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Raptiva Approved for Psoriasis Treatment

High-Tech Drug Blocks Immune Cells That Cause Psoriasis
By
WebMD Health News

Oct. 28, 2003 -- Raptiva is the newest drug to gain FDA approval for chronic moderate to severe psoriasis.

It's the second so-called biologic agent to treat the autoimmune problems at the heart of psoriasis. Raptiva -- generic name, efalizumab -- is a designer antibody. It's designed to throw a monkey wrench into the mechanisms by which immune cells cause psoriasis.

"I've been treating psoriasis for over 15 years and have always been frustrated by the limited options available to treat patients with this chronic disease," Craig Leonardi, MD, clinical associate professor of dermatology of Saint Louis University in St. Louis, Mo., and a Raptiva clinical investigator, says in a news release. "Raptiva has the potential to break the cycle of intermittent therapy by offering patients and their doctors a convenient treatment regimen that can be used continuously."

"This is not just a victory for psoriasis patients, it is a victory for biomedical research," Gail Zimmerman, president and CEO of the Psoriasis Foundation, says in a news release. "In just 20 years we have gone from having little understanding of the roots of psoriasis to seeing the FDA approve drugs, like Raptiva, that improve a patient's symptoms by targeting specific cells in the immune system. The biologic revolution is generating valuable new choices for those living with this incurable disease."

Raptiva is administered by a once-weekly injection under the skin. Patients give themselves the simple injections at home.

Other biologic drugs that can or could potentially be used to treat psoriasis include:

  • Amevive, the first systemic biologic agent approved specifically for psoriasis treatment. It's given by intravenous feed or intramuscular injection.
  • Enbrel is approved for psoriatic rheumatoid arthritis. It's given twice weekly by skin injection. The FDA is reviewing it for treatment of psoriasis.
  • Remicade is approved for rheumatoid arthritis and Crohn's disease. It's given by intravenous infusion every several weeks. It is also in advanced clinical trials for treatment of psoriasis.

Side Effects

In clinical trials, common adverse events that occurred at least 2% more frequently in patients treated with Raptiva than in patients treated with placebo include:

  • Headache, chills, fever, nausea, and muscle pain. These symptoms usually followed the first two Raptiva injections. Subsequent injections were no more likely to cause these symptoms than placebo.
  • Infection (mostly upper respiratory infections)

Precautions

Raptiva suppresses the immune system. It therefore can increase risk of infection and reactivate existing latent infections. It's not known whether Raptiva affects cancer risk, although some immune-suppressing drugs do increase the risk of some cancers.

When It Will Be Available

Raptiva is expected to be available by the end of 2003. Invented by the small biotech firm XOMA, Raptiva is manufactured by Genentech Inc., a WebMD sponsor.

Basis of Approval

Raptiva approval is based on clinical trials involving some 2,700 psoriasis patients.

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