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Rheumatology 2005 44(Supplement 4):iv18-iv22; doi:10.1093/rheumatology/kei056
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© The Author 2005. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Supplement Article

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

F. Wolfe1,2 and K. Michaud1,3

1 National Data Bank for Rheumatic Diseases, Wichita, KS, 2 University of Kansas School of Medicine, Wichita, KS and 3 Center for Primary Care and Outcomes Research, Stanford University, Stanford, CA, USA.

Correspondence to: F. Wolfe, National Data Bank for Rheumatic Diseases, Arthritis Research Center Foundation, 1035 N. Emporia, Suite 230, Wichita, KS 67214, USA. E-mail: fwolfe{at}arthritis-research.org

The results and outcomes of randomized clinical trials of leflunomide and anti-TNF therapy are much better than are seen in rheumatoid arthritis patients in the community. This appears to be an effect of the clinical trial system. The consequence of deriving effectiveness estimates from clinical trials is to overestimate the effectiveness and thereby the cost-effectiveness of rheumatoid arthritis treatments.

KEY WORDS: Randomized controlled trials, Observational studies, Bias, Outcome, Rheumatoid arthritis


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