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 af dette arbejde

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

7 Citationer (Scopus)

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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.

Originalsprog	Engelsk
Artikelnummer	002560
Tidsskrift	RMD Open
Vol/bind	8
Udgave nummer	2
ISSN	2056-5933
DOI	https://doi.org/10.1136/rmdopen-2022-002560
Status	Udgivet - 2022

Bibliografisk note

Funding Information:
HN: Research grant from AbbVie and Sandoz. AGL: AbbVie, Eli Lilly Denmark A/S, Janssen-Cilag A/S, MSD, Novartis, Pfizer, UCB teaching or consultancy fees. OH: AbbVie, Pfizer, Novartis. MLH: AbbVie, Biogen, BMS, Celtrion, Eli Lilly Denmark A/S, Janssen Biologics B.V, Lundbeck Fonden, MSD, Pfizer, Roche, Samsung Bioepis, Sandoz. Furthermore, chair of the steering committee of the Danish Rheumatology Quality Registry (DANBIO), which receives public funding from the hospital owners and funding from pharmaceutical companies. Co-chair EuroSpA, which generates real-world evidence of treatment of psoriatic arthritis and axial spondyloarthritis based on secondary data and is partly funded by Novartis. BG: BMS, Pfizer, Sandoz (research grants).

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Citationsformater

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), [002560]. https://doi.org/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. / Nabi, Hafsah; Hendricks, Oliver; Jensen, Dorte Vendelbo; Loft, Anne Gitte; Pedersen, Jens Kristian; Just, Søren Andreas; Danebod, Kamilla; Munk, Heidi Lausten; Kristensen, Salome; Manilo, Natalia; Colic, Ada; Linauskas, Asta; Thygesen, Pia Høger; Christensen, Louise Brot; Kalisz, Maren Høgberget; Lomborg, Niels; Chrysidis, Stavros; Raun, Johnny Lillelund; Andersen, Marlene; Mehnert, Frank; Krogh, Niels Steen; Hetland, Merete Lund ; Glintborg, Bente.

I: RMD Open, Bind 8, Nr. 2, 002560, 2022.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

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, bind 8, nr. 2, 002560. https://doi.org/10.1136/rmdopen-2022-002560

Nabi, Hafsah ; Hendricks, Oliver ; Jensen, Dorte Vendelbo ; Loft, Anne Gitte ; Pedersen, Jens Kristian ; Just, Søren Andreas ; Danebod, Kamilla ; Munk, Heidi Lausten ; Kristensen, Salome ; Manilo, Natalia ; Colic, Ada ; Linauskas, Asta ; Thygesen, Pia Høger ; Christensen, Louise Brot ; Kalisz, Maren Høgberget ; Lomborg, Niels ; Chrysidis, Stavros ; Raun, Johnny Lillelund ; Andersen, Marlene ; Mehnert, Frank ; Krogh, Niels Steen ; Hetland, Merete Lund ; Glintborg, Bente. / Infliximab biosimilar-to-biosimilar switching in patients with inflammatory rheumatic disease : Clinical outcomes in real-world patients from the DANBIO registry. I: RMD Open. 2022 ; Bind 8, Nr. 2.

@article{f16e6363794a472c97c808ac4d41f27c,

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, arthritis, rheumatoid, biosimilar pharmaceuticals, infliximab, 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 = "Publisher Copyright: {\textcopyright} ",

year = "2022",

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

language = "English",

volume = "8",

journal = "RMD Open",

issn = "2056-5933",

publisher = "BMJ Publishing Group",

number = "2",

}

TY - JOUR

T1 - Infliximab biosimilar-to-biosimilar switching in patients with inflammatory rheumatic disease

T2 - 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

Y1 - 2022

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

KW - arthritis, rheumatoid

KW - biosimilar pharmaceuticals

KW - infliximab

KW - spondylitis, ankylosing

U2 - 10.1136/rmdopen-2022-002560

DO - 10.1136/rmdopen-2022-002560

M3 - Journal article

C2 - 36418087

AN - SCOPUS:85142939150

VL - 8

JO - RMD Open

JF - RMD Open

SN - 2056-5933

IS - 2

M1 - 002560

ER -