Comparison of the Efficacy of Biologic Therapy for Rheumatoid Arthritis: Can the Clinical Trials Be Accurately Compared?

Rheumatic Disease Clinics of North America

Volumn 32, Issue SUPPL. 1, 2006, Pages 21-28

  FLEISCHMANN, ROY M ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ABATACEPT; ADALIMUMAB; BIOLOGICAL FACTOR; CYCLOPHOSPHAMIDE; DISEASE MODIFYING ANTIRHEUMATIC DRUG; ETANERCEPT; INFLIXIMAB; METHOTREXATE; METHYLPREDNISOLONE; PREDNISONE; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; RITUXIMAB;

ARTICLE; CLINICAL FEATURE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTINUOUS INFUSION; DISEASE COURSE; DISEASE DURATION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; HUMAN; MONOTHERAPY; PRIORITY JOURNAL; RHEUMATOID ARTHRITIS; TREATMENT OUTCOME; TREATMENT RESPONSE;

ARTHRITIS, RHEUMATOID; BIOLOGICAL RESPONSE MODIFIERS; CLINICAL TRIALS; HUMANS; IMMUNOSUPPRESSIVE AGENTS; TREATMENT OUTCOME;

EID: 34147176006     PISSN: 0889857X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0889-857X(07)70005-4     Document Type: Article

References (60)

1. Bathon J., Martin R., Fleischmann R., et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med 343 (2000) 1586-1593
2. Genovese M., Bathon J., Martin R., et al. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum 46 (2002) 1443-1450
3. Keystone E., Kavanaugh A., Sharp J., 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 randomized, placebo-controlled, 52-week trial. Arthritis Rheum 50 (2004) 1400-1411
4. Klareskog L., van der Heijde D., de Jager J., et al. 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 (2004) 675-681
5. Lipsky P., van der Heijde D., St Clair E., 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 343 (2000) 1594-1602
6. Lovell D., Giannini E., Reiff A., et al. Etanercept in children with polyarticular juvenile rheumatoid arthritis. Pediatric Rheumatology Collaborative Study Group. N Engl J Med 342 (2000) 763-769
7. Maini R., St Clair E., 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 354 (1999) 1932-1939
8. Maini R., Breedveld F., Kalden J., 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 41 (1998) 1552-1563
9. Moreland L., Baumgartner S., Schiff M., et al. Treatment of rheumatoid arthritis with a recombinant human tumor necrosis factor receptor (p75)-Fc fusion protein. N Engl J Med 337 (1997) 141-147
10. Moreland L., Schiff M., Baumgartner S., et al. Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial. Ann Intern Med 130 (1999) 478-486
11. St Clair E., van der Heijde D., Smolen J., et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum 50 (2004) 3432-3443
12. van de Putte L., Rau R., Breedveld F., et al. Efficacy and safety of the fully human anti-tumour necrosis factor alpha monoclonal antibody adalimumab (D2E7) in DMARD refractory patients with rheumatoid arthritis: a 12 week, phase II study. Ann Rheum Dis 62 (2003) 1168-1177
13. Weinblatt M., Kremer J., Bankhurst A., et al. A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med 340 (1999) 253-259
14. Breedveld F., Weisman M., Kavanaugh A., 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 54 (2006) 26-37
15. Bresnihan B., Alvaro-Gracia J., Cobby M., et al. Treatment of rheumatoid arthritis with recombinant human interleukin-1 receptor antagonist. Arthritis Rheum 41 (1998) 2196-2204
16. Cohen S., Hurd E., Cush J., et al. Treatment of rheumatoid arthritis with anakinra, a recombinant human interleukin-1 receptor antagonist, in combination with methotrexate: results of a twenty-four-week, multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 46 (2002) 614-624
17. Cohen S., Woolley J., and Chan W. Interleukin 1 receptor antagonist anakinra improves functional status in patients with rheumatoid arthritis. J Rheumatol 30 (2003) 225-231
18. Cohen S., Moreland L., Cush J., et al. A multicentre, double blind, randomised, placebo controlled trial of anakinra (Kineret), a recombinant interleukin 1 receptor antagonist, in patients with rheumatoid arthritis treated with background methotrexate. Ann Rheum Dis 63 (2004) 1062-1068
19. Jiang Y., Genant H., Watt I., Cobby M., Bresnihan B., and Aitchison R. 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 (2000) 1001-1009
20. Genovese M., Becker J., Schiff M., et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med 353 (2005) 1114-1123
21. Kremer J., Westhovens R., Leon M., et al. Treatment of rheumatoid arthritis by selective inhibition of T-cell activation with fusion protein CTLA4Ig. N Engl J Med 349 (2003) 1907-1915
22. Kremer J., Westhovens R., Moreland L., et al. Efficacy and safety of the selective co-stimulation modulator abatacept with methotrexate for treating rheumatoid arthritis: 1-year clinical and radiographic results from the phase III AIM (Abatacept in Inadequate responders to Methotrexate) trial. Arthritis Rheum 50 Suppl 9 (2004) Abstract L2.
23. 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 350 (2004) 2572-2581
24. Cohen S., Greenwald M., Dougados M., et al. Efficacy and safety of rituximab in active ra patients who experienced an inadequate response to one or more anti-TNF a therapies (REFLEX Study). Arthritis Rheum 52 9 suppl (2005) Abstract 1839.
25. Fleischmann R., Racewicz A., Schechtman J., et al. Rituximab efficacy in rheumatoid arthritis is independent of coadministration of glucocorticoids: results from the dose-ranging assessment international clinical evaluation of rituximab in rheumatoid arthritis (DANCER) study. Arthritis Rheum 52 suppl 9 (2005) Abstract 263.
26. Emery P., Fleischmann R., Filipowicz-Sosnowska A., et al. Rituximab in rheumatoid arthritis: a double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum 52 suppl 9 (2005) Abstract 1917.
27. van Vollenhoven R., Schechtman J., Szczepanski L., et al. Safety and tolerability of rituximab in patients with moderate to severe rheumatoid arthritis: results from the dose-ranging assessment international clinical evaluation of rituximab in rheumatoid arthritis (DANCER) study. Arthritis Rheum 52 suppl 9 (2005) Abstract 1922.
28. Joosten L., Helsen M., Saxne T., van de Loo F., Heinegard D., and van den Berg W. IL-1 blockade prevents cartilage and bone destruction in murine type II collagen-induced arthritis, whereas TNF- blockade only ameliorates joint inflammation. J Immunol 163 (1999) 5049-5055
29. van den Berg W. Uncoupling of inflammatory and destructive mechanisms in arthritis. Semin Arthritis Rheum 30 suppl 2 (2001) 7-16
30. van Lent P., van de Loo F., Holthuysen A., et al. Major role of interleukin 1 but not for tumor necrosis factor in early cartilage damage in immune complex arthritis in mice. J Rheumatol 22 (1995) 2250-2258
31. Breedveld F., and Kalden J. Appropriate and effective management of rheumatoid arthritis. Ann Rheum Dis 63 (2004) 627-633
32. Breedveld F., Han C., Bala M., et al. Association between baseline radiographic damage and improvement in physical function after treatment of patients with rheumatoid arthritis. Ann Rheum Dis 64 (2005) 52-55
33. Baumgartner S., Fleischmann R., Moreland L., Schiff M., Markenson J., and Whitmore J. Etanercept (Enbrel) in patients with rheumatoid arthritis with recent onset versus established disease: improvement in disability. J Rheumatol 31 (2004) 1532-1537
34. Felson D., Anderson J., Boers M., et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 38 (1995) 727-735
35. van der Heijde D., vant Hof M., Van Riel P., and van de Putte L. Development of a disease activity score based on judgment in clinical practice by rheumatologists. J Rheumatol 20 (1993) 579-581
36. van Gestel A., Anderson J., Van Riel P., et al. ACR and EULAR improvement criteria have comparable validity in rheumatoid arthritis trials. American College of Rheumatology European League of Associations for Rheumatology. J Rheumatol 26 (1999) 705-711
37. van Gestel A., Haagsma C., and Van Riel P. Validation of rheumatoid arthritis improvement criteria that include simplified joint counts. Arthritis Rheum 41 (1998) 1845-1850
38. Van Riel P., van Gestel A., and van de Putte L. Development and validation of response criteria in rheumatoid arthritis: steps towards an international consensus on prognostic markers. Br J Rheumatol 35 suppl (1996) 24-27
39. van Gestel A., Prevoo M., van 't Hof M., van Rijswijk M., van de Putte L., and Van Riel P. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis. Comparison with the preliminary American College of Rheumatology and the World Health Organization/International League Against Rheumatism Criteria. Arthritis Rheum 39 (1996) 34-40
40. Fuchs H., Kaye J., Callahan L., Nance E., and Pincus T. Evidence of significant radiographic damage in rheumatoid arthritis within the first 2 years of disease. J Rheumatol 16 (1989) 585-591
41. Kirwan J. Links between radiological change, disability, and pathology in rheumatoid arthritis. J Rheumatol 28 (2001) 881-886
42. Lard L., Visser H., Speyer I., et al. Early versus delayed treatment in patients with recent-onset rheumatoid arthritis: comparison of two cohorts who received different treatment strategies. Am J Med 111 (2001) 446-451
43. van der Heijde D., Van Leeuwen M., Van Riel P., and van de Putte L. Radiographic progression on radiographs of hands and feet during the first 3 years of rheumatoid arthritis measured according to Sharp's method (van der Heijde modification). J Rheumatol 22 (1995) 1792-1796
44. Sharp J. Scoring radiographic abnormalities in rheumatoid arthritis. J Rheumatol 16 (1989) 568-569
45. Genovese M., Bathon J., Fleischmann R., et al. Longterm safety, efficacy, and radiographic outcome with etanercept treatment in patients with early rheumatoid arthritis. J Rheumatol 32 (2005) 1232-1242
46. Weinblatt M., Keystone E., Furst D., 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 48 (2003) 35-45
47. Smolen J., Han C., Bala M., et al. Evidence of radiographic benefit of treatment with infliximab plus methotrexate in rheumatoid arthritis patients who had no clinical improvement: a detailed subanalysis of data from the anti-tumor necrosis factor trial in rheumatoid arthritis with concomitant therapy study. Arthritis Rheum 52 (2005) 1020-1030
48. Shergy W., Cohen S., Greenwald M., et al. Anakinra (Kineret®) inhibits the progression of radiographically measured joint destruction in rheumatoid arthritis. Arthritis Rheum 46 suppl 9 (2002) Abstract LB 10.
49. Kremer J., Dougados M., Emery P., et al. Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve-month results of a phase iib, double-blind, randomized, placebo-controlled trial. Arthritis Rheum 52 (2005) 2263-2271
50. Genant H., Jiang Y., Peterfy C., Lu Y., Redei J., and Countryman P. Assessment of rheumatoid arthritis using a modified scoring method on digitized and original radiographs. Arthritis Rheum 41 (1998) 1583-1590
51. Emery P., Fleischmann R., Filipowicz-Sosnowska A., et al. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIB double-blind, placebo-controlled, dose-ranging trial (DANCER). Arthritis Rheum 54 (2006) 1390-1400
52. Paulus H., Egger M., Ward J., Williams H., and the Cooperative Systemic Studies of Rheumatic Disease Group. Analysis of improvement in individual rheumatoid arthritis patients treated with disease-modifying antirheumatic drugs, based on the findings in patients treated with placebo. Arthritis Rheum 33 (1990) 477-484
53. Larsen A., Dale K., and Eek M. Radiographic evaluation of rheumatoid arthritis and related conditions by standard reference films. Acta Radiol Diagn (Stockh) 18 (1977) 481-491
54. Young A., and van der Heijde D. Can we predict aggressive disease?. Baillieres Clin Rheumatol 11 (1997) 27-48
55. Landewe R., Boers M., and van der Heijde D. How to interpret radiological progression in randomized clinical trials. Rheumatology (Oxford) 42 (2003) 2-5
56. van der Heijde D. Overview of radiologic efficacy of new treatments. Rheum Dis Clin North Am 30 (2004) 285-293
57. Landewe R., and Van Der H. Radiographic progression depicted by probability plots: presenting data with optimal use of individual values. Arthritis Rheum 50 (2004) 699-706
58. van der Heijde D., Landewe R., Klareskog L., et al. Presentation and analysis of data on radiographic outcome in clinical trials: experience from the TEMPO study. Arthritis Rheum 52 (2005) 49-60
59. van der Heijde D., Landewe R., Keystone E., Van Riel P., Sasso E., and Perez J. Adalimumab (Humira®) plus MTX prevents nearly all severe radiographic progression observed with methotrexate monotherapy in early, aggressive rheumatoid arthritis. Arthritis Rheum 52 suppl 9 (2005) Abstract 207.
60. Genant H., Peterfy C., Paira S., et al. Abatacept significantly inhibits structural damage progression as assessed by the Genant modified Sharp scoring system in rheumatoid arthritis patients with inadequate methotrexate response. Ann Rheum Dis 64 suppl III (2005) Abstract OP0001.