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Adalimumab Cleared for Treating Moderate-to-Severe Chronic Plaque Psoriasis

ABBOTT PARK, Ill., Jan. 18 /PRNewswire-FirstCall/ -- Abbott (NYSE:ABT) announced today it has received U.S. Food and Drug Administration (FDA) approval to market Humira (adalimumab) as a treatment for adult patients with moderate to severe chronic plaque psoriasis, an autoimmune disease characterized by skin lesions that are sometimes painful and itchy. Humira has been approved for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Humira should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

The approval is based on two pivotal trials, REVEAL and CHAMPION, showing that nearly 3 in 4 patients achieved 75 percent clearance or better at week 16 of treatment versus placebo. Humira has 10 years of clinical trial experience beginning with rheumatoid arthritis patients. It was approved for moderate to severe rheumatoid arthritis in 2002, psoriatic arthritis in 2005, ankylosing spondylitis in 2006, and moderate to severe Crohn's disease in 2007.

"The approval of Humira for psoriasis is welcome news for people living with this challenging, lifelong disease," said Pam Field, acting president and CEO, National Psoriasis Foundation. "We are pleased to let people with plaque psoriasis know they now have a new treatment option available to them."

Psoriasis affects an estimated 125 million people worldwide, with approximately 25 percent of patients experiencing moderate 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 PASI 75 correlates to a 75 percent improvement in signs and symptoms of psoriasis. PGA also measures efficacy of therapy. On a six-point scale, a zero score means no signs, one means minimal and a five means signs of very severe psoriasis.

Key Data
In REVEAL, a pivotal 52-week trial, the short-term and sustained clinical efficacy and safety of Humira were evaluated in more than 1,200 patients from the United States and Canada with moderate to severe chronic plaque psoriasis. Patients experienced a significant reduction in the signs and symptoms of their disease at 16 weeks when treated with Humira. Specifically,
-- Almost 3 out of 4 patients (71%) receiving Humira achieved PASI 75 compared to 7 percent of patients receiving placebo at week 16.
-- At week 16, 62 percent of Humira-treated patients achieved a PGA score of clear or minimal (0 or 1) compared to 4 percent of placebo-treated patients.

In CHAMPION, a pivotal 16-week study evaluating 271 psoriasis patients from eight European countries and Canada, Humira-treated patients experienced a significant reduction in the signs and symptoms of their disease compared with methotrexate or placebo-treated patients.
-- Nearly 80 percent (78%) of patients treated with Humira (n=99) achieved a PASI 75 response, compared to 19 percent of patients treated with placebo (n=48).
-- More than 70 percent (71%) of patients treated with Humira achieved a PGA score of clear or minimal at 16 weeks of treatment, compared with only 10 percent of placebo-treated patients.

The safety profile of Humira in the plaque psoriasis clinical trials was similar to that seen in Humira clinical trials for rheumatoid arthritis (RA). The most commonly reported adverse events in Humira psoriasis trials were upper respiratory tract infection, nasopharyngitis (inflammation of the nose and pharynx), headache, sinusitis and arthralgia. Humira is self-administered as an injection. Patients are treated with an initial 80 mg dose of Humira (two 40 mg injections) followed by one Humira injection (40 mg) one week later. After that, a maintenance dose of 40 mg is administered every other week.

"Humira has demonstrated its versatility in effectively treating multiple autoimmune diseases, and this approval expands the therapeutic resources available to dermatologists and other physicians who take care of patients with psoriasis and psoriatic arthritis," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott.

In April 2007, Abbott simultaneously submitted a supplemental Biologics License Application (sBLA) with the FDA and a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market Humira (adalimumab) as a treatment for chronic plaque psoriasis. EMEA approval was received in December 2007, and the U.S. approval makes psoriasis the fifth autoimmune disease indication for Humira.

More Information on Psoriasis
While psoriasis can occur in people of all ages, it typically appears in patients between the ages of 15 and 35, and currently has no cure. In a recent survey from the National Psoriasis Foundation, nearly 40 percent of psoriasis respondents reported feelings of helplessness and self-consciousness as a result of their disease.

Psoriasis varies from person to person and treatment depends largely on type, location, severity, age and medical history, and the primary treatment goals are to reduce the thickness, redness, scaling and itching of the skin. Treatment may include topical agents, phototherapy or medication taken by pill or injection.

Source: Abbott

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