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

ASI 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, sinusi
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SOURCE Abbott
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