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, all departments of rheumatology in Denmark

Research output: Contribution to journalJournal articleResearchpeer-review

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.

Original languageEnglish
JournalAnnals of the Rheumatic Diseases
Volume76
Issue number8
Pages (from-to)1426-1431
ISSN0003-4967
DOIs
Publication statusPublished - Aug 2017

Fingerprint

Biosimilar Pharmaceuticals
Registries
Switches
Psoriatic Arthritis
Joint Diseases
CT-P13
Infliximab
Guidelines

Keywords

  • Journal Article
  • Ankylosing Spondylitis
  • Rheumatoid arthritis
  • Anti-TNF
  • Outcomes research
  • Psoriatic arthritis
  • Humans
  • Middle Aged
  • Antibodies, Monoclonal/therapeutic use
  • Arthritis, Rheumatoid/drug therapy
  • Male
  • Treatment Outcome
  • Biosimilar Pharmaceuticals
  • Arthritis, Psoriatic/drug therapy
  • Spondylarthropathies/drug therapy
  • Infliximab
  • Denmark
  • Adult
  • Female
  • Registries
  • Aged
  • Antirheumatic Agents/therapeutic use
  • Drug Substitution

Cite this

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 ; all departments of rheumatology in Denmark. / 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. In: Annals of the Rheumatic Diseases. 2017 ; Vol. 76, No. 8. pp. 1426-1431.
@article{a4b1ea2f5d3746cbbbf35e9efbe80a31,
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 (∆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.",
keywords = "Journal Article, Ankylosing Spondylitis, Rheumatoid arthritis, Anti-TNF, Outcomes research, Psoriatic arthritis, Humans, Middle Aged, Antibodies, Monoclonal/therapeutic use, Arthritis, Rheumatoid/drug therapy, Male, Treatment Outcome, Biosimilar Pharmaceuticals, Arthritis, Psoriatic/drug therapy, Spondylarthropathies/drug therapy, Infliximab, Denmark, Adult, Female, Registries, Aged, Antirheumatic Agents/therapeutic use, Drug Substitution",
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 {all departments of rheumatology in Denmark}",
note = "{\circledC} Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.",
year = "2017",
month = "8",
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",

}

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 & 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

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; 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; all departments of rheumatology in Denmark.

In: Annals of the Rheumatic Diseases, Vol. 76, No. 8, 08.2017, p. 1426-1431.

Research output: Contribution to journalJournal articleResearchpeer-review

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 - all departments of rheumatology in Denmark

N1 - © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

PY - 2017/8

Y1 - 2017/8

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 (∆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.

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 (∆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.

KW - Journal Article

KW - Ankylosing Spondylitis

KW - Rheumatoid arthritis

KW - Anti-TNF

KW - Outcomes research

KW - Psoriatic arthritis

KW - Humans

KW - Middle Aged

KW - Antibodies, Monoclonal/therapeutic use

KW - Arthritis, Rheumatoid/drug therapy

KW - Male

KW - Treatment Outcome

KW - Biosimilar Pharmaceuticals

KW - Arthritis, Psoriatic/drug therapy

KW - Spondylarthropathies/drug therapy

KW - Infliximab

KW - Denmark

KW - Adult

KW - Female

KW - Registries

KW - Aged

KW - Antirheumatic Agents/therapeutic use

KW - Drug Substitution

U2 - 10.1136/annrheumdis-2016-210742

DO - 10.1136/annrheumdis-2016-210742

M3 - Journal article

C2 - 28473425

VL - 76

SP - 1426

EP - 1431

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

SN - 0003-4967

IS - 8

ER -