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Abbott's HUMIRA(R) (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis
Date:1/18/2008

ate to severe disease. Psoriasis is a serious, sometimes painful autoimmune disease resulting in inflamed, scaly, red skin lesions known as plaques, which may crack and bleed. In addition to visible symptoms, people with psoriasis may suffer from poor self-image and social isolation, and even feelings of depression, such as sadness and despair. Recent research also suggests psoriasis may be associated with other serious health risks. Up to 30 percent of psoriasis patients develop psoriatic arthritis, which combines skin symptoms with arthritis symptoms, including joint pain and inflammation.

"The approval of HUMIRA is excellent news for patients suffering from psoriasis, which can have a profound physical and emotional impact on a person's life," said Alan Menter, M.D., chairman, division of dermatology, Baylor University Medical Center, Dallas. "HUMIRA offers dermatologists an important new therapeutic option that has been shown to help alleviate a range of psoriasis signs and symptoms, including redness, scaling and itching, in many psoriasis patients."

HUMIRA for Plaque Psoriasis

The approval of HUMIRA is based on data from more than 1,400 adult patients in two pivotal trials -- REVEAL and CHAMPION. Both studies evaluated the efficacy and safety of HUMIRA in clearing skin in moderate to severe adult plaque psoriasis patients versus placebo. In addition, CHAMPION compared a biologic medication to methotrexate, a standard systemic treatment for psoriasis. REVEAL results were published in the Journal of the American Academy of Dermatology in January 2008 and CHAMPION results were published online in the British Journal of Dermatology.

In each trial, reduction in disease activity was determined by the Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA). The PASI score measures the extent and severity of psoriasis. PASI may be calculated before and after a treatment period to determine efficacy; for example, a P
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SOURCE Abbott
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