Rheumatology Advance Access published online on March 2, 2004
Rheumatology, doi:10.1093/rheumatology/keh152
Rheumatology © British Society for Rheumatology 2004; all rights reserved
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Original Papers
1 Radiant Research, Dallas, Texas, USA
* Corresponding author. E-mail: Stanleycohen{at}radiantresearch.com.
Received 28 August 2003
; accepted 14 January 2004
Objectives. To determine whether patient-reported outcomes may differentiate treatment response better than physician-reported outcomes for rheumatoid arthritis (RA) patients being treated with anakinra. Methods. A meta-analysis was conducted using data obtained from three separate randomized controlled clinical trials (RCTs) (n = 1007). Outcomes from 6-month assessments were grouped into four categories: American College of Rheumatology (ACR) response criteria, patient-reported measures (patient-reported pain, patient global assessment, and assessment of physical function using the Health Assessment Questionnaire), physician-reported measures (tender and swollen joint counts and physician global assessment), and laboratory tests (C-reactive protein and erythrocyte sedimentation rate). Effect sizes were calculated using changes from baseline and pooled standard deviations for each of these types of outcome. Results. Active treatment with anakinra was superior to placebo by ACR20 responses in all three RCTs. Effect sizes for patient-reported outcomes were greater than for physician-reported outcomes, and also greater than ACR20 in three of five anakinra cohorts. Across the RCTs, placebo responses were greater with physician-reported than with patient-reported outcomes. In the two studies evaluating patients with longer-standing disease, differences between pooled effect sizes for patient-reported and physician-reported outcomes were even more pronounced. Conclusions. In three pivotal RCTs, active treatment with anakinra resulted in greater improvements in patient-reported than physician-reported outcomes compared with placebo. These observations confirm those previously reported from RCTs evaluating conventional DMARDs, demonstrating better discrimination of treatment effect with patient-reported outcomes.
Key words: Health status, Joints, Meta-analysis, Pain measurement, Randomized controlled trials, Recombinant interleukin-1 receptor antagonist, Rheumatoid arthritis, Treatment outcome.
Patient- versus physician-reported outcomes in rheumatoid arthritis patients treated with recombinant interleukin-1 receptor antagonist (anakinra) therapy
2 Stanford University Medical Center, Palo Alto, California, USA
3 Zynx Health, Los Angeles, California, USA
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