Four Years


Enbrel (Etanercept) Maintains Suppression Of Joint Pain, Swelling After Four   Years PHILADELPHIA, PA -- October 30, 2000 -- 

Patients with moderately to severely   active rheumatoid arthritis experienced sustained reduction of joint pain   and swelling for as long as four years of treatment with Enbrel®   (etanercept), according to results from a long-term open-label study. Interim results of this on going study are being presented at the 64th   Annual Scientific Meeting of the American College of Rheumatology by Dr.   Larry Moreland of the University of Alabama at Birmingham. 

These data have   not been submitted to the U.S. Food and Drug Administration. In the study, Enbrel continues to be generally well tolerated in patients   who have received it for as long as four years. No significant differences   in the rate or type of adverse events were seen in these patients treated   with Enbrel over time. Infections resulting in hospitalization and/or   treatment with IV antibiotics observed in this study have occurred at rates   similar to those seen in controlled trials. In those controlled trials, the   rates of infection in patients receiving Enbrel and placebo were comparable.   No opportunistic infections were reported in the long-term study. 

There were   nine malignancies reported, of various types, similar to the number (12.7)   expected in the general population (calculated from the NCI SEER database). Additional highlights from this long-term study of Enbrel include: -- At 30 months of treatment (n=300), 24 percent of patients experienced no   tender joints and 21 percent had no swollen joints. -- Joint improvement was rapid and sustained. -- Steroid use decreased in 59 percent of 337 patients. 29 percent of   patients were able to discontinue corticosteroids use, while five percent   increased steroid use. -- 479 patients on Enbrel have been followed for more than one year. 420   patients on Enbrel were followed for two years and 164 have been followed   for three years. Twelve patients on Enbrel were followed for over four   years.

 All patients in this trial had moderately to severely active   rheumatoid arthritis and had failed treatment with one or more disease   modifying anti-rheumatic drugs prior to starting Enbrel. Over two million Americans suffer from the crippling effects of rheumatoid   arthritis, a chronic disorder that causes the body's immune system to attack   the lining of the joints, resulting in pain, swelling, fatigue and   disability. The exact cause of the disease is unknown although biotechnology   research has advanced understanding of the role of genes and factors causing   inflammation. 

The U.S. Food and Drug Administration (FDA) has approved Enbrel as a   first-line treatment of moderately to severely active rheumatoid arthritis.   Enbrel is indicated for reducing signs and symptoms and delaying structural   damage in patients with moderately to severely active rheumatoid arthritis. In postmarketing use, serious infections and sepsis, including fatalities,   have been reported. Many of these events occurred in patients predisposed to   infections, such as those with advanced or poorly controlled diabetes.   Discontinue Enbrel in patients with serious infections or sepsis. Do not   start Enbrel in the presence of sepsis, infection (including chronic or   localized), or allergy to Enbrel or its components. Use caution in patients predisposed to infection. Rare cases of central nervous system (CNS) demyelinating disorders have been   reported, although the causal relationship to Enbrel remains unclear.   Exercise caution when considering Enbrel for patients with these disorders.   Rare cases of pancytopenia, including aplastic anemia, some fatal, have been   reported in RA patients. Exercise caution in patients who have a previous   history of significant hematologic abnormalities. Although the causal relationship to Enbrel remains unclear, advise patients   to seek immediate medical attention if they develop signs or symptoms of   blood dyscrasias or infection. If significant hematologic abnormalities are   confirmed, consider discontinuing Enbrel. 

The most frequent adverse events in placebo-controlled clinical trials   (n=349) with Enbrel were injection site reactions (ISR) (37 percent),   infections (35 percent), and headache (17 percent). Only the rate of ISR was   higher than that of placebo. The most frequent adverse events in the   methotrexate-controlled trial (n=415) were infections (64 percent), ISR (34   percent), and headache (24 percent). Only the rate of ISR was higher than   that of MTX. In all RA patients treated in clinical trials (n=1,197),   malignancies were rare (1 percent). Enbrel acts by binding tumor necrosis factor (TNF). TNF is one of the   dominant cytokines or proteins that play an important role in normal immune   function and the cascade of reactions that cause the inflammatory process of   RA. Enbrel competitively inhibits the binding of TNF molecules to the TNF   receptor (TNFR) sites. The binding of Enbrel to TNF renders the bound TNF   biologically inactive, resulting in significant reduction in inflammatory   activity. Related Link: Enbrel® (etanercept).

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