J Rheum Dis.  2024 Jul;31(3):171-177. 10.4078/jrd.2024.0029.

The effectiveness of tumor necrosis factor-α blocker therapy in patients with axial spondyloarthritis who failed conventional treatment: a comparative study focused on improvement in ASAS Health Index

• Choi AR
• Park KJ
• Kang JH
• Lee YJ
• Jang HH
• Kim MJ
• Kim TJ

• KMID: 2557405
• DOI: http://doi.org/10.4078/jrd.2024.0029

Abstract

Objective
The purpose of this study is to evaluate the impact of tumor necrosis factor (TNF)-α blocker therapy on the Assessment of SpondyloArthritis international Society Health Index (ASAS-HI) among patients who have failed conventional nonsteroidal anti-inflammatory drugs.
Methods
A comparative study was conducted involving axial spondyloarthritis (axSpA) patients treated with either TNF-α blocker or conventional therapy. Patient data, including demographics, disease characteristics, and ASAS-HI scores, were collected before and after treatment. Statistical analysis was performed to compare changes in ASAS-HI scores between the TNF-α blocker and the conventional therapy group.
Results
The study population consisted of patients with axSpA, with a mean age of 38.3 years in conventional treatment group and 29.3 years in TNF-α blocker group. Most variables, including C-reactive protein levels, other comorbidities, and disease assessment scores showed no significant difference between groups. Longitudinal analysis within each treatment group from Week 0 to 12 showed no significant change in the conventional treatment group, whereas the TNF-α blocker group experienced a significant reduction in ASAS-HI scores, demonstrating the effectiveness of the treatment. The TNF-α blocker group exhibited a significantly greater improvement in ASAS-HI scores compared to the conventional therapy group. The Bath Ankylosing Spondylitis Functional Index and the Bath Ankylosing Spondylitis Disease Activity Index demonstrated strong positive correlations with ASAS-HI scores, indicating higher disease activity and functional limitation are associated with worse health outcomes in patients.
Conclusion
The research demonstrates that ASAS-HI scores significantly improve with TNF-α blocker therapy in axSpA patients, underscoring ASAS-HI's effectiveness as a tool for evaluating drug responses.

Keyword

Axial spondyloarthritis; Tumor necrosis factor-α blocker; Assessment of SpondyloArthritis international Society Health Index

Figure

• 

  Figure 1 Comparison of ASAS-HI changes from baseline to Week 12 between groups. (A) Illustrates the baseline ASAS-HI scores for both groups, while (B) shows the scores at Week 12, highlighting the changes over time. Further dissect these comparisons by (C) focusing on the conventional treatment group and (D) on the TNF-α blocker group, both from baseline to Week 12. ASAS-HI: Assessment of SpondyloArthritis international Society Health Index, TNF: tumor necrosis factor, ns: no significant. **p<0.01, ****p<0.0001.

• 

  Figure 2 Assessing ASAS-HI score dynamics from baseline to Week 12 across treatment responder and non-responder. (A) For non-responders, ASAS-HI scores remained unchanged from week 0 to week 12, as depicted by the mostly flat lines. (B) In the conventional treatment group, there is no significant change in ASAS-HI scores from week 0 to week 12. However, in the TNF-α blocker group, there is a significant decrease in ASAS-HI scores from week 0 to week 12. Responder defined as clinically important improvement according to ASDAS criteria (Delta≥1.1), ASAS-HI: Assessment of SpondyloArthritis international Society Health Index, TNF: tumor necrosis factor, ASDAS: Ankylosing Spondylitis Disease Activity Score, ns: no significant. ****p<0.0001.

Reference

1. Seo MR, Yeo J, Park JW, Lee YA, Lee JH, Kang EH, et al. 2023; Korean treatment recommendations for patients with axial spondyloarthritis. J Rheum Dis. 30:151–69. Erratum in: J Rheum Dis 2024;31:62-3. DOI: 10.4078/jrd.2023.0025C. PMID: 38164191. PMCID: PMC10730801.

2. Kiltz U, van der Heijde D, Boonen A, Akkoc N, Bautista-Molano W, Burgos-Vargas R, et al. 2018; Measurement properties of the ASAS Health Index: results of a global study in patients with axial and peripheral spondyloarthritis. Ann Rheum Dis. 77:1311–7. DOI: 10.1136/annrheumdis-2017-212076. PMID: 29858176.

3. Rudwaleit M, Landewé R, van der Heijde D, Listing J, Brandt J, Braun J, et al. 2009; The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part I): classification of paper patients by expert opinion including uncertainty appraisal. Ann Rheum Dis. 68:770–6. Erratum in: Ann Rheum Dis 2011;70:1519. DOI: 10.1136/ard.2009.108217. PMID: 19297345.

4. van der Heijde D, Lie E, Kvien TK, Sieper J, Van den Bosch F, Listing J, et al. 2009; ASDAS, a highly discriminatory ASAS-endorsed disease activity score in patients with ankylosing spondylitis. Ann Rheum Dis. 68:1811–8. DOI: 10.1136/ard.2008.100826. PMID: 19060001.

5. Garrett S, Jenkinson T, Kennedy LG, Whitelock H, Gaisford P, Calin A. 1994; A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol. 21:2286–91.

6. Calin A, Garrett S, Whitelock H, Kennedy LG, O'Hea J, Mallorie P, et al. 1994; A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index. J Rheumatol. 21:2281–5.

7. Kiltz U, van der Heijde D, Boonen A, Braun J. 2014; The ASAS Health Index (ASAS-HI)- a new tool to assess the health status of patients with spondyloarthritis. Clin Exp Rheumatol. 32(5 Suppl 8):S-105–8.

8. Kiltz U, van der Heijde D, Boonen A, Cieza A, Stucki G, Khan MA, et al. 2015; Development of a health index in patients with ankylosing spondylitis (ASAS-HI): final result of a global initiative based on the ICF guided by ASAS. Ann Rheum Dis. 74:830–5. DOI: 10.1136/annrheumdis-2013-203967. PMID: 24399232. PMCID: PMC4511705.

9. Navarro-Compán V, Boel A, Boonen A, Mease PJ, Dougados M, Kiltz U, et al. 2023; Instrument selection for the ASAS core outcome set for axial spondyloarthritis. Ann Rheum Dis. 82:763–72. DOI: 10.1136/annrheumdis-2022-222747. PMID: 35680390.

10. Navarro-Compán V, Boel A, Boonen A, Mease P, Landewé R, Kiltz U, et al. 2021; The ASAS-OMERACT core domain set for axial spondyloarthritis. Semin Arthritis Rheum. 51:1342–9. DOI: 10.1016/j.semarthrit.2021.07.021. PMID: 34489113.

11. Molto A, López-Medina C, Van den Bosch FE, Boonen A, Webers C, Dernis E, et al. 2021; Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial. Ann Rheum Dis. 80:1436–44. DOI: 10.1136/annrheumdis-2020-219585. PMID: 33958325. PMCID: PMC8522451.

12. Choi JH, Kim TJ, Shin K, Choi CB, Kim JH, Kim SH, et al. 2014; The reliability and validity of a Korean translation of the ASAS Health Index and Environmental Factors in Korean patients with axial spondyloarthritis. J Korean Med Sci. 29:334–7. DOI: 10.3346/jkms.2014.29.3.334. PMID: 24616580. PMCID: PMC3945126.

13. Di Carlo M, Lato V, Carotti M, Salaffi F. 2016; Clinimetric properties of the ASAS health index in a cohort of Italian patients with axial spondyloarthritis. Health Qual Life Outcomes. 14:78. DOI: 10.1186/s12955-016-0463-1. PMID: 27188166. PMCID: PMC4869300.

14. Akgul O, Bodur H, Ataman S, Yurdakul FG, Capkin E, Gurer G, et al. 2020; Clinical performance of ASAS Health Index in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis: real-world evidence from Multicenter Nationwide Registry. Rheumatol Int. 40:1793–801. DOI: 10.1007/s00296-020-04680-8. PMID: 32814986.

15. Redeker I, Landewé R, van der Heijde D, Ramiro S, Boonen A, Dougados M, et al. 2023; Impact of disease outcomes on the Assessment of SpondyloArthritis International Society Health Index (ASAS-HI): a Bayesian network analysis of the DESIR cohort. RMD Open. 9:e003587. DOI: 10.1136/rmdopen-2023-003587. PMID: 38123481. PMCID: PMC10748975.

16. Regierer AC, Weiß A, Kiltz U, Sieper J, Schwarze I, Bohl-Bühler M, et al. 2023; The sensitivity to change of the ASAS Health Index in an observational real-life cohort study. J Rheumatol. 50:185–91. DOI: 10.3899/jrheum.220212. PMID: 35914790.

17. Başkan BM, Sivas F, Inal EE, Duran S, Elverici E, Ozoran K, et al. 2010; Comparison of the Bath Ankylosing Spondylitis Radiology Index and the modified Stoke Ankylosing Spondylitis Spine Score in Turkish patients with ankylosing spondylitis. Clin Rheumatol. 29:65–70. DOI: 10.1007/s10067-009-1290-0. PMID: 19813046.

18. Landewé R, Dougados M, Mielants H, van der Tempel H, van der Heijde D. 2009; Physical function in ankylosing spondylitis is independently determined by both disease activity and radiographic damage of the spine. Ann Rheum Dis. 68:863–7. DOI: 10.1136/ard.2008.091793. PMID: 18628283.

19. Machado P, Landewé R, Braun J, Hermann KG, Baker D, van der Heijde D. 2010; Both structural damage and inflammation of the spine contribute to impairment of spinal mobility in patients with ankylosing spondylitis. Ann Rheum Dis. 69:1465–70. DOI: 10.1136/ard.2009.124206. PMID: 20498215.