October 30, 2008

Amgen and Wyeth Announce Positive Data From Arthritis Drug Study

Amgen and Wyeth Pharmaceuticals, a division of Wyeth, have announced that Enbrel is the first biologic with published clinical trial data to show sustained improvements in multiple measures of efficacy in moderate to severe rheumatoid arthritis patients completing up to 10 years of therapy.

Data from two long-term, open-label extension studies has showed that Enbrel provided improvement in the signs and symptoms of rheumatoid arthritis (RA) that was maintained for up to 10 years in adult patients with early rheumatoid arthritis (ERA) or long-standing RA (LRA). Approximately one-third of patients who started either study continued on Enbrel throughout the decade of use.

Of the proportion of patients evaluated for efficacy and still on therapy for up to 10 years, 56% achieved an ACR 50 response. Further 39% and 31% (ERA and LRA, respectively) achieved an ACR 70 response. These scores represent a 50% or 70% improvement in RA outcome measures that include joint swelling and tenderness, pain, level of disability, overall patient and physician disease assessment, and an objective marker of inflammation.

Additional data demonstrated sustained improvement in physical function in the subset of patients studied for efficacy. Yearly snapshots of the health assessment questionnaire (HAQ) score showed that 73-86% of patients with ERA and 64-72% of patients with LRA achieved a clinically significant improvement in HAQ disability index. HAQ scores measure a patient's self-reported ability to perform activities of daily living such as dressing, walking, and grooming.