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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
  1. Lykke Midtbøll Ørnbjerg1,2,
  2. Cecilie Heegaard Brahe1,2,
  3. Johan Askling3,
  4. Adrian Ciurea4,
  5. Herman Mann5,
  6. Fatos Onen6,
  7. Eirik Klami Kristianslund7,
  8. Dan Nordström8,
  9. Maria Jose Santos9,
  10. Catalin Codreanu10,
  11. Juan Gómez-Reino11,
  12. Ziga Rotar12,
  13. Bjorn Gudbjornsson13,
  14. Daniela Di Giuseppe3,
  15. Michael J Nissen14,
  16. Karel Pavelka5,
  17. Merih Birlik6,
  18. Tore Kvien7,
  19. Kari Kalervo Eklund15,
  20. Anabela Barcelos16,
  21. Ruxandra Ionescu10,
  22. Carlos Sanchez-Piedra11,
  23. Matija Tomsic12,
  24. Árni Jón Geirsson17,
  25. Anne Gitte Loft2,
  26. Irene van der Horst-Bruinsma18,
  27. Gareth Jones19,
  28. Florenzo Iannone20,
  29. Lise Hyldstrup1,
  30. Niels Steen Krogh21,
  31. Merete Lund Hetland1,22,
  32. Mikkel Østergaard1,22
  1. 1 EuroSpA Coordinating Center, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark
  2. 2 DANBIO Registry, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark
  3. 3 Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden
  4. 4 Department of Rheumatology, Zurich University Hospital, Zurich, Switzerland
  5. 5 Institute of Rheumatology, Department of Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic
  6. 6 TURKBIO Registry, Division of Rheumatology, School of Medicine Dokuz Eylul University, Izmir, Turkey
  7. 7 NOR-DMARD Registry, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
  8. 8 ROB-FIN Registry, Helsinki University and Helsinki University Hospital, Helsinki, Finland
  9. 9 Reuma.pt registry and Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal
  10. 10 Department of Rheumatology, RRBR Registry and University of Medicine and Pharmacy “Carol Davila”, Bucharest, Romania
  11. 11 Research Unit, Spanish Society of Rheumatology, Madrid, Spain
  12. 12 biorx.si and the Department of Rheumatology, University Medical Centre Ljubljana, Ljubljana, Slovenia
  13. 13 Centre for Rheumatology Research (ICEBIO), University Hospital and Faculty of Medicine, University of Iceland, Reykjavik, Iceland
  14. 14 Department of Rheumatology, Geneva University Hospital, Geneva, Switzerland
  15. 15 Inflammation Center, Department of Rheumatology, Helsinki University Hospital, Helsinki, Finland
  16. 16 Rheuma.pt registry, Rheumatology Department - Centro Hospitalar do Baixo Vouga and Ibimed, Institute for Biomedicine, University of Aveiro, Aveiro, Portugal
  17. 17 Department of Rheumatology, University Hospital of Iceland, Reykjavik, Iceland
  18. 18 Amsterdam UMC, Department of Rheumatology, VU University Medical Centre Amsterdam, Amsterdam, The Netherlands
  19. 19 Epidemiology Group, School of Medicine, Medical Science and Nutrition, University of Aberdeen, Aberdeen, UK
  20. 20 GISEA Registry, Rheumatology Unit – DETO, University of Bari, Bari, Italy
  21. 21 Zitelabs Aps, Copenhagen, Denmark
  22. 22 Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
  1. Correspondence to Dr Cecilie Heegaard Brahe, EuroSpA Coordinating Center, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark; cecilie.cornelia.heegaard.brahe{at}regionh.dk

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.

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

  • LMØ and CHB are joint first authors.

  • MLH and MØ are joint senior authors.

  • Handling editor Josef S Smolen

  • Contributors Study leads were CHB, LMØ, MØ and MLH. All authors took part in discussions around setting up the collaboration and planning this study. The study analysis plan was drafted by CHB, LMØ, MØ and MLH and all authors gave input and approved it. Data cleaning was performed by NSK, LMØ, CHB and overseen by MØ and MLH. Data analyses were conducted by NSK, CHB and LMØ. The manuscript was drafted by CHB, MMØ and MLH and the final version of the manuscript was revised and approved by all authors, who also approved submission.

  • 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.

  • Competing interests LMØ: Novartis; CHB: Novartis; JA: has entered into agreements with Abbvie, BMS, Lilly, Merck, Pfizer, Roche, Samsung Bioepis, and UCB, mainly for safety monitoring via the Swedish ARTIS system, and received a travel reimbursement from Novartis. Karolinska Institutet has received remuneration for JA’s participation in meetings arranged by Pfizer and by Lilly; AC: AbbVie, Celgene, Eli Lilly, Janssen-Cilag, MSD, Novartis, Pfizer and UCB; HM: AbbVie, MSD, Novartis, Pfizer, Sanofi; FO: Abbvie, Novartis, Pfizer, Roche, UCB; EKK: none; DN: AbbVie, BMS, Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, UCB; MJS: Abbvie, Biogen, Roche, Lilly, Pfizer, Novartis; Catalin Codreanu: AbbVie, Amgen, Angellini, Astra Zeneca, BMS, Egis, MSD, Pfizer, Richter, Roche, Sanofi, Servier, Teva, UCB, Zentiva; JGR: none; ZR: speaker or consulting fees from Abbvie, Amgen, Biogen, CellGen, Eli-Lilly, Jansen, Medis, MSD, Novartis, Pfizer, and Roche. BioRx.si has received funding for clinical research paid to Društvo za razvoj revmatologije from AbbVie, Celgene, Celtrion, Eli Lilly, Johnson & Johnson, Medis, MSD, Novartis, Pfizer and Roche; BG: Amgen, Novartis, Pfizer; MJN: Abbvie, Lilly, Pfizer, Novartis; KP: AbbVie, Roche, Pfizer, Amgen, Sanofi, Egis, BMS, UCB, MSD, Eli Lilly; TKK: AbbVie, Biogen, BMS, Celltrion, Egis, Eli Lilly, MSD, Mylan, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz, Sanofi and UCB; AB: Abbvie, Lilly, MSD, Novartis, Pfizer; MT: Abbvie, Amgen, Biogen, CellGen, Eli-Lilly, Jansen, Medis, MSD, Novartis, Pfizer, and Roche; FI: BMS, Pfizer, Abbvie, UCB, Roche, Celgene, Eli-Lilly, Hospira, Janssen, Merck; LHH: Novartis; MØ: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Orion, Pfizer, Regeneron, Roche, UCB; MLH: Abbvie, Biogen, BMS, CellTrion, MSD, Novartis, Orion, Pfizer, Samsung, UCB.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon reasonable request.

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