Abbott's HUMIRA(R) (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque...(upperrespiratory infection (17 percent v...),Health

Date:1/18/2008

upper respiratory infection (17 percent vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for HUMIRA and 4 percent for placebo. As with any treatment program, the benefits and risks of HUMIRA should be carefully considered before initiating therapy.

In HUMIRA clinical trials for ankylosing spondylitis, psoriatic arthritis, Crohn's disease and plaque psoriasis, the safety profile for adult patients treated with HUMIRA was similar to the safety profile seen in adult patients with rheumatoid arthritis. In placebo-controlled clinical trials in plaque psoriasis, the incidence of arthralgia was 3 percent in HUMIRA-treated patients versus 1 percent in controls.

About HUMIRA

In addition to its approval for chronic plaque psoriasis, HUMIRA is approved by the FDA for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of joint structural damage, and improving physical function in adult patients with moderately to severely active RA. HUMIRA is indicated for reducing the signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis. HUMIRA resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-alpha), an inflammatory protein that, when produced in excess, plays a key role in the inflammatory responses of some autoimmune diseases.

To date, HUMIRA has been approved in 72 countries and more than 250,000 people worldwide are currently being treated with HUMIRA. Clinical trials are currently under way evaluating the potential of HUMIRA in other immune-mediated diseases.

In May 2007, Abbott announced it had also submitted an FDA regulatory application for HUMIRA to treat juvenile rheumatoid ar
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SOURCE Abbott Copyright©2008 PR Newswire. All rights reserved

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