Upadacitinib in real clinical practice: new horizons in the treatment of axial spondyloarthritis
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Keywords

Spondyloarthritis
upadacitinib
treatment
Clinical practice

How to Cite

Shivacheva, T., Dimova, Z., Simeonova, D., Dimitrov, S., Georgiev, T., Bogdanova, S., Moraliyska, R., Hristova, S., & Gerganov, G. (2023). Upadacitinib in real clinical practice: new horizons in the treatment of axial spondyloarthritis. Rheumatology (Bulgaria), 31(3), 3-18. https://doi.org/10.35465/31.3.2023.pp3-18

Abstract

Introduction. Axial spondyloarthritis (axSpA) is an inflammatory disorder affecting the axial skeleton, accompanied by pain, restricted mobility, and other symptoms. The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a metric expressing disease activity, assessing inflammation and symptoms. In clinical trials, Upadacitinib has demonstrated reduced axSpA activity, but real-world evidence remains limited. Objective. The objective of this study is to evaluate the therapeutic effectiveness of Upadacitinib in axSpA by analysing its impact on symptoms, activity, and inflammatory markers in real clinical practice. Additional goals include comparing outcomes between biologic-naive and biologic-experienced patients, as well as assessing the influence of radiographic stage on Upadacitinib's therapeutic response. Methods. Sixty-four patients with axSpA were enrolled in Upadacitinib treatment. Among them, 42 were evaluated after 6 months and 13 after 12 months of therapy. ASDAS was assessed at various time points and analyzed based on prior experience with biologic drugs and radiographic stage of sacroiliitis. Results. A notable reduction in mean ASDAS values was observed after 6 months of Upadacitinib treatment (3.5 vs. 1.9, p < 0.001), with this reduction being sustained after 12 months (1.6 vs. 1.9, p > 0.05). A substantial proportion of patients (80.9%) achieved ASDAS values below 2.1 after 6 months, and this achievement was maintained after 12 months (84.6%, p > 0.05). No significant differences were found between biologic-naive and biologic-experienced patient subgroups (84.2% vs. 78.3%, p > 0.05). Similar trends were observed in the analysis of other parameters such as BASDAI, fatigue, pain, CRP, haemoglobin, and ESR. Upadacitinib increased the number of patients with low disease activity regardless of radiographic stage after 6 and 12 months (23.7 vs. 83.3% and 5.7 vs. 85.3%, p < 0.001). Conclusion. Upadacitinib proves to be effective in axSpA treatment. Regardless of demographic, clinical, and radiographic disease characteristics, as well as "biologic-naive/biofailure" status, Upadacitinib leads to ASDAS improvement after 6 and 12 months of treatment. This medication represents an effective tool in real-world clinical practice for controlling axSpA activity.

https://doi.org/10.35465/31.3.2023.pp3-18
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References

  1. Navarro-Compán V, Sepriano A, El-Zorkany B, Heijde D van der. Axial spondyloarthritis. Annals of the Rheumatic Diseases 2021; 80:15;
  2. Braun J, Kiltz U, Baraliakos X. Management of Axial Spondyloarthritis - Insights into Upadacitinib. Drug Des Devel Ther. 2022 Oct 19;16:3609-3620.
  3. Rudwaleit M, van der Heijde D, Landewé R, et alThe development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selectionAnnals of the Rheumatic Diseases 2009;68:777-783.
  4. Magrey MN, Danve AS, Ermann J, Walsh JA. Recognizing Axial Spondyloarthritis: A Guide for Primary Care. Mayo Clinic Proceedings 2020;95:2499–2508.
  5. Zhao SS, Harrison SR, Chan A, Clarke N, Davis C, Eddison J, et al. Treatment of axial spondyloarthritis with biologic and targeted synthetic DMARDs: British Society for Rheumatology guideline scope. Rheumatology Advances in Practice 2023;7
  6. Heijde D van der, Song I-H, Pangan AL, Deodhar A, Bosch F van den, Maksymowych WP, et al. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial. The Lancet 2019;394:2108–2117.
  7. Deodhar A, Van den Bosch F, Poddubnyy D, Maksymowych WP, Heijde D van der, Kim T-H, et al. Upadacitinib for the treatment of active non-radiographic axial spondyloarthritis (SELECT-AXIS 2): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet 2022;400:369–379.
  8. Baraliakos X, Ranza R, Östör A, Ciccia F, Coates LC, Rednic S, et al. Efficacy and safety of upadacitinib in patients with active psoriatic arthritis and axial involvement: results from two phase 3 studies. Arthritis Research & Therapy 2023;25
  9. Paroli M, Caccavale R, Paroli MP, Spadea L, Accapezzato D. Janus Kinase Inhibitors: A New Tool for the Treatment of Axial Spondyloarthritis. Int J Mol Sci. 2023 Jan 5;24(2):1027
  10. Ramiro S, Nikiphorou E, Sepriano A, et alASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 updateAnnals of the Rheumatic Diseases 2023;82:19-34
  11. Jones A, Harrison N, Jones T, Rees JD, Bennett AN. Time to diagnosis of axial spondylarthritis in clinical practice: signs of improving awareness? Rheumatology (Oxford). 2014;53(11):2126-2127
  12. Juanola X, Ramos MJM, Belzunegui JM, Fernández-Carballido C, Gratacós J. Treatment Failure in Axial Spondyloarthritis: Insights for a Standardized Definition. Adv Ther. 2022 Apr;39(4):1490-1501
  13. Dougados M, Maksymowych WP, Landewé RBM, et al.. Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis. Ann Rheum Dis 2018;77:221–7.
  14. Molnar C, Scherer A, Baraliakos X. Rheumatologists of the Swiss clinical quality management program. TNF blockers inhibit spinal radiographic progression in ankylosing spondylitis by reducing disease activity: results from the Swiss clinical quality management cohort. Ann Rheum Dis 2018;77:63–9
  15. Micheroli R, Kissling S, Bürki K, et al.. Sacroiliac joint radiographic progression in axial spondyloarthritis is retarded by the therapeutic use of TNF inhibitors: 12-year data from the SCQM registry. RMD Open 2022;8:e002551
  16. Nair S, Singh Kahlon S, Sikandar R, Peddemul A, Tejovath S, Hassan D, Patel KK, Mostafa JA. Tumor Necrosis Factor-Alpha Inhibitors and Cardiovascular Risk in Rheumatoid Arthritis: A Systematic Review. Cureus. 2022 Jun 29;14(6):e26430
  17. Mehaffey E, Majid DSA. Tumor necrosis factor-α, kidney function, and hypertension. Am J Physiol Renal Physiol. 2017 Oct 1;313(4):F1005-F1008.
  18. Van der Heijde, D., Song, I.-H., Pangan, A. L., Deodhar, A., van den Bosch, F., Maksymowych, W. P., … Sieper, J. (2019). Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled
  19. Deodhar A, Van den Bosch F, Poddubnyy D, Maksymowych WP, van der Heijde D, Kim TH, Kishimoto M, Blanco R, Duan Y, Li Y, Pangan AL, Wung P, Song IH. Upadacitinib for the treatment of active non-radiographic axial spondyloarthritis (SELECT-AXIS 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022 Jul 30;400(10349):369-379
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