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New Phase 2 study shows ankylosing spondylitis patients respond to ENBREL (etanercept)

s after four months showed that:

  • 80 percent of patients receiving ENBREL (etanercept) 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. For information about enrolling in the study, call toll-free: 1-800-IMMUNEX (1-800-466-8639).

ABOUT ANKYLOSING SPONDYLITIS

Ankylosing spondylitis is a chronic inflammatory arthritis characterized by joint stiffness, pain and extra bone growth that can result in partial or complete fusion of the spine. The bones of the spine may grow together, causing the spine to become rigid and inflexible. Other joints such as the hips, shoulders, knees, or ankles also may become involved. About 300,000 people in the U.S. suffer from ankylosing spondylitis. Symptoms of the disease appear most frequently in young men between the ages of 16 and 35. There is currently no cure for ankylosing spondylitis. For more information regarding ankylosing spondylitis and the Spondylitis Association of America, please refer to www.StopAS.org or call 1.800.777.8189.

ABOUT ENBREL

An application for marketing approval of ENBREL (etanercept) to treat RA was fast-tracked by the U.S. Food and Drug Administration in 1998. Six months after the application was submitted, the FDA approved ENBREL for reducing the signs and symptoms of moderately to severely active RA in patients who have had an inadequate response to one or more DMARDs. The following year, the FDA approved ENBREL for reducing signs and symptoms of moderately to sever
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12-Nov-2001


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