To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry

Bente Glintborg, Anne Gitte Loft, Emina Omerovic, Oliver Hendricks, Asta Linauskas, Jakob Espesen, Kamilla Danebod, Dorte Vendelbo Jensen, Henrik Nordin, Emil Barner Dalgaard, Stavros Chrysidis, Salome Kristensen, Johnny Lillelund Raun, Hanne Lindegaard, Natalia Manilo, Susanne Højmark Jakobsen, Inger Marie Jensen Hansen, Dorte Dalsgaard Pedersen, Inge Juul Sørensen, Lis Smedegaard AndersenJolanta Grydehøj, Frank Mehnert, Niels Steen Krogh, Merete Lund Hetland

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

OBJECTIVES: Real-world evidence on effectiveness of switching to biosimila r etanercept is scarce. In Denmark, a nationwide guideline of mandatory switch from 50 mg originator (ETA) to biosimilar (SB4) etanercept was issued for patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA) in 2016. Clinical characteristics and treatment outcomes were studied in ETA-treated patients, who switched to SB4 (switchers) or maintained ETA (non-switchers). Retention rates were compared with that of a historic cohort of ETA-treated patients. Switchers who resumed ETA treatment (back-switchers) were characterised.

METHODS: Observational cohort study based on the DANBIO registry. Treatment retention was explored by Kaplan-Meier plots and Cox regression (crude, adjusted).

RESULTS: 1621 (79%) of 2061 ETA-treated patients switched to SB4. Disease activity was unchanged 3 months' preswitch/postswitch. Non-switchers often received 25 mg ETA (ETA 25 mg pens/syringes and powder solution were still available). One-year adjusted retention rates were: non-switchers: 77% (95% CI: 72% to 82%)/switchers: 83% (79% to 87%)/historic cohort: 90% (88% to 92%). Patients not in remission had lower retention rates than patients in remission, both in switchers (crude HR 1.7 (1.3 to 2.2)) and non-switchers (2.4 (1.7 to 3.6)). During follow-up, 120 patients (7% of switchers) back-switched to ETA. Back-switchers' clinical characteristics were similar to switchers, and reasons for SB4 withdrawal were mainly subjective.

CONCLUSION: Seventy-nine per cent of patients switched from ETA to SB4. After 1 year, adjusted treatment retention rates were lower in switchers versus the historic ETA cohort, but higher than in non-switchers. Withdrawal was more common in patients not in remission. The results suggest that switch outcomes in routine care are affected by patient-related factors and non-specific drug effects.

OriginalsprogEngelsk
TidsskriftAnnals of the Rheumatic Diseases
Vol/bind78
Udgave nummer2
Sider (fra-til)192-200
ISSN0003-4967
DOI
StatusUdgivet - 1. feb. 2019

Fingeraftryk

Biosimilar Pharmaceuticals
Registries
Switches
Guidelines
Syringes
Powders
Pharmaceutical Preparations
Etanercept
Psoriatic Arthritis
Denmark

Bibliografisk note

© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.

Citer dette

Glintborg, Bente ; Loft, Anne Gitte ; Omerovic, Emina ; Hendricks, Oliver ; Linauskas, Asta ; Espesen, Jakob ; Danebod, Kamilla ; Jensen, Dorte Vendelbo ; Nordin, Henrik ; Dalgaard, Emil Barner ; Chrysidis, Stavros ; Kristensen, Salome ; Raun, Johnny Lillelund ; Lindegaard, Hanne ; Manilo, Natalia ; Jakobsen, Susanne Højmark ; Hansen, Inger Marie Jensen ; Dalsgaard Pedersen, Dorte ; Sørensen, Inge Juul ; Andersen, Lis Smedegaard ; Grydehøj, Jolanta ; Mehnert, Frank ; Krogh, Niels Steen ; Hetland, Merete Lund. / To switch or not to switch : results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. I: Annals of the Rheumatic Diseases. 2019 ; Bind 78, Nr. 2. s. 192-200.
@article{c551e2d791ef4041a76cd41f02bf5725,
title = "To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry",
abstract = "OBJECTIVES: Real-world evidence on effectiveness of switching to biosimila r etanercept is scarce. In Denmark, a nationwide guideline of mandatory switch from 50 mg originator (ETA) to biosimilar (SB4) etanercept was issued for patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA) in 2016. Clinical characteristics and treatment outcomes were studied in ETA-treated patients, who switched to SB4 (switchers) or maintained ETA (non-switchers). Retention rates were compared with that of a historic cohort of ETA-treated patients. Switchers who resumed ETA treatment (back-switchers) were characterised.METHODS: Observational cohort study based on the DANBIO registry. Treatment retention was explored by Kaplan-Meier plots and Cox regression (crude, adjusted).RESULTS: 1621 (79{\%}) of 2061 ETA-treated patients switched to SB4. Disease activity was unchanged 3 months' preswitch/postswitch. Non-switchers often received 25 mg ETA (ETA 25 mg pens/syringes and powder solution were still available). One-year adjusted retention rates were: non-switchers: 77{\%} (95{\%} CI: 72{\%} to 82{\%})/switchers: 83{\%} (79{\%} to 87{\%})/historic cohort: 90{\%} (88{\%} to 92{\%}). Patients not in remission had lower retention rates than patients in remission, both in switchers (crude HR 1.7 (1.3 to 2.2)) and non-switchers (2.4 (1.7 to 3.6)). During follow-up, 120 patients (7{\%} of switchers) back-switched to ETA. Back-switchers' clinical characteristics were similar to switchers, and reasons for SB4 withdrawal were mainly subjective.CONCLUSION: Seventy-nine per cent of patients switched from ETA to SB4. After 1 year, adjusted treatment retention rates were lower in switchers versus the historic ETA cohort, but higher than in non-switchers. Withdrawal was more common in patients not in remission. The results suggest that switch outcomes in routine care are affected by patient-related factors and non-specific drug effects.",
keywords = "DMARDs (biologic), anti-TNF, epidemiology, outcomes research",
author = "Bente Glintborg and Loft, {Anne Gitte} and Emina Omerovic and Oliver Hendricks and Asta Linauskas and Jakob Espesen and Kamilla Danebod and Jensen, {Dorte Vendelbo} and Henrik Nordin and Dalgaard, {Emil Barner} and Stavros Chrysidis and Salome Kristensen and Raun, {Johnny Lillelund} and Hanne Lindegaard and Natalia Manilo and Jakobsen, {Susanne H{\o}jmark} and Hansen, {Inger Marie Jensen} and {Dalsgaard Pedersen}, Dorte and S{\o}rensen, {Inge Juul} and Andersen, {Lis Smedegaard} and Jolanta Grydeh{\o}j and Frank Mehnert and Krogh, {Niels Steen} and Hetland, {Merete Lund}",
note = "{\circledC} Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.",
year = "2019",
month = "2",
day = "1",
doi = "10.1136/annrheumdis-2018-213474",
language = "English",
volume = "78",
pages = "192--200",
journal = "Annals of the Rheumatic Diseases",
issn = "0003-4967",
publisher = "B M J Group",
number = "2",

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Glintborg, B, Loft, AG, Omerovic, E, Hendricks, O, Linauskas, A, Espesen, J, Danebod, K, Jensen, DV, Nordin, H, Dalgaard, EB, Chrysidis, S, Kristensen, S, Raun, JL, Lindegaard, H, Manilo, N, Jakobsen, SH, Hansen, IMJ, Dalsgaard Pedersen, D, Sørensen, IJ, Andersen, LS, Grydehøj, J, Mehnert, F, Krogh, NS & Hetland, ML 2019, 'To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry', Annals of the Rheumatic Diseases, bind 78, nr. 2, s. 192-200. https://doi.org/10.1136/annrheumdis-2018-213474

To switch or not to switch : results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. / Glintborg, Bente; Loft, Anne Gitte; Omerovic, Emina; Hendricks, Oliver; Linauskas, Asta; Espesen, Jakob; Danebod, Kamilla; Jensen, Dorte Vendelbo; Nordin, Henrik; Dalgaard, Emil Barner; Chrysidis, Stavros; Kristensen, Salome; Raun, Johnny Lillelund; Lindegaard, Hanne; Manilo, Natalia; Jakobsen, Susanne Højmark; Hansen, Inger Marie Jensen; Dalsgaard Pedersen, Dorte; Sørensen, Inge Juul; Andersen, Lis Smedegaard; Grydehøj, Jolanta; Mehnert, Frank; Krogh, Niels Steen; Hetland, Merete Lund.

I: Annals of the Rheumatic Diseases, Bind 78, Nr. 2, 01.02.2019, s. 192-200.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - To switch or not to switch

T2 - results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry

AU - Glintborg, Bente

AU - Loft, Anne Gitte

AU - Omerovic, Emina

AU - Hendricks, Oliver

AU - Linauskas, Asta

AU - Espesen, Jakob

AU - Danebod, Kamilla

AU - Jensen, Dorte Vendelbo

AU - Nordin, Henrik

AU - Dalgaard, Emil Barner

AU - Chrysidis, Stavros

AU - Kristensen, Salome

AU - Raun, Johnny Lillelund

AU - Lindegaard, Hanne

AU - Manilo, Natalia

AU - Jakobsen, Susanne Højmark

AU - Hansen, Inger Marie Jensen

AU - Dalsgaard Pedersen, Dorte

AU - Sørensen, Inge Juul

AU - Andersen, Lis Smedegaard

AU - Grydehøj, Jolanta

AU - Mehnert, Frank

AU - Krogh, Niels Steen

AU - Hetland, Merete Lund

N1 - © Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2019/2/1

Y1 - 2019/2/1

N2 - OBJECTIVES: Real-world evidence on effectiveness of switching to biosimila r etanercept is scarce. In Denmark, a nationwide guideline of mandatory switch from 50 mg originator (ETA) to biosimilar (SB4) etanercept was issued for patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA) in 2016. Clinical characteristics and treatment outcomes were studied in ETA-treated patients, who switched to SB4 (switchers) or maintained ETA (non-switchers). Retention rates were compared with that of a historic cohort of ETA-treated patients. Switchers who resumed ETA treatment (back-switchers) were characterised.METHODS: Observational cohort study based on the DANBIO registry. Treatment retention was explored by Kaplan-Meier plots and Cox regression (crude, adjusted).RESULTS: 1621 (79%) of 2061 ETA-treated patients switched to SB4. Disease activity was unchanged 3 months' preswitch/postswitch. Non-switchers often received 25 mg ETA (ETA 25 mg pens/syringes and powder solution were still available). One-year adjusted retention rates were: non-switchers: 77% (95% CI: 72% to 82%)/switchers: 83% (79% to 87%)/historic cohort: 90% (88% to 92%). Patients not in remission had lower retention rates than patients in remission, both in switchers (crude HR 1.7 (1.3 to 2.2)) and non-switchers (2.4 (1.7 to 3.6)). During follow-up, 120 patients (7% of switchers) back-switched to ETA. Back-switchers' clinical characteristics were similar to switchers, and reasons for SB4 withdrawal were mainly subjective.CONCLUSION: Seventy-nine per cent of patients switched from ETA to SB4. After 1 year, adjusted treatment retention rates were lower in switchers versus the historic ETA cohort, but higher than in non-switchers. Withdrawal was more common in patients not in remission. The results suggest that switch outcomes in routine care are affected by patient-related factors and non-specific drug effects.

AB - OBJECTIVES: Real-world evidence on effectiveness of switching to biosimila r etanercept is scarce. In Denmark, a nationwide guideline of mandatory switch from 50 mg originator (ETA) to biosimilar (SB4) etanercept was issued for patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA) in 2016. Clinical characteristics and treatment outcomes were studied in ETA-treated patients, who switched to SB4 (switchers) or maintained ETA (non-switchers). Retention rates were compared with that of a historic cohort of ETA-treated patients. Switchers who resumed ETA treatment (back-switchers) were characterised.METHODS: Observational cohort study based on the DANBIO registry. Treatment retention was explored by Kaplan-Meier plots and Cox regression (crude, adjusted).RESULTS: 1621 (79%) of 2061 ETA-treated patients switched to SB4. Disease activity was unchanged 3 months' preswitch/postswitch. Non-switchers often received 25 mg ETA (ETA 25 mg pens/syringes and powder solution were still available). One-year adjusted retention rates were: non-switchers: 77% (95% CI: 72% to 82%)/switchers: 83% (79% to 87%)/historic cohort: 90% (88% to 92%). Patients not in remission had lower retention rates than patients in remission, both in switchers (crude HR 1.7 (1.3 to 2.2)) and non-switchers (2.4 (1.7 to 3.6)). During follow-up, 120 patients (7% of switchers) back-switched to ETA. Back-switchers' clinical characteristics were similar to switchers, and reasons for SB4 withdrawal were mainly subjective.CONCLUSION: Seventy-nine per cent of patients switched from ETA to SB4. After 1 year, adjusted treatment retention rates were lower in switchers versus the historic ETA cohort, but higher than in non-switchers. Withdrawal was more common in patients not in remission. The results suggest that switch outcomes in routine care are affected by patient-related factors and non-specific drug effects.

KW - DMARDs (biologic)

KW - anti-TNF

KW - epidemiology

KW - outcomes research

U2 - 10.1136/annrheumdis-2018-213474

DO - 10.1136/annrheumdis-2018-213474

M3 - Journal article

C2 - 30396903

VL - 78

SP - 192

EP - 200

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

SN - 0003-4967

IS - 2

ER -