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| |  ACR: Ankylosing Spondylitis Patients Respond to Enbrel (Etanercept) SAN FRANCISCO, CA -- November 12, 2001 -- Data from a Phase 2 clinical study of Enbrel® (etanercept) in ankylosing spondylitis will be presented this week at the 65th Annual Scientific Meeting of the American College of Rheumatology (ACR). This study, conducted by Dr. John Davis and colleagues at the University of California, San Francisco, is the first randomized, placebo-controlled study of Enbrel for the treatment of ankylosing spondylitis. Phase 2 results showed that 80 percent of 20 patients receiving Enbrel reached the primary composite endpoint of improvement compared to 30 percent of 20 patients receiving placebo. "This is pioneering work in ankylosing spondylitis," says Jane Bruckel, Executive Director, Spondylitis Association of America. "The community looks forward to additional data from the new study." In the Phase 2 double-blind, placebo-controlled study, 40 patients with ankylosing spondylitis were randomized to receive either 25 mg of Enbrel via subcutaneous (under the skin) injection or placebo twice per week for a four-month period. The primary endpoint was a comparison of the number of patients achieving a clinical response in the Enbrel and placebo groups. A clinical response was pre-specified as a >20 percent improvement in three of five outcome measures (duration of morning stiffness, nocturnal spinal pain, a functional index (BASFI), patient global assessment and swollen joint score). Eligible patients fulfilled the modified New York clinical criteria for ankylosing spondylitis, and were required to have evidence of active spondylitis, which was defined as presence of inflammatory back pain, morning stiffness equal to or greater than 45 minutes, and patient and physician global assessment of moderate or higher disease activity. Patients were able to continue nonsteroidal anti-inflammatory drugs (NSAIDs), prednisone and disease modifying anti-rheumatic drugs (DMARDs) at stable dosages during the trial. Results after four months showed that 80 percent of patients receiving Enbrel achieved a clinical response compared to 30 percent of patients receiving placebo (primary endpoint of the study), as measured by a composite measure. Enbrel was generally well-tolerated with no differences in rates of adverse events between the two groups. There were no serious adverse events and no withdrawals due to adverse events. A large, multicenter Phase 3 clinical study of Enbrel for the treatment of ankylosing spondylitis has been initiated. SOURCE: Immunex Corporation and Wyeth-Ayerst Laboratories
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