THOUSAND OAKS, Calif., November 13, 2006 -- Amgen (NASDAQ: AMGN), today announced that data from an ongoing open-label, multinational, phase 4 extension study showed that patients with ankylosing spondylitis (AS) who received treatment with Enbrel? (etanercept) experienced sustained improvement in signs and symptoms, spinal mobility and physical function over 148 to 160 weeks of therapy. These results are consistent with an ENBREL phase 3 clinical trial at 24 weeks. The 160-week results will be presented at the American College of Rheumatology (ACR) Scientific Meeting in Washington, D.C.
"These data demonstrate that ENBREL can provide substantial long-term improvement in AS symptoms such as total back pain and spinal mobility," said Joachim Sieper, M.D., professor of rheumatology, Charite University in Berlin, Germany. "Because AS is a chronic inflammatory disease that requires ongoing management, it is important to offer patients a treatment option that is effective, has an established safety profile, and can be used over the long-term."
Data presented at ACR showed that 59 patients who received open-label ENBREL treatment for up to 160 weeks experienced sustained clinical improvements. Overall, 78 percent of patients (n=46) continuing treatment with ENBREL achieved a 20 percent improvement in the Assessment on Ankylosing Spondylitis Response Criteria (ASAS 20) after 160 weeks of treatment. ASAS is a composite measure of improvement in AS symptoms that include total back pain, patient assessment of disease activity, inflammation and physical function. Thirty-one percent of patients (n= 18) achieved partial remission at week 160. Partial remission, as defined by ASAS, is a low disease activity level (score < 20 units out of 100 in each of the four ASAS criteria).
Additional ENBREL data presented at ACR from this phase 4 extension study show that improvement in spinal mobility was also sustained through 148 to 160 weeks of
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