The Korean journal of internal medicine

The Korean Association of Internal Medicine (대한내과학회)
권호 표지
DOI QR코드

DOI QR Code

Comparative efficacy of biological agents in methotrexate-refractory rheumatoid arthritis patients: a Bayesian mixed treatment comparison

  • Choi, Miyoung (National Evidence-Based Healthcare Collaboration Agency (NECA)) ;
  • Hyun, Min Kyung (Department of Preventive Medicine, Dongguk University College of Korean Medicine) ;
  • i Choi, Seongm (Korea Appraisal Board, Real Estate R&D Institute) ;
  • Tchoe, Ha Jin (National Evidence-Based Healthcare Collaboration Agency (NECA)) ;
  • Lee, Sung Yeon (Department of Internal Medicine, Hallym University Sacred Heart Hospital) ;
  • Son, Kyeong Min (Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital) ;
  • Kim, Min-Jeong (National Evidence-Based Healthcare Collaboration Agency (NECA)) ;
  • Jung, Young Ok (Department of Internal Medicine, Hallym University Kangnam Sacred Heart Hospital) ;
  • Kim, Hyun Ah (Department of Internal Medicine, Hallym University Sacred Heart Hospital)
  • Received : 2015.05.13
  • Accepted : 2015.06.26
  • Published : 2017.05.01
⟨ Previous Next ⟩

Abstract

Background/Aims: Biological agents (biologics) targeting proinflammatory signaling have emerged as an important treatment option in rheumatoid arthritis (RA). Despite the clinical effectiveness of biologics for patients with RA who do not respond to 'traditional' disease-modifying anti-rheumatic drugs (DMARDs), there are concerns regarding their cost and long-term safety. In this study, we aimed to compare the efficacy of various biologics and traditional DMARDs in RA patients refractory to methotrexate (MTX). Methods: Four DMARDs (hydroxychloroquine, sulfasalazine, MTX, lef lunomide) and five anti-tumor necrosis factor drugs (adalimumab, etanercept, golimumab, infliximab, and certolizumab) were selected. A systematic search of published studies was performed from inception through July 2013. Randomized trials of adults with MTX-refractory RA comparing two or more of the selected medications were included. Among 7,938 titles identified, in total, 16 head-to-head trials were selected. Two reviewers independently abstracted the study data and assessed methodological quality using the Cochrane Risk of Bias. Comparative efficacy was analyzed using a Bayesian mixed treatment comparison (MTC). Results: In total, 9, 4, and 11 studies were included for the outcome measures of the Health Assessment Questionnaire (HAQ), Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) < 2.6 (remission), and American College of Rheumatology (ACR) 70 response, respectively. The treatments with the highest efficacy for each outcome measure were certolizumab combined with MTX, golimumab combined with MTX, and certolizumab combined with MTX, respectively. Conclusions: Based on MTC analysis, using data from published randomized controlled trials, certolizumab and golimumab combined with MTX showed the highest efficacy in the three outcome measures (HAQ, DAS28-ESR < 2.6, and ACR 70 response) in MTX-refractory RA patients.

Keywords

Acknowledgement

Supported by : National Evidence-based Healthcare Collaborating Agency (NECA), Ministry of Health and Welfare

References

  1. Schmitz S, Adams R, Walsh CD, Barry M, FitzGerald O. A mixed treatment comparison of the efficacy of anti-TNF agents in rheumatoid arthritis for methotrexate non-responders demonstrates differences between treatments: a Bayesian approach. Ann Rheum Dis 2012;71:225-230. https://doi.org/10.1136/annrheumdis-2011-200228
  2. Devine EB, Alfonso-Cristancho R, Sullivan SD. Effectiveness of biologic therapies for rheumatoid arthritis: an indirect comparisons approach. Pharmacotherapy 2011;31:39-51. https://doi.org/10.1592/phco.31.1.39
  3. Gallego-Galisteo M, Villa-Rubio A, Alegre-del Rey E, Marquez-Fernandez E, Ramos-Baez JJ. Indirect comparison of biological treatments in refractory rheumatoid arthritis. J Clin Pharm Ther 2012;37:301-307. https://doi.org/10.1111/j.1365-2710.2011.01292.x
  4. Singh JA, Cameron DR. Summary of AHRQ's comparative effectiveness review of drug therapy for rheumatoid arthritis (RA) in adults: an update. J Manag Care Pharm 2012;18(4 Supp C):S1-S18.
  5. Golicki D, Newada M, Lis J, Pol K, Hermanowski T, Tlustochowicz M. Leflunomide in monotherapy of rheumatoid arthritis: meta-analysis of randomized trials. Pol Arch Med Wewn 2012;122:22-32.
  6. Ahn J, Choi S, Cho S, Tchoe HJ. Bayesian Meta-Analysis Method. Seoul: National Evidence-based Healthcare Collaborating Agency, 2014.
  7. Higgins JP, Green S. Cochrane Handbook for Systematic Reviews of Interventions. Chichester: Wiley-Blackwell, 2008.
  8. Whitlock EP, Lin JS, Chou R, Shekelle P, Robinson KA. Using existing systematic reviews in complex systematic reviews. Ann Intern Med 2008;148:776-782. https://doi.org/10.7326/0003-4819-148-10-200805200-00010
  9. Aaltonen KJ, Virkki LM, Malmivaara A, Konttinen YT, Nordstrom DC, Blom M. Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatoid arthritis. PLoS One 2012;7:e30275. https://doi.org/10.1371/journal.pone.0030275
  10. Gaujoux-Viala C, Smolen JS, Landewe R, et al. Current evidence for the management of rheumatoid arthritis with synthetic disease-modifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis 2010;69:1004-1009. https://doi.org/10.1136/ard.2009.127225
  11. Turkstra E, Ng SK, Scuffham PA. A mixed treatment comparison of the short-term efficacy of biologic disease modifying anti-rheumatic drugs in established rheumatoid arthritis. Curr Med Res Opin 2011;27:1885-1897. https://doi.org/10.1185/03007995.2011.608655
  12. Graudal N, Jurgens G. Similar effects of disease-modifying antirheumatic drugs, glucocorticoids, and biologic agents on radiographic progression in rheumatoid arthritis: meta-analysis of 70 randomized placebo-controlled or drug-controlled studies, including 112 comparisons. Arthritis Rheum 2010;62:2852-2863. https://doi.org/10.1002/art.27592
  13. Genovese MC, Han C, Keystone EC, et al. Effect of golimumab on patient-reported outcomes in rheumatoid arthritis: results from the GO-FORWARD study. J Rheumatol 2012;39:1185-1191. https://doi.org/10.3899/jrheum.111195
  14. Huang J, Xie B, Li Q, et al. Infliximab reduces CD147, MMP-3, and MMP-9 expression in peripheral blood monocytes in patients with active rheumatoid arthritis. Eur J Pharmacol 2013;698:429-434. https://doi.org/10.1016/j.ejphar.2012.10.030
  15. Jobanputra P, Maggs F, Deeming A, et al. A randomised efficacy and discontinuation study of etanercept versus adalimumab (RED SEA) for rheumatoid arthritis: a pragmatic, unblinded, non-inferiority study of first TNF inhibitor use: outcomes over 2 years. BMJ Open 2012;2:e001395. https://doi.org/10.1136/bmjopen-2012-001395
  16. Joo K, Park W, Kwon SR, Lim MJ. Safety and efficacy evaluation for the addition of either etanercept or leflunomide in Korean rheumatoid arthritis patients inadequately responding to methotrexate. J Rheum Dis 2013;20:166-171. https://doi.org/10.4078/jrd.2013.20.3.166
  17. Kameda H, Ueki Y, Saito K, et al. Etanercept (ETN) with methotrexate (MTX) is better than ETN monotherapy in patients with active rheumatoid arthritis despite MTX therapy: a randomized trial. Mod Rheumatol 2010;20:531-538. https://doi.org/10.3109/s10165-010-0324-4
  18. Kay J, Matteson EL, Dasgupta B, et al. Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebo-controlled, dose-ranging study. Arthritis Rheum 2008;58:964-975. https://doi.org/10.1002/art.23383
  19. Keystone E, Van Der Heijde D, Mason D Jr, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum 2008;58:3319-3329. https://doi.org/10.1002/art.23964
  20. Keystone EC, Genovese MC, Klareskog L, et al. Golimumab, a human antibody to tumour necrosis factor {alpha} given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study. Ann Rheum Dis 2009;68:789-796. https://doi.org/10.1136/ard.2008.099010
  21. Keystone EC, Schiff MH, Kremer JM, et al. Once-weekly administration of 50 mg etanercept in patients with active rheumatoid arthritis: results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2004;50:353-363. https://doi.org/10.1002/art.20019
  22. Schiff M, Keiserman M, Codding C, et al. Efficacy and safety of abatacept or infliximab vs placebo in ATTEST: a phase III, multi-centre, randomised, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis 2008;67:1096-1103. https://doi.org/10.1136/ard.2007.080002
  23. Strand V, Mease P, Burmester GR, et al. Rapid and sustained improvements in health-related quality of life, fatigue, and other patient-reported outcomes in rheumatoid arthritis patients treated with certolizumab pegol plus methotrexate over 1 year: results from the RAPID 1 randomized controlled trial. Arthritis Res Ther 2009;11:R170. https://doi.org/10.1186/ar2859
  24. Strand V, Smolen JS, van Vollenhoven RF, et al. Certolizumab pegol plus methotrexate provides broad relief from the burden of rheumatoid arthritis: analysis of patient-reported outcomes from the RAPID 2 trial. Ann Rheum Dis 2011;70:996-1002. https://doi.org/10.1136/ard.2010.143586
  25. van Vollenhoven RF, Ernestam S, Geborek P, et al. Addition of infliximab compared with addition of sulfasalazine and hydroxychloroquine to methotrexate in patients with early rheumatoid arthritis (Swefot trial): 1-year results of a randomised trial. Lancet 2009;374:459-466. https://doi.org/10.1016/S0140-6736(09)60944-2
  26. Weinblatt ME, Bingham CO 3rd, Mendelsohn AM, et al. Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial. Ann Rheum Dis 2013;72:381-389. https://doi.org/10.1136/annrheumdis-2012-201411
  27. Weinblatt ME, Keystone EC, Furst DE, et al. Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum 2003;48:35-45. https://doi.org/10.1002/art.10697
  28. Wong M, Oakley SP, Young L, et al. Infliximab improves vascular stiffness in patients with rheumatoid arthritis. Ann Rheum Dis 2009;68:1277-1284. https://doi.org/10.1136/ard.2007.086157
  29. Canadian Agency for Drugs and Technologies in Health. Therapeutic review. Clinical and economic overview: biological response modifier agents for adults with rheumatoid arthritis [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health, c2010 [cited 2016 Apr 22]. Available from: https://www.cadth.ca/media/pdf/TR_RA_Clinical_and_Economic_Overview_e.pdf.
  30. Graudal N, Hubeck-Graudal T, Tarp S, Christensen R, Jurgens G. Effect of combination therapy on joint destruction in rheumatoid arthritis: a network meta-analysis of randomized controlled trials. PLoS One 2014;9:e106408. https://doi.org/10.1371/journal.pone.0106408
  31. Baji P, Pentek M, Czirjak L, et al. Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison. Eur J Health Econ 2014;15 Suppl 1:S53-S64. https://doi.org/10.1007/s10198-014-0594-4
  32. Singh JA, Christensen R, Wells GA, et al. A network meta-analysis of randomized controlled trials of biologics for rheumatoid arthritis: a Cochrane overview. CMAJ 2009;181:787-796. https://doi.org/10.1503/cmaj.091391
  33. Launois R, Avouac B, Berenbaum F, et al. Comparison of certolizumab pegol with other anticytokine agents for treatment of rheumatoid arthritis: a multiple-treatment Bayesian metaanalysis. J Rheumatol 2011;38:835-845. https://doi.org/10.3899/jrheum.100665
  34. Nesbitt A, Fossati G, Bergin M, et al. Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor alpha agents. Inflamm Bowel Dis 2007;13:1323-1332. https://doi.org/10.1002/ibd.20225
  35. Nesbitt A, Fossati G, Brown D, Henry A, Palframan R, Stephens S. Effect of structure of conventional anti-TNFs and certolizumab pegol on mode of action in rheumatoid arthritis. Ann Rheum Dis 2007;66(Suppl 2):296.
  36. Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, et al. Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial. Arthritis Rheum 2005;52:3381-3390. https://doi.org/10.1002/art.21405
  37. Messori A, Fadda V, Maratea D, et al. Biological drugs for the treatment of rheumatoid arthritis by the subcutaneous route: interpreting efficacy data to assess statistical equivalence. Ther Adv Musculoskelet Dis 2014;6:207-216. https://doi.org/10.1177/1759720X14554792
  38. Jansen JP, Fleurence R, Devine B, et al. Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 1. Value Health 2011;14:417-428. https://doi.org/10.1016/j.jval.2011.04.002
  39. Ades AE, Madan J, Welton NJ. Indirect and mixed treatment comparisons in arthritis research. Rheumatology (Oxford) 2011;50 Suppl 4:iv5-iv9.

Cited by

  1. The Efficacy and Safety of Mainstream Medications for Patients With cDMARD-Naïve Rheumatoid Arthritis: A Network Meta-Analysis vol.9, pp.None, 2017, https://doi.org/10.3389/fphar.2018.00138
  2. First line of biological drugs in rheumatoid arthritis: a medication persistence analysis vol.12, pp.4, 2017, https://doi.org/10.1080/17512433.2019.1586533
  3. The Use of Biological Disease-modifying Antirheumatic Drugs for Inflammatory Arthritis in Korea: Results of a Korean Expert Consensus vol.27, pp.1, 2017, https://doi.org/10.4078/jrd.2020.27.1.4