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| |  ACR: Kineret (Anakinra) Effective in Treatment for Rheumatoid Arthritis By Lynn Haley Special to DG News SAN FRANCISCO, CA -- November 16, 2001 -- Kineret (anakinra), a new treatment in the fight against rheumatoid arthritis (RA) was granted approved by the U.S. Food and Drug Administration (FDA). The announcement was made at the 2001 Annual Scientific Meeting of the American College of Rheumatology, held here November 10th-15th. Kineret is the first interleukin-1 receptor antagonist to treat the signs and symptoms of moderate to severe RA in patients suffering from the disease who have failed to derive benefits from other disease-modifying anti-rheumatic drugs (DMARDs). The drug can be used alone or in conjunction with other DMARDs, with the exception of tumor necrosis factor (TNF) blocking agents. Kineret is the first direct and selective blocker of interleukin-1 (IL-1), a protein present in excess in patients suffering from RA. The drug inhibits the inflammatory response in RA, including pain, by blocking IL-1. In making the announcement, Kineret manufacturer, Amgen, said new therapies are necessary in the ongoing management of RA. "In rheumatoid arthritis, there is a need for new therapies like Kineret," said Kevin Sharer, Amgen’s Chief Executive Officer. "Kineret is the first therapy from Amgen’s rheumatology research program and demonstrates our commitment to discovering and developing new medicines for the treatment of inflammation and bone diseases." The FDA moved to approve the drug based on randomised, double-blinded, placebo-controlled clinical trials involving 2,932 patients. In total, 2,600 patients were treated with Kineret, which taken alone or in combination with other disease-modifying therapies, provided RA patients with relief, including a decrease in pain and inflammation. Clinical responses to the drug were reported by the fourth week of treatment, with the majority of patients reporting improvement by week 13. At six months, 38 percent of patients reported a 20 percent improvement based on the American College of Rheumatology (ACR) criteria, compared to 22 percent of placebo-treated patients. ACR criteria included a 20 percent improvement in the number of swollen and tender joints, plus greater than 20 percent improvement in at least three to five of criteria, such as physician assessment of disease, patient assessment of their pain, C-reactive protein (a general lab marker of the inflammation), and health assessment questionnaire. Dr. Stanley Cohen, a clinical professor at the University of Texas Southwestern Medical Centre and a clinical investigator participating in the trials, said the drug worked for many of his patients. "I am impressed with the improvements in my patients' painful and swollen joints," he said.
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