To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ACR: Kineret (Anakinra) May Bring Quality of Life Improvements to Rheumatoid Arthritis Patients URL: http://www.pslgroup.com/dg/20D5AE.htm Doctor's Guide November 12, 2001
SAN FRANCISCO, CA -- November 12, 2001 -- Amgen today announced the results of three studies demonstrating that Kineret™ (anakinra), an investigational rheumatoid arthritis (RA) therapy not yet approved by the U.S. Food and Drug Administration, may provide quality of life benefits for patients with RA. The three studies, which are being presented here this week at the 65th annual scientific meeting of the American College of Rheumatology (ACR), assessed patient-reported measures such as pain, productivity, quality of life and physical disability using components of the Health Assessment Questionnaire (HAQ) and other scales.
In the first study (n=473) by Dr. Barry Bresnihan, professor of rheumatology at St. Vincent's University Hospital in Dublin, Ireland, and colleagues, patients taking Kineret increased productivity (their ability to work in or outside the home) by a mean of 13 days compared to three days for patients taking placebo after the first six months of the study. Kineret-treated patients gained another 17 productive days during the second six months, resulting in a total gain in productivity of approximately a full month over the course of a year.
A third (32 percent) of Kineret patients on the highest dose gained full productivity (no missed work or domestic activity days) at 12 months compared to baseline.
Patients who completed six months on placebo then switched to Kineret for six months gained a mean of 15 productive days over the course of the second six-month period compared to three days in the first six months.
"Being able to go to a job or work in the home taking care of children and a household is an extremely high priority for most RA patients, but fatigue and pain can often complicate their ability to function normally," said Dr. Bresnihan.
A second study (n=76) by Dr. George Nuki of the University of Edinburgh and colleagues found that patients taking Kineret experienced improvements in functional status as measured by a mean change in HAQ. After six months on placebo, patients showed little improvement in functional status (-0.10 mean change in HAQ). But when these patients were switched to treatment with Kineret for six months, their functional status showed improvement more than double that in the first six months (-0.25 mean change in HAQ).
A third study, a meta-analysis of three Kineret clinical trials (n=1,003) by Dr. Stanley Cohen, clinical associate professor at the University of Texas Southwestern Medical Center at Dallas, and associates evaluated the effect of Kineret on patient-reported measures, such as pain and disability, compared to physician-reported measures, such as tender and swollen joint counts, after six months of therapy.
The study found that Kineret, when used alone or in combination with methotrexate, had a consistently greater impact on patient-reported measures than physician-reported measures across the five study arms. For example, patients taking 2 mg/kg of Kineret (n=72) reported an effect size (measure of magnitude of treatment benefit) of 0.66 on a scale from 0 to 1, compared with the effect size of 0.34 reported for these same patients by their physicians.
"As we've seen in other studies, patient-reported measures may be more reliable and less susceptible to the 'placebo effect' in assessing therapeutic benefit," said Dr. Cohen. "Patient measures are used more extensively than composite scores in clinical practice because patients are good judges of how they are feeling and how therapies are affecting their disease."
If approved, Kineret would be the first drug to directly and selectively block interleuken-1 (IL-1), a protein present in excess in RA patients that results in inflammation and joint damage. Amgen has filed for regulatory approval of Kineret in the United States, Canada and the European Union.
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