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; A G Loft; Hanne Lindegaard; Asta Linauskas; Oliver Hendricks; Inger Marie Jensen Hansen; Dorte Vendelbo Jensen; Natalia Manilo; Jakob Espesen; Mette Klarlund; J Grydehøj; Sabine Sparre Dieperink; S Kristensen; Jimmi Sloth Olsen; H Nordin; Stavros Chrysidis; Dorte Dalsgaard Pedersen; Michael Veedfald Sørensen; L S Andersen; Kathrine Lederballe Grøn; Niels Steen Krogh; Lars Pedersen; Merete Lund Hetland; 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, A G Loft, Hanne Lindegaard, Asta Linauskas, Oliver Hendricks, Inger Marie Jensen Hansen, Dorte Vendelbo Jensen, Natalia Manilo, Jakob Espesen, Mette Klarlund, J Grydehøj, Sabine Sparre Dieperink, S Kristensen, Jimmi Sloth Olsen, H Nordin, Stavros Chrysidis, Dorte Dalsgaard Pedersen, Michael Veedfald Sørensen, L S AndersenKathrine Lederballe Grøn, Niels Steen Krogh, Lars Pedersen, Merete Lund Hetland, All Departments of Rheumatology in Denmark

192 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 (∆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 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 - Aug 2017

Keywords

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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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., ... 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, A G et al.
In: Annals of the Rheumatic Diseases, Vol. 76, No. 8, 08.2017, 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 & 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 (∆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 = "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",

author = "Bente Glintborg and S{\o}rensen, {Inge Juul} and Loft, {A G} 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 J Grydeh{\o}j and Dieperink, {Sabine Sparre} and S Kristensen and Olsen, {Jimmi Sloth} and H Nordin and Stavros Chrysidis and {Dalsgaard Pedersen}, Dorte and S{\o}rensen, {Michael Veedfald} and Andersen, {L S} 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 = "COPECARE",

year = "2017",

month = aug,

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, A G

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, J

AU - Dieperink, Sabine Sparre

AU - Kristensen, S

AU - Olsen, Jimmi Sloth

AU - Nordin, H

AU - Chrysidis, Stavros

AU - Dalsgaard Pedersen, Dorte

AU - Sørensen, Michael Veedfald

AU - Andersen, L S

AU - Grøn, Kathrine Lederballe

AU - Krogh, Niels Steen

AU - Pedersen, Lars

AU - Hetland, Merete Lund

AU - All Departments of Rheumatology in Denmark

N1 - COPECARE

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 - Adult

KW - Aged

KW - Antibodies, Monoclonal

KW - Antirheumatic Agents

KW - Arthritis, Psoriatic

KW - Arthritis, Rheumatoid

KW - Biosimilar Pharmaceuticals

KW - Denmark

KW - Drug Substitution

KW - Female

KW - Humans

KW - Infliximab

KW - Male

KW - Middle Aged

KW - Registries

KW - Spondylarthropathies

KW - Treatment Outcome

KW - Journal Article

U2 - 10.1136/annrheumdis-2016-210742

DO - 10.1136/annrheumdis-2016-210742

M3 - Journal article

C2 - 28473425

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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