Anne Gitte Rasmussen Loft

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

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaperJournal articleResearchpeer-review

  • Bente Glintborg, Department of Rheumatology, Gentofte and Herlev University Hospital, Gentofte, Denmark., The DANBIO registry and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.
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  • Inge Juul Sørensen, University of Copenhagen, Faculty of Health and Medical Sciences, Department of Clinical Medicine, Copenhagen 2200, Denmark., COPECARE, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.
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  • Anne Gitte Loft
  • Hanne Lindegaard, j Department of Rheumatology , Odense University Hospital , Odense , Denmark.
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  • Asta Linauskas
  • Oliver Hendricks, University of Southern Denmark, Odense, Denmark, and King Christian 10th Hospital for Rheumatic Diseases, Graasten, Denmark.
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  • Inger Marie Jensen Hansen, Department of Rheumatology, OUH, Svendborg Hospital, Svendborg, Denmark.
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  • Dorte Vendelbo Jensen, COPECARE, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark., Department of Rheumatology, Gentofte and Herlev University Hospital, Gentofte, Denmark.
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  • Natalia Manilo, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Denmark.
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  • Jakob Espesen, l Department of Rheumatology , Vejle Hospital , Vejle , Denmark.
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  • Mette Klarlund, Department of Rheumatology, Hillerød Hospital, Hillerød, Denmark.
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  • Jolanta Grydehøj, Department of Rheumatology, Holstebro Hospital, Holstebro, Denmark.
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  • Sabine Sparre Dieperink, COPECARE, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.
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  • Salome Kristensen, Department of Rheumatology, Aalborg University Hospital, Denmark.
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  • Jimmi Sloth Olsen, Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark Department of Rheumatology, Odense University Hospital, Odense, Denmark.
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  • Henrik Nordin, Department of Rheumatology, Zealand University Hospital, Køge, Denmark.
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  • Stavros Chrysidis, Department of Rheumatology, Esbjerg Hospital, Esbjerg, Denmark.
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  • Dorte Dalsgaard Pedersen, Department of Rheumatology, Viborg Hospital, Viborg, Denmark.
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  • Michael Veedfald Sørensen
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  • Lis Smedegaard Andersen, Department of Internal Medicine, Rønne Hospital, Rønne, Denmark.
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  • Kathrine Lederballe Grøn, COPECARE, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.
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  • Niels Steen Krogh, ZiteLab ApS, Copenhagen, Denmark.
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  • Lars Pedersen
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  • Merete Lund Hetland, University of Copenhagen, Faculty of Health and Medical Sciences, Department of Clinical Medicine, Copenhagen 2200, Denmark., The DANBIO registry and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.

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.

Original languageEnglish
JournalAnnals of the Rheumatic Diseases
Volume76
Issue8
Pages (from-to)1426-1431
Number of pages6
ISSN0003-4967
DOIs
Publication statusPublished - Aug 2017

    Research areas

  • Adult, Aged, Antibodies, Monoclonal, Antirheumatic Agents, Arthritis, Psoriatic, Arthritis, Rheumatoid, Biosimilar Pharmaceuticals, Denmark, Drug Substitution, Female, Humans, Infliximab, Male, Middle Aged, Registries, Spondylarthropathies, Treatment Outcome, Journal Article

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