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| |  ACR: Kineret (Anakinra) Proves Safe For Rheumatoid Arthritis SAN FRANCISCO, CA -- November 12, 2001 -- Amgen today announced positive results of the largest-ever clinical trial for a biologic therapy in rheumatoid arthritis (RA), studying the safety of Kineret™ (anakinra), an investigational RA therapy not yet approved by the U.S. Food and Drug Administration. The results of this trial and two other studies evaluating the safety of Kineret are being presented here this week at the 65th annual scientific meeting of the American College of Rheumatology (ACR). "This large trial was designed to assess the safety of Kineret among ‘real world’ patients, including those taking multiple other RA medications, and those predisposed to infection due to a history of underlying disease like pneumonia, asthma, and chronic obstructive pulmonary disease," said lead author Dr. Roy Fleischmann, clinical professor at the University of Texas Southwestern Medical Center at Dallas. The double blind, placebo controlled study (n=1,414 patients; randomized as four anakinra:one placebo) found that at the end of six months, the most frequently reported adverse event (73 percent) was a mild to moderate reaction at the site of injection. Patients who did not experience this reaction in the first month of therapy were unlikely to experience one with continuing therapy. The incidence of infectious episodes was similar in the Kineret-treated (41 percent) and placebo-treated (44 percent) groups, while the rate of serious infections occurred slightly more frequently in the Kineret patients (2 percent versus 0.4 percent). Most Kineret patients (74 percent) resumed therapy once the infection cleared. "We were pleased to see no increase in overall infections, no cases of sepsis, no opportunistic infections such as tuberculosis, and no neurologic events such as mental status changes or seizure disorders," said Dr. Fleischmann. A second large (n=506), placebo-controlled trial by Dr. Stanley Cohen, clinical associate professor at the University of Texas Southwestern Medical Center at Dallas, and his colleagues evaluated the safety and efficacy of Kineret. Results of this study will be presented later this week in a late-breaking podium presentation. The study found that Kineret plus methotrexate (MTX) improved patients’ signs and symptoms compared to placebo plus MTX as measured by the American College of Rheumatology composite score (38 percent versus 22 percent improved over baseline levels by 20 percent) and Health Assessment Questionnaire (61 percent improvement). Nearly twice as many Kineret-treated patients (21 percent) as placebo patients (11 percent) achieved an ACR20 score (which represents a 20 percent improvement in the signs and symptoms of RA) by week four, and more than twice as many Kineret patients (27 percent) compared to placebo patients (12 percent) achieved sustained ACR20 scores throughout the 24-week trial. The most common adverse event was a mild reaction at the site of injection. Serious infections occurred at a similar rate (0.8 percent) in the treatment and placebo groups and there were no reports of tuberculosis or opportunistic infections in the Kineret group. If approved, Kineret would be the first drug to directly and selectively block interleukin-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. SOURCE: Amgen
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