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

Bente Glintborg; Inge Juul Sørensen; Anne Gitte Loft; Hanne Lindegaard; Asta Linauskas; Oliver Hendricks; Inger Marie Jensen Hansen; Dorte Vendelbo Jensen; Natalia Manilo; Jakob Espesen; Mette Klarlund; Jolanta Grydehøj; Sabine Sparre Dieperink; Salome Kristensen; Jimmi Sloth Olsen; Henrik Nordin; Stavros Chrysidis; Dorte Dalsgaard Pedersen; Michael Veedfald Sørensen; Lis Smedegaard Andersen; Kathrine Lederballe Grøn; Niels Steen Krogh; Lars Pedersen; Merete Lund Hetland; On behalf of all departments of rheumatology in Denmark

doi:10.1136/annrheumdis-2016-210742

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

Bente Glintborg^*, Inge Juul Sørensen, Anne Gitte Loft, Hanne Lindegaard, Asta Linauskas, Oliver Hendricks, Inger Marie Jensen Hansen, Dorte Vendelbo Jensen, Natalia Manilo, Jakob Espesen, Mette Klarlund, Jolanta Grydehøj, Sabine Sparre Dieperink, Salome Kristensen, Jimmi Sloth Olsen, Henrik Nordin, Stavros Chrysidis, Dorte Dalsgaard Pedersen, Michael Veedfald Sørensen, Lis Smedegaard AndersenKathrine Lederballe Grøn, Niels Steen Krogh, Lars Pedersen, Merete Lund Hetland, On behalf of all departments of rheumatology in Denmark

^*Corresponding author for this work

Department of Clinical Medicine

142 Citations (Scopus)

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 (ΔDAS28) ≥1.2 (RA/PsA) or Ankylosing Spondylitis Disease Activity Score (ΔASDAS) ≥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 language	English
Journal	Annals of the Rheumatic Diseases
Volume	76
Issue number	8
Pages (from-to)	1426-1431
Number of pages	6
ISSN	0003-4967
DOIs	https://doi.org/10.1136/annrheumdis-2016-210742
Publication status	Published - 2017

Keywords

Ankylosing Spondylitis
Anti-TNF
Outcomes research
Psoriatic arthritis
Rheumatoid arthritis

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10.1136/annrheumdis-2016-210742

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Glintborg, B., Sørensen, I. J., Loft, A. G., Lindegaard, H., Linauskas, A., Hendricks, O., Hansen, I. M. J., Jensen, D. V., Manilo, N., Espesen, J., Klarlund, M., Grydehøj, J., Dieperink, S. S., Kristensen, S., Olsen, J. S., Nordin, H., Chrysidis, S., Dalsgaard Pedersen, D., Sørensen, M. V., ... On behalf of all departments of rheumatology in Denmark (2017). 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. Annals of the Rheumatic Diseases, 76(8), 1426-1431. https://doi.org/10.1136/annrheumdis-2016-210742

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. / Glintborg, Bente; Sørensen, Inge Juul; Loft, Anne Gitte et al.
In: Annals of the Rheumatic Diseases, Vol. 76, No. 8, 2017, p. 1426-1431.

Research output: Contribution to journal › Journal article › Research › peer-review

Glintborg, B, Sørensen, IJ, Loft, AG, Lindegaard, H, Linauskas, A, Hendricks, O, Hansen, IMJ, Jensen, DV, Manilo, N, Espesen, J, Klarlund, M, Grydehøj, J, Dieperink, SS, Kristensen, S, Olsen, JS, Nordin, H, Chrysidis, S, Dalsgaard Pedersen, D, Sørensen, MV, Andersen, LS, Grøn, KL, Krogh, NS, Pedersen, L, Hetland, ML & On behalf of all departments of rheumatology in Denmark 2017, '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', Annals of the Rheumatic Diseases, vol. 76, no. 8, pp. 1426-1431. https://doi.org/10.1136/annrheumdis-2016-210742

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title = "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",

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 (ΔDAS28) ≥1.2 (RA/PsA) or Ankylosing Spondylitis Disease Activity Score (ΔASDAS) ≥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.",

keywords = "Ankylosing Spondylitis, Anti-TNF, Outcomes research, Psoriatic arthritis, Rheumatoid arthritis",

author = "Bente Glintborg and S{\o}rensen, {Inge Juul} and Loft, {Anne Gitte} and Hanne Lindegaard and Asta Linauskas and Oliver Hendricks and Hansen, {Inger Marie Jensen} and Jensen, {Dorte Vendelbo} and Natalia Manilo and Jakob Espesen and Mette Klarlund and Jolanta Grydeh{\o}j and Dieperink, {Sabine Sparre} and Salome Kristensen and Olsen, {Jimmi Sloth} and Henrik Nordin and Stavros Chrysidis and {Dalsgaard Pedersen}, Dorte and S{\o}rensen, {Michael Veedfald} and Andersen, {Lis Smedegaard} and Gr{\o}n, {Kathrine Lederballe} and Krogh, {Niels Steen} and Lars Pedersen and Hetland, {Merete Lund} and {On behalf of all departments of rheumatology in Denmark}",

year = "2017",

doi = "10.1136/annrheumdis-2016-210742",

language = "English",

volume = "76",

pages = "1426--1431",

journal = "Annals of the Rheumatic Diseases",

issn = "0003-4967",

publisher = "B M J Group",

number = "8",

}

TY - JOUR

T1 - A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis

T2 - 1-year clinical outcomes from the DANBIO registry

AU - Glintborg, Bente

AU - Sørensen, Inge Juul

AU - Loft, Anne Gitte

AU - Lindegaard, Hanne

AU - Linauskas, Asta

AU - Hendricks, Oliver

AU - Hansen, Inger Marie Jensen

AU - Jensen, Dorte Vendelbo

AU - Manilo, Natalia

AU - Espesen, Jakob

AU - Klarlund, Mette

AU - Grydehøj, Jolanta

AU - Dieperink, Sabine Sparre

AU - Kristensen, Salome

AU - Olsen, Jimmi Sloth

AU - Nordin, Henrik

AU - Chrysidis, Stavros

AU - Dalsgaard Pedersen, Dorte

AU - Sørensen, Michael Veedfald

AU - Andersen, Lis Smedegaard

AU - Grøn, Kathrine Lederballe

AU - Krogh, Niels Steen

AU - Pedersen, Lars

AU - Hetland, Merete Lund

AU - On behalf of all departments of rheumatology in Denmark

PY - 2017

Y1 - 2017

N2 - 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 (ΔDAS28) ≥1.2 (RA/PsA) or Ankylosing Spondylitis Disease Activity Score (ΔASDAS) ≥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.

AB - 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 (ΔDAS28) ≥1.2 (RA/PsA) or Ankylosing Spondylitis Disease Activity Score (ΔASDAS) ≥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.

KW - Ankylosing Spondylitis

KW - Anti-TNF

KW - Outcomes research

KW - Psoriatic arthritis

KW - Rheumatoid arthritis

U2 - 10.1136/annrheumdis-2016-210742

DO - 10.1136/annrheumdis-2016-210742

M3 - Journal article

C2 - 28473425

AN - SCOPUS:85020798557

SN - 0003-4967

VL - 76

SP - 1426

EP - 1431

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

IS - 8

ER -

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

Abstract

Keywords

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