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Hospital contacts due to hepatobiliary adverse events in >5000 patients with inflammatory joint disease treated with originator or biosimilar etanercept (SB4): an observational nationwide study applying linkage between DANBIO and national registries
  1. Bente Glintborg1,2,
  2. Stylianos Georgiadis1,
  3. Anne Gitte Loft3,4,
  4. Asta Linauskas5,
  5. Hanne Lindegaard6,
  6. Oliver Hendricks7,
  7. Dorte V Jensen8,
  8. Birgitte Lange Andersen9,
  9. Kamilla Danebod10,
  10. Anders Villumsen11,
  11. Grith Eng12,
  12. Charlotte Wiell13,
  13. Natalia Manilo14,
  14. Salome Kristensen15,16,
  15. Johnny Raun17,
  16. Jolanta Grydehøj18,
  17. Stavros Chrysidis19,
  18. Mette Nørgaard20,
  19. Frank Mehnert20,
  20. Niels Steen Krogh21,
  21. Merete Lund Hetland1,2
  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, Glostrup, Denmark
  2. 2 Department of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, 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, North Denmark Regional Hospital, Hjørring, Denmark
  6. 6 Department of Rheumatology, Odense University Hospital, Odense, Denmark
  7. 7 Danish Hospital for Rheumatology, University of Southern Denmark, Sønderborg, Denmark
  8. 8 Department of Internal Medicine, Bornholms Hospital, Ronne, Denmark
  9. 9 Department of Rheumatology, Esbjerg Central Hospital, Esbjerg, Denmark
  10. 10 Department of Rheumatology, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet Glostrup, Glostrup, Denmark
  11. 11 Department of Rheumatology, Silkeborg Regional Hospital, Silkeborg, Denmark
  12. 12 Department of Rheumatology, Zealand University Hospital Koge, Koge, Denmark
  13. 13 Department of Rheumatology, Gentofte University Hospital, Hellerup, Denmark
  14. 14 Department of Rheumatology, Frederiksberg Hospital, Frederiksberg, Denmark
  15. 15 Department of Rheumatology, Aalborg University Hospital, Aalborg, Denmark
  16. 16 Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
  17. 17 Department of Rheumatology, Sygehus Lillebælt Kolding Sygehus, Kolding, Denmark
  18. 18 Department of Rheumatolgy, Holstebro Central Hospital, Holstebro, Denmark
  19. 19 Rheumatology, Sydvestjysk Sygehus Esbjerg, Esbjerg, Denmark
  20. 20 Department of Clinical Epidemiology, Aarhus Universitetshospital, Aarhus, Denmark
  21. 21 Zitelab Aps, Copenhagen, Denmark
  1. Correspondence to Dr Bente Glintborg, The DANBIO registry and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet Glostrup, Glostrup 2600, Denmark; glintborg{at}

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Recent international guidelines recommend the use of biosimilar biological drugs on similar terms as their corresponding originators, including switching from a bio-originator to the biosimilar.1 However, the comparative safety of biosimilars in patients with inflammatory joint diseases (IJD) in routine care is still debated.2 In a phase 3 randomised trial among patients with rheumatoid arthritis, biosimilar etanercept (SB4) had slightly more hepatobiliary adverse events compared with the originator (ETN), possibly explained by differences in patients’ comorbid diseases and comedication use.3 The occurrence of, for example, hepatobiliary safety events is likely to differ across indications (due to differences in age, body weight, use of methotrexate, comedication, etc) and has not been explored in etanercept-treated patients with psoriatic arthritis or axial spondyloarthritis.4

In April 2016, a mandatory switch from ETN to SB4 was performed in Denmark to save costs and the 1-year clinical …

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  • Handling editor Josef S Smolen

  • HL and OH contributed equally.

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

  • Competing interests BG: AbbVie, Biogen, Pfizer, MSD. MLH: Orion, BMS, AbbVie, Biogen, Pfizer, MSD, Celltrion. AGL: AbbVie, MSD, Novartis, Pfizer, Roche, UCB. OH: AbbVie, Roche, Novartis. GE: Pfizer, Medac.

  • Patient consent for publication Not required.

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