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Rheumatology Advance Access first published online on March 23, 2004
This version published online on March 24, 2004
Rheumatology, doi:10.1093/rheumatology/keh140
Rheumatology © British Society for Rheumatology 2004; all rights reserved
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© 2004 British Society for Rheumatology; all rights reserved

Original Papers

Patient-reported outcomes better discriminate active treatment from placebo in randomized controlled trials in rheumatoid arthritis

V. Strand 1*, S. Cohen 2, B. Crawford 3, J. S. Smolen 4, for the Leflunomide Investigators Groups , and D. L. Scott 5

1 Division of Immunology, Stanford University School of Medicine, Palo Alto, CA, USA
2 St Paul Medical Center, Dallas, TX, USA
3 Mapi Values, Boston, MA, USA
4 Centre for Rheumatic Diseases at Lainz Hospital, Vienna, Austria
5 Guy’s, King’s and St Thomas’s School of Medicine, King’s College, London, UK

* Corresponding author. E-mail: Vstrand{at}aol.com.

Received 22 August 2003 ; accepted 23 December 2003

Abstract

Background. Recent randomized controlled trials (RCTs) in rheumatoid arthritis (RA) have used patient- and physician-reported outcomes, ESR and/or CRP as components of ACR response criteria to assess efficacy.

Objectives. Mean changes from baseline in patient- and physician-reported outcome measures, ESR and CRP were compared in two RCTs in patients with active RA. Comparisons between active and placebo treatment used mean percentage improvements and standard effect sizes (SESs).

Results. In both protocols, patient-reported assessments of disease activity, pain and physical function reflected little or no improvement with placebo, best discriminating between active and placebo therapy, as did ESR and CRP.

Conclusion. Improvements in signs and symptoms of active RA in placebo RCTs appear to be best reflected by patient-reported measures of physical function, as long as reported changes in global assessments of disease activity and/or pain reflect similar benefit. Patient-reported outcome measures should be considered objective; treatment-associated changes are congruent with measures of inflammation, and appear less susceptible to the placebo response.

Key words: Placebo effect, Rheumatoid arthritis, Patient-reported outcome measures, ACR response criteria.
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