본문 바로가기
KERD
논문KCI 등재

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

0

조회

0

다운로드

3

인용

0

참고문헌

키워드

주제분류내과학

초록

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, inf liximab, 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-tohead 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.

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, inf liximab, 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-tohead 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.

참고문헌 (39)

  1. Schmitz S, "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, 71, pp.225~230 (2012)
  2. Devine EB, "Effectiveness of biologic therapies for rheumatoid arthritis:an indirect comparisons approach", Pharmacotherapy, 31, pp.39~51 (2011)
  3. Gallego-Galisteo M, "Indirect comparison of biological treatments in refractory rheumatoid arthritis", J Clin Pharm Ther, 37, pp.301~307 (2012)
  4. Singh JA, "Summary of AHRQ’s comparative effectiveness review of drug therapy for rheumatoid arthritis (RA) in adults: an update", J Manag Care Pharm, 18(4 Supp C), pp.S1~S18 (2012)
  5. Golicki D, "Leflunomide in monotherapy of rheumatoid arthritis: meta-analysis of randomized trials", Pol Arch Med Wewn, 122, pp.22~32 (2012)
  6. Ahn J, "Bayesian Meta-Analysis Method" (2014), National Evidence-based Healthcare Collaborating Agency
  7. Higgins JP, "Cochrane Handbook for Systematic Reviews of Interventions" (2008), Wiley-Blackwell
  8. Whitlock EP, "Using existing systematic reviews in complex systematic reviews", Ann Intern Med, 148, pp.776~782 (2008)
  9. Aaltonen KJ, "Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatoid arthritis", PLoS One, 7, pp.e30275~ (2012)
  10. Gaujoux-Viala C, "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, 69, pp.1004~1009 (2010)
  11. Turkstra E, "A mixed treatment comparison of the short-term efficacy of biologic disease modifying anti-rheumatic drugs in established rheumatoid arthritis", Curr Med Res Opin, 27, pp.1885~1897 (2011)
  12. Graudal N, "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, 62, pp.2852~2863 (2010)
  13. Genovese MC, "Effect of golimumab on patient-reported outcomes in rheumatoid arthritis: results from the GO-FORWARD study", J Rheumatol, 39, pp.1185~1191 (2012)
  14. Huang J, "Infliximab reduces CD147, MMP-3, and MMP-9 expression in peripheral blood monocytes in patients with active rheumatoid arthritis", Eur J Pharmacol, 698, pp.429~434 (2013)
  15. Jobanputra P, "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, 2, pp.e001395~ (2012)
  16. 주고운, "Safety and Efficacy Evaluation for the Addition of Either Etanercept or Leflunomide in Korean Rheumatoid Arthritis Patients Inadequately Responding to Methotrexate", 대한류마티스학회지, 20(3), pp.166~171 (2013), 대한류마티스학회
  17. Kameda H, "Etanercept (ETN) with methotrexate (MTX) is better than ETN monotherapy in patients with active rheumatoid arthritis despite MTX therapy: a randomized trial", Mod Rheumatol, 20, pp.531~538 (2010)
  18. Kay J, "Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebo-controlled, dose-ranging study", Arthritis Rheum, 58, pp.964~975 (2008)
  19. Keystone E, "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, 58, pp.3319~3329 (2008)
  20. Keystone EC, "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, 68, pp.789~796 (2009)
  21. Keystone EC, "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, 50, pp.353~363 (2004)
  22. Schiff M, "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, 67, pp.1096~1103 (2008)
  23. Strand V, "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, 11, pp.R170~ (2009)
  24. Strand V, "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, 70, pp.996~1002 (2011)
  25. van Vollenhoven RF, "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, 374, pp.459~466 (2009)
  26. Weinblatt ME, "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, 72, pp.381~389 (2013)
  27. Weinblatt ME, "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, 48, pp.35~45 (2003)
  28. Wong M, "Infliximab improves vascular stiffness in patients with rheumatoid arthritis", Ann Rheum Dis, 68, pp.1277~1284 (2009)
  29. "Clinical and economic overview:biological response modifier agents for adults with rheumatoid arthritis" (2010)[URL]
  30. Graudal N, "Effect of combination therapy on joint destruction in rheumatoid arthritis: a network meta-analysis of randomized controlled trials", PLoS One, 9, pp.e106408~ (2014)
  31. Baji P, "Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison", Eur J Health Econ, 15(Suppl 1), pp.S53~S64 (2014)
  32. Singh JA, "A network meta-analysis of randomized controlled trials of biologics for rheumatoid arthritis: a Cochrane overview", CMAJ, 181, pp.787~796 (2009)
  33. Launois R, "Comparison of certolizumab pegol with other anticytokine agents for treatment of rheumatoid arthritis: a multiple-treatment Bayesian metaanalysis", J Rheumatol, 38, pp.835~845 (2011)
  34. Nesbitt A, "Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor alpha agents", Inflamm Bowel Dis, 13, pp.1323~1332 (2007)
  35. Nesbitt A, "Effect of structure of conventional anti-TNFs and certolizumab pegol on mode of action in rheuma toid arthritis", Ann Rheum Dis, 66(Suppl 2), pp.296~ (2007)
  36. Goekoop-Ruiterman YP, "Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial", Arthritis Rheum, 52, pp.3381~3390 (2005)
  37. Messori A, "Biological drugs for the treatment of rheumatoid arthritis by the subcutaneous route: interpreting efficacy data to assess statistical equivalence", Ther Adv Musculoskelet Dis, 6, pp.207~216 (2014)
  38. Jansen JP, "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, 14, pp.417~428 (2011)
  39. Ades AE, "Indirect and mixed treatment comparisons in arthritis research", Rheumatology (Oxford), 50(Suppl 4), pp.i5~i9 (2011)

관련 논문AI추천

Conventional DMARDs 치료에 실패한 류마티스 관절염 환자에서 Biologic DMARDs의 임상적 효과 비교: 베이지안 네트워크 메타분석김안나, 김혜린, 박선경, 이민영, 이의경한국임상약학회 · 한국임상약학회지2015 · 제25권 제1호Rapid onset of efficacy predicts response to therapy with certolizumab plus methotrexate in patients with active rheumatoid arthritis박민찬, 이상헌, Bin Yoo, Catherine Arendt, Chang-Hee Suh, Chul-Soo Cho, Eun Mi Koh, Hoon-Suk Cha, Jung-Yoon Choe, Sang Cheol Bae, Seung-Cheol Shim, Shin-Seok Lee, Soo-Kon Lee, Willem Koetse, Won Park, Yeong-Wook Song, Young-Eun Park, Young Mo Kang대한내과학회 · The Korean Journal of Internal Medicine2018 · 제33권 제6호Current concepts in the management of rheumatoid arthritisYoshiya Tanaka대한내과학회 · The Korean Journal of Internal Medicine2016 · 제31권 제2호Simplified disease activity changes in real-world practice: a nationwide observational study of seropositive rheumatoid arthritis patients with moderate-to-high disease activity소민욱, 신기철, 이상헌, 이승근, Chang-Hee Suh, Dae-Hyun Yoo, Dong-Hyuk Sheen, Eun Young Lee, Hoon-Suk Cha, Hye Soon Lee, Jin Seok Kim, Jin-Wuk Hur, Jung Soo Song, Jung-Yoon Choe, Seong Ho Kim, Seung-Jae Hong, Seung Won Choi, Shin-Seok Lee, Sung-Hwan Park, Sung Jae Choi, Sung Soo Kim, Sung Soo Na, Wan Hee Ryu, Won Park대한내과학회 · The Korean Journal of Internal Medicine2020 · 제35권 제1호Description of the Efficacy and Safety of Three New Biologics in the Treatment of Rheumatoid ArthritisDaniel E. Furst, Harsh Agrawal, Steven S. Storage대한내과학회 · The Korean Journal of Internal Medicine2010 · 제25권 제1호Two-year clinical outcomes after discontinuation of long-term golimumab therapy in Korean patients with rheumatoid arthritis강성욱, 박성환, 배상철, Chang-Hee Suh, Choong Ki Lee, Hyun Ah Kim, Hyun Gyung Chai, Hyun Mi Kwon, Kichul Shin, Min Jung Kim, Myung Jae Yoon, Seung-Geun Lee, Won Park, Yeong Wook Song, Yong-Beom Park대한내과학회 · The Korean Journal of Internal Medicine2022 · 제37권 제5호

이 간행물의 다른 논문 (29건)