Towards an epidemiology of rheumatoid arthritis outcome with respect to treatment: Randomized controlled trials overestimate treatment response and effectiveness

Rheumatology

Volumn 44, Issue SUPPL. 4, 2005, Pages

  Wolfe, F ^a,b   Michaud, K ^a,c  

^a NATIONAL DATA BANK FOR RHEUMATIC DISEASES   (United States)

^b UNIVERSITY OF KANSAS SCHOOL OF MEDICINE WICHITA   (United States)

^c STANFORD UNIVERSITY   (United States)

Author keywords

Bias; Observational studies; Outcome; Randomized controlled trials; Rheumatoid arthritis

Indexed keywords

ADALIMUMAB; ANTIRHEUMATIC AGENT; ETANERCEPT; INFLIXIMAB; LEFLUNOMIDE; PLACEBO; TUMOR NECROSIS FACTOR ANTIBODY;

ARTICLE; BIOSTATISTICS; CLINICAL OBSERVATION; CLINICAL STUDY; CLINICAL TRIAL; COST EFFECTIVENESS ANALYSIS; DRUG EFFICACY; HUMAN; PRIORITY JOURNAL; RANDOMIZATION; RHEUMATOID ARTHRITIS; SCORING SYSTEM; TREATMENT OUTCOME;

ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIAS (EPIDEMIOLOGY); EPIDEMIOLOGIC STUDIES; HUMANS; ISOXAZOLES; MODELS, STATISTICAL; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN; TREATMENT OUTCOME;

EID: 28444499035     PISSN: 14620324     EISSN: 14620332     Source Type: Journal    
DOI: 10.1093/rheumatology/kei056     Document Type: Article

References (24)

1. Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. N Engl J Med 2000;342:1878-86.
2. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 2000;342:1887-92.
3. Wolfe F, Michaud K. Heart failure in rheumatoid arthritis: Rates, predictors, and the effect of anti-tumor necrosis factor therapy. Am J Med 2004;116:305-11.
4. Wolfe F, Michaud K. Severe rheumatoid arthritis (RA), worse outcomes, comorbid illness, and sociodemographic disadvantage characterize RA patients with fibromyalgia. J Rheumatol 2004;31: 695-700.
5. Wolfe F, Michaud K, Anderson J, Urbansky K. Tuberculosis infection in patients with rheumatoid arthritis and the effect of infliximab therapy. Arthritis Rheum 2004;50:372-9.
6. Wolfe F, Michaud K. Lymphoma in rheumatoid arthritis: The effect of methotrexate and anti-tumor necrosis factor therapy in 18,572 patients. Arthritis Rheum 2004;50:1740-51.
7. Wiles NJ, Scott DG, Barrett EM et al. Benchmarking: The five year outcome of rheumatoid arthritis assessed using a pain score, the Health Assessment Questionnaire, and the Short Form-36 (SF-36) in a community and a clinic based sample. Ann Rheum Dis 2001; 60:956-61.
8. Wolfe F, Choi HK. Benchmarking and the percentile assessment of RA: adding a new dimension to rheumatic disease measurement. Ann Rheum Dis 2001;60:994-5.
9. Petri H, Urquhart J. Channeling bias in the interpretation of drug effects. Stat Med 1991;10:577-81.
10. Fries JF, Spitz PW, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum 1980;23:137-45.
11. Wolfe F. A reappraisal of HAQ disability in rheumatoid arthritis. Arthritis Rheum 2000;43:2751-61.
12. Kobelt G, Eberhardt K, Jonsson L, Jonsson B. Economic consequences of the progression of rheumatoid arthritis in Sweden. Arthritis Rheum 1999;42:347-56.
13. Brennan A, Bansback N, Reynolds A, Conway P. Modelling the cost-effectiveness of etanercept in adults with rheumatoid arthritis in the UK. Rheumatology 2004;43:62-72.
14. Wolfe F, Michaud K, Pincus T. Do rheumatology cost-effectiveness analyses make sense? Rheumatology 2004;43:4-6.
15. Bathon JM. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med 2000;343:1586-93. Erratum in: N Engl J Med 2001;344:240 and N Engl J Med 2001;344:76.
16. 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.
17. Lipsky PE, van der Heijde DMFM, St Clair EW et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. N Engl J Med 2000;343:1594-602.
18. Maini RN, Breedveld FC, Kalden JR et al. 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 2004;50: 1051-65.
19. Felson DT, Anderson JJ, Boers M et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. The Committee on Outcome Measures in Rheumatoid Arthritis Clinical Trials. Arthritis Rheum 1993;36:729-40.
20. van der Heijde DMFM, Van 't hof MA, van Riel PLCM, van Leeuwen MA, van Rijswijk MH, van de Putte LBA. Validity of single variables and composite indices for measuring disease activity in rheumatoid arthritis. Ann Rheum Dis 1992;51:177-81.
21. Strand V, Tugwell P, Bombardier C et al. Function and health-related quality of life: Results from a randomized controlled trial of leflunomide versus methotrexate or placebo in patients with active rheumatoid arthritis. Leflunomide Rheumatoid Arthritis Investigators Group. Arthritis Rheum 1999;42:1870-8.
22. Wolfe F, Michaud K, Dewitt EM. Why results of clinical trials and observational studies of antitumour necrosis factor (anti-TNF) therapy differ: Methodological and interpretive issues. Ann Rheum Dis 2004;63(Suppl. 2):iI13-ii17.
23. Pincus T, Strand V, Koch G et al. An index of the three core data set patient questionnaire measures distinguishes efficacy of active treatment from that of placebo as effectively as the American College of Rheumatology 20% response criteria (ACR 20) or the Disease Activity Score (DAS) in a rheumatoid arthritis clinical trial. Arthritis Rheum 2003;48:625-30.
24. Kolata G. Medicare covers new treatments with a catch. New York Times, November 5, 2005.