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

• Published in: Annals of the rheumatic diseases Vol. 76; no. 8; pp. 1426 - 1431
• Main Authors: Glintborg, Bente, Sørensen, Inge Juul, Loft, Anne Gitte, Lindegaard, Hanne, Linauskas, Asta, Hendricks, Oliver, Hansen, Inger Marie Jensen, Jensen, Dorte Vendelbo, Manilo, Natalia, Espesen, Jakob, Klarlund, Mette, Grydehøj, Jolanta, Dieperink, Sabine Sparre, Kristensen, Salome, Olsen, Jimmi Sloth, Nordin, Henrik, Chrysidis, Stavros, Dalsgaard Pedersen, Dorte, Sørensen, Michael Veedfald, Andersen, Lis Smedegaard, Grøn, Kathrine Lederballe, Krogh, Niels Steen, Pedersen, Lars, Hetland, Merete Lund
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01.08.2017
• Subjects: Adult; Aged; Ankylosing spondylitis; Antibodies, Monoclonal - therapeutic use; Antirheumatic Agents - therapeutic use; Arthritis, Psoriatic - drug therapy; Arthritis, Rheumatoid - drug therapy; Biosimilar Pharmaceuticals; Clinical outcomes; Comorbidity; Denmark; Drug Substitution; Female; Humans; Immunotherapy; Inflammation; Inflammatory bowel disease; Inflammatory diseases; Infliximab; Male; Middle Aged; Monoclonal antibodies; Patients; Psoriatic arthritis; Registries; Rheumatic diseases; Rheumatoid arthritis; Spondylarthropathies - drug therapy; Spondylitis; Studies; TNF inhibitors; Treatment Outcome; Tumor necrosis factor-α; Denmark; Ankylosing Spondylitis; Anti-TNF; Outcomes research; Rheumatoid arthritis; Psoriatic arthritis
• ISSN: 0003-4967; 1468-2060
• DOI: 10.1136/annrheumdis-2016-210742

ObjectivesAccording 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.MethodsDisease 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.ResultsEight 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.ConclusionIn 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.