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Abbott's HUMIRA(R) Receives Positive Opinion From EMEA for Treatment of Moderate to Severe Plaque Psoriasis
Date:11/16/2007

Food and Drug Administration approval for this indication.

"The skin clearance we have seen in HUMIRA psoriasis clinical trials, combined with ten years of clinical experience across indications and the convenience of self-injection, make HUMIRA a much anticipated treatment option for this condition," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development at Abbott.

About HUMIRA Psoriasis Clinical Trials

The opinion is primarily based on the results of two randomized, controlled, multi-center clinical trials in adult patients: REVEAL and CHAMPION. In both trials, the signs and symptoms of psoriasis were measured and evaluated using the Psoriasis Area and Severity Index (PASI) among other measures. CHAMPION was the first head-to-head study comparing a biologic medication to methotrexate, the standard systemic treatment for psoriasis.

-- 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 three out of four patients

(71 percent) receiving HUMIRA achieved PASI 75 (75 percent or better

improvement in PASI), compared to 6.5 percent of patients receiving

placebo.

One in five patients (20 percent) receiving HUMIRA achieved

PASI 100 (complete clearance), compared to 1 percent of patients

receiving placebo. For patients who maintained a PASI 75 response

after eight months of continuous HUMIRA therapy, patients were either

continued on HUMIRA or administered placebo for the remainder of the

study. Significantly fewer patients (5 percent) on HUMIRA lost


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SOURCE Abbott
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