Estimation of a numerical value for joint damage-related physical disability in rheumatoid arthritis clinical trials

Annals of the Rheumatic Diseases

Volumn 69, Issue 6, 2010, Pages 1058-1064

  Smolen, Josef S ^a   Aletaha, Daniel ^a   Grisar, Johannes C ^a   Stamm, Tanja A ^a   Sharp, John T ^b  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b UNIVERSITY OF WASHINGTON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; DISEASE MODIFYING ANTIRHEUMATIC DRUG; ETANERCEPT; GLUCOCORTICOID; INFLIXIMAB; LEFLUNOMIDE; METHOTREXATE; METHYLPREDNISOLONE; PREDNISOLONE; SALAZOSULFAPYRIDINE; TUMOR NECROSIS FACTOR INHIBITOR;

ARTICLE; CLINICAL ASSESSMENT; CLINICAL EVALUATION; CORTICOSTEROID THERAPY; DISEASE ACTIVITY; FEMALE; HEALTH ASSESSMENT QUESTIONNAIRE; HUMAN; JOINT INJURY; JOINT RADIOGRAPHY; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; OBSERVATIONAL STUDY; PHYSICAL DISABILITY; PRIORITY JOURNAL; RHEUMATOID ARTHRITIS; SCORING SYSTEM; TOTAL SHARP SCORE;

ADULT; AGED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DISABILITY EVALUATION; FEMALE; GLUCOCORTICOIDS; HUMANS; MALE; METHYLPREDNISOLONE; MIDDLE AGED; REPRODUCIBILITY OF RESULTS; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA;

EID: 77953701043     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/ard.2009.114652     Document Type: Article

References (38)

1. Van Leeuwen MA, van Rijswijk MH, Sluiter WJ, 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.
2. Aletaha D, Nell VP, Stamm T, 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.
3. Drossaers-Bakker KW, de Buck M, van Zeben D, et al. Long-term course and outcome of functional capacity in rheumatoid arthritis: the effect of disease activity and radiologic damage over time. Arthritis Rheum 1999;42:1854-60.
4. Welsing PM, van Gestel AM, Swinkels HL, et al. The relationship between disease activity, joint destruction and functional capacity over the course of rheumatoid arthritis. Arthritis Rheum 2001;44:2009-17.
5. Scott DL, Pugner K, Kaarela K, et al. The links between joint damage and disability in rheumatoid arthritis. Rheumatology (Oxford) 2000;39:122-32. (Pubitemid 30139344)
6. van der Heijde D, Landewé R, van Vollenhoven R, et al. Level of radiographic damage and radiographic progression are determinants of physical function: a longitudinal analysis of the TEMPO trial. Ann Rheum Dis 2008;67:1267-70.
7. Ødegård S, Landewé R, van der Heijde D, et al. Association of early radiographic damage with impaired physical function in rheumatoid arthritis: a ten-year, longitudinal observational study in 238 patients. Arthritis Rheum 2006;54:68-75.
8. Vita AJ, Terry RB, Hubert HB, et al. Aging, health risks and cumulative disability. N Engl J Med 1998;338:1035-41.
9. Morris A, Yelin EH, Wong B, et al. Patterns of psychosocial risk and long-term outcomes in rheumatoid arthritis. Psychol Health Med 2008;13:529-44.
10. Escalante A, del Rincón I. How much disability in rheumatoid arthritis is explained by rheumatoid arthritis? Arthritis Rheum 1999;42:1712-21.
11. Aletaha D, Smolen J, Ward MM. Measuring function in rheumatoid arthritis: Identifying reversible and irreversible components. Arthritis Rheum 2006;54:2784-92.
12. Aletaha D, Strand V, Smolen JS, et al. Treatment-related improvement in physical function varies with duration of rheumatoid arthritis: a pooled analysis of clinical trial results. Ann Rheum Dis 2008;67:238-43.
13. Aletaha D, Smolen JS. The definition and measurement of disease modification in inflammatory rheumatic diseases. Rheum Dis Clin North Am 2006;32:9-44.
14. Sharp JT, Strand V, Leung H, et al. Treatment with leflunomide slows radiographic progression of rheumatoid arthritis. results from three randomized controlled trials of leflunomide in patients with active rheumatoid arthritis. Arthritis Rheum 2000;43:495-505.
15. Wolf J, Kapral T, Grisar J, et al. Glucocorticoid treatment in rheumatoid arthritis: lowdose therapy does not reduce responsiveness to higher doses. Clin Exp Rheumatol 2008;26:113-16. (Pubitemid 351385263)
16. 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;343:1594-602.
17. 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;50:3432-43.
18. 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 randomized, placebo-controlled, 52-week trial. Arthritis Rheum 2004;50:1400-11.
19. 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.
20. Bathon JM, Martin RW, Fleischmann RM, et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med 2000;343:1586-93.
21. Klareskog L, Hamsten A. Statins in rheumatoid arthritis-two birds with one stone? Lancet 2004;363:2011-12.
22. Smolen JS, Kalden JR, Scott DL, et al. Efficacy and safety of leflunomide compared with placebo and sulphasalazine in active rheumatoid arthritis: a double-blind, randomised, multicentre trial. European Leflunomide Study Group. Lancet 1999;353:259-66.
23. Emery P, Breedveld FC, Lemmel EM, et al. A comparison of the efficacy and safety of leflunomide and methotrexate for the treatment of rheumatoid arthritis. Rheumatology (Oxford) 2000;39:655-65.
24. Smolen JS, Breedveld FC, Schiff MH, et al. A simplified disease activity index for rheumatoid arthritis for use in clinical practice. Rheumatology (Oxford) 2003;42:244-57.
25. Verbrugge LM, Lepkowski JM, Imanaka Y. Comorbidity and its impact on disability. Milbank Q 1989;67:450-84.
26. Sokka T, Kautiainen H, Hannonen P, et al. Changes in Health Assessment Questionnaire disability scores over five years in patients with rheumatoid arthritis compared with the general population. Arthritis Rheum 2006;54:3113-18.
27. Jansen LM, van Schaardenburg D, van Der Horst-Bruinsma IE, et al. Predictors of functional status in patients with early rheumatoid arthritis. Ann Rheum Dis 2000;59:223-6.
28. Smolen JS, 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 2005;52:1020-30.
29. Landewé R, van der Heijde D, Klareskog L, et al. Disconnect between inflammation and joint destruction after treatment with etanercept plus methotrexate: results from the trial of etanercept and methotrexate with radiographic and patient outcomes. Arthritis Rheum 2006;54:3119-25.
30. Smolen JS, Han C, Van der Heijde DM, et al. Radiographic changes in rheumatoid arthritis patients attaining different disease activity states with methotrexate monotherapy and infliximab plus methotrexate: the impacts of remission and TNF-blockade. Ann Rheum Dis 2009;68:823-27.
31. Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: a review of its history, issues, progress and documentation. J Rheumatol 2003;30:167-78. (Pubitemid 36077790)
32. Welsing PM, Landewé RB, van Riel PL, et al. The relationship between disease activity and radiologic progression in patients with rheumatoid arthritis: a longitudinal analysis. Arthritis Rheum 2004;50:2082-93.
33. Smolen JS, Aletaha D. Patients with rheumatoid arthritis in clinical care. Ann Rheum Dis 2004;63:221-5. (Pubitemid 38250660)
34. Tugwell P, Bombardier C. A methodologic framework for developing and selecting endpoints in clinical trials. J Rheumatol 1982;9:758-62.
35. Van der Heijde DM, van't Hof MA, van Riel PL, et al. Validity of single variables and composite indices for measuring disease activity in rheumatoid arthritis. Ann Rheum Dis 1992;51:177-81.
36. Bakker MF, Jacobs JW, Verstappen SM, Bijlsma JW. Tight control in the treatment of rheumatoid arthritis: efficacy and feasibility. Ann Rheum Dis 2007;66(Suppl 3):iii56-60.
37. Van der Heijde D, Landewé R, Klareskog L, et al. Presentation and analysis of data on radiographic outcome in clinical trials: experience from the TEMPO study. Arthritis Rheum 2005;52:49-60. (Pubitemid 40129232)
38. Aletaha D, Funovits J, Smolen JS. The importance of reporting disease activity states in rheumatoid arthritis clinical trials. Arthritis Rheum 2008;58:2622-31.