The importance of reporting disease activity states in rheumatoid arthritis clinical trials

Arthritis and Rheumatism

Volumn 58, Issue 9, 2008, Pages 2622-2631

  Aletaha, Daniel ^a   Funovits, Julia ^a   Smolen, Josef S ^a  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; ETANERCEPT; INFLIXIMAB; METHOTREXATE; PLACEBO; TUMOR NECROSIS FACTOR ANTIBODY;

ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; DISABILITY; DISEASE ACTIVITY; DISEASE COURSE; FUNCTIONAL DISEASE; FUNCTIONAL STATUS; HUMAN; JOINT RADIOGRAPHY; MONOTHERAPY; PRIORITY JOURNAL; REMISSION; RHEUMATOID ARTHRITIS; SCORING SYSTEM; TREATMENT OUTCOME;

ANALYSIS OF VARIANCE; ANTIRHEUMATIC AGENTS; AREA UNDER CURVE; ARTHRITIS, RHEUMATOID; ARTHROGRAPHY; CLINICAL TRIALS AS TOPIC; DISEASE PROGRESSION; HUMANS; INFORMATION STORAGE AND RETRIEVAL; QUESTIONNAIRES; REMISSION INDUCTION; REMISSION, SPONTANEOUS; RHEUMATOLOGY; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 51849121176     PISSN: 00043591     EISSN: None     Source Type: Journal    
DOI: 10.1002/art.23733     Document Type: Article

References (38)

1. Van der Heijde D, Klareskog L, Boers M, Landewe R, Codreanu C, Bolosiu HD, et al. Comparison of different definitions to classify remission and sustained remission: 1 year TEMPO results. Ann Rheum Dis 2005;64:1582-7.
2. Aletaha D, Ward MM, Machold KP, Nell VP, Stamm T, Smolen JS. Remission and active disease in rheumatoid arthritis: defining criteria for disease activity states. Arthritis Rheum 2005;52:2625-36.
3. Mierau M, Schoels M, Gonda G, Fuchs J, Aletaha D, Smolen JS. Assessing remission in clinical practice. Rheumatology (Oxford) 2007;46:975-9.
4. Pincus T, Kavanaugh A, Aletaha D, Smolen J. Complexities in defining remission in rheumatic diseases [review]. Clin Exp Rheumatol 2006;24(6 Suppl 43):S-1-6.
5. Sokka T, Pincus T. Eligibility of patients in routine care for major clinical trials of anti-tumor necrosis factor α agents in rheumatoid arthritis. Arthritis Rheum 2003;48:313-8.
6. Pincus T, Wolfe F. "No evidence of disease" in rheumatoid arthritis using methotrexate in combination with other drugs: a contemporary goal for rheumatology care? Clin Exp Rheumatol 1997;15:591-6.
7. Smolen JS, Aletaha D. What should be our treatment goal in rheumatoid arthritis today? Clin Exp Rheumatol 2006;24(6 Suppl 43):S-7-13.
8. Emery P, Salmon M. Early rheumatoid arthritis: time to aim for remission? Ann Rheum Dis 1995;54:944-7.
9. Grigor C, Capell H, Stirling A, McMahon AD, Lock P, Vallance R, et al. Effect of a treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trial. Lancet 2004;36:263-9.
10. Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, van Zeben D, Kerstens PJ, Hazes JM, 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;52:3381-90.
11. Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727-35.
12. Van Gestel AM, Prevoo ML, van 't Hof MA, van Rijswijk MH, van de Putte LB, van Riel PL. 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 1996;39:34-40.
13. Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts: development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 1995;38:44-8.
14. Aletaha D, Smolen JS. The definition and measurement of disease modification in inflammatory rheumatic diseases. Rheum Dis Clin North Am 2006;32:9-44, vii.
15. Smolen JS, Breedveld FC, Schiff MH, Kalden JR, Emery P, Eberl G, et al. A Simplified Disease Activity Index for rheumatoid arthritis for use in clinical practice. Rheumatology (Oxford) 2003;42:244-57.
16. Lipsky PE, van der Heijde DM, St.Clair EW, Furst DE, Breedveld FC, Kalden JR, et al, for the Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. Infliximab and methotrexate in the treatment of rheumatoid arthritis. N Engl J Med 2000;343:1594-602.
17. St.Clair EW, van der Heijde DM, Smolen JS, Maini RN, Bathon JM, Emery P, et al, for the Active-Controlled Study of Patients Receiving Infliximab for the Treatment of Rheumatoid Arthritis of Early Onset Study Group. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized controlled trial. Arthritis Rheum 2004;50:3432-43.
18. Keystone EC, Kavanaugh AF, Sharp JT, Tannenbaum H, Hua Y, Teoh LS, 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 2004;50:1400-11.
19. Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, et al, for the PREMIER Investigators. 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.
20. Bathon JM, Martin RW, Fleischmann RM, Tesser JR, Schiff MH, Keystone EC, et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis [published erratum appears in N Engl J Med 2001;344:76 and in N Engl J Med 2001;344:240]. N Engl J Med 2000;343:1586-93.
21. Klareskog L, van der Heijde D, de Jager JP, Gough AK, Malaise M, Martin-Mola E, 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 2004;363:675-81.
22. Sharp JT, Lidsky MD, Collins LC, Moreland J. Methods of scoring the progression of radiologic changes in rheumatoid arthritis: correlation of radiologic, clinical and laboratory abnormalities. Arthritis Rheum 1971;14:706-20.
23. 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;1:1036-8.
24. Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum 1980;23:137-45.
25. Aletaha D, Nell VP, Stamm T, Uffmann M, Pflugbeil S, Machold K, et al. Acute phase reactants add little to composite disease activity indices for rheumatoid arthritis: validation of a clinical activity score. Arthritis Res Ther 2005;7:R796-806.
26. Van der Heijde DM, van 't Hof MA, van Riel PL, Theunisse LA, Lubberts EW, van Leeuwen MA, et al. Judging disease activity in clinical practice in rheumatoid arthritis: first step in the development of a disease activity score. Ann Rheum Dis 1990;49:916-20.
27. Felson DT, Anderson JJ, Lange ML, Wells G, LaValley MP. Should improvement in rheumatoid arthritis clinical trials be defined as fifty percent or seventy percent improvement in core set measures, rather than twenty percent? Arthritis Rheum 1998;41:1564-70.
28. Siegel JN, Zhen BG. Use of the American College of Rheumatology N (ACR-N) index of improvement in rheumatoid arthritis: argument in favor. Arthritis Rheum 2005;52:1637-41.
29. Smolen JS, Han C, Bala M, Maini RN, Kalden JR, van der Heijde D, et al, for the ATTRACT Study Group. 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 2005;52:1020-30.
30. Aletaha D, Smolen JS. Remission of rheumatoid arthritis: should we care about definitions? Clin Exp Rheumatol 2006;24(6 Suppl 43):S-45-51.
31. Gossec L, Dougados M, Goupille P, Cantagrel A, Sibilia J, Meyer O, et al. Prognostic factors for remission in early rheumatoid arthritis: a multiparameter prospective study. Ann Rheum Dis 2004;63:675-80.
32. Makinen H, Kautiainen H, Hannonen P, Sokka T. Is DAS28 an appropriate tool to assess remission in rheumatoid arthritis? Ann Rheum Dis 2005;64:1410-3.
33. Van Gestel AM, Haagsma CJ, van Riel PL. Validation of rheumatoid arthritis improvement criteria that include simplified joint counts. Arthritis Rheum 1998;41:1845-50.
34. Van Leeuwen MA, van Rijswijk MH, Sluiter WJ, van Riel PL, Kuper IH, van de Putte LB, et al. Individual relationship between progression of radiological damage and the acute phase response in early rheumatoid arthritis: towards development of a decision support system. J Rheumatol 1997;24:20-7.
35. Van der Heijde D, Klareskog L, Landewe R, Bruyn GA, Cantagrel A, Durez P, et al. Disease remission and sustained halting of radiographic progression with combination etanercept and methotrexate in patients with rheumatoid arthritis. Arthritis Rheum 2007;56:3928-39.
36. Smolen JS, Han C, van der Heijde D, Emery P, Bathon JM, Keystone E, et al. Infliximab inhibits radiographic progression regardless of disease activity at baseline and following treatment in patients with early active rheumatoid arthritis [abstract]. Arthritis Rheum 2006;54 Suppl 9:S231.
37. Sokka T, Pincus T. Most patients receiving routine clinical care for rheumatoid arthritis in 2001 did not meet inclusion criteria for most recent clinical trials or American College of Rheumatology remission criteria. J Rheumatol 2003;30:1138-46.
38. Food and Drug Administration (US). Guidance for industry: clinical development programs for drugs, devices and biological products for the treatment of rheumatoid arthritis (RA). Dept. of Health and Human Services (US), FDA; 1999 Feb. URL: www.fda.gov/cber/gdlns/rheumcln.pdf.