AMEVIVE® (alefacept)

FACTS ABOUT PSORIASIS

Important Facts

Psoriasis is an autoimmune skin disease.
Psoriasis is not contagious.
Psoriasis is often itchy and sometimes painful.
Approximately 25 percent of psoriasis cases are classified as moderate-to-severe.
Moderate disease is defined as having psoriasis cover 3 percent to 10 percent of body surface area. Severe disease is defined as more than 10 percent coverage. (Note: The palm of the hand represents about 1 percent of a body's surface area.)
About 15 percent of people with psoriasis develop psoriatic arthritis, a condition similar to rheumatoid arthritis that causes inflammation and stiffness in and around joints.
The average cost of therapy to treat psoriasis is estimated around $4,000-$7,000 per year. Psoriasis represents a significant societal burden, costing in aggregate $1.6 million to 3.2 billion per year and 56 million lost hours of work due to illness.

The Cause of Psoriasis
The cause of psoriasis is not fully understood. The disease may be caused by memory effector T-cells that trigger an increased number of skin cells in the top layers of the skin. Normal skin cells mature in 28 to 30 days and are then shed from the skin's surface. In psoriasis, the immune system causes skin cells to regenerate much more quickly - every three to four days. As the skin cells accumulate, they form scaly areas of skin called plaques that appear red and raised.

Types of Psoriasis

Plaque - Raised, reddened lesions; represents 80 percent of psoriasis cases (all disease types may be chronic or acute)
Guttate - Small, dot-like lesions covering the body
Pustular - Pus-filled lesions and intense scaling usually localized to the palms and soles
Erythrodermic - Intense scaling with marked inflammation of the skin covering the body

Who Develops Psoriasis?

Psoriasis is a chronic but treatable skin disease that affects more than 80 million people worldwide and approximately 4.5 million adults in the U.S.
1.5 million adult Americans suffer from moderate-to-severe forms of the disease.
Doctors characterize psoriasis as an "equal-opportunity disease," occurring equally in men and women.

Levels of Severity
Psoriasis is a very individual disease. Its location on the body and the amount of skin affected varies from patient to patient. In some people, the symptoms of the disease are virtually unnoticeable; in others, the raised, red lesions can be widespread. As a rule of thumb, the more skin covered with psoriasis, the more severe the disease.

Unlike illnesses such as multiple sclerosis and rheumatoid arthritis, mild forms of psoriasis do not tend to progress into more severe cases. However, people who develop psoriasis early are more likely to have widespread, recurrent disease.

To a large extent, severity is related to how psoriasis makes a person feel and how much it affects quality of life. Psoriasis on the hands and feet, for example, is often considered severe because it's painful and makes daily tasks more difficult.

When Does Psoriasis Develop?

While it's possible to develop psoriasis at any age, it appears most commonly between the ages of 15 and 35.
Psoriasis is usually a lifelong condition with alternating periods of flare-ups and clearing.

What Incidents Trigger the Onset of Psoriasis?
The exact causes of psoriasis are complex and not fully understood, but genetic traits leading to abnormalities in the body's response to infection are believed to be the underlying basis. However, emotional stress, skin injury, infection or reactions to certain medications often trigger its initial appearance. A specialized white blood cell called a T-cell has been identified as playing a key role in the onset of the disease.

Where Do Symptoms Typically Appear?
Psoriatic skin plaques are most commonly found on the scalp, knees, elbows and torso, but can develop anywhere on the body.

What Are the Treatment Options for Psoriasis?
Until recently, treatments for psoriasis included topical medicines and creams, light therapy and pills or injections. While these treatments provide some relief from symptoms, they offer no cure. With the understanding that psoriasis is an immune-mediated disease, scientists have developed targeted therapies that may be effective and have fewer side effects than existing treatments. These new treatments are known as biologics, and they are believed to specifically interrupt the chain of events in the immune response that leads to psoriasis.

Important Safety Information
Commonly observed adverse events that occurred in clinical studies more frequently with AMEVIVE® (alefacept) included: sore throat, dizziness, increased cough, nausea, itching, muscle aches, chills, injection site pain, injection site inflammation, and accidental injury.

AMEVIVE must be administered under the supervision of a physician.

AMEVIVE reduces lymphocyte counts (also called T-cells). T-cell levels should be measured weekly during the 12-week dosing period.

AMEVIVE reduces immune cell counts, which could increase your chance of developing infection or malignancy, which you should discuss with your doctor. If you develop any signs of infection or malignancy while undergoing a course of treatment with AMEVIVE, you should notify your doctor.

AMEVIVE should not be taken if you are known to be allergic to AMEVIVE or any of its components.

If you become pregnant while you are receiving AMEVIVE or within 8 weeks of finishing AMEVIVE, notify your doctor and consider enrolling in the Pregnancy Registry by calling 1-866-AMEVIVE.