Description

RAPTIVA® (efalizumab) is the first FDA-approved biologic therapy designed to provide continuous control of chronic moderate-to-severe plaque psoriasis, and the first biological treatment for psoriasis authorized for marketing in the 25 countries of the European Union (EU). More than 44 countries worldwide have approved RAPTIVA® for the treatment of moderate-to-severe plaque psoriasis. RAPTIVA® is administered once-weekly via subcutaneous injection and can be self-administered by patients at home. The recommended dose of RAPTIVA® is a single 0.7 mg/kg SC conditioning dose followed by weekly SC doses of 1 mg/kg.

Mechanism of Action

RAPTIVA® is a humanized therapeutic antibody designed to selectively and reversibly block the activation, reactivation and trafficking of T-cells that lead to the development of psoriasis.

In psoriasis, immune cells called T-cells become overactive. This sets off a series of events that speeds up the life cycle of skin cells, so that they pile up on the surface of the skin, forming red, scaly patches called plaques. Patients suffer various degrees of abnormal redness, flaking, itching, and sometimes pain and bleeding.

RAPTIVA® prevents T-cells from becoming activated and entering the skin. This, in turn, inhibits the process that leads to plaque formation. As RAPTIVA® starts working in the body and plaque formation is slowed, psoriasis symptoms start to clear.

At a Glance:

An estimated 4.5 million Americans have psoriasis and of these 1.5 million are considered to have moderate-to-severe disease.
In clinical studies, RAPTIVA® demonstrated a rapid onset of action in the reduction of symptoms associated with psoriasis, within four weeks of initial treatment in some patients.
More than 3,500 patients in the United States and Europe have been included in RAPTIVA® trials to date, creating the largest existing database of patients taking part in studies with a biological therapy for psoriasis
In October of 2003, RAPTIVA® received U.S. FDA approval for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or phototherapy.
In September of 2004, Serono received European Commission Marketing Authorization for its product RAPTIVA® (efalizumab) for people with moderate-to-severe chronic plaque psoriasis for whom other systemic treatments or phototherapy have been inadequate or inappropriate.
In February of 2005, investigators presented final results of a three year-study of RAPTIVA® in moderate-to-severe plaque psoriasis at the American Academy of Dermatology meeting, providing additional confirmation of the long-term safety and sustained treatment benefit of the product.
Raptiva® is now approved in more than 44 countries for moderate-to-severe plaque psoriasis.

©XOMA 2008