Treatment retention of infliximab and etanercept originators versus their corresponding biosimilars: Nordic collaborative observational study of 2334 biologics naïve patients with spondyloarthritis

Ulf Lindström; Bente Glintborg; Daniela Di Giuseppe; Dan Nordström; Sella Aarrestad Provan; Bjorn Gudbjornsson; Johan Askling; Merete Lund Hetland; Kalle Aaltonen; Niels Steen Krogh; Arni Jon Geirsson; Lennart T.H. Jacobsson

doi:10.1136/rmdopen-2019-001079

Treatment retention of infliximab and etanercept originators versus their corresponding biosimilars: Nordic collaborative observational study of 2334 biologics naïve patients with spondyloarthritis

Ulf Lindström^*, Bente Glintborg, Daniela Di Giuseppe, Dan Nordström, Sella Aarrestad Provan, Bjorn Gudbjornsson, Johan Askling, Merete Lund Hetland, Kalle Aaltonen, Niels Steen Krogh, Arni Jon Geirsson, Lennart T.H. Jacobsson

^*Corresponding author for this work

Department of Clinical Medicine

4 Citations (Scopus)

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Abstract

Objective Although clinical trials support equivalence of originator products and biosimilars for etanercept and infliximab, real-world studies among biologics-naïve patients with spondyloarthritis (SpA) are lacking. The objectives were to compare treatment retention in biologics-naïve patients with SpA starting either the originator product or a biosimilar of infliximab and etanercept, and to explore the baseline characteristics of these patients. Methods Patients with SpA (ankylosing spondylitis/non-radiographical axial SpA/undifferentiated SpA), starting infliximab or etanercept as their first-ever biological disease-modifying antirheumatic drug during January 2014-June 2017 were identified in five Nordic biologics-rheumatology registers. Baseline characteristics were retrieved from each registry; comorbidity data were identified through linkage to national health registers. Country-specific data were pooled, and data on infliximab and etanercept were analysed separately. Comparisons of treatment retention between originators and biosimilars were assessed through survival probability curves, retention rates (2 years for infliximab/1 year for etanercept) and Hazard Ratios (HR). Results We included 1319 patients starting infliximab (24% originator/76% biosimilar), and 1015 patients starting etanercept (49% originator/51% biosimilar). Baseline characteristics were largely similar for the patients treated with the originators compared with the corresponding biosimilars. Survival probability curves were highly similar for the originator and its biosimilar, as were retention rates: Infliximab 2-year retention originator, 44% (95% CI 38% to 50%)/biosimilar, 46% (95% CI: 42% to 51%); and etanercept 1-year retention originator, 66% (95% CI 61% to 70%)/biosimilar, 73% (95% CI 68% to 78%). HRs were not statistically significant. Conclusion This observational study of biologics-naïve patients with SpA from five Nordic countries showed similar baseline characteristics and very similar retention rates in patients treated with originators versus biosimilars, for both infliximab and etanercept, indicating comparable effectiveness in clinical practice.

Original language	English
Article number	e001079
Journal	RMD Open
Volume	5
Issue number	2
Number of pages	8
ISSN	2056-5933
DOIs	https://doi.org/10.1136/rmdopen-2019-001079
Publication status	Published - 2019

Keywords

ankylosing spondylitis
anti-TNF
epidemiology
outcomes research
spondyloarthritis

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Lindström, U., Glintborg, B., Di Giuseppe, D., Nordström, D., Aarrestad Provan, S., Gudbjornsson, B., Askling, J., Lund Hetland, M., Aaltonen, K., Krogh, N. S., Geirsson, A. J., & Jacobsson, L. T. H. (2019). Treatment retention of infliximab and etanercept originators versus their corresponding biosimilars: Nordic collaborative observational study of 2334 biologics naïve patients with spondyloarthritis. RMD Open, 5(2), [e001079]. https://doi.org/10.1136/rmdopen-2019-001079

Treatment retention of infliximab and etanercept originators versus their corresponding biosimilars : Nordic collaborative observational study of 2334 biologics naïve patients with spondyloarthritis. / Lindström, Ulf; Glintborg, Bente; Di Giuseppe, Daniela et al.

In: RMD Open, Vol. 5, No. 2, e001079, 2019.

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

Lindström, U, Glintborg, B, Di Giuseppe, D, Nordström, D, Aarrestad Provan, S, Gudbjornsson, B, Askling, J, Lund Hetland, M, Aaltonen, K, Krogh, NS, Geirsson, AJ & Jacobsson, LTH 2019, 'Treatment retention of infliximab and etanercept originators versus their corresponding biosimilars: Nordic collaborative observational study of 2334 biologics naïve patients with spondyloarthritis', RMD Open, vol. 5, no. 2, e001079. https://doi.org/10.1136/rmdopen-2019-001079

@article{221d0a754bca47a1b93b1526d97fcd23,

title = "Treatment retention of infliximab and etanercept originators versus their corresponding biosimilars: Nordic collaborative observational study of 2334 biologics na{\"i}ve patients with spondyloarthritis",

abstract = "Objective Although clinical trials support equivalence of originator products and biosimilars for etanercept and infliximab, real-world studies among biologics-na{\"i}ve patients with spondyloarthritis (SpA) are lacking. The objectives were to compare treatment retention in biologics-na{\"i}ve patients with SpA starting either the originator product or a biosimilar of infliximab and etanercept, and to explore the baseline characteristics of these patients. Methods Patients with SpA (ankylosing spondylitis/non-radiographical axial SpA/undifferentiated SpA), starting infliximab or etanercept as their first-ever biological disease-modifying antirheumatic drug during January 2014-June 2017 were identified in five Nordic biologics-rheumatology registers. Baseline characteristics were retrieved from each registry; comorbidity data were identified through linkage to national health registers. Country-specific data were pooled, and data on infliximab and etanercept were analysed separately. Comparisons of treatment retention between originators and biosimilars were assessed through survival probability curves, retention rates (2 years for infliximab/1 year for etanercept) and Hazard Ratios (HR). Results We included 1319 patients starting infliximab (24% originator/76% biosimilar), and 1015 patients starting etanercept (49% originator/51% biosimilar). Baseline characteristics were largely similar for the patients treated with the originators compared with the corresponding biosimilars. Survival probability curves were highly similar for the originator and its biosimilar, as were retention rates: Infliximab 2-year retention originator, 44% (95% CI 38% to 50%)/biosimilar, 46% (95% CI: 42% to 51%); and etanercept 1-year retention originator, 66% (95% CI 61% to 70%)/biosimilar, 73% (95% CI 68% to 78%). HRs were not statistically significant. Conclusion This observational study of biologics-na{\"i}ve patients with SpA from five Nordic countries showed similar baseline characteristics and very similar retention rates in patients treated with originators versus biosimilars, for both infliximab and etanercept, indicating comparable effectiveness in clinical practice.",

keywords = "ankylosing spondylitis, anti-TNF, epidemiology, outcomes research, spondyloarthritis",

author = "Ulf Lindstr{\"o}m and Bente Glintborg and {Di Giuseppe}, Daniela and Dan Nordstr{\"o}m and {Aarrestad Provan}, Sella and Bjorn Gudbjornsson and Johan Askling and {Lund Hetland}, Merete and Kalle Aaltonen and Krogh, {Niels Steen} and Geirsson, {Arni Jon} and Jacobsson, {Lennart T.H.}",

year = "2019",

doi = "10.1136/rmdopen-2019-001079",

language = "English",

volume = "5",

journal = "RMD Open",

issn = "2056-5933",

publisher = "BMJ Publishing Group",

number = "2",

}

TY - JOUR

T1 - Treatment retention of infliximab and etanercept originators versus their corresponding biosimilars

T2 - Nordic collaborative observational study of 2334 biologics naïve patients with spondyloarthritis

AU - Lindström, Ulf

AU - Glintborg, Bente

AU - Di Giuseppe, Daniela

AU - Nordström, Dan

AU - Aarrestad Provan, Sella

AU - Gudbjornsson, Bjorn

AU - Askling, Johan

AU - Lund Hetland, Merete

AU - Aaltonen, Kalle

AU - Krogh, Niels Steen

AU - Geirsson, Arni Jon

AU - Jacobsson, Lennart T.H.

PY - 2019

Y1 - 2019

N2 - Objective Although clinical trials support equivalence of originator products and biosimilars for etanercept and infliximab, real-world studies among biologics-naïve patients with spondyloarthritis (SpA) are lacking. The objectives were to compare treatment retention in biologics-naïve patients with SpA starting either the originator product or a biosimilar of infliximab and etanercept, and to explore the baseline characteristics of these patients. Methods Patients with SpA (ankylosing spondylitis/non-radiographical axial SpA/undifferentiated SpA), starting infliximab or etanercept as their first-ever biological disease-modifying antirheumatic drug during January 2014-June 2017 were identified in five Nordic biologics-rheumatology registers. Baseline characteristics were retrieved from each registry; comorbidity data were identified through linkage to national health registers. Country-specific data were pooled, and data on infliximab and etanercept were analysed separately. Comparisons of treatment retention between originators and biosimilars were assessed through survival probability curves, retention rates (2 years for infliximab/1 year for etanercept) and Hazard Ratios (HR). Results We included 1319 patients starting infliximab (24% originator/76% biosimilar), and 1015 patients starting etanercept (49% originator/51% biosimilar). Baseline characteristics were largely similar for the patients treated with the originators compared with the corresponding biosimilars. Survival probability curves were highly similar for the originator and its biosimilar, as were retention rates: Infliximab 2-year retention originator, 44% (95% CI 38% to 50%)/biosimilar, 46% (95% CI: 42% to 51%); and etanercept 1-year retention originator, 66% (95% CI 61% to 70%)/biosimilar, 73% (95% CI 68% to 78%). HRs were not statistically significant. Conclusion This observational study of biologics-naïve patients with SpA from five Nordic countries showed similar baseline characteristics and very similar retention rates in patients treated with originators versus biosimilars, for both infliximab and etanercept, indicating comparable effectiveness in clinical practice.

AB - Objective Although clinical trials support equivalence of originator products and biosimilars for etanercept and infliximab, real-world studies among biologics-naïve patients with spondyloarthritis (SpA) are lacking. The objectives were to compare treatment retention in biologics-naïve patients with SpA starting either the originator product or a biosimilar of infliximab and etanercept, and to explore the baseline characteristics of these patients. Methods Patients with SpA (ankylosing spondylitis/non-radiographical axial SpA/undifferentiated SpA), starting infliximab or etanercept as their first-ever biological disease-modifying antirheumatic drug during January 2014-June 2017 were identified in five Nordic biologics-rheumatology registers. Baseline characteristics were retrieved from each registry; comorbidity data were identified through linkage to national health registers. Country-specific data were pooled, and data on infliximab and etanercept were analysed separately. Comparisons of treatment retention between originators and biosimilars were assessed through survival probability curves, retention rates (2 years for infliximab/1 year for etanercept) and Hazard Ratios (HR). Results We included 1319 patients starting infliximab (24% originator/76% biosimilar), and 1015 patients starting etanercept (49% originator/51% biosimilar). Baseline characteristics were largely similar for the patients treated with the originators compared with the corresponding biosimilars. Survival probability curves were highly similar for the originator and its biosimilar, as were retention rates: Infliximab 2-year retention originator, 44% (95% CI 38% to 50%)/biosimilar, 46% (95% CI: 42% to 51%); and etanercept 1-year retention originator, 66% (95% CI 61% to 70%)/biosimilar, 73% (95% CI 68% to 78%). HRs were not statistically significant. Conclusion This observational study of biologics-naïve patients with SpA from five Nordic countries showed similar baseline characteristics and very similar retention rates in patients treated with originators versus biosimilars, for both infliximab and etanercept, indicating comparable effectiveness in clinical practice.

KW - ankylosing spondylitis

KW - anti-TNF

KW - epidemiology

KW - outcomes research

KW - spondyloarthritis

U2 - 10.1136/rmdopen-2019-001079

DO - 10.1136/rmdopen-2019-001079

M3 - Journal article

C2 - 31749988

AN - SCOPUS:85074441619

SN - 2056-5933

VL - 5

JO - RMD Open

JF - RMD Open

IS - 2

M1 - e001079

ER -

Treatment retention of infliximab and etanercept originators versus their corresponding biosimilars: Nordic collaborative observational study of 2334 biologics naïve patients with spondyloarthritis

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Keywords

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