Treatment response and drug retention rates in 24 195 biologic-naïve patients with axial spondyloarthritis initiating TNFi treatment: routine care data from 12 registries in the EuroSpA collaboration

Lykke Midtbøll Ørnbjerg, Cecilie Heegaard Brahe* (Corresponding Author), Johan Askling, Adrian Ciurea, Herman Mann, Fatos Onen, Eirik Klami Kristianslund, Dan Nordström, Maria Jose Santos, Catalin Codreanu, Juan Gómez-Reino, Ziga Rotar, Bjorn Gudbjornsson, Daniela Di Giuseppe, Michael J Nissen, Karel Pavelka, Merih Birlik, Tore Kvien, Kari Kalervo Eklund, Anabela BarcelosRuxandra Ionescu, Carlos Sanchez-Piedra, Matija Tomsic, Árni Jón Geirsson, Anne Gitte Loft, Irene van der Horst-Bruinsma, Gareth Jones, Florenzo Iannone, Lise Hyldstrup, Niels Steen Krogh, Merete Lund Hetland, Mikkel Østergaard

*Corresponding author for this work

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

OBJECTIVE: To study drug retention and response rates in patients with axial spondyloarthritis (axSpA) initiating a first tumour necrosis factor inhibitor (TNFi).

METHODS: Data from 12 European registries, prospectively collected in routine care, were pooled. TNFi retention rates (Kaplan-Meier statistics), Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive disease (<1.3), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <40 mm and Assessment of SpondyloArthritis International Society responses (ASAS 20/40) were assessed at 6, 12 and 24 months.

RESULTS: A first TNFi was initiated in 24 195 axSpA patients. Heterogeneity of baseline characteristics between registries was observed. Twelve-month retention was 80% (95% CI 79% to 80%), ranging from 71% to 94% across registries. At 6 months, ASDAS Inactive disease/BASDAI<40 rates were 33%/72% (LUNDEX-adjusted: 27%/59%), ASAS 20/40 response rates 64%/49% (LUNDEX-adjusted 52%/40%). In patients initiating first TNFi after 2009, 6097 patients was registered to fulfil ASAS criteria for axSpA, 2935 was registered to fulfil modified New York Criteria for Ankylosing Spondylitis and 1178 patients was registered as having non-radiographic axSpA. In nr-axSpA patients, we observed lower 12-month retention rates (73% (70%-76%)) and lower 6-month LUNDEX adjusted response rates (ASDAS Inactive disease/BASDAI40 20%/50%, ASAS 20/40 45%/33%). For patients initiating first TNFi after 2014, 12-month retention rate, but not 6-month response rate, was numerically higher compared with patients initiating TNFi in 2009-2014.

CONCLUSION: A large European database of patients with axSpA initiating a first TNFi treatment in routine care, demonstrated that 27% of patients achieved ASDAS inactive disease after 6 months, while 59% achieved BASDAI <40. Four of five patients continued treatment after 1 year.

Original languageEnglish
Pages (from-to)1536-1544
Number of pages9
JournalAnnals of the Rheumatic Diseases
Volume78
Issue number11
Early online date20 Aug 2019
DOIs
Publication statusPublished - Nov 2019

Fingerprint

Biological Products
Registries
Ankylosing Spondylitis
Tumor Necrosis Factor-alpha
Pharmaceutical Preparations
Baths
Therapeutics
Patient treatment
Statistics
Databases

Keywords

  • anti-TNF
  • DMARDS (biologic)
  • epidemiology
  • outcomes research
  • spondyloarthritis

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Rheumatology
  • Immunology and Allergy
  • Immunology

Cite this

Treatment response and drug retention rates in 24 195 biologic-naïve patients with axial spondyloarthritis initiating TNFi treatment : routine care data from 12 registries in the EuroSpA collaboration. / Ørnbjerg, Lykke Midtbøll; Brahe, Cecilie Heegaard (Corresponding Author); Askling, Johan; Ciurea, Adrian; Mann, Herman; Onen, Fatos; Kristianslund, Eirik Klami; Nordström, Dan; Santos, Maria Jose; Codreanu, Catalin; Gómez-Reino, Juan; Rotar, Ziga; Gudbjornsson, Bjorn; Di Giuseppe, Daniela; Nissen, Michael J; Pavelka, Karel; Birlik, Merih; Kvien, Tore; Eklund, Kari Kalervo; Barcelos, Anabela; Ionescu, Ruxandra; Sanchez-Piedra, Carlos; Tomsic, Matija; Geirsson, Árni Jón; Loft, Anne Gitte; van der Horst-Bruinsma, Irene; Jones, Gareth; Iannone, Florenzo; Hyldstrup, Lise; Krogh, Niels Steen; Hetland, Merete Lund; Østergaard, Mikkel.

In: Annals of the Rheumatic Diseases, Vol. 78, No. 11, 11.2019, p. 1536-1544.

Research output: Contribution to journalArticle

Ørnbjerg, LM, Brahe, CH, Askling, J, Ciurea, A, Mann, H, Onen, F, Kristianslund, EK, Nordström, D, Santos, MJ, Codreanu, C, Gómez-Reino, J, Rotar, Z, Gudbjornsson, B, Di Giuseppe, D, Nissen, MJ, Pavelka, K, Birlik, M, Kvien, T, Eklund, KK, Barcelos, A, Ionescu, R, Sanchez-Piedra, C, Tomsic, M, Geirsson, ÁJ, Loft, AG, van der Horst-Bruinsma, I, Jones, G, Iannone, F, Hyldstrup, L, Krogh, NS, Hetland, ML & Østergaard, M 2019, 'Treatment response and drug retention rates in 24 195 biologic-naïve patients with axial spondyloarthritis initiating TNFi treatment: routine care data from 12 registries in the EuroSpA collaboration', Annals of the Rheumatic Diseases, vol. 78, no. 11, pp. 1536-1544. https://doi.org/10.1136/annrheumdis-2019-215427
Ørnbjerg, Lykke Midtbøll ; Brahe, Cecilie Heegaard ; Askling, Johan ; Ciurea, Adrian ; Mann, Herman ; Onen, Fatos ; Kristianslund, Eirik Klami ; Nordström, Dan ; Santos, Maria Jose ; Codreanu, Catalin ; Gómez-Reino, Juan ; Rotar, Ziga ; Gudbjornsson, Bjorn ; Di Giuseppe, Daniela ; Nissen, Michael J ; Pavelka, Karel ; Birlik, Merih ; Kvien, Tore ; Eklund, Kari Kalervo ; Barcelos, Anabela ; Ionescu, Ruxandra ; Sanchez-Piedra, Carlos ; Tomsic, Matija ; Geirsson, Árni Jón ; Loft, Anne Gitte ; van der Horst-Bruinsma, Irene ; Jones, Gareth ; Iannone, Florenzo ; Hyldstrup, Lise ; Krogh, Niels Steen ; Hetland, Merete Lund ; Østergaard, Mikkel. / Treatment response and drug retention rates in 24 195 biologic-naïve patients with axial spondyloarthritis initiating TNFi treatment : routine care data from 12 registries in the EuroSpA collaboration. In: Annals of the Rheumatic Diseases. 2019 ; Vol. 78, No. 11. pp. 1536-1544.
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title = "Treatment response and drug retention rates in 24 195 biologic-na{\"i}ve patients with axial spondyloarthritis initiating TNFi treatment: routine care data from 12 registries in the EuroSpA collaboration",
abstract = "OBJECTIVE: To study drug retention and response rates in patients with axial spondyloarthritis (axSpA) initiating a first tumour necrosis factor inhibitor (TNFi).METHODS: Data from 12 European registries, prospectively collected in routine care, were pooled. TNFi retention rates (Kaplan-Meier statistics), Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive disease (<1.3), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <40 mm and Assessment of SpondyloArthritis International Society responses (ASAS 20/40) were assessed at 6, 12 and 24 months.RESULTS: A first TNFi was initiated in 24 195 axSpA patients. Heterogeneity of baseline characteristics between registries was observed. Twelve-month retention was 80{\%} (95{\%} CI 79{\%} to 80{\%}), ranging from 71{\%} to 94{\%} across registries. At 6 months, ASDAS Inactive disease/BASDAI<40 rates were 33{\%}/72{\%} (LUNDEX-adjusted: 27{\%}/59{\%}), ASAS 20/40 response rates 64{\%}/49{\%} (LUNDEX-adjusted 52{\%}/40{\%}). In patients initiating first TNFi after 2009, 6097 patients was registered to fulfil ASAS criteria for axSpA, 2935 was registered to fulfil modified New York Criteria for Ankylosing Spondylitis and 1178 patients was registered as having non-radiographic axSpA. In nr-axSpA patients, we observed lower 12-month retention rates (73{\%} (70{\%}-76{\%})) and lower 6-month LUNDEX adjusted response rates (ASDAS Inactive disease/BASDAI40 20{\%}/50{\%}, ASAS 20/40 45{\%}/33{\%}). For patients initiating first TNFi after 2014, 12-month retention rate, but not 6-month response rate, was numerically higher compared with patients initiating TNFi in 2009-2014.CONCLUSION: A large European database of patients with axSpA initiating a first TNFi treatment in routine care, demonstrated that 27{\%} of patients achieved ASDAS inactive disease after 6 months, while 59{\%} achieved BASDAI <40. Four of five patients continued treatment after 1 year.",
keywords = "anti-TNF, DMARDS (biologic), epidemiology, outcomes research, spondyloarthritis",
author = "{\O}rnbjerg, {Lykke Midtb{\o}ll} and Brahe, {Cecilie Heegaard} and Johan Askling and Adrian Ciurea and Herman Mann and Fatos Onen and Kristianslund, {Eirik Klami} and Dan Nordstr{\"o}m and Santos, {Maria Jose} and Catalin Codreanu and Juan G{\'o}mez-Reino and Ziga Rotar and Bjorn Gudbjornsson and {Di Giuseppe}, Daniela and Nissen, {Michael J} and Karel Pavelka and Merih Birlik and Tore Kvien and Eklund, {Kari Kalervo} and Anabela Barcelos and Ruxandra Ionescu and Carlos Sanchez-Piedra and Matija Tomsic and Geirsson, {{\'A}rni J{\'o}n} and Loft, {Anne Gitte} and {van der Horst-Bruinsma}, Irene and Gareth Jones and Florenzo Iannone and Lise Hyldstrup and Krogh, {Niels Steen} and Hetland, {Merete Lund} and Mikkel {\O}stergaard",
note = "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.",
year = "2019",
month = "11",
doi = "10.1136/annrheumdis-2019-215427",
language = "English",
volume = "78",
pages = "1536--1544",
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TY - JOUR

T1 - Treatment response and drug retention rates in 24 195 biologic-naïve patients with axial spondyloarthritis initiating TNFi treatment

T2 - routine care data from 12 registries in the EuroSpA collaboration

AU - Ørnbjerg, Lykke Midtbøll

AU - Brahe, Cecilie Heegaard

AU - Askling, Johan

AU - Ciurea, Adrian

AU - Mann, Herman

AU - Onen, Fatos

AU - Kristianslund, Eirik Klami

AU - Nordström, Dan

AU - Santos, Maria Jose

AU - Codreanu, Catalin

AU - Gómez-Reino, Juan

AU - Rotar, Ziga

AU - Gudbjornsson, Bjorn

AU - Di Giuseppe, Daniela

AU - Nissen, Michael J

AU - Pavelka, Karel

AU - Birlik, Merih

AU - Kvien, Tore

AU - Eklund, Kari Kalervo

AU - Barcelos, Anabela

AU - Ionescu, Ruxandra

AU - Sanchez-Piedra, Carlos

AU - Tomsic, Matija

AU - Geirsson, Árni Jón

AU - Loft, Anne Gitte

AU - van der Horst-Bruinsma, Irene

AU - Jones, Gareth

AU - Iannone, Florenzo

AU - Hyldstrup, Lise

AU - Krogh, Niels Steen

AU - Hetland, Merete Lund

AU - Østergaard, Mikkel

N1 - 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.

PY - 2019/11

Y1 - 2019/11

N2 - OBJECTIVE: To study drug retention and response rates in patients with axial spondyloarthritis (axSpA) initiating a first tumour necrosis factor inhibitor (TNFi).METHODS: Data from 12 European registries, prospectively collected in routine care, were pooled. TNFi retention rates (Kaplan-Meier statistics), Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive disease (<1.3), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <40 mm and Assessment of SpondyloArthritis International Society responses (ASAS 20/40) were assessed at 6, 12 and 24 months.RESULTS: A first TNFi was initiated in 24 195 axSpA patients. Heterogeneity of baseline characteristics between registries was observed. Twelve-month retention was 80% (95% CI 79% to 80%), ranging from 71% to 94% across registries. At 6 months, ASDAS Inactive disease/BASDAI<40 rates were 33%/72% (LUNDEX-adjusted: 27%/59%), ASAS 20/40 response rates 64%/49% (LUNDEX-adjusted 52%/40%). In patients initiating first TNFi after 2009, 6097 patients was registered to fulfil ASAS criteria for axSpA, 2935 was registered to fulfil modified New York Criteria for Ankylosing Spondylitis and 1178 patients was registered as having non-radiographic axSpA. In nr-axSpA patients, we observed lower 12-month retention rates (73% (70%-76%)) and lower 6-month LUNDEX adjusted response rates (ASDAS Inactive disease/BASDAI40 20%/50%, ASAS 20/40 45%/33%). For patients initiating first TNFi after 2014, 12-month retention rate, but not 6-month response rate, was numerically higher compared with patients initiating TNFi in 2009-2014.CONCLUSION: A large European database of patients with axSpA initiating a first TNFi treatment in routine care, demonstrated that 27% of patients achieved ASDAS inactive disease after 6 months, while 59% achieved BASDAI <40. Four of five patients continued treatment after 1 year.

AB - OBJECTIVE: To study drug retention and response rates in patients with axial spondyloarthritis (axSpA) initiating a first tumour necrosis factor inhibitor (TNFi).METHODS: Data from 12 European registries, prospectively collected in routine care, were pooled. TNFi retention rates (Kaplan-Meier statistics), Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive disease (<1.3), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <40 mm and Assessment of SpondyloArthritis International Society responses (ASAS 20/40) were assessed at 6, 12 and 24 months.RESULTS: A first TNFi was initiated in 24 195 axSpA patients. Heterogeneity of baseline characteristics between registries was observed. Twelve-month retention was 80% (95% CI 79% to 80%), ranging from 71% to 94% across registries. At 6 months, ASDAS Inactive disease/BASDAI<40 rates were 33%/72% (LUNDEX-adjusted: 27%/59%), ASAS 20/40 response rates 64%/49% (LUNDEX-adjusted 52%/40%). In patients initiating first TNFi after 2009, 6097 patients was registered to fulfil ASAS criteria for axSpA, 2935 was registered to fulfil modified New York Criteria for Ankylosing Spondylitis and 1178 patients was registered as having non-radiographic axSpA. In nr-axSpA patients, we observed lower 12-month retention rates (73% (70%-76%)) and lower 6-month LUNDEX adjusted response rates (ASDAS Inactive disease/BASDAI40 20%/50%, ASAS 20/40 45%/33%). For patients initiating first TNFi after 2014, 12-month retention rate, but not 6-month response rate, was numerically higher compared with patients initiating TNFi in 2009-2014.CONCLUSION: A large European database of patients with axSpA initiating a first TNFi treatment in routine care, demonstrated that 27% of patients achieved ASDAS inactive disease after 6 months, while 59% achieved BASDAI <40. Four of five patients continued treatment after 1 year.

KW - anti-TNF

KW - DMARDS (biologic)

KW - epidemiology

KW - outcomes research

KW - spondyloarthritis

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