Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
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Effects of Tumor Necrosis Factor-alpha Inhibitors on the Incidence of Tuberculosis

Tumor Necrosis Factor-alpha 저해제가 결핵 발생에 미치는 영향

  • Park, Hyun Jin (College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University) ;
  • Choi, Bo Yoon (College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University) ;
  • Sohn, Minji (College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University) ;
  • Han, Na Young (College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University) ;
  • Kim, In-Wha (College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University) ;
  • Oh, Jung Mi (College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University)
  • 박현진 (서울대학교 약학대학, 종합약학연구소) ;
  • 최보윤 (서울대학교 약학대학, 종합약학연구소) ;
  • 손민지 (서울대학교 약학대학, 종합약학연구소) ;
  • 한나영 (서울대학교 약학대학, 종합약학연구소) ;
  • 김인화 (서울대학교 약학대학, 종합약학연구소) ;
  • 오정미 (서울대학교 약학대학, 종합약학연구소)
  • Received : 2018.11.19
  • Accepted : 2018.12.11
  • Published : 2018.12.29
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Abstract

Objective: Tumor necrosis factor-alpha (TNF-alpha) inhibitors are used as a treatment in various immune-mediated inflammatory diseases (IMIDs). Tuberculosis (TB) risk is reported in several meta-analyses in patients treated with TNF-alpha inhibitors. The purpose of this study is to collect, review, and evaluate the TB risk in TNF-alpha inhibitors according to IMIDs indications and between soluble-receptor TNF-alpha inhibitor and monoclonal-antibody TNF-alpha inhibitors. Methods: A systematic literature search on systematic reviews and meta-analyses was performed in PubMed, MEDLINE, Cochrane library, and EMBASE. We identified meta-analyses that evaluated TB infection risk of TNF-alpha inhibitors in IMIDs patients. Results: Thirteen meta-analyses including 41 study results were included in this umbrella review. IMIDs patients treated with TNF-alpha inhibitors had an increased risk of TB than control group (placebo with or without standard therapy patients) (relative risk ratio (RR) 2.057, 95% confidence interval (CI) 1.697 to 2.495). Among them, RA patients with TNF-alpha inhibitors had a higher risk of TB than control group (RR 1.847, 95% CI 1.385 to 2.464), and non-RA patients with TNF-alpha inhibitors had an increased risk of TB (RR 2.236, 95% CI 1.284 to 3.894). In subgroup analysis on TB risk between soluble-receptor TNF-alpha inhibitor and monoclonal-antibody TNF-alpha inhibitors in RA patients, the analysis indicated that monoclonal-antibody TNF-alpha inhibitors had higher risk of TB than soluble-receptor TNF-alpha inhibitor (RR 2.880, 95% CI 1.730 to 4.792). Conclusion: This umbrella review confirms that the risk of TB is significantly increased in TNF-alpha inhibitor treated patients compared to control group.

Keywords

References

  1. Bradley JR. TNF-mediated inflammatory disease. J Pathol 2008;214:149-60. https://doi.org/10.1002/path.2287
  2. Firestein GS, Corr M. Common mechanisms in immune-mediated inflammatory disease. J Rheumatol Suppl 2005;73:8-13.
  3. Kuek A, Hazleman BL, Ostor AJ. Immunemediated inflammatory diseases (IMIDs) and biologic therapy: a medical revolution. Postgrad Med J 2007;83:251-60. https://doi.org/10.1136/pgmj.2006.052688
  4. Blandizzi C, Gionchetti P, Armuzzi A, et al. The role of tumour necrosis factor in the pathogenesis of immune-mediated diseases. Int J Immunopathol Pharmacol 2014;27(Suppl):1-10.
  5. Burmester GR, Mariette X, Montecucco C, et al. Adalimumab alone and in combination with disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis in clinical practice: the research in active rheumatoid arthritis (ReAct) trial. Ann Rheum Dis 2007;66:732-9. https://doi.org/10.1136/ard.2006.066761
  6. Sampaio-Barros PD, van der Horst-Bruinsma IE. Adverse effects of TNF inhibitors in SpA: are they different from RA? Best Pract Res Clin Rheumatol 2014;28:747-63. https://doi.org/10.1016/j.berh.2014.10.001
  7. Askling J, Fored CM, Brandt L, et al. Risk and case characteristics of tuberculosis in rheumatoidarthritis associated with tumor necrosis factor antagonists inSweden. Arthritis Rheum 2005;52:1986-92. https://doi.org/10.1002/art.21137
  8. Dixon WG, Watson K, Lunt M, et al. Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy: results from the British society for rheumatology biologics register. Arthritis Rheum 2006;54:2368-76. https://doi.org/10.1002/art.21978
  9. Ai JW, Zhang S, Ruan QL, et al. The risk of tuberculosis in patients with rheumatoid arthritis treated with tumor necrosis factor-a antagonist: a metaanalysis of both randomized controlled trials and registry/cohort studies. J Rheumatol 2015;42(12):2229-37. https://doi.org/10.3899/jrheum.150057
  10. Bonovas S, Fiorino G, Allocca M, et al. Biologic therapies and risk of infection and malignancy in patients with inflammatory bowel disease: a systematic review and network meta-analysis. Clin Gastroenterol Hepatol 2016;14(10):1385-97.e10. https://doi.org/10.1016/j.cgh.2016.04.039
  11. Capogrosso Sansone A, Mantarro S, Tuccori M, et al. Safety profile of certolizumab pegol in patients with immune-mediated inflammatory diseases: a systematic review and meta-analysis. Drug Saf 2015;38(10):869-88. https://doi.org/10.1007/s40264-015-0336-2
  12. Ford AC, Peyrin-Biroulet L. Opportunistic infections with anti-tumor necrosis factor- $\alpha$ therapy in inflammatory bowel disease: meta-analysis of randomized controlled trials. Am J Gastroenterol 2013; 108(8):1268-76. https://doi.org/10.1038/ajg.2013.138
  13. Liao H, Zhong Z, Liu Z, et al. Comparison of the risk of infections in different anti-TNF agents: a meta-analysis. Int J Rheum Dis 2017;20(2):161-8. https://doi.org/10.1111/1756-185X.12970
  14. Minozzi S, Bonovas S, Lytras T, et al. Risk of infections using anti-TNF agents in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: a systematic review and meta-analysis. Expert Opin Drug Saf 2016;15(suppl):11-34. https://doi.org/10.1080/14740338.2016.1240783
  15. Ruiz Garcia V, Burls A, Cabello JB, et al. Certolizumab pegol (CDP870) for rheumatoid arthritis in adults. Cochrane Database Syst Rev 2017;9:CD007649. DOI: 10.1002/14651858.CD007649.pub4.
  16. Singh JA, Nooribaloochi S, Singh G. Golimumab for theumatoid arthritis (Review). Cochrane Database Syst Rev 2010;1: CD008341. DOI: 10.1002/14651858.CD008341.
  17. Souto A, Maneiro JR, Salgado E, et al. Risk of tuberculosis in patients with chronic immune-mediated inflammatory diseases treated with biologics and tofacitinib: a systematic review and meta-analysis of randomized controlled trials and long-term extension studies. Rheumatology 2014;53:1872-85. https://doi.org/10.1093/rheumatology/keu172
  18. Wang Q, Wen Z, Cao Q. Risk of tuberculosis during infliximab therapy for inflammatory bowel disease, rheumatoid arthritis, and spondyloarthropathy: a meta-analysis. Exp Ther Med 2016;12(3):1693-704. https://doi.org/10.3892/etm.2016.3548
  19. Xie X, Chen J, Peng Y, et al. Meta analysis of infection risks of anti-TNF-$\alpha$ treatment in rheumatoid arthritis. Zhong Nan Da Xue Xue Bao Yi Xue Ban 2013;38(7):722-36.
  20. Xu Z, Xu P, Fan W, et al. Risk of infection in patients with spondyloarthritis and ankylosing spondylitis receiving antitumor necrosis factor therapy: a meta-analysis of randomized controlled trials. Exp Ther Med 2017;14(4):3491-500. https://doi.org/10.3892/etm.2017.5003
  21. Zhang Z, Fan W, Yang G, et al. Risk of tuberculosis in patients treated with TNF-$\alpha$ antagonists: a systematic review and meta-analysis of randomised controlled trials. BMJ Open 2017;7:e012567. DOI: 10.1136/bmjopen-2016-012567.
  22. Ke WM, Chen LS, Parng IM, et al. Risk of tuberculosis in rheumatoid arthritis patients on tumour necrosis factor-alpha inhibitor treatment in Taiwan. Int J Tuberc Lung Dis 2017;17(12):1590-95. https://doi.org/10.5588/ijtld.13.0368
  23. Wallis RS. Reactivation of latent tuberculosis by TNF blockade: the role of interferon gamma. J Investig Dermatol Symp Proc 2007;12(1):16-21. https://doi.org/10.1038/sj.jidsymp.5650031
  24. Green S, Higgins JPT, Alderson P, et al. Chapter 1: introduction. In: Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of interventions (version 5.1.0). The Cochrane Collaboration; 2011. Available from http://www.handbook.cochrane.org. Accessed Oct 30, 2018.
  25. Pollock M, Fernandes RM, Becker LA, et al. What guidance is available for researchers conducting overviews of reviews of healthcare interventions? A scoping review and qualitative metasummary. Syst Rev 2016;5(1):190. DOI: 10.1186/s13643-016-0367-5.
  26. Deeks J, Higgins J, Altman D. Chapter 9: Analysing data and undertaking meta-analyses, Cochrane handbook for systematic reviews of interventions version 5.0.0 (updated February 2008). The Cochrane Collaboration. Available from http://www.cochrane-handbook.org. Accessed Oct 30, 2018.
  27. Fusar-Poli P, Radua J. Ten simple rules for conducting umbrella reviews. Evid Based Ment Health 2018;21(3):95-100. https://doi.org/10.1136/ebmental-2018-300014
  28. Wang Z. Converting odds ratio to relative risk in cohort studies with partial data information. J Stat Soft 2013;55(5)1-11.
  29. Becker LA, Oxman AD. Chapter 22: overviews of reviews. In: Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of interventions (version 5.1.0). The Cochrane Collaboration; 2011. Available from http://www.handbook.cochrane.org. Accessed Oct 30, 2018.
  30. Solovic I, Sester M, Gomez-Reino JJ, et al. The risk of tuberculosis related to tumour necrosis factor antagonist therapies: a TBNET consensus statement. Eur Respir J 2010;36:1185-206. https://doi.org/10.1183/09031936.00028510
  31. Wallis RS. Tumour necrosis factor antagonists: structure, function, and tuberculosis risks. Lancet Infect Dis 2008; 8(10):601-11. https://doi.org/10.1016/S1473-3099(08)70227-5
  32. Scallon B, Cai A, Solowski N, et al. Binding and functional comparisons of two types of tumor necrosis factor antagonists. J Pharmacol Exp Ther 2002;301(2):418-26. https://doi.org/10.1124/jpet.301.2.418
  33. Scallon BJ, Moore MA, Trinh H, et al. Chimeric anti-TNF-alpha monoclonal antibody cA2 binds recombinant transmembrane TNFalpha and activates immune effector functions. Cytokine 1995; 7(3):251-9. https://doi.org/10.1006/cyto.1995.0029
  34. Banner DW, D'Arcy A, Janes W, et al. Crystal structure of the soluble human 55 kd TNF receptor-human TNF beta complex: implications for TNF receptor activation. Cell 1993;73(3):431-45. https://doi.org/10.1016/0092-8674(93)90132-A
  35. Bonovas S, Pantavou K, Evripidou D, et al. Safety of biological therapies in ulcerative colitis: an umbrella review of meta-analyses. Best Pract Res Clin Gastroenterol 2018;32-33:43-7. https://doi.org/10.1016/j.bpg.2018.05.005
  36. Adalimumab. Micromedex Solutions. Truven Health Analytics, Inc. Greenwood Village, CO. Available from http://www.micromedexsolutions. com. Accessed Oct 30, 2018.
  37. Infliximab. Micromedex Solutions. Truven Health Analytics, Inc. Greenwood Village, CO. Available from http://www.micromedexsolutions.com. Accessed Oct 30, 2018.
  38. Certolizumab pegol. Micromedex Solutions. Truven Health Analytics, Inc. Greenwood Village, CO. Available from http://www.micromedexsolutions.com. Accessed Oct 30, 2018.
  39. Golimumab. Micromedex Solutions. Truven Health Analytics, Inc. Greenwood Village, CO. Available from http://www.micromedexsolutions.com. Accessed Oct 30, 2018.
  40. Etanercept. Micromedex Solutions. Truven Health Analytics, Inc. Greenwood Village, CO. Available from http://www.micromedexsolutions. com. Accessed Oct 30, 2018.

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