FDA approves Enbrel for psoriasis First biologic approved to treat moderate to severe psoriasis and psoriatic arthritis
The U.S. Food and Drug Administration (FDA) approved on April 30, 2004, a new use for the biologic drug Enbrel; it now can be used to treat moderate to severe plaque psoriasis in adults who are candidates for systemic treatment or phototherapy. National Psoriasis Foundation Press Release In January 2002, Enbrel became the first biologic approved for psoriatic arthritis; it is now the first biologic to be approved to treat both psoriasis and psoriatic arthritis. In addition to psoriasis and psoriatic arthritis, Enbrel is approved for rheumatoid arthritis, juvenile rheumatoid arthritis and ankylosing spondylitis, a disease that causes inflammation in the spine. "Managing psoriasis is a lifelong battle, and patients frequently tell us they need additional treatment options," said Gail Zimmerman, president and CEO of the National Psoriasis Foundation. "The past 18 months have brought several new choices for patients, and with Enbrel, we now have a drug approved for both psoriasis and psoriatic arthritis. This is an exciting time for psoriasis patients and their families." How will patients use it? Enbrel is given by injection under the skin; patients give themselves the shot once or twice per week at home. The medication is meant to be taken continuously to maintain the results. The FDA approved dose administration for Enbrel is 50 milligrams (mg) twice per week for three months, followed by a maintenance dose of 50 mg once weekly thereafter. Each dose is taken in two 25 mg injections within a 24-hour period or three or four days apart. How effective is Enbrel for psoriasis? The new label use is significant because the dosing regimen has been shown in many patients to improve symptoms quickly and maintain the results. The FDA's decision was based on two phase III studies evaluating more than 1200 patients with moderate to severe psoriasis, which demonstrated that psoriasis patients may be able to speed their clearing time at a higher dose and then maintain it at a lower dose. Patients received placebo, or Enbrel 25 mg twice weekly or 50 mg twice weekly for 12 weeks. Patients then continued treatment for an additional 12 weeks, but those who were given 50 mg initially were "stepped down" to 25 mg twice weekly. Of those given the 50 mg loading dose and then stepped down, nearly half (47 percent) achieved 75 percent improvement in their psoriasis score. In psoriasis studies, many patients experienced clinical improvement as early as four weeks or up to a few months after starting Enbrel. How is Enbrel different? The medicine works by blocking a chemical in the immune system that overstimulates inflammation. This chemical is called "tumor necrosis factor-alpha" (TNF-alpha), an immune-system chemical messenger. More treatments to target psoriasis pathway
The psoriasis approval follows the approvals in January 2003 of Amevive and in October 2003 of Raptiva, two other biologic medications for psoriasis treatment. Other biologics are on their way: - Remicade is already on the market for rheumatoid arthritis and Crohn's disease; additional late-stage clinical studies in psoriasis and psoriatic arthritis are ongoing.
- Humira is already on the market for rheumatoid arthritis; additional late-stage clinical studies in psoriasis and psoriatic arthritis are ongoing.
More than 5 million Americans and their families are affected by psoriasis and/or psoriatic arthritis. Moderate psoriasis is defined as affecting between 2 percent and 10 percent of the body's surface, and psoriasis covering more than 10 percent of the body is considered severe. (The area of skin that can be covered by the palm of the hand is considered to be 1 percent of the body.) What are the side effects? Injection site reactions (redness, itching, pain, swelling) were the most common short-term side effect among patients taking Enbrel in the psoriasis studies. Serious infections, including some fatalities, have been reported with the use of Enbrel. The infections often occurred in patients using other medications that suppress the immune system, like methotrexate. Serious infections are rare in patients taking Enbrel alone. Also, rare cases of tuberculosis have been observed in patients taking medications that target TNF-alpha. The medication should not be started in someone with an active infection, and it may not be recommended for someone with a history of recurring infections. If a serious infection develops, a doctor will most likely stop Enbrel treatment. Cases of multiple sclerosis and other central nervous system disorders have been observed in association with Enbrel and medications that target TNF-alpha, although the connection between the disorders and the medications remains unclear. Due to rare reports of blood disorders, people taking Enbrel are advised to contact their doctor if they experience persistent fever, bruising, bleeding or paleness. In 2003, the FDA reviewed the association between TNF-alpha medications like Enbrel and an increased risk of developing lymphoma, a type of cancer. There is not enough data to know if the medication contributed to higher risk. Enbrel's safety and side effects continue to be monitored by Amgen and Wyeth and the FDA. Who should not take Enbrel? - People with active infections should not start Enbrel
- Caution is advised for the elderly, due to the already increased risk of infection for this age group
The impact of Enbrel on pregnant women or developing fetuses is not known, nor is it known if the medication passes into breast milk in nursing women. Enbrel should only be given to pregnant or nursing women if there is a clear medical need, and if this decision is reached by a patient and doctor together. How will I get it? Amgen does not expect any major change in insurance reimbursement or distribution for the new psoriasis approval. For more information, including prescribing information, please visit our Biologic Fact Sheets or our Biologic Medications for Psoriasis and Psoriatic Arthritis booklet. | 
