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Marc Jay Bern
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New Quarterly Medication Approved to Treat Severe Plaque Psoriasis

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The Food and Drug Administration gave approval earlier this week for a medication that will treat adult patients who suffer from moderate to severe plaque psoriasis. The medication, Stelara (ustekinumab), will be taken four times a year to control the skin disease. Centocor Ortho Biotech Inc. is the manufacturer of the breakthrough treatment.

Psoriasis is a chronic skin disease that is the result of the over production of skin cells. These cells accumulate on the skin’s surface and create scaly red lesions that oftentimes bleed. There are more than 7.5 million people in the United States who suffer from some form of psoriasis and nearly one quarter of them are moderate to severe and might benefit from using Stelara.

Stelara is an antibody that targets the natural occurring proteins that have been attributed to the development of psoriasis. It is given to patients as an injection every 12 weeks after the first two starter doses. Clinical studies showed that around seven out of ten patients who received Stelara saw 75 percent of their skin clear up with just the first two doses. They were able to maintain these results with follow up maintenance injections for a full year.

The clinical trials included over 2,200 people with psoriasis and the improvements were gauged by the Psoriasis Area and Severity Index (PASI). The clinical trials showed a 75 percent improvement in patients receiving the Stelara injections as compared to those receiving a placebo.

The side effects from taking Stelara can possibly be serious as the medication does affect your immune system. It could lower your body’s ability to deal with infections and could even increase your risk of getting infections. You may be at risk for tuberculosis or other bacterial infections or diseases.

General side effects from Stelara injections include headache, tiredness and upper respiratory infections. If you have any of these symptoms when you first start your treatments talk with your physician. You should not take Stelara if you already have a compromised immune system.

You should also not take Stelara if you suffer from any form of cancer. If your immune system is compromised by taking Stelara you are at risk for several types of cancer, one of which is reversible posterior leukoencephalopathy syndrome (RPLS). It is a rare form of cancer that affects your brain. If caught early enough it is treatable but if it is not treated early enough it could result in death.

All in all, the effectiveness and safety of Stelara were carried out through the largest clinical development programs for a biologic medication as a treatment for psoriasis. If you suffer from moderate to severe psoriasis and you are at least 18 years of age you may want to ask your doctor if you would be a good candidate for these quarterly injections.

Centocor Ortho Biotech has already gathered three years of research into the safety of Stelara and is supported by a Risk Evaluation and Mitigation Strategy that will help physicians gauge the risk factor for their patients.