AMEVIVE® (alefacept)

AMEVIVE - AMEVIVE® (alefacept) is the first FDA-approved biologic for treatment of moderate-to-severe chronic plaque psoriasis. It works by selectively targeting the T-cells responsible for the disease without disrupting normal immune function. AMEVIVE is indicated for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. For full prescribing information please visit www.Amevive.com.

Antigen - A part of a microorganism (such as bacteria, virus, fungus) or toxin that the immune system recognizes as foreign, and reacts against. Antigens trigger the production of an antibody. Some antigens, called allergens, cause an allergic reaction.

Biologic - Biologics represent a new class of systemic therapies. They contain proteins derived from living cells, as opposed to traditional pharmaceutical drugs that are made up of non-living chemicals. Biologics are typically administered through injection because they would be digested if taken orally.

Moderate-to-Severe Psoriasis - Approximately 1.5 million Americans suffer from moderate-to-severe psoriasis, which means they have psoriasis on more than 2 percent of their body's surface (the palm of the hand represents approximately one percent of body surface area). PASI (Psoriasis Area and Severity Index) - A widely used scale in clinical trials for assessing the severity of psoriasis and the effectiveness of treatment. It assesses four main body areas (the head, upper extremities, lower extremities, and torso) and, for each of these areas, provides a methodically derived "score" of 0-72 based upon both the extent of psoriatic coverage and the severity of psoriatic lesions. The four sub-scores are then combined, providing the composite PASI, which ranges from 0.0 (no psoriasis) to 72.0 (the worst possible severity) in steps of 0.1.

Plaque Psoriasis - This type of psoriasis is most common, accounting for 80 percent of all psoriasis cases. It is characterized by raised, reddened, scaly patches of skin. Plaque psoriasis is commonly found on the scalp, knees, elbows and torso, but it may appear anywhere on the body and can involve extensive areas of the skin.

Protein - Proteins are complex organic compounds composed of amino acids. They are present in all living cells and are essential for the growth and repair of human tissue.

Psoriasis - Psoriasis is an autoimmune skin disease. It is characterized by accelerated skin growth that leads to skin cells building up on the surface of the skin, forming red, raised scaly plaques. Psoriasis can involve large areas of skin and is often itchy and painful.

Systemic Therapy - Systemic therapies treat psoriasis internally by disrupting the immune system processes that cause the disease.

T-cell - A T-cell is a type of white blood cell that functions in the immune system to protect the body against harmful organisms. Sometimes, in immune diseases like psoriasis, the T-cells become dysfunctional and attack a body's own tissues.

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.