Drug retention, inactive disease and response rates in 1860 patients with axial spondyloarthritis initiating secukinumab treatment: routine care data from 13 registries in the EuroSpA collaboration

Brigitte Michelsen; Ulf Lindström; Catalin Codreanu; Adrian Ciurea; Jakub Zavada; Anne Gitte Loft; Manuel Pombo-Suarez; Fatos Onen; Tore K Kvien; Ziga Rotar; Maria Jose Santos; Florenzo Iannone; Anna-Mari Hokkanen; Bjorn Gudbjornsson; Johan Askling; Ruxandra Ionescu; Michael J Nissen; Karel Pavelka; Carlos Sanchez-Piedra; Servet Akar; Joseph Sexton; Matija Tomsic; Helena Santos; Marco Sebastiani; Jenny Österlund; Arni Jon Geirsson; Gary Macfarlane; Irene van der Horst-Bruinsma; Stylianos Georgiadis; Cecilie Heegaard Brahe; Lykke Midtbøll Ørnbjerg; Merete Lund Hetland; Mikkel Østergaard

doi:10.1136/rmdopen-2020-001280

Drug retention, inactive disease and response rates in 1860 patients with axial spondyloarthritis initiating secukinumab treatment: routine care data from 13 registries in the EuroSpA collaboration

Brigitte Michelsen^* (Corresponding Author), Ulf Lindström, Catalin Codreanu, Adrian Ciurea, Jakub Zavada, Anne Gitte Loft, Manuel Pombo-Suarez, Fatos Onen, Tore K Kvien, Ziga Rotar, Maria Jose Santos, Florenzo Iannone, Anna-Mari Hokkanen, Bjorn Gudbjornsson, Johan Askling, Ruxandra Ionescu, Michael J Nissen, Karel Pavelka, Carlos Sanchez-Piedra, Servet AkarJoseph Sexton, Matija Tomsic, Helena Santos, Marco Sebastiani, Jenny Österlund, Arni Jon Geirsson, Gary Macfarlane, Irene van der Horst-Bruinsma, Stylianos Georgiadis, Cecilie Heegaard Brahe, Lykke Midtbøll Ørnbjerg, Merete Lund Hetland, Mikkel Østergaard

^*Corresponding author for this work

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Abstract

OBJECTIVES: To explore 6-month and 12-month secukinumab effectiveness in patients with axial spondyloarthritis (axSpA) overall, as well as across (1) number of previous biologic/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs), (2) time since diagnosis and (3) different European registries.

METHODS: Real-life data from 13 European registries participating in the European Spondyloarthritis Research Collaboration Network were pooled. Kaplan-Meier with log-rank test, Cox regression, χ² and logistic regression analyses were performed to assess 6-month and 12-month secukinumab retention, inactive disease/low-disease-activity states (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <2/<4, Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3/<2.1) and response rates (BASDAI50, Assessment of Spondyloarthritis International Society (ASAS) 20/40, ASDAS clinically important improvement (ASDAS-CII) and ASDAS major improvement (ASDAS-MI)).

RESULTS: We included 1860 patients initiating secukinumab as part of routine care. Overall 6-month/12-month secukinumab retention rates were 82%/72%, with significant (p<0.001) differences between the registries (6-month: 70-93%, 12-month: 53-86%) and across number of previous b/tsDMARDs (b/tsDMARD-naïve: 90%/73%, 1 prior b/tsDMARD: 83%/73%, ≥2 prior b/tsDMARDs: 78%/66%). Overall 6-month/12-month BASDAI<4 were observed in 51%/51%, ASDAS<1.3 in 9%/11%, BASDAI50 in 53%/47%, ASAS40 in 28%/22%, ASDAS-CII in 49%/46% and ASDAS-MI in 25%/26% of the patients. All rates differed significantly across number of previous b/tsDMARDs, were numerically higher for b/tsDMARD-naïve patients and varied significantly across registries. Overall, time since diagnosis was not associated with secukinumab effectiveness.

CONCLUSIONS: In this study of 1860 patients from 13 European countries, we present the first comprehensive real-life data on effectiveness of secukinumab in patients with axSpA. Overall, secukinumab retention rates after 6 and 12 months of treatment were high. Secukinumab effectiveness was consistently better for bionaïve patients, independent of time since diagnosis and differed across the European countries.

Original language	English
Article number	e001280
Number of pages	12
Journal	RMD Open
Volume	6
Issue number	3
Early online date	19 Sept 2020
DOIs	https://doi.org/10.1136/rmdopen-2020-001280
Publication status	Published - 2020

Bibliographical note

Acknowledgements
Thanks to Novartis Pharma AG and IQVIA for supporting the EuroSpA collaboration. Novartis had no influence on the data collection, statistical analyses, manuscript preparation or decision to submit.

Contributors
The study protocol and analysis plan was drafted by BM, MØ and MLH and revised and approved by all authors. Data analyses were done by BM and draft of the manuscript by BM, MØ, MLH and LØ. All authors have contributed substantially to the acquisition and interpretation of data, revised the manuscript for importantintellectual content and approved the final submitted version.

Funding
The EuroSpA collaboration was financially supported by Novartis. Novartis had no influence on the data collection, statistical analyses, manuscript preparation or decision to submit. The national registries have received financial support froma range of pharmaceutical companies, including Novartis. These funds are given as unrestricted grants.

Keywords

DMARDs (biologic)
Outcomes research
Spondyloarthritis

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Cite this

Michelsen, B., Lindström, U., Codreanu, C., Ciurea, A., Zavada, J., Loft, A. G., Pombo-Suarez, M., Onen, F., Kvien, T. K., Rotar, Z., Santos, M. J., Iannone, F., Hokkanen, A-M., Gudbjornsson, B., Askling, J., Ionescu, R., Nissen, M. J., Pavelka, K., Sanchez-Piedra, C., ... Østergaard, M. (2020). Drug retention, inactive disease and response rates in 1860 patients with axial spondyloarthritis initiating secukinumab treatment: routine care data from 13 registries in the EuroSpA collaboration. RMD Open, 6(3), [e001280]. https://doi.org/10.1136/rmdopen-2020-001280

Drug retention, inactive disease and response rates in 1860 patients with axial spondyloarthritis initiating secukinumab treatment: routine care data from 13 registries in the EuroSpA collaboration. / Michelsen, Brigitte (Corresponding Author); Lindström, Ulf; Codreanu, Catalin et al.
In: RMD Open, Vol. 6, No. 3, e001280, 2020.

Research output: Contribution to journal › Article › peer-review

Michelsen, B, Lindström, U, Codreanu, C, Ciurea, A, Zavada, J, Loft, AG, Pombo-Suarez, M, Onen, F, Kvien, TK, Rotar, Z, Santos, MJ, Iannone, F, Hokkanen, A-M, Gudbjornsson, B, Askling, J, Ionescu, R, Nissen, MJ, Pavelka, K, Sanchez-Piedra, C, Akar, S, Sexton, J, Tomsic, M, Santos, H, Sebastiani, M, Österlund, J, Geirsson, AJ, Macfarlane, G, van der Horst-Bruinsma, I, Georgiadis, S, Brahe, CH, Ørnbjerg, LM, Hetland, ML & Østergaard, M 2020, 'Drug retention, inactive disease and response rates in 1860 patients with axial spondyloarthritis initiating secukinumab treatment: routine care data from 13 registries in the EuroSpA collaboration', RMD Open, vol. 6, no. 3, e001280. https://doi.org/10.1136/rmdopen-2020-001280

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title = "Drug retention, inactive disease and response rates in 1860 patients with axial spondyloarthritis initiating secukinumab treatment: routine care data from 13 registries in the EuroSpA collaboration",

abstract = "OBJECTIVES: To explore 6-month and 12-month secukinumab effectiveness in patients with axial spondyloarthritis (axSpA) overall, as well as across (1) number of previous biologic/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs), (2) time since diagnosis and (3) different European registries.METHODS: Real-life data from 13 European registries participating in the European Spondyloarthritis Research Collaboration Network were pooled. Kaplan-Meier with log-rank test, Cox regression, χ² and logistic regression analyses were performed to assess 6-month and 12-month secukinumab retention, inactive disease/low-disease-activity states (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <2/<4, Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3/<2.1) and response rates (BASDAI50, Assessment of Spondyloarthritis International Society (ASAS) 20/40, ASDAS clinically important improvement (ASDAS-CII) and ASDAS major improvement (ASDAS-MI)).RESULTS: We included 1860 patients initiating secukinumab as part of routine care. Overall 6-month/12-month secukinumab retention rates were 82%/72%, with significant (p<0.001) differences between the registries (6-month: 70-93%, 12-month: 53-86%) and across number of previous b/tsDMARDs (b/tsDMARD-na{\"i}ve: 90%/73%, 1 prior b/tsDMARD: 83%/73%, ≥2 prior b/tsDMARDs: 78%/66%). Overall 6-month/12-month BASDAI<4 were observed in 51%/51%, ASDAS<1.3 in 9%/11%, BASDAI50 in 53%/47%, ASAS40 in 28%/22%, ASDAS-CII in 49%/46% and ASDAS-MI in 25%/26% of the patients. All rates differed significantly across number of previous b/tsDMARDs, were numerically higher for b/tsDMARD-na{\"i}ve patients and varied significantly across registries. Overall, time since diagnosis was not associated with secukinumab effectiveness.CONCLUSIONS: In this study of 1860 patients from 13 European countries, we present the first comprehensive real-life data on effectiveness of secukinumab in patients with axSpA. Overall, secukinumab retention rates after 6 and 12 months of treatment were high. Secukinumab effectiveness was consistently better for biona{\"i}ve patients, independent of time since diagnosis and differed across the European countries.",

keywords = "DMARDs (biologic), Outcomes research, Spondyloarthritis",

author = "Brigitte Michelsen and Ulf Lindstr{\"o}m and Catalin Codreanu and Adrian Ciurea and Jakub Zavada and Loft, {Anne Gitte} and Manuel Pombo-Suarez and Fatos Onen and Kvien, {Tore K} and Ziga Rotar and Santos, {Maria Jose} and Florenzo Iannone and Anna-Mari Hokkanen and Bjorn Gudbjornsson and Johan Askling and Ruxandra Ionescu and Nissen, {Michael J} and Karel Pavelka and Carlos Sanchez-Piedra and Servet Akar and Joseph Sexton and Matija Tomsic and Helena Santos and Marco Sebastiani and Jenny {\"O}sterlund and Geirsson, {Arni Jon} and Gary Macfarlane and {van der Horst-Bruinsma}, Irene and Stylianos Georgiadis and Brahe, {Cecilie Heegaard} and {\O}rnbjerg, {Lykke Midtb{\o}ll} and Hetland, {Merete Lund} and Mikkel {\O}stergaard",

note = "Acknowledgements Thanks to Novartis Pharma AG and IQVIA for supporting the EuroSpA collaboration. Novartis had no influence on the data collection, statistical analyses, manuscript preparation or decision to submit. Contributors The study protocol and analysis plan was drafted by BM, M{\O} and MLH and revised and approved by all authors. Data analyses were done by BM and draft of the manuscript by BM, M{\O}, MLH and L{\O}. All authors have contributed substantially to the acquisition and interpretation of data, revised the manuscript for importantintellectual content and approved the final submitted version. Funding The EuroSpA collaboration was financially supported by Novartis. Novartis had no influence on the data collection, statistical analyses, manuscript preparation or decision to submit. The national registries have received financial support froma range of pharmaceutical companies, including Novartis. These funds are given as unrestricted grants.",

year = "2020",

doi = "10.1136/rmdopen-2020-001280",

language = "English",

volume = "6",

journal = "RMD Open",

issn = "2056-5933",

publisher = "BMJ Publishing Group",

number = "3",

}

TY - JOUR

T1 - Drug retention, inactive disease and response rates in 1860 patients with axial spondyloarthritis initiating secukinumab treatment

T2 - routine care data from 13 registries in the EuroSpA collaboration

AU - Michelsen, Brigitte

AU - Lindström, Ulf

AU - Codreanu, Catalin

AU - Ciurea, Adrian

AU - Zavada, Jakub

AU - Loft, Anne Gitte

AU - Pombo-Suarez, Manuel

AU - Onen, Fatos

AU - Kvien, Tore K

AU - Rotar, Ziga

AU - Santos, Maria Jose

AU - Iannone, Florenzo

AU - Hokkanen, Anna-Mari

AU - Gudbjornsson, Bjorn

AU - Askling, Johan

AU - Ionescu, Ruxandra

AU - Nissen, Michael J

AU - Pavelka, Karel

AU - Sanchez-Piedra, Carlos

AU - Akar, Servet

AU - Sexton, Joseph

AU - Tomsic, Matija

AU - Santos, Helena

AU - Sebastiani, Marco

AU - Österlund, Jenny

AU - Geirsson, Arni Jon

AU - Macfarlane, Gary

AU - van der Horst-Bruinsma, Irene

AU - Georgiadis, Stylianos

AU - Brahe, Cecilie Heegaard

AU - Ørnbjerg, Lykke Midtbøll

AU - Hetland, Merete Lund

AU - Østergaard, Mikkel

N1 - Acknowledgements Thanks to Novartis Pharma AG and IQVIA for supporting the EuroSpA collaboration. Novartis had no influence on the data collection, statistical analyses, manuscript preparation or decision to submit. Contributors The study protocol and analysis plan was drafted by BM, MØ and MLH and revised and approved by all authors. Data analyses were done by BM and draft of the manuscript by BM, MØ, MLH and LØ. All authors have contributed substantially to the acquisition and interpretation of data, revised the manuscript for importantintellectual content and approved the final submitted version. Funding The EuroSpA collaboration was financially supported by Novartis. Novartis had no influence on the data collection, statistical analyses, manuscript preparation or decision to submit. The national registries have received financial support froma range of pharmaceutical companies, including Novartis. These funds are given as unrestricted grants.

PY - 2020

Y1 - 2020

N2 - OBJECTIVES: To explore 6-month and 12-month secukinumab effectiveness in patients with axial spondyloarthritis (axSpA) overall, as well as across (1) number of previous biologic/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs), (2) time since diagnosis and (3) different European registries.METHODS: Real-life data from 13 European registries participating in the European Spondyloarthritis Research Collaboration Network were pooled. Kaplan-Meier with log-rank test, Cox regression, χ² and logistic regression analyses were performed to assess 6-month and 12-month secukinumab retention, inactive disease/low-disease-activity states (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <2/<4, Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3/<2.1) and response rates (BASDAI50, Assessment of Spondyloarthritis International Society (ASAS) 20/40, ASDAS clinically important improvement (ASDAS-CII) and ASDAS major improvement (ASDAS-MI)).RESULTS: We included 1860 patients initiating secukinumab as part of routine care. Overall 6-month/12-month secukinumab retention rates were 82%/72%, with significant (p<0.001) differences between the registries (6-month: 70-93%, 12-month: 53-86%) and across number of previous b/tsDMARDs (b/tsDMARD-naïve: 90%/73%, 1 prior b/tsDMARD: 83%/73%, ≥2 prior b/tsDMARDs: 78%/66%). Overall 6-month/12-month BASDAI<4 were observed in 51%/51%, ASDAS<1.3 in 9%/11%, BASDAI50 in 53%/47%, ASAS40 in 28%/22%, ASDAS-CII in 49%/46% and ASDAS-MI in 25%/26% of the patients. All rates differed significantly across number of previous b/tsDMARDs, were numerically higher for b/tsDMARD-naïve patients and varied significantly across registries. Overall, time since diagnosis was not associated with secukinumab effectiveness.CONCLUSIONS: In this study of 1860 patients from 13 European countries, we present the first comprehensive real-life data on effectiveness of secukinumab in patients with axSpA. Overall, secukinumab retention rates after 6 and 12 months of treatment were high. Secukinumab effectiveness was consistently better for bionaïve patients, independent of time since diagnosis and differed across the European countries.

AB - OBJECTIVES: To explore 6-month and 12-month secukinumab effectiveness in patients with axial spondyloarthritis (axSpA) overall, as well as across (1) number of previous biologic/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs), (2) time since diagnosis and (3) different European registries.METHODS: Real-life data from 13 European registries participating in the European Spondyloarthritis Research Collaboration Network were pooled. Kaplan-Meier with log-rank test, Cox regression, χ² and logistic regression analyses were performed to assess 6-month and 12-month secukinumab retention, inactive disease/low-disease-activity states (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <2/<4, Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3/<2.1) and response rates (BASDAI50, Assessment of Spondyloarthritis International Society (ASAS) 20/40, ASDAS clinically important improvement (ASDAS-CII) and ASDAS major improvement (ASDAS-MI)).RESULTS: We included 1860 patients initiating secukinumab as part of routine care. Overall 6-month/12-month secukinumab retention rates were 82%/72%, with significant (p<0.001) differences between the registries (6-month: 70-93%, 12-month: 53-86%) and across number of previous b/tsDMARDs (b/tsDMARD-naïve: 90%/73%, 1 prior b/tsDMARD: 83%/73%, ≥2 prior b/tsDMARDs: 78%/66%). Overall 6-month/12-month BASDAI<4 were observed in 51%/51%, ASDAS<1.3 in 9%/11%, BASDAI50 in 53%/47%, ASAS40 in 28%/22%, ASDAS-CII in 49%/46% and ASDAS-MI in 25%/26% of the patients. All rates differed significantly across number of previous b/tsDMARDs, were numerically higher for b/tsDMARD-naïve patients and varied significantly across registries. Overall, time since diagnosis was not associated with secukinumab effectiveness.CONCLUSIONS: In this study of 1860 patients from 13 European countries, we present the first comprehensive real-life data on effectiveness of secukinumab in patients with axSpA. Overall, secukinumab retention rates after 6 and 12 months of treatment were high. Secukinumab effectiveness was consistently better for bionaïve patients, independent of time since diagnosis and differed across the European countries.

KW - DMARDs (biologic)

KW - Outcomes research

KW - Spondyloarthritis

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U2 - 10.1136/rmdopen-2020-001280

DO - 10.1136/rmdopen-2020-001280

M3 - Article

C2 - 32950963

SN - 2056-5933

VL - 6

JO - RMD Open

JF - RMD Open

IS - 3

M1 - e001280

ER -

Drug retention, inactive disease and response rates in 1860 patients with axial spondyloarthritis initiating secukinumab treatment: routine care data from 13 registries in the EuroSpA collaboration

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