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Progress Towards Optimal Trial End-Points in Rheumatoid Arthritis

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Summary

Trials in rheumatoid arthritis have been difficult to perform and interpret due to disagreement over what to measure. This paper reviews the most frequently used measures and their validity against the background of the Outcome Measures in Rheumatology (OMERACT) consensus conferences. These conferences have resulted in the adoption of a core set of end-points to be used as a minimum in all clinical trials in rheumatoid arthritis. These are known as the World Health Organization/International League of Associations for Rheumatology (WHOIILAR) core set. p ]This set of measures comprises: (i) pain; (ii) patient global assessment; (iii) physical disability; (iv) swollen joints; (v) tender joints; (vi) acute phase reactants; (vii) physician (assessor) global assessment; and, in studies of 1 or more years duration, (viii) radiographs of joints.

Other developments include a renewed interest in aggregate end-points (indices) such as response criteria, and in the measurement of adverse effects and economic costs.

In sum, measurement methodology in rheumatoid arthritis has been improved in time to take advantage of expected important advances in treatment.

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Authors and Affiliations

  1. Department of Internal Medicine/Rheumatology, University of Maastricht, University Hospital, PO Box 5800, 6202, AZ Maastricht, The Netherlands

    Maarten Boers

  2. Department of Internal Medicine, University of Ottawa, Ontario, Canada

    Peter Tugwell

  3. Department of Medicine, University of New South Wales, St Vincent’s Hospital, Darlinghurst, New South Wales, Australia

    Peter M. Brooks

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  1. Maarten Boers
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  2. Peter Tugwell
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  3. Peter M. Brooks
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Correspondence to Maarten Boers.

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Boers, M., Tugwell, P. & Brooks, P.M. Progress Towards Optimal Trial End-Points in Rheumatoid Arthritis. BioDrugs 7, 40–50 (1997). https://doi.org/10.2165/00063030-199707010-00006

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