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  • A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry

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Clinical and epidemiological research
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A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry
  1. Bente Glintborg1,2,
  2. Inge Juul Sørensen3,4,
  3. Anne Gitte Loft5,
  4. Hanne Lindegaard6,
  5. Asta Linauskas7,
  6. Oliver Hendricks8,
  7. Inger Marie Jensen Hansen9,
  8. Dorte Vendelbo Jensen2,3,
  9. Natalia Manilo10,
  10. Jakob Espesen11,
  11. Mette Klarlund12,
  12. Jolanta Grydehøj13,
  13. Sabine Sparre Dieperink3,
  14. Salome Kristensen14,
  15. Jimmi Sloth Olsen15,
  16. Henrik Nordin16,
  17. Stavros Chrysidis17,
  18. Dorte Dalsgaard Pedersen18,
  19. Michael Veedfald Sørensen19,
  20. Lis Smedegaard Andersen20,
  21. Kathrine Lederballe Grøn3,
  22. Niels Steen Krogh21,
  23. Lars Pedersen22,
  24. Merete Lund Hetland1,4
  25. On behalf of all departments of rheumatology in Denmark
  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 University Hospital, Gentofte, Denmark
  3. 3 COPECARE, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark
  4. 4 Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
  5. 5 Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark
  6. 6 Department of Rheumatology, Odense University Hospital, Odense, Denmark
  7. 7 Department of Rheumatology, North Denmark Regional Hospital, Hjørring, Denmark
  8. 8 King Christian 10th Hospital for Rheumatic Diseases, Graasten, Denmark
  9. 9 Department of Rheumatology, OUH, Svendborg Hospital, Svendborg, Denmark
  10. 10 Department of Rheumatology, Frederiksberg Hospital, Copenhagen, Denmark
  11. 11 Department of Rheumatology, Vejle Hospital, Vejle, Denmark
  12. 12 Department of Rheumatology, Hillerød Hospital, Hillerød, Denmark
  13. 13 Department of Rheumatology, Holstebro Hospital, Holstebro, Denmark
  14. 14 Department of Rheumatology, Aalborg University Hospital, Aalborg, Denmark
  15. 15 Department of Rheumatology, Silkeborg Hospital, Silkeborg, Denmark
  16. 16 Department of Rheumatology, Zealand University Hospital, Køge, Denmark
  17. 17 Department of Rheumatology, Esbjerg Hospital, Esbjerg, Denmark
  18. 18 Department of Rheumatology, Viborg Hospital, Viborg, Denmark
  19. 19 Department of Rheumatology, Horsens Hospital, Horsens, Denmark
  20. 20 Department of Internal Medicine, Rønne Hospital, Rønne, Denmark
  21. 21 ZiteLab ApS, Copenhagen, Denmark
  22. 22 Department of Clinical Epidemiology (KEA), Aarhus University Hospital, Aarhus, Denmark
  1. Correspondence to Dr Bente Glintborg, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark; glintborg{at}dadlnet.dk

Abstract

Objectives According to guidelines, a nationwide non-medical switch from originator (INX, Remicade) to biosimilar infliximab (Remsima, CT-P13) was conducted in Danish patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA). We investigated disease activity before/after switching and retention rates in the DANBIO registry.

Methods Disease activities 3 months before and after switch and changes over time were calculated. Flare was defined as change in 28 Joint Disease Activity Score (∆DAS28) ≥1.2 (RA/PsA) or Ankylosing Spondylitis Disease Activity Score (∆ASDAS) ≥1.3 (AxSpA). Crude and adjusted retention rates were compared with a historic cohort of INX-treated patients.

Results Eight hundred and two patients switched (403 RA/120 PsA/279 AxSpA; 51% women, age (median (IQR): 55 (44-66)) years). Follow-up was 413 (339–442) days. Prior INX treatment duration was 6.8 (4.3–9.5) years. Disease activities were similar 3 months before/after switch. Crude 1-year CT-P13 retention rate (84.1 (95% CI 81.3 to 86.5)) was similar to the historic IFX cohort (86.2 (95% CI 84.0 to 88.0), p=0.22). The adjusted absolute retention rates were 83.4 (95% CI 80.8 to 86.2) and 86.8% (95% CI 84.8 to 88.8), respectively (p=0.03). In total 132 patients withdrew (lack of effect: 71/132=54%, adverse events: 37/132=28%). Patients with previous INX treatment duration >5 years had longer CT-P13 retention.

Conclusion In 802 arthritis patients treated with INX for median >6 years, a nationwide non-medical switch to CT-P13 had no negative impact on disease activity. Adjusted 1-year CT-P13 retention rate was slightly lower than for INX in a historic cohort.

  • Anti-TNF
  • Outcomes research
  • Ankylosing Spondylitis
  • Psoriatic arthritis
  • Rheumatoid arthritis

https://doi.org/10.1136/annrheumdis-2016-210742

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    Footnotes

    • Contributors BG and MLH contributed to the study design.

      BG, MLH, NSK and LP contributed to data analyses and interpretation.

      All authors contributed to data collection and contributed to and approved the final manuscript.

    • Funding The study was funded in part by a research grant from AbbVie.

    • Competing interests BG: AbbVie; IMJH: Roche; AGL, MLH: AbbVie, BMS, MSD, Pfizer, Roche and UCB; the remaining authors: none declared.

    • Ethics approval According to Danish legislation, registration and publication of data from clinical registries do not require patient consent or approval by ethics committees.

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