vs. after the switch (Table). The proportion of patients with disease flare pre-/post switch was 8%/13% (RA), 9%/13% (PsA), 5%/5% (SpA).

Overall, 129 pts (9%) stopped SB4 treatment during 5 months' follow-up (Table). Prior ETA treatment duration in these patients was 4.5 (2.7–7.1) years.

Higher patient's global score (HR 1.12/cm, 95% CI (1.05–1.21), p=0.002) and no concomitant methotrexate (HR 2.28 (1.48–3.52), p<0.001) at baseline were associated with withdrawal.

Conclusions In 1548 patients with inflammatory rheumatic diseases treated with ETA for >5 years, disease activity was largely unaffected in the majority of patients 3 months after non-medical switch to SB4 and comparable to the fluctuations observed in the 3 months prior to the switch. Several patients (≈9%) stopped treatment during 5 months follow-up. Higher patient's global score and no use of methotrexate were associated with withdrawal. Longer follow-up will offer additional understanding of the potential efficacy and safety consequences of the non-medical switch.


  1. Glintborg et al. Arthritis Rheumatol. 2016; 68 (suppl 10): Abstract no 951.


Acknowledgements Data analysis was partly financially supported by Biogen.

Disclosure of Interest B. Glintborg Grant/research support from: Abbvie, Biogen, I. Sørensen: None declared, A. G. Loft: None declared, J. Esbesen: None declared, H. Lindegaard: None declared, D. Jensen: None declared, K. Danebod: None declared, S. Dieperink: None declared, O. Hendricks: None declared, I. M. Hansen Grant/research support from: Roche, A. Linauskas: None declared, S. Kristensen: None declared, L. Andersen: None declared, M. Hossein: None declared, H. Nordin: None declared, B. Andersen: None declared, S. Chrysidis: None declared, J. Raun: None declared, N. Manilo: None declared, J. Grydehøj: None declared, E. Dalgaard: None declared, D. Pedersen: None declared, N. Krogh: None declared, M. Hetland Grant/research support from: Orion, BMS, AbbVie, Biogen, Pfizer, MSD, Eli Lilly

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.