The FDA has approved the expanded use of etanercept (Enbrel®, Amgen/ Wyeth) for patients with ankylosing spondylitis, a chronic inflammatory disease that primarily affects the lower back and joints. Approximately 350,000 patients in the U.S. have this condition.
In the 277-patient trial, the drug benefited 70% of patients younger than age 42 and 48% of patients older than age 42. The women had a lower response rate (45%) than the men did (65%). Of the patients receiving the drug, 58% showed significant improvement of measured pain, function, and inflammation after six months of twice-weekly treatments, compared with 23% of patients receiving placebo.
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Etanercept patients who carried the HLAB27 genetic marker had a higher rate of response (65%) than patients who were HLAB27-negative (38%).
Etanercept was approved to treat rheumatoid arthritis in 1998, juvenile rheumatoid arthritis in 1999, and psori-atic arthritis in 2002.