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Sustained Improvement in Physical Function With Etanercept For Rheumatoid Arthritis: Presented at ACR

By Bruce Sylvester

NEW ORLEANS, LA -- October 30, 2002 -- Patients with rheumatoid arthritis who take etanercept may achieve and maintain improved physical function for up to three years, say researchers.

This finding is based on findings at year three of an on-going five-year open-label study by researchers from University Erlangen, Nuremberg, Germany, and Wyeth Research in Collegeville, Pennsylvania, United States.

The interim report on the research was presented here at the annual meeting of the American College of Rheumatology.

The investigators enrolled 549 RA subjects in the five-year extension trial which followed the completion of double-blind placebo-controlled trials.

All enrolled subjects had shown an inadequate response to disease modifying anti-rheumatic drugs (DMARDs) and are being treated with etanercept 25 mg subcutaneously twice weekly at 58 sites in Europe.

At baseline, all subjects completed standard safety and efficacy assessments and a validated language-specific Health Assessment Questionnaire (HAQ). They continue to do so at three-month intervals.

The investigators gave priority to HAQ responses in this interim analysis. They applied Pearson correlation to HAQ and the other efficacy variables (patient and physician global assessment, pain score, tender and swollen joint counts, and C-Reactive Protein).

The mean HAQ score at baseline was 1.8 (0-3 scale). The researchers report that it improved by 39 percent at three months; the mean improvement was sustained at three years.

At baseline, 5 percent of the 549 patients had a HAQ score of 0.5 or less (no or borderline functional impairment). After three years of etanercept therapy, 34 percent of the subjects had achieved this endpoint.

Of the eight HAQ subscales, improvement ranged from 36 to 61 percent at three years, with reaching, eating, and activities showing the greatest mean improvements.

"Etanercept improved and maintained patients' physical function for up to three years based on HAQ and its subscales. A correlation was demonstrated between HAQ and other standard efficacy outcomes," the authors wrote.

"The improvements we saw with etanercept were remarkable in terms of allowing patients with rheumatoid arthritis to perform activities of daily living," added investigator Joachim Malden, professor of medicine at the University of Erlangen in Germany.

The study was supported by Wyeth Research.

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