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To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry
  1. Bente Glintborg1,2,
  2. Anne Gitte Loft3,4,
  3. Emina Omerovic5,
  4. Oliver Hendricks6,
  5. Asta Linauskas7,
  6. Jakob Espesen8,
  7. Kamilla Danebod2,
  8. Dorte Vendelbo Jensen2,
  9. Henrik Nordin9,
  10. Emil Barner Dalgaard10,
  11. Stavros Chrysidis11,
  12. Salome Kristensen12,
  13. Johnny Lillelund Raun13,
  14. Hanne Lindegaard14,
  15. Natalia Manilo15,
  16. Susanne Højmark Jakobsen16,
  17. Inger Marie Jensen Hansen16,
  18. Dorte Dalsgaard Pedersen17,
  19. Inge Juul Sørensen18,19,
  20. Lis Smedegaard Andersen20,
  21. Jolanta Grydehøj21,
  22. Frank Mehnert22,
  23. Niels Steen Krogh23,
  24. Merete Lund Hetland18,19
  1. 1 The DANBIO registry and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark
  2. 2 Department of Rheumatology, Gentofte and Herlev Hospital, Copenhagen University Hospital, Gentofte, Denmark
  3. 3 Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark
  4. 4 Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
  5. 5 Department of Rheumatology, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Copenhagen University Hospital, Glostrup, Denmark
  6. 6 Kong Christian X’s Gigthospital, Gråsten, Denmark
  7. 7 Department of Rheumatology, North Denmark Regional Hospital, Hjørring, Denmark
  8. 8 Department of Rheumatology, Vejle Hospital Lillebælt, Vejle, Denmark
  9. 9 Department of Rheumatology, Zealand University Hospital, Køge, Denmark
  10. 10 Department of Rheumatology, Silkeborg Hospital, Silkeborg, Denmark
  11. 11 Department of Rheumatology, Esbjerg Hospital, Esbjerg, Denmark
  12. 12 Department of Rheumatology, Aalborg University Hospital, Aalborg, Denmark
  13. 13 Department of Rheumatology, Sygehus Lillebælt, Fredericia, Kolding, Denmark
  14. 14 Department of Rheumatology, Odense University Hospital, Odense, Denmark
  15. 15 Department of Rheumatology, Frederiksberg Hospital, Copenhagen, Denmark
  16. 16 Department of Rheumatology, OUH, Svendborg Hospital, Svendborg, Denmark
  17. 17 Department of Rheumatology, Viborg Hospital, Viborg, Denmark
  18. 18 Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
  19. 19 The DANBIO registry and COPECARE, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Copenhagen University Hospital, Glostrup, Denmark
  20. 20 Department of Internal Medicine, Rønne Hospital, Rønne, Denmark
  21. 21 Department of Rheumatology, Holstebro hospital, Holstebro, Denmark
  22. 22 Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark
  23. 23 Zitelab Aps, Copenhagen, Denmark
  1. Correspondence to Dr Bente Glintborg, The DANBIO registry, Rigshospitalet, and Department of Rheumatology, Gentofte and Herlev University Hospital, Hellerup 2730, Denmark; glintborg{at}


Objectives Real-world evidence on effectiveness of switching to biosimila r etanercept is scarce. In Denmark, a nationwide guideline of mandatory switch from 50 mg originator (ETA) to biosimilar (SB4) etanercept was issued for patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA) in 2016. Clinical characteristics and treatment outcomes were studied in ETA-treated patients, who switched to SB4 (switchers) or maintained ETA (non-switchers). Retention rates were compared with that of a historic cohort of ETA-treated patients. Switchers who resumed ETA treatment (back-switchers) were characterised.

Methods Observational cohort study based on the DANBIO registry. Treatment retention was explored by Kaplan-Meier plots and Cox regression (crude, adjusted).

Results 1621 (79%) of 2061 ETA-treated patients switched to SB4. Disease activity was unchanged 3 months’ preswitch/postswitch. Non-switchers often received 25 mg ETA (ETA 25 mg pens/syringes and powder solution were still available). One-year adjusted retention rates were: non-switchers: 77% (95% CI: 72% to 82%)/switchers: 83% (79% to 87%)/historic cohort: 90% (88% to 92%). Patients not in remission had lower retention rates than patients in remission, both in switchers (crude HR 1.7 (1.3 to 2.2)) and non-switchers (2.4 (1.7 to 3.6)). During follow-up, 120 patients (7% of switchers) back-switched to ETA. Back-switchers’ clinical characteristics were similar to switchers, and reasons for SB4 withdrawal were mainly subjective.

Conclusion Seventy-nine per cent of patients switched from ETA to SB4. After 1 year, adjusted treatment retention rates were lower in switchers versus the historic ETA cohort, but higher than in non-switchers. Withdrawal was more common in patients not in remission. The results suggest that switch outcomes in routine care are affected by patient-related factors and non-specific drug effects.

  • DMARDs (biologic)
  • epidemiology
  • anti-TNF
  • outcomes research
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  • Handling editor Josef S Smolen

  • Presented at Results have previously been presented as abstracts at the EULAR European Congress of Rheumatology 2017 (ARD, Vol 76, Suppl 2, p 553) and 2018 (ARD, Vol 77, Suppl, p A595) and the Scandinavian Congress of Rheumatology 2018 (PP66, PP67).

  • Contributors BG, MLH: contributed to the study design. BG, MLH, NSK, FM: contributed to data analyses and interpretation. All authors contributed to data collection and contributed to and approved the final manuscript.

  • Funding The study was partly funded by a grant from Biogen, who had no influence on the study design, analyses, interpretation or the decision to publish the results.

  • Competing interests BG: AbbVie, Biogen, Pfizer, MSD. MLH: Orion, BMS, AbbVie, Biogen, Pfizer, MSD, Celltrion. IMJH: Roche. AGL: AbbVie, MSD, Novartis, Pfizer, Roche, UCB OH: AbbVie, Roche, Novartis. HN: AbbVie, Novartis, Medac. LSA: Pfizer. The remaining authors: none declared.

  • Patient consent Not required.

  • Ethics approval Observational registry.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement No additional unpublished data are available.

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