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Carol Eustice

Stelara (ustekinumab) FDA-Approved for Psoriasis

By September 25, 2009

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The U.S. Food and Drug Administration has approved Stelara (ustekinumab), a monoclonal antibody given by subcutaneous injection (under the skin), for the treatment of moderate to severe plaque psoriasis in adults. The biologic drug targets two cytokines, IL-12 and IL-23, that contribute to the overproduction of skin cells and inflammation associated with psoriasis. The effectiveness and safety of Stelara was evaluated in 3 studies that involved more than 2,200 patients.

For patients with psoriatic arthritis, symptoms of psoriasis and chronic joint inflammation often develop separately. In 85% of psoriatic arthritis patients, symptoms of psoriasis develop before arthritis symptoms. Arthritis develops before psoriasis in up to 15% of psoriatic arthritis patients. Psoriasis and arthritis can develop years apart.

Plaque psoriasis is one of 5 major types of psoriasis. It is the most common type and appears as raised, reddish skin covered by a silvery-white scale. The patches can occur anywhere on the skin. Most frequently, they are found on the elbows, knees, lower back, and scalp.

Centocor first applied for approval of Stelara in December 2007 and an advisory committee recommended approval in June 2008. The FDA extended the review due to concerns about cancer and infection risks -- but has granted approval now with strategies for communication about risk, including a medication guide for patients.

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