LYCOS RETRIEVER 
Enbrel
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Etanercept (Enbrel®, Amgen) is a recombinant human protein with anti-inflammatory properties that was the first approved treatment for psoriatic arthritis by the US FDA in January 2002. It was approved by TPP Canada in January 2004 for the same indication.1-3 In May 2004, the US FDA approved this drug for the treatment of adult patients with chronic moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In September 2004, the European Union approved it for the treatment of adult patients with moderate-to-severe plaque psoriasis who failed to respond to, or have a contraindication to, or are intolerant of other systemic therapies. Also in September 2004, the US FDA approved a new dosing form: a 50mg/ml prefilled syringe, which will allow most patients to take only one injection per week instead of two. Additional indications for etanercept include the treatment of rheumatoid and polyarticular-course juvenile rheumatoid arthritis (RA and JA respectively), and ankylosing spondylities. In RA the clinical responses to etanercept have been maintained for up to 7 years in clinical trials.4
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Reported by Wyeth's marketing partner Amgen, full year Enbrel net revenue in North America was $1.9 billion, an increase of 46%. Wyeth has exclusive rights to Enbrel outside of North America where net revenue for the year reached $680 million, more than double the previous year. In the U.S., new and total prescriptions for the four-week period ended December 31, 2004 increased 90% and 44%, respectively, over the corresponding period in the prior year. The launch of the psoriasis indication in the U.S. in April has contributed significantly to recent Enbrel prescription growth. As of December, more than half of U.S. based dermatologists have written a prescription for Enbrel.
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Do not use or handle Enbrel without first talking to your doctor if you have an allergy to latex. The needle cover is made from latex and you may have an allergic reaction to it. In rare cases, Enbrel has caused serious blood problems. Notify your doctor immediately if you develop persistent fever; extreme or unusual fatigue; unexplained or prolonged bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection such as sore throat or pale skin. These symptoms may be signs of blood problems.
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Enbrel works by intercepting and blocking the inflammatory TNF circulating in the bloodstream before it has had time to bind to the cells driving the inflammation. Enbrel (Embril) stops the inflammatory process in both already affected joints and in ligaments as well as in skin affected by psoriasis. The drug offers a long lasting effect on both joint and skin symptoms which is very important in the treatment of chronical inflammatory diseases.
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The efficacy of Enbrel was compared to methotrexate in a third randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis (<3 years duration) who had never received treatment with methotrexate. Doses of 10 mg or 25 mg Enbrel were administered SC twice a week for up to 24 months. Methotrexate doses were escalated from 7.5 mg/week to a maximum of 20 mg/week over the first 8 weeks of the trial and continued for up to 24 months. Clinical improvement including onset of action within 2 weeks with Enbrel 25 mg was similar to that seen in the previous trials, and was maintained for up to 24 months. At baseline, patients had a moderate degree of disability, with mean HAQ scores of 1.4 to 1.5. Treatment with Enbrel 25 mg resulted in substantial improvement at 12 months, with about 44% of patients achieving a normal HAQ score (less than 0.5).
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Within months of approval, reports about Enbrel noted nearly thirty serious infections and six fatalities. This prompted a warning letter to be send out to prescribing doctors and added to the drug label warnings section. The new warnings discussed infections and sepsis and advised doctors not to use Enbrel to use caution in patients with a history of recurring infections, and to stop Enbrel if serious infection arises.
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Enbrel