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Abstract
Objective
To compare the functional status and well-being of patients with rheumatoid arthritis
(RA) who were randomly assigned to receive placebo, etanercept 10 mg, or etanercept
25 mg during a 26-week, phase III, double-blind clinical trial.
Background
No single indicator of disease activity, severity, or therapeutic efficacy has been
established for RA. During the past decade, health-related quality of life, a multidimensional
way to assess physical, emotional, and social aspects of a disease or its treatment,
has become an important outcome in RA studies and in assessments of RA drug therapies.
Methods
A total of 234 patients completed the Health Assessment Questionnaire (HAQ), the Short-Form
36 (SF-36) (n = 48 patients), items assessing energy and mental health from the Medical
Outcomes Study (MOS), and a single-item rating scale assessing current health (feeling
thermometer) at baseline and several times during 6 months.
Results
Significant improvements from baseline to last assessment were reported with etanercept
versus placebo and in the HAQ Disability Index score (ie, the total HAQ score) and
all 8 HAQ categories (P < 0.05), with the exception of grip. Significant improvements with etanercept in
the MOS energy and mental health subscales, current health (from the feeling thermometer),
and mental and physical function components of the SF-36 were reported (P < 0.05).
Conclusions
Patients receiving 10- or 25-mg doses of etanercept reported significantly better
functional status and well-being than did patients receiving placebo.
Key words
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Article info
Publication history
Accepted:
November 17,
1999
Identification
Copyright
© 2000 Published by Elsevier Inc.
