Infliximab biosimilar-to-biosimilar switching in patients with inflammatory rheumatic disease: clinical outcomes in real-world patients from the DANBIO registry

Hafsah Nabi; Oliver Hendricks; Dorte Vendelbo Jensen; Anne Gitte Loft; Jens Kristian Pedersen; Søren Andreas Just; Kamilla Danebod; Heidi Lausten Munk; Salome Kristensen; Natalia Manilo; Ada Colic; Asta Linauskas; Pia Høger Thygesen; Louise Brot Christensen; Maren Høgberget Kalisz; Niels Lomborg; Stavros Chrysidis; Johnny Lillelund Raun; Marlene Andersen; Frank Mehnert; Niels Steen Krogh; Merete Lund Hetland; Bente Glintborg

doi:10.1136/rmdopen-2022-002560

Infliximab biosimilar-to-biosimilar switching in patients with inflammatory rheumatic disease: clinical outcomes in real-world patients from the DANBIO registry

Hafsah Nabi^*, Oliver Hendricks, Dorte Vendelbo Jensen, Anne Gitte Loft, Jens Kristian Pedersen, Søren Andreas Just, Kamilla Danebod, Heidi Lausten Munk, Salome Kristensen, Natalia Manilo, Ada Colic, Asta Linauskas, Pia Høger Thygesen, Louise Brot Christensen, Maren Høgberget Kalisz, Niels Lomborg, Stavros Chrysidis, Johnny Lillelund Raun, Marlene Andersen, Frank MehnertNiels Steen Krogh, Merete Lund Hetland, Bente Glintborg

^*Corresponding author for this work

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

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Abstract

OBJECTIVE: Successful uptake of biosimilars in rheumatology is limited by lack of real-world evidence regarding effectiveness of biosimilar-to-biosimilar switching. We investigated infliximab biosimilars CT-P13-to-GP1111 switching among patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA).

METHODS: Observational cohort study from the DANBIO registry. Patients were classified as originator-naïve or originator-experienced. Retention rates of 1-year GP1111 treatment were explored (Kaplan-Meier). We identified baseline factors (at the time of switch) associated with withdrawal of GP1111 (multivariable Cox-regression analyses with HRs including originator treatment history). Changes in subjective and objective measures of disease activity 4 months before and after the switch were assessed in individual patients.

RESULTS: Of 1605 patients (685 RA, 314 PsA and 606 AxSpA, median disease duration was 9 years, 37% in Clinical Disease Activity Index/Ankylosing Spondylitis Disease Activity Score remission), 1171 were originator-naïve. Retention rates at 1-year were 83% (95% CI: 81% to 85%) and 92% (95% CI: 90% to 95%) for the originator-naïve and originator-experienced, respectively. GP1111 retention rates were higher in originator-experienced compared to originator-naïve with RA (HR=0.4 (95% CI: 0.2 to 0.7)) and PsA (HR=0.2 (95% CI: 0.1 to 0.8)), but not significantly for AxSpA: HR=0.6 (95% CI: 0.3 to 1.2). Lower disease activity was associated with higher retention. Changes in disease activity preswitch and postswitch were close to zero.

CONCLUSION: This real-world observational study of more than 1600 patients with inflammatory arthritis showed high 1-year retention following a nationwide infliximab biosimilar-to-biosimilar switch. Retention was higher in originator-experienced and in patients with low disease activity, suggesting outcomes to be affected by patient-related rather than drug-related factors.

Original language	English
Article number	e002560
Journal	RMD Open
Volume	8
Issue number	2
DOIs	https://doi.org/10.1136/rmdopen-2022-002560
Publication status	Published - 23 Nov 2022

Bibliographical note

Keywords

Arthritis, Psoriatic/diagnosis
Arthritis, Rheumatoid/diagnosis
Biosimilar Pharmaceuticals/therapeutic use
Humans
Infliximab/therapeutic use
Registries
Treatment Outcome
arthritis, rheumatoid
biosimilar pharmaceuticals
infliximab
arthritis, psoriatic
spondylitis, ankylosing

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Nabi et al. (2022). Infliximab biosimilar-to-biosimilar switching in patients with inflammatory rheumatic disease - clinical outcomes in real-world patients from the DANBIO registryFinal published version, 677 KBLicence: CC BY-NC 4.0

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Nabi, H., Hendricks, O., Jensen, D. V., Loft, A. G., Pedersen, J. K., Just, S. A., Danebod, K., Munk, H. L., Kristensen, S., Manilo, N., Colic, A., Linauskas, A., Thygesen, P. H., Christensen, L. B., Kalisz, M. H., Lomborg, N., Chrysidis, S., Raun, J. L., Andersen, M., ... Glintborg, B. (2022). Infliximab biosimilar-to-biosimilar switching in patients with inflammatory rheumatic disease: clinical outcomes in real-world patients from the DANBIO registry. RMD Open, 8(2), Article e002560. https://doi.org/10.1136/rmdopen-2022-002560

@article{1224b0b0ee614f51a1172bb3d48fd527,

title = "Infliximab biosimilar-to-biosimilar switching in patients with inflammatory rheumatic disease: clinical outcomes in real-world patients from the DANBIO registry",

abstract = "OBJECTIVE: Successful uptake of biosimilars in rheumatology is limited by lack of real-world evidence regarding effectiveness of biosimilar-to-biosimilar switching. We investigated infliximab biosimilars CT-P13-to-GP1111 switching among patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA).METHODS: Observational cohort study from the DANBIO registry. Patients were classified as originator-na{\"i}ve or originator-experienced. Retention rates of 1-year GP1111 treatment were explored (Kaplan-Meier). We identified baseline factors (at the time of switch) associated with withdrawal of GP1111 (multivariable Cox-regression analyses with HRs including originator treatment history). Changes in subjective and objective measures of disease activity 4 months before and after the switch were assessed in individual patients.RESULTS: Of 1605 patients (685 RA, 314 PsA and 606 AxSpA, median disease duration was 9 years, 37% in Clinical Disease Activity Index/Ankylosing Spondylitis Disease Activity Score remission), 1171 were originator-na{\"i}ve. Retention rates at 1-year were 83% (95% CI: 81% to 85%) and 92% (95% CI: 90% to 95%) for the originator-na{\"i}ve and originator-experienced, respectively. GP1111 retention rates were higher in originator-experienced compared to originator-na{\"i}ve with RA (HR=0.4 (95% CI: 0.2 to 0.7)) and PsA (HR=0.2 (95% CI: 0.1 to 0.8)), but not significantly for AxSpA: HR=0.6 (95% CI: 0.3 to 1.2). Lower disease activity was associated with higher retention. Changes in disease activity preswitch and postswitch were close to zero.CONCLUSION: This real-world observational study of more than 1600 patients with inflammatory arthritis showed high 1-year retention following a nationwide infliximab biosimilar-to-biosimilar switch. Retention was higher in originator-experienced and in patients with low disease activity, suggesting outcomes to be affected by patient-related rather than drug-related factors.",

keywords = "Arthritis, Psoriatic/diagnosis, Arthritis, Rheumatoid/diagnosis, Biosimilar Pharmaceuticals/therapeutic use, Humans, Infliximab/therapeutic use, Registries, Treatment Outcome, arthritis, rheumatoid, biosimilar pharmaceuticals, infliximab, arthritis, psoriatic, spondylitis, ankylosing",

author = "Hafsah Nabi and Oliver Hendricks and Jensen, {Dorte Vendelbo} and Loft, {Anne Gitte} and Pedersen, {Jens Kristian} and Just, {S{\o}ren Andreas} and Kamilla Danebod and Munk, {Heidi Lausten} and Salome Kristensen and Natalia Manilo and Ada Colic and Asta Linauskas and Thygesen, {Pia H{\o}ger} and Christensen, {Louise Brot} and Kalisz, {Maren H{\o}gberget} and Niels Lomborg and Stavros Chrysidis and Raun, {Johnny Lillelund} and Marlene Andersen and Frank Mehnert and Krogh, {Niels Steen} and Hetland, {Merete Lund} and Bente Glintborg",

note = "{\textcopyright} Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",

year = "2022",

month = nov,

day = "23",

doi = "10.1136/rmdopen-2022-002560",

language = "English",

volume = "8",

journal = "RMD Open",

issn = "2056-5933",

publisher = "BMJ Group",

number = "2",

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Nabi, H, Hendricks, O, Jensen, DV, Loft, AG, Pedersen, JK, Just, SA, Danebod, K, Munk, HL, Kristensen, S, Manilo, N, Colic, A, Linauskas, A, Thygesen, PH, Christensen, LB, Kalisz, MH, Lomborg, N, Chrysidis, S, Raun, JL, Andersen, M, Mehnert, F, Krogh, NS, Hetland, ML & Glintborg, B 2022, 'Infliximab biosimilar-to-biosimilar switching in patients with inflammatory rheumatic disease: clinical outcomes in real-world patients from the DANBIO registry', RMD Open, vol. 8, no. 2, e002560. https://doi.org/10.1136/rmdopen-2022-002560

TY - JOUR

T1 - Infliximab biosimilar-to-biosimilar switching in patients with inflammatory rheumatic disease: clinical outcomes in real-world patients from the DANBIO registry

AU - Nabi, Hafsah

AU - Hendricks, Oliver

AU - Jensen, Dorte Vendelbo

AU - Loft, Anne Gitte

AU - Pedersen, Jens Kristian

AU - Just, Søren Andreas

AU - Danebod, Kamilla

AU - Munk, Heidi Lausten

AU - Kristensen, Salome

AU - Manilo, Natalia

AU - Colic, Ada

AU - Linauskas, Asta

AU - Thygesen, Pia Høger

AU - Christensen, Louise Brot

AU - Kalisz, Maren Høgberget

AU - Lomborg, Niels

AU - Chrysidis, Stavros

AU - Raun, Johnny Lillelund

AU - Andersen, Marlene

AU - Mehnert, Frank

AU - Krogh, Niels Steen

AU - Hetland, Merete Lund

AU - Glintborg, Bente

PY - 2022/11/23

Y1 - 2022/11/23

N2 - OBJECTIVE: Successful uptake of biosimilars in rheumatology is limited by lack of real-world evidence regarding effectiveness of biosimilar-to-biosimilar switching. We investigated infliximab biosimilars CT-P13-to-GP1111 switching among patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA).METHODS: Observational cohort study from the DANBIO registry. Patients were classified as originator-naïve or originator-experienced. Retention rates of 1-year GP1111 treatment were explored (Kaplan-Meier). We identified baseline factors (at the time of switch) associated with withdrawal of GP1111 (multivariable Cox-regression analyses with HRs including originator treatment history). Changes in subjective and objective measures of disease activity 4 months before and after the switch were assessed in individual patients.RESULTS: Of 1605 patients (685 RA, 314 PsA and 606 AxSpA, median disease duration was 9 years, 37% in Clinical Disease Activity Index/Ankylosing Spondylitis Disease Activity Score remission), 1171 were originator-naïve. Retention rates at 1-year were 83% (95% CI: 81% to 85%) and 92% (95% CI: 90% to 95%) for the originator-naïve and originator-experienced, respectively. GP1111 retention rates were higher in originator-experienced compared to originator-naïve with RA (HR=0.4 (95% CI: 0.2 to 0.7)) and PsA (HR=0.2 (95% CI: 0.1 to 0.8)), but not significantly for AxSpA: HR=0.6 (95% CI: 0.3 to 1.2). Lower disease activity was associated with higher retention. Changes in disease activity preswitch and postswitch were close to zero.CONCLUSION: This real-world observational study of more than 1600 patients with inflammatory arthritis showed high 1-year retention following a nationwide infliximab biosimilar-to-biosimilar switch. Retention was higher in originator-experienced and in patients with low disease activity, suggesting outcomes to be affected by patient-related rather than drug-related factors.

AB - OBJECTIVE: Successful uptake of biosimilars in rheumatology is limited by lack of real-world evidence regarding effectiveness of biosimilar-to-biosimilar switching. We investigated infliximab biosimilars CT-P13-to-GP1111 switching among patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA).METHODS: Observational cohort study from the DANBIO registry. Patients were classified as originator-naïve or originator-experienced. Retention rates of 1-year GP1111 treatment were explored (Kaplan-Meier). We identified baseline factors (at the time of switch) associated with withdrawal of GP1111 (multivariable Cox-regression analyses with HRs including originator treatment history). Changes in subjective and objective measures of disease activity 4 months before and after the switch were assessed in individual patients.RESULTS: Of 1605 patients (685 RA, 314 PsA and 606 AxSpA, median disease duration was 9 years, 37% in Clinical Disease Activity Index/Ankylosing Spondylitis Disease Activity Score remission), 1171 were originator-naïve. Retention rates at 1-year were 83% (95% CI: 81% to 85%) and 92% (95% CI: 90% to 95%) for the originator-naïve and originator-experienced, respectively. GP1111 retention rates were higher in originator-experienced compared to originator-naïve with RA (HR=0.4 (95% CI: 0.2 to 0.7)) and PsA (HR=0.2 (95% CI: 0.1 to 0.8)), but not significantly for AxSpA: HR=0.6 (95% CI: 0.3 to 1.2). Lower disease activity was associated with higher retention. Changes in disease activity preswitch and postswitch were close to zero.CONCLUSION: This real-world observational study of more than 1600 patients with inflammatory arthritis showed high 1-year retention following a nationwide infliximab biosimilar-to-biosimilar switch. Retention was higher in originator-experienced and in patients with low disease activity, suggesting outcomes to be affected by patient-related rather than drug-related factors.

KW - Arthritis, Psoriatic/diagnosis

KW - Arthritis, Rheumatoid/diagnosis

KW - Biosimilar Pharmaceuticals/therapeutic use

KW - Humans

KW - Infliximab/therapeutic use

KW - Registries

KW - Treatment Outcome

KW - arthritis, rheumatoid

KW - biosimilar pharmaceuticals

KW - infliximab

KW - arthritis, psoriatic

KW - spondylitis, ankylosing

UR - http://www.scopus.com/inward/record.url?scp=85142939150&partnerID=8YFLogxK

U2 - 10.1136/rmdopen-2022-002560

DO - 10.1136/rmdopen-2022-002560

M3 - Journal article

C2 - 36418087

SN - 2056-5933

VL - 8

JO - RMD Open

JF - RMD Open

IS - 2

M1 - e002560

ER -

Infliximab biosimilar-to-biosimilar switching in patients with inflammatory rheumatic disease: clinical outcomes in real-world patients from the DANBIO registry

Abstract

Bibliographical note

Keywords

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