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Psoriasis
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FDA Approves First Biologic Therapy for Psoriasis
FDA Talk Paper
January 2003
FDA today announced the approval of Amevive (alefacept), an injected medication that treats adults with moderate to severe plaque psoriasis.
Plaque psoriasis is the most common form of psoriasis, a chronic (lasting a long time) relapsing disease of the skin that is characterized by scaling and inflammation. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, psoriasis affects between 1 and 2 percent of the United States population, or as many as 5.5 million people. Psoriasis primarily affects adults. People with psoriasis may suffer discomfort, including pain and itching, restricted motion in their joints, and emotional distress.
Amevive treats plaque psoriasis through a unique immunosuppressive mechanism of action. Specifically, Amevive is believed to work by simultaneously blocking and reducing the cellular component of the immune system that is thought to play a significant role in the disease process.
FDA based its approval of Amevive on the results of two randomized, double-blind, placebo-controlled studies that enrolled a total of 1060 adults with chronic (lasting a long time) plaque psoriasis. Both of these studies showed that a significantly higher percentage of patients receiving Amevive responded to treatment compared to those receiving placebo based on pre- and post-treatment measurements of the percentage of affected skin surface area and severity of scaling and inflammation.
In the approved labeling for Amevive, FDA is encouraging physicians to inform patients of the need for regular monitoring of white blood cell counts during therapy and that Amevive must be administered under the supervision of a physician. Moreover, the approved labeling states that patients should be informed that Amevive suppresses their immune system, which could increase their chances of developing an infection or malignancy. Therefore, patients should inform their physician promptly if they develop any signs of an infection or malignancy while undergoing a course of treatment with Amevive.
Women of childbearing potential make up a considerable segment of the patient population affected by psoriasis. Because the effect of Amevive on pregnancy and fetal development, including immune system development, is not known, health care providers are encouraged to enroll patients taking Amevive who become pregnant into the manufacturer's pregnancy registry by calling 1-866-AMEVIVE (263-8483).
Amevive is manufactured by Biogen, Inc., of Cambridge, Mass.
References:
1) National Women's Health Information Center (NWHIC) - May 2008 - www.4woman.gov
2) U.S. Food and Drug Administration - FDA Talk Paper - January 2003 - www.fda.gov
3) U.S. Food and Drug Administration - FDA Consumer Magazine - September - October 2004 - www.fda.gov
4) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) - Information Clearinghouse - National Institutes of Health - May 2003 - www.niams.nih.gov
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