Skip to main content
SpringerLink
Log in
Book cover

Clinical Trials in Rheumatoid Arthritis and Osteoarthritis pp 37–49Cite as

Development of Biological Therapies for Inflammatory Arthritis

  • Chapter

  • 1265 Accesses

Part of the book series: Clinical Trials ((CLINICAL))

This is a preview of subscription content, log in via an institution.

Chapter
USD   29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD   84.99
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD   109.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Learn about institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Feldmann M, Brennan F, Williams RO, et al. The transfer of a laboratory based hypothesis to a clinically useful therapy: the development of anti-TNF therapy of rheumatoid arthritis. Best Pract Res Clin Rheumatol 2004;18(1):59–80.

    Article  PubMed  CAS  Google Scholar 

  2. Neidel J, Schulze M, Lindschau J. Association between degree of bone-erosion and synovial fluid-levels of tumor necrosis factor alpha in the knee-joints of patients with rheumatoid arthritis. Inflamm Res 1995;44:217–221.

    Article  PubMed  CAS  Google Scholar 

  3. Braun J, Sieper J. Biological therapies in the spondylarthritides—the current state. Rheumatology 2004;43(9):1072–1084.

    Article  PubMed  CAS  Google Scholar 

  4. Grom AA, Murray KJ, Luyrink L, et al. Patterns of expression of tumor necrosis factor alpha, tumor necrosis factor beta, and their receptors in synovia of patients with juvenile rheumatoid arthritis and juvenile spondylarthopathy. Arthritis Rheum 1996;39:1703–1710.

    Article  PubMed  CAS  Google Scholar 

  5. Moreland LW, Schiff MH, Baumgartner SE, et al. Etanercept therapy in rheumatoid arthritis: a randomised controlled trial. Ann Intern Med 1999;130:478–486.

    PubMed  CAS  Google Scholar 

  6. Weinblatt ME, Kremer JM, Bankhurst AD, et al. A trial of etanercept, a recombinant tumour necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med 1999;340:253–259.

    Article  PubMed  CAS  Google Scholar 

  7. Klareskog L, van der Heijde D, de Jager JP, et al., for the TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcome) study investigators. 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 2004;363:675–681.

    Article  PubMed  CAS  Google Scholar 

  8. van der Heijde DM, van Riel PL, Nuver-Zwart IH, Gribnau FW, van de Putte LB. Effects of hydroxychloroquine and sulphasalazine on progression of joint damage in rheumatoid arthritis. Lancet 1989;1:1036–1038.

    PubMed  Google Scholar 

  9. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology:preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727–735.

    Article  PubMed  CAS  Google Scholar 

  10. Maini RN, Breedveld FC, Kalden JR, et al. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum 1998;41:1552–1563.

    Article  PubMed  CAS  Google Scholar 

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

    Article  PubMed  CAS  Google Scholar 

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

    Article  PubMed  CAS  Google Scholar 

  13. Weinblatt ME, Keystone EC, Furst DE, et al. Adalimumab 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.

    Article  PubMed  CAS  Google Scholar 

  14. Keystone EC, Kavanaugh AF, Sharp JT, et al. 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 randomised, placebo-controlled, 52 week trial. Arthritis Rheum 2004;50:1400–1411.

    Article  PubMed  CAS  Google Scholar 

  15. Wilkins N, Jackson G, Gardner J. Biologic therapies for juvenile arthritis. Ann Dis Childhood 2003;88(3):186–191.

    Article  Google Scholar 

  16. Ledingham J, Deighton C. Update on the British Society for Rheumatology guidelines for prescribing TNFα blockers in adults with rheumatoid arthritis (update of previous guidelines of April 2001). Rheumatology 2005;44:157–163.

    Article  PubMed  CAS  Google Scholar 

  17. Brown SL, Greene MH, Gershon SK, Edwards ET, Braun MM. Tumour necrosis factor antagonist therapy and lymphoma development. 26 cases reported to the Food and Drug Administration. Arthritis Rheum 2002;46:3151–3158.

    Article  PubMed  CAS  Google Scholar 

  18. NICE. The clinical effectiveness and cost effectiveness of etanercept and infliximab for rheumatoid arthritis and juvenile poly-articular idiopathic arthritis. Available at www.nice.org.uk/pdf/RAAssessmentReport.pdf. Accessed February 10, 2006.

    Google Scholar 

  19. Choi HK, Seeger JD, Kuntz KM. A cost effectiveness analysis of treatment options for patients with methotrexate resistant rheumatoid arthritis. Arthritis Rheum 2000;43(10): 2316–2327.

    Article  PubMed  CAS  Google Scholar 

  20. Banthon JM, Martin RW, Fleischmann RM, et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med 2000;343:1586–1593.

    Article  Google Scholar 

  21. St Clair EW, van der Heijde DM, Smolen JS, et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum. 2004;50:3432–3443.

    Article  PubMed  CAS  Google Scholar 

  22. Breedveld FC, Weisman MH, Kavanaugh AF, et al. The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum 2006;54:26–37.

    Article  PubMed  CAS  Google Scholar 

  23. Goldblatt F, Isenberg D. New therapies for rheumatoid arthritis, Clin Exp Immunol 2005;140(2):195–204.

    Article  PubMed  CAS  Google Scholar 

  24. Kay J, Matteson EL, Dasgupta B, et al. Subcutaneous injection of CNTO 148 compared with placebo in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, dose-ranging trial. 2005 ACR/ARHP Annual Scientific Meeting, November 12–17, 2005, San Diego, CA. Presentation 1921.

    Google Scholar 

  25. Dinarello CA. Biologic basis for interleukin-1 in disease. Blood 1996;87(6):2095–2147.

    PubMed  CAS  Google Scholar 

  26. Cohen SB. The use of anakinra, an interleukin-1 receptor antagonist, in the treatment of rheumatoid arthritis. Rheum Dis Clin North Am 2004;2(30):365–380.

    Article  Google Scholar 

  27. Firestein GS, Boyle DL, Yu C, et al. Synovial interleukin-1 receptor antagonist and interleukin-1 balance in rheumatoid arthritis. Arthritis Rheum 1994;37(5):644–6650.

    Article  PubMed  CAS  Google Scholar 

  28. Bresnihan B, Alvaro-Gracia J-M, Cobby M, et al. Treatment of rheumatoid arthritis with recombinant human interleukin-1 receptor antagonist. Arthritis Rheum 1998;41:2196–2204

    Article  PubMed  CAS  Google Scholar 

  29. Cohen S, Hurd E, Cush J, et al. Treatment of rheumatoid arthritis with recombinant human interleukin-1 receptor antagonist, in combination with methotrexate. Results of a twenty-four week, multicenter, randomised, double-blind, placebo-controlled trial. Arthritis Rheum 2002;46:614–624.

    Article  PubMed  CAS  Google Scholar 

  30. Cohen SB, Moreland LW, Cush JJ, et al. Kineret™ (anakinra) (recombinant interleukin-1 receptor antagonist): a large, placebo controlled efficacy trial of Kineret in patients with erosive rheumatoid arthritis disease. [Abstract] Ann Rheum Dis 2002;61(Suppl 1):173.

    Google Scholar 

  31. NICE. Anakinra for rheumatoid arthritis. Available at www.nice.org.uk/pdf/TA072 guidance.pdf. Accessed February 2, 2006.

    Google Scholar 

  32. Jiang Y, Genant HK, Watt I, et al. A multicenter, double-blind, dose ranging, randomised, placebo-controlled study of recombinant human interleukin-1 receptor antagonists in patients with rheumatoid arthritis: radiologic progression and correlation of Genant and Larsen scores. Arthritis Rheum 2000;43(5):1001–1009.

    Article  PubMed  CAS  Google Scholar 

  33. Shaw T, Quan J, Totoritis MC. B Cell therpay for rheumatoid arthritis: the rituximab (anti-CD20) experience. Ann Rheum Dis 2003;62(Suppl II):55–59.

    Google Scholar 

  34. Edwards J, Szczepanski L, Szechinski J, et al. Efficacy of B-cell targeted therapy with rituximab in patients with rheumatoid arthritis. N Engl J Med 2004;350:2572–2581.

    Article  PubMed  CAS  Google Scholar 

  35. Cohen SB, Greenwald M, Dougados MR, et al. Efficacy and safety of rituximab in active RA patients who experienced an inadequate response to one or more anti-TNFα therapies (REFLEX study). ACR/ARHP Annual Scientific Meeting, November 13-16, 2005, San Diego, CA. Abstract 1830.

    Google Scholar 

  36. Goldblatt, F, Isenberg D. New therapies for rheumatoid arthritis. Clin Exp Immunol 2005;140(2):195–204.

    Article  PubMed  CAS  Google Scholar 

  37. Mima T, Saeki Y, Oshima S, et al. Transfer of rheumatoid arthritis into severe combined immunodeficient mice. The pathogenic implications of T cell populations oligoclonally expanding in the rheumatoid joints. J Clin Invest 1995;96:1746–1758.

    Article  PubMed  CAS  Google Scholar 

  38. Genorese MC, Becker JC, Schiff M, et al. Abatacept for rheumatoid arthritis refactory to tumor necrosis factor-alpha inhibition. New Engl J Med 2005;353:1114–1123.

    Article  Google Scholar 

  39. Kremer JM, Dougados M, Emery P, et al. Treatment of rheumatoid arthritis with the selective co-stimulation modulator abatacept: twelve month results of a phase IIb, double blind randomised, placebo-controlled trial. Arthritis Rheum 2005;52:2263–2271.

    Article  PubMed  CAS  Google Scholar 

  40. Weinblatt M, Combe B, White A, et al. Safety of abatacept in patients with active rheumatoid arthritis receiving background non-biologic and biologic DMARDs: one year results of ASSURE trial. EULAR 2005, June 8–11, 2005, Vienna, Austria. Abstract OP0012.

    Google Scholar 

  41. Maini RN Anti-IL-6 receptor therapy: rationale and early results in rheumatoid arthritis. EULAR 2004, June 9–12, 2004, Berlin, Germany. Abstract SP0074.

    Google Scholar 

  42. Woo P, Wilkinson N, Prieur A, et al. Proof of principle of the efficacy of IL-6 receptor blockade in severe systemic juvenile idiopathic arthritis. EULAR 2005, June 8–11, 2005, Vienna, Austria. Abstract OP0086.

    Google Scholar 

  43. Singh R, Robinson D, El-Gabalawy, Hani S. Emerging biological therapies in rheumatoid arthritis: cell targets and cytokines. Curr Opin Rheum 2005;17:274–279.

    Article  CAS  Google Scholar 

  44. McKay J, Chwalinska SH, Boling E, et al. Belimumab, a fully human monoclonal antibody to B-lymphocyte stimulator, combined with standard care of therapy reduces the signs and symptoms of rheumatoid arthritis in a heterogeneous subject population. 2005 ACR/ARHP Annual Scientific Meeting, November 12–17, 2005, San Diego, CA. Abstract 1920.

    Google Scholar 

  45. Kaplan M. Eculizumab (Alexia). Current Opin Investig Drugs 2002;3(7):1017–1023.

    CAS  Google Scholar 

  46. Natalizumab in the treatment of rheumatoid arthritis in subjects receiving methotrexate. Available at www.clinicaltrial.gov/ct/show/NCT00083759. Accessed February 20, 2006.

    Google Scholar 

  47. Chaudhuri A. Lessons for clinical trials from natalizumab in multiple sclerosis. Br Med J 2006;332:416–419.

    Article  Google Scholar 

  48. Chustecka Z. Progress with new drugs for RA. Available at www.jointandbone.org/printArticle.do?primary101696. Accessed February 20, 2006.

    Google Scholar 

  49. Suntharalingam G, Perry M, Ward S, et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med 2006;355:1018–1028.

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Grampian, Aberdeen Royal Infirmary, Aberdeen, UK

    Neil Basu

Authors
  1. Neil Basu
    View author publications

    You can also search for this author in PubMed Google Scholar

Editor information

Editors and Affiliations

  1. Department of Medicine and Therapeutics, University of Aberdeen, Aberdeen, UK

    David M. Reid MBChB, MD, FRCP

  2. Bio-Imaging Technologies Inc, Newtown, PA, USA

    Colin G. Miller BSc, PhD, FICR

Rights and permissions

Reprints and permissions

Copyright information

© 2008 Springer-Verlag London Limited

About this chapter

Cite this chapter

Basu, N. (2008). Development of Biological Therapies for Inflammatory Arthritis. In: Reid, D.M., Miller, C.G. (eds) Clinical Trials in Rheumatoid Arthritis and Osteoarthritis. Clinical Trials. Springer, London. https://doi.org/10.1007/978-1-84628-742-8_3

Download citation

  • DOI: https://doi.org/10.1007/978-1-84628-742-8_3

  • Publisher Name: Springer, London

  • Print ISBN: 978-1-85233-874-9

  • Online ISBN: 978-1-84628-742-8

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation