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Amevive Approved for Treating Psoriasis

First of New Class of Psoriasis Therapy

First posted Jan. 31, 2003

The U.S. Food and Drug Administration (FDA) has approved the drug alefacept (brand name Amevive) for the treatment of moderate to severe plaque psoriasis, Biogen announced today. Amevive is the first biologic drug approved for the treatment of psoriasis. Amevive will be available to patients to request from their physicians as of Monday, Feb. 3, 2003. Patients' insurers will evaluate their use of Amevive while their physicians begin testing patients before starting therapy.

The price of Amevive will range from $7,000 to $10,000 per course depending on the size of the dose. Private insurance companies have varying policies. Some patients will be fully covered for Amevive; others may be partially covered or, in some cases, responsible for between $1,400 and $2,000 out of pocket. Patients on Medicare will be covered for 80 percent of the prescription cost, or more if they have supplemental insurance. Biogen is offering to help patients work through insurance issues by enrolling in the Amevive Start Assistance Program.

"Today's announcement that the FDA has approved Amevive is a significant step forward for the psoriasis community," said Gail Zimmerman, president and CEO of the National Psoriasis Foundation. "This drug is the first of a new class of treatment that represents the most significant advance in psoriasis care in 20 years."

As a new class of treatment for people with psoriasis and psoriatic arthritis, biologic therapy offers needed new options for dermatologists and patients. Biologics are a class of drugs engineered from proteins produced by living cells; they disrupt the immune-system processes that drive the disease. Other treatments for psoriasis and psoriatic arthritis, particularly those used in moderate to severe cases, are effective but can have a widespread impact on the immune system.

Amevive is the first biologic available for psoriasis, but others are on the way.

• Amgen's Enbrel is already on the market for treating psoriatic arthritis and rheumatoid arthritis, and recent study results indicate it is effective for psoriasis as well. It could be submitted to the FDA by the end of the year.
• After successful clinical trials, efalizumab (brand name Raptiva) was recently submitted to the FDA for treating psoriasis and could be approved by the end of 2003.
• Centocor's Remicade is already on the market for rheumatoid arthritis and Crohn's disease; small studies have indicated its effectiveness in treating psoriasis, and additional studies in psoriasis and psoriatic arthritis are ongoing.

Psoriasis affects approximately 4.5 million people in the United States; about 1.5 million in the U.S. have moderate to severe psoriasis. Moderate psoriasis is defined as affecting between 2 percent and 10 percent of the body's surface. One percent equals the palm of the hand. Psoriasis covering more than 10 percent of the body is considered severe.

How is Amevive different?

Amevive is a systemic therapy that works by blocking and eliminating certain T cells that play a role in psoriasis. T cells are a type of white blood cell in the body that normally fight foreign invaders; in psoriasis, T cells are mistakenly activated and trigger other immune responses that fuel the development of psoriasis lesions.

How will patients use it?

Amevive is a drug that is given by injection. It can be injected into the muscle (IM) or directly into the veins (IV). Patients will receive an injection once a week for 12 weeks. Patients' white blood cell count will be monitored while on the treatment.

After the first 12-week course, patients wait 12 weeks. If they meet certain criteria and T cells are normal, patients are eligible for a second course of treatment.

Patients who may be candidates for the treatment are those who are candidates for other systemic treatments (methotrexate or cyclosporine, for example) or phototherapy who have stopped responding to traditional treatments. Gerald Krueger, M.D., who led the clinical trials of Amevive, said he plans to administer Amevive mainly to patients who have used built up resistance to systemic therapy or PUVA (the use of a light-sensitizing drug and ultraviolet light A).

"I estimate that about 80 percent of people who have chronically (more than 15 years) been on systemic therapy or PUVA to control their disease have evidence of cumulative toxicity that makes other less toxic therapies, such as Amevive, an attractive alternative," said Dr. Krueger. As Amevive's long-term safety becomes more established, he said he may offer Amevive to other patients as a first-line treatment.

How effective is Amevive?

At a scientific meeting in early 2001, investigators reported results of a phase III clinical trial of Amevive in more than 1,000 patients. Among patients who received one course of Amevive by intravenous (IV) injection, 28 percent achieved a 75 percent or greater improvement in their psoriasis. Fifty-six percent of patients achieved 50 percent improvement in their disease.

One course of treatment consisted of 12 weekly injections. Investigators determined there was cumulative benefit from Amevive. After a second 12-week course of treatment, 40 percent of patients achieved a 75 percent or greater improvement in their disease, and 71 percent reached 50 percent improvement. After the first course, remission time ranged from two months to 3.5 months. After the second course, a smaller group used placebo and had 50 percent reduction for a median of 7 months.

What are the side effects?

In the phase III trial, there was no evidence of toxic reaction in patients to the drug and no psoriasis rebounds after patients stopped treatment with Amevive, according to researchers. The most frequently reported side effects included sore throat, dizziness, increased cough, headache, nausea, itching, muscle aches, chills, injection site pain, injection site inflammation and accidental injury.

The most serious side effects were rare, but included lymphopenia (decreased number of lymphocytes circulating in the blood); malignancies; serious infections requiring hospitalization and allergic reactions.

It is not yet known whether Amevive will interact with other medications, or how long patients should wait after stopping their course of treatment before using other immunosuppressive therapies.

Who should not take Amevive?

• The FDA classified Amevive as a category B treatment, meaning pregnant women should take Amevive only if clearly needed.
• Women who are nursing should consult with their physician about whether to discontinue the drug, based on the mothers' severity of psoriasis.
• Elderly patients should exercise caution with Amevive; it is not clearly known whether Amevive will affect them differently than younger patients.
• Children should not take Amevive; the safety and efficacy of Amevive has not been studied in this group.
• People with infections or low T cell counts
• People who develop a malignancy or serious infection should discontinue treatment

Amevive will be available on Feb. 3, 2003, through direct distribution to a physician's office or a specialty pharmacy. Both options are available through the toll-free number 1-866-AMEVIVE. The price of Amevive will range from $7,000 to $10,000 per course depending on the size of the dose.

The cost for patients may vary depending on their health insurance coverage. It is likely to be treated as a medical benefit, in which patients would pay 20 percent of the cost. Based on the average remission time from clinical trials of the drug, patients may be treated about twice per year.