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„Biologics“ bei der rheumatoiden Arthritis

Sind sie wirklich kosteneffektiv?

Cost effectiveness of biologics in the treatment of rheumatoid arthritis

  • Schwerpunkt: Was ist gesichert in der Therapie?
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Zusammenfassung

Seit der Einführung der „biologischen Wirkstoffe“ in das therapeutische Armamentarium der rheumatoiden Arthritis (RA) hat sich die Landschaft für die medikamentösen Optionen dieser Erkrankung grundsätzlich geändert. Trotz der inzwischen erfolgten Verankerung der Biologics in den nationalen und internationalen Therapiealgorithmen wird deren routinemäßiger Einsatz kontinuierlich diskutiert, auch da die Jahrestherapiekosten der Biologics um ein Vielfaches höher als bei den konventionellen Basistherapeutika liegen. Hinsichtlich der klinisch messbaren Effektivität auf die Reduktion der Aktivität der Erkrankung lässt sich die Frage nach deren „Effektivität“ inzwischen für einen Zeitraum von mehreren Jahren gut beantworten, wohingegen dies für die Langzeitnebenwirkungen und das Kosten-Nutzen-Verhältnis derzeit nur eingeschränkt möglich ist. Fasst man alle aktuellen Berechnungen zusammen und wendet den internationalen Konsensusvorschlag an, dass der Preis für ein Quality-Adjusted Life-Year nicht über 40.000 € liegen sollte, kann man die TNF-Hemmer zum derzeitigen Zeitpunkt aber formal als (kosten)effektiv bezeichnen.

Abstract

Since the biologics have been introduced in clinical rheumatology, the landscape for medication of rheumatoid arthritis has changed substantially. A completely new family of drugs had to be evaluated for efficacy with regard to its impact on amelioration of disease activity but also with regard to long-term side effects and costs. This evaluation of effectiveness of biologics belongs to the most intensively discussed topics in rheumatology, and at present, only for the clinical side adequate answers can be obtained from the published data. On the other hand, more long-term observation and prospective studies are needed to be able to answer the question of real cost-effectiveness adequately. However, when all current data are summarized, the cost for a TNF-inhibitor in regard of one quality-adjusted life-year ranges below the internationally recommended critical amount of 40.000 €.

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Literatur

  1. Kaiser H, Kley HK (2002) Cortisontherapie. Corticoide in Klinik und Praxis, 11. Aufl. Thieme, Stuttgart

  2. Boers M (2004) Glukocoticoids in rheumatoid arthritis: a senescent research agenda on the brink of rejuvenation? Best Pract Res Clin Rheumatol 18: 21–29

    Article  CAS  PubMed  Google Scholar 

  3. Antoni CE, Manger B (2004) Biotechnologische Medikamente bei entzündlichen Erkrankungen. Internist 45 [Suppl]: S31–S37

    Article  PubMed  Google Scholar 

  4. Wollenhaupt J, Zeidler H (2001) Behandlung der Rheumatoiden Arthritis mit Basistherapeutika-Kombinationen. Dtsch Ärztebl 98: 1196–1200

    Google Scholar 

  5. Müller-Ladner U, Rüther W, Burmester GR (2004) Aktuelle Diagnostik und Therapie der rheumatoiden Arthritis. Dtsch Med Wochenschr 129: 1318–1321

    Article  PubMed  Google Scholar 

  6. Breedveld FC, Kalden JR (2004) Appropiate and effective management of rheumatoid arthritis. Ann Rheum Dis 63: 627–633

    Article  CAS  PubMed  Google Scholar 

  7. Bongartz T, Müller-Ladner U (2002) Monoklonale Antikörper in der Therapie rheumatischer Erkrankungen. Arzneimitteltherapie 20: 324–338

    Google Scholar 

  8. Maini RN, St. Clair EW, Breedveld F et al. for the ATTRACT Study Group (1999) Infliximab (chimeric anti-tumour necrosis factor α monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. Lancet 354: 1932–1939

    Article  CAS  PubMed  Google Scholar 

  9. Lipsky PE, van der Heijde DM, St. Clair EW et al. for the Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group (2000) Infliximab and methotrexate in the treatment of rheumatoid arthritis. N Engl J Med 343: 1594–1602

    Article  CAS  PubMed  Google Scholar 

  10. Klareskog L, van der Heijde D, de Jager JP et al.; TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) study investigators (2004) Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial. Lancet 363: 675–681

    Article  CAS  PubMed  Google Scholar 

  11. Weinblatt ME, Keystone EC, Furst DE et al. (2003) 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: 35–45

    Article  CAS  PubMed  Google Scholar 

  12. Hochberg MC, Tracy JK, Hawkins-Holt M, Flores RH (2003) Comparison of the efficacy of the tumour necrosis factor α blocking agents adalimumab, etanercept, and infliximab when added to methotrexate in patients with active rheumatoid arthritis. Ann Rheum Dis 62 [Suppl]: ii13–ii16

    CAS  PubMed  Google Scholar 

  13. Genovese MC, Cohen S, Moreland L, Lium D, Robbins S, Newmark R, Bekker P, 20000223 Study Group (2004) Combination therapy with etanercept and anakinra in the treatment of patients with rheumatoid arthritis who have been treated unsuccessfully with methotrexate. Arthritis Rheum 50: 1412–1419

    Article  CAS  PubMed  Google Scholar 

  14. O’Dell JR, Leff R, Paulsen G et al. (2002) Treatment of rheumatoid arthritis with methotrexate and hydroxychloroquine, methotrexate and sulfasalazine, or a combination of the three medications: results of a two-year, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 46: 1164–1170

    Article  PubMed  Google Scholar 

  15. Keystone EC, Kavanaugh AF, Sharp JT et al. (2004) Radiographic, clinical and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial. Arthritis Rheum 50: 1400–1411

    Article  CAS  PubMed  Google Scholar 

  16. Furst DE, Breedveld FC, Kalden JR et al. (2003) Updated consensus statement on biological agents for the treatment of rheumatoid arthritis and other immune mediated inflammatory diseases. Ann Rheum Dis 62 [Suppl]: ii2–ii9

    PubMed  Google Scholar 

  17. Maini RN, Breedveld FC, Kalden JR et al. for the Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group (2004) Sustained improvement over two years in physical function, structural damage, and signs and symptoms among patients with rheumatoid arthritis treated with infliximab and methotrexate. Arthritis Rheum 50: 1051–1065

    Article  CAS  PubMed  Google Scholar 

  18. Keystone EC (2003) Advances in targeted therapy: safety of biological agents. Ann Rheum Dis 62 [Suppl]: ii34–ii36

    PubMed  Google Scholar 

  19. Furst DE, Schiff MH, Fleischmann RM et al. (2003) Adalimumab, a fully human anti tumor necrosis factor-alpha monoclonal antibody, and concomitant standard antirheumatic therapy for the treatment of rheumatoid arthritis: results of STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis). J Rheumatol 30: 2563–2571

    CAS  PubMed  Google Scholar 

  20. Wolfe F, Michaud K (2004) Lymphoma in rheumatoid arthritis. The effect of methotrexate and anti-tumor necrosis factor therapy in 18.572 patients. Arthritis Rheum 50: 1740–1751

    Google Scholar 

  21. Fleischmann RM, Schechtman J, Bennett R et al. (2003) Anakinra, a recombinant human interleukin-1 receptor antagonist (r-metHuIL-1ra), in patients with rheumatoid arthritis: A large, international, multicenter, placebo-controlled trial. Arthritis Rheum 48: 937–934

    Article  Google Scholar 

  22. Tesser J, Fleischmann R, Dore R et al.; 990757 Study Group (2004) Concomitant medication use in a large, international, multicenter, placebo controlled trial of anakinra, a recombinant interleukin-1 receptor antagonist, in patients with rheumatoid arthritis. J Rheumatol 31: 649–654

    CAS  PubMed  Google Scholar 

  23. Wong JB, Singh G, Kavanaugh A (2002) Estimating the cost-effectiveness of 54 weeks of infliximab for rheumatoid arthritis. Am J Med 113: 400–408

    Article  PubMed  Google Scholar 

  24. Torrance GW, Tugwell P, Amorosi S, Chartash E, Sengupta N (2004) Improvement in health utility among patients with rheumatoid arthritis treated with adalimumab (a human anti-TNF monoclonal antibody) plus methotrexate. Rheumatology 43: 712–718

    Article  CAS  PubMed  Google Scholar 

  25. Merkesdal S, Ruof J (2002) Betrachtungen zur Kosteneffektivität der Therapie mit TNF-alpha blockierenden Substanzen bei Patienten mit chronischer Polyarthritis. Z Rheumatol 61 [Suppl]: II/29–II/32

    Google Scholar 

  26. Brennan A, Bansback N, Reynolds A, Conway P (2004) Modelling the cost-effectiveness of etanercept in adults with rheumatoid arthritis in the UK. Rheumatology 43: 62–72

    Article  CAS  PubMed  Google Scholar 

  27. Wolfe F, Michaud K, Pincus T (2004) Do rheumatology cost-effectiveness analyses make sense? Rheumatology 43: 4–6

    Article  CAS  PubMed  Google Scholar 

  28. Clark W, Jobanputra P, Barton P, Burls A (2004) The clinical and cost-effectiveness of anakinra for the treatment of rheumatoid arthritis in adults: a systematic review and economic analysis. Health Technol Assess 8: 1–105

    Article  Google Scholar 

  29. Jiang Y, Genant HK, Watt I, Cobby M, Bresnihan B, Aitchinson R, McCabe D (2000) A multicenter, double-blind, dose-ranging, randomized, placebo-controlled study of recombinant human interleukin-1 receptor antagonist in patients with rheumatoid arthritis: radiologic progression and correlation of Genant and Larsen scores. Arthritis Rheum 43: 1001–1009

    Article  CAS  PubMed  Google Scholar 

  30. Genovese MC, Bathon JM, Martin RW et al. (2002) Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum 46: 1443–1450

    Article  CAS  PubMed  Google Scholar 

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  1. Bereich Rheumatologie/Klinische Immunologie, Klinik und Poliklinik für Innere Medizin I der Universität Regensburg

    U. Müller-Ladner

  2. Bereich Rheumatologie/Klinische Immunologie, Klinik und Poliklinik für Innere Medizin I der Universität Regensburg, 93042, Regensburg

    U. Müller-Ladner

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Müller-Ladner, U. „Biologics“ bei der rheumatoiden Arthritis. Internist 45, 1402–1406 (2004). https://doi.org/10.1007/s00108-004-1297-1

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  • DOI: https://doi.org/10.1007/s00108-004-1297-1

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