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Once weekly ENBREL significantly reduced rheumatoid arthritis pain, inflammation & improved function

ials of ENBREL. Only injection site reactions occurred more frequently in the ENBREL groups.

The most frequent adverse events in placebo-controlled RA clinical trials (n=349) were injection site reactions (ISR) (37%), infections (35%), and headache (17%). Only the rate of ISR was higher than that of placebo. The most frequent adverse events in a methotrexate-controlled trial (n=415) were infections (64%), ISR (34%), and headache (24%). Only the rate of ISR was higher than that of methotrexate. A supplemental Biologics License Application seeking to expand the labeling of ENBREL to include once-weekly dosing is currently under review by the U.S. Food and Drug Administration.

More than two million Americans suffer from RA, a chronic disease that causes pain, stiffness, swelling, and limitation in the motion and function of multiple joints. If left untreated, or under-treated, RA can produce serious destruction of one or more joints, which frequently leads to permanent disability and significant decline in quality of life.

ABOUT ENBREL
ENBREL is the only fully human anti-TNF receptor approved for use to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis, and to reduce the signs and symptoms and inhibit the structural damage in patients with moderately to severely active RA. ENBREL is the only biologic therapy approved to treat newly diagnosed RA patients, and can be used alone. It is also approved to reduce the signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis (JRA) in patients as young as four years of age who have had an inadequate response to disease-modifying medicines.

Physicians have become familiar with the benefits and proven long-term tolerability profile of ENBREL. It has been used to treat over 180,000 patients worldwide across all indications since becoming commercially available four years ago.

ENBREL acts by
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Contact: Rebecca Hamm, Amgen
805-447-3872
Porter Novelli
20-Jun-2003


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