HUMIRA receives FDA approval for the treatment of plaque psoriasis

Abbott Park, Ill.

- Abbot announces it has received U.S. Food and Drug Administration (FDA) approval for HUMIRA (adalimumab) as a treatment for adult patients with moderate to severe chronic plaque psoriasis, PRNewswire reports.

The approval is based on the pivotal trials REVEAL and CHAMPION, which showed three in four patients achieved 75 percent clearance or better at week 16 of treatment versus placebo. The results of REVEAL were published in the January 2008 issue of the Journal of the American Academy of Dermatology and the Champion results were published online in the British Journal of Dermatology.

In REVEAL, 1,200 patients with moderate to severe chronic plaque psoriasis in the U.S. and Canada participated, and 71 percent of patients receiving HUMIRA achieved a Psoriasis Area and Severity Index (PASI) score of 75. In CHAMPION, 271 psoriasis patients were treated with HUMIRA, methotrexate or placebo. 78 percent of patients treated with HUMIRA achieved a PASI 75 response compared with 19 percent of patients treated with placebo.

HUMIRA is already approved for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn’s disease, giving it 10 years of clinical trial experience.