The Korean journal of internal medicine

The Korean Association of Internal Medicine (대한내과학회)
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Drug survival of tumor necrosis factor α inhibitors in patients with ankylosing spondylitis in Korea

  • Jeong, Hyemin (Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Eun, Yeong Hee (Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Kim, In Young (Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Kim, Hyungjin (Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Ahn, Joong Kyong (Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine) ;
  • Lee, Jaejoon (Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Koh, Eun-Mi (Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Cha, Hoon-Suk (Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine)
  • Received : 2016.02.12
  • Accepted : 2016.04.12
  • Published : 2018.03.01
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Abstract

Background/Aims: To evaluate drug survival of the tumor necrosis factor ${\alpha}$ inhibitors (TNFi) and risk factors for the drug discontinuation in patients with ankylosing spondylitis (AS). Methods: We retrospectively evaluated 487 AS patients at a single tertiary hospital. Among the TNFi users, drug survival and risk factors of TNFi discontinuation were investigated. Results: Among 487 patients, 128 AS patients were treated with at least one TNFi. Patients who were treated with TNFi were younger at disease onset, had more peripheral manifestations, and had higher level of acute phase reactants and body mass index than those of TNFi non-users at baseline. Of 128 patients, 28 patients (21.9%) discontinued first TNFi therapy during the follow-up period of $65.1{\pm}27.9=;months$. In the multivariable analysis, female (hazard ratio [HR], 6.08; 95% confidence interval [CI], 2.27 to 16.27; p = 0.003), hip involvement (HR, 2.52; 95% CI, 1.08 to 5.87; p = 0.033) and a high C-reactive protein (CRP; HR, 1.10; 95% CI, 1.00 to 1.21; p = 0.044) were risk factors for drug discontinuation. Etanercept showed better survival rate than infliximab. The main reason for discontinuation of TNFi was inefficacy. Conclusions: TNFi discontinuation rate of Korean patients with AS seems to be similar to those with the European patients. Female sex, hip involvement, CRP, and the type of TNFi were associated with TNFi discontinuation.

Keywords

Acknowledgement

Supported by : Korea Health Industry Development Institute

References

  1. Braun J, Bollow M, Neure L, et al. Use of immunohisto logic and in situ hybridization techniques in the examination of sacroiliac joint biopsy specimens from patients with ankylosing spondylitis. Arthritis Rheum 1995;38:499-505. https://doi.org/10.1002/art.1780380407
  2. Francois RJ, Neure L, Sieper J, Braun J. Immunohistological examination of open sacroiliac biopsies of patients with ankylosing spondylitis: detection of tumour necrosis factor alpha in two patients with early disease and transforming growth factor beta in three more advanced cases. Ann Rheum Dis 2006;65:713-720. https://doi.org/10.1136/ard.2005.037465
  3. Braun J, Brandt J, Listing J, et al. Treatment of active ankylosing spondylitis with infliximab: a randomized controlled multicentre trial. Lancet 2002;359:1187-1193. https://doi.org/10.1016/S0140-6736(02)08215-6
  4. Gorman JD, Sack KE, Davis JC Jr. Treatment of ankylos ing spondylitis by inhibition of tumor necrosis factor alpha. N Engl J Med 2002;346:1349-1356. https://doi.org/10.1056/NEJMoa012664
  5. van der Heijde D, Kivitz A, Schiff MH, et al. Efficacy and safety of adalimumab in patients with ankylosing spondylitis: results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2006;54:2136-2146. https://doi.org/10.1002/art.21913
  6. Machado MA, Barbosa MM, Almeida AM, et al. Treatment of ankylosing spondylitis with TNF blockers: a metaanalysis. Rheumatol Int 2013;33:2199-2213. https://doi.org/10.1007/s00296-013-2772-6
  7. Scire CA, Caporali R, Sarzi-Puttini P, et al. Drug survival of the first course of anti-TNF agents in patients with rheumatoid arthritis and seronegative spondyloarthritis: analysis from the MonitorNet database. Clin Exp Rheumatol 2013;31:857-863.
  8. van der Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis: a proposal for modification of the New York criteria. Arthritis Rheum 1984;27:361-368. https://doi.org/10.1002/art.1780270401
  9. MacKay K, Brophy S, Mack C, Doran M, Calin A. The development and validation of a radiographic grading system for the hip in ankylosing spondylitis: the bath ankylosing spondylitis radiology hip index. J Rheumatol 2000;27:2866-2872.
  10. Amor B, Santos RS, Nahal R, Listrat V, Dougados M. Predictive factors for the longterm outcome of spondyloarthropathies. J Rheumatol 1994;21:1883-1887.
  11. Deng Y, Scherer PE. Adipokines as novel biomarkers and regulators of the metabolic syndrome. Ann N Y Acad Sci 2010;1212:E1-E19.
  12. Park MC, Lee SW, Choi ST, Park YB, Lee SK. Serum leptin levels correlate with interleukin-6 levels and disease activity in patients with ankylosing spondylitis. Scand J Rheumatol 2007;36:101-106. https://doi.org/10.1080/03009740600991760
  13. Kim KJ, Kim JY, Park SJ, et al. Serum leptin levels are associated with the presence of syndesmophytes in male patients with ankylosing spondylitis. Clin Rheumatol 2012;31:1231-1238. https://doi.org/10.1007/s10067-012-1999-z
  14. Glintborg B, Ostergaard M, Krogh NS, Dreyer L, Kristensen HL, Hetland ML. Predictors of treatment response and drug continuation in 842 patients with ankylosing spondylitis treated with anti-tumour necrosis factor: results from 8 years’ surveillance in the Danish nationwide DANBIO registry. Ann Rheum Dis 2010;69:2002-2008. https://doi.org/10.1136/ard.2009.124446
  15. Konttinen L, Tuompo R, Uusitalo T, et al. Anti-TNF therapy in the treatment of ankylosing spondylitis: the Finnish experience. Clin Rheumatol 2007;26:1693-1700. https://doi.org/10.1007/s10067-007-0574-5
  16. Heiberg MS, Koldingsnes W, Mikkelsen K, et al. The comparative one-year performance of anti-tumor necrosis factor alpha drugs in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: results from a longitudinal, observational, multicenter study. Arthritis Rheum 2008;59:234-240. https://doi.org/10.1002/art.23333
  17. Lie E, van der Heijde D, Uhlig T, et al. Effectiveness of switching between TNF inhibitors in ankylosing spondylitis: data from the NOR-DMARD register. Ann Rheum Dis 2011;70:157-163. https://doi.org/10.1136/ard.2010.131797
  18. Vander Cruyssen B, Munoz-Gomariz E, Font P, et al. Hip involvement in ankylosing spondylitis: epidemiology and risk factors associated with hip replacement surgery. Rheumatology (Oxford) 2010;49:73-81. https://doi.org/10.1093/rheumatology/kep174
  19. Poddubnyy D, Haibel H, Listing J, et al. Baseline radiographic damage, elevated acute-phase reactant levels, and cigarette smoking status predict spinal radiographic progression in early axial spondylarthritis. Arthritis Rheum 2012;64:1388-1398. https://doi.org/10.1002/art.33465
  20. Chen HA, Chen CH, Liao HT, et al. Factors associated with radiographic spinal involvement and hip involvement in ankylosing spondylitis. Semin Arthritis Rheum 2011;40:552-558. https://doi.org/10.1016/j.semarthrit.2010.07.008
  21. Neovius M, Arkema EV, Olsson H, et al. Drug survival on TNF inhibitors in patients with rheumatoid arthritis comparison of adalimumab, etanercept and infliximab. Ann Rheum Dis 2015;74:354-360. https://doi.org/10.1136/annrheumdis-2013-204128
  22. Lee W, Reveille JD, Davis JC Jr, Learch TJ, Ward MM, Weisman MH. Are there gender differences in severity of ankylosing spondylitis? Results from the PSOAS cohort. Ann Rheum Dis 2007;66:633-638. https://doi.org/10.1136/ard.2006.060293
  23. Sokka T, Toloza S, Cutolo M, et al. Women, men, and rheumatoid arthritis: analyses of disease activity, disease characteristics, and treatments in the QUEST-RA study. Arthritis Res Ther 2009;11:R7.
  24. Katz PP, Criswell LA. Differences in symptom reports between men and women with rheumatoid arthritis. Arthritis Care Res 1996;9:441-448. https://doi.org/10.1002/art.1790090605
  25. Marchesoni A, Zaccara E, Gorla R, et al. TNF-alpha antagonist survival rate in a cohort of rheumatoid arthritis patients observed under conditions of standard clinical practice. Ann N Y Acad Sci 2009;1173:837-846. https://doi.org/10.1111/j.1749-6632.2009.04621.x
  26. Gulyas K, Bodnar N, Nagy Z, et al. Real-life experience with switching TNF-${\alpha}$ inhibitors in ankylosing spondylitis. Eur J Health Econ 2014;15 Suppl 1:S93-S100.
  27. Hackshaw A. Small studies: strengths and limitations. Eur Respir J 2008;32:1141-1143. https://doi.org/10.1183/09031936.00136408
  28. Plasencia C, Pascual-Salcedo D, Nuno L, et al. Influence of immunogenicity on the efficacy of longterm treatment of spondyloarthritis with infliximab. Ann Rheum Dis 2012;71:1955-1960. https://doi.org/10.1136/annrheumdis-2011-200828
  29. Maneiro JR, Salgado E, Gomez-Reino JJ. Immunogenicity of monoclonal antibodies against tumor necrosis factor used in chronic immune-mediated inflammatory conditions: systematic review and meta-analysis. JAMA Intern Med 2013;173:1416-1428. https://doi.org/10.1001/jamainternmed.2013.7430
  30. Arends S, Lebbink HR, Spoorenberg A, et al. The formation of autoantibodies and antibodies to TNF-${\alpha}$ blocking agents in relation to clinical response in patients with ankylosing spondylitis. Clin Exp Rheumatol 2010;28:661-668.
  31. Plasencia C, Pascual-Salcedo D, Garcia-Carazo S, et al. The immunogenicity to the first anti-TNF therapy determines the outcome of switching to a second anti-TNF therapy in spondyloarthritis patients. Arthritis Res Ther 2013;15:R79. https://doi.org/10.1186/ar4258
  32. Garces S, Demengeot J, Benito-Garcia E. The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis. Ann Rheum Dis 2013;72:1947-1955. https://doi.org/10.1136/annrheumdis-2012-202220
  33. Lie E, Kristensen LE, Forsblad-d'Elia H, et al. The effect of comedication with conventional synthetic disease modifying antirheumatic drugs on TNF inhibitor drug survival in patients with ankylosing spondylitis and undifferentiated spondyloarthritis: results from a nationwide prospective study. Ann Rheum Dis 2015;74:970-978. https://doi.org/10.1136/annrheumdis-2014-206616

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