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ABBOTT ANNOUNCES DATA ON HUMIRA FOR PSORIASIS

February 6, 2007

Psoriasis patients experienced a significant reduction in the signs of their disease when treated with Abbott's Humira (adalimumab), and they were significantly less likely to have their disease signs worsen when they used the drug continuously, new study results show. The safety profile of Humira was found to be consistent with earlier clinical studies of the drug in psoriasis and rheumatoid arthritis.

The REVEAL trial is the second Phase III study to show positive results for Humira in psoriasis. Abbott will submit REVEAL results as part of a regulatory application for a psoriasis indication in the U.S. and Europe, expected during the first half of 2007.

The study evaluated both the short-term and sustained clinical efficacy and safety of Humira in 1,200 patients with moderate to severe chronic plaque psoriasis. The study had two independent primary endpoints. The first endpoint was the proportion of patients achieving 75 percent improvement in skin clearance after 16 weeks. The second endpoint was the proportion of patients who lost adequate response through week 52 after stopping treatment with Humira at week 33. Signs of psoriasis were evaluated using the Psoriasis Area and Severity Index (PASI), among other measures.

In the first 16 weeks of the study, researchers evaluated short-term efficacy and safety. Patients were randomized to receive either Humira (40 mg every other week after a starting dose of 80 mg) or placebo. Results showed that nearly three out of four patients (71 percent) achieved at least 75 percent improvement in disease signs (PASI 75) after 16 weeks of Humira treatment, compared with just 6.5 percent of patients who achieved PASI 75 after receiving placebo. Nearly half of the patients (45 percent) achieved 90 percent improvement (PASI 90), versus 1.8 percent of patients receiving placebo.

In the second primary endpoint, 28 percent of patients receiving placebo lost adequate response at week 52 compared with 5 percent of patients receiving Humira.

Humira is currently approved to treat psoriatic arthritis.