FDA Approves New Psoriasis Drug
Raptiva joins growing list of biologic medications
First posted Oct. 27, 2003
Last updated Nov. 11, 2003
On Oct. 27, 2003, the FDA approved the psoriasis drug efalizumab (brand name Raptiva) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic treatment or phototherapy. Raptiva is part of a new class of treatments called "biologics." Genentech, the manufacturer of Raptiva, said patients can talk about Raptiva with their doctor right away, and the medication will be distributed by early December.
Raptiva is given by injection under the skin; patients give themselves the shot once per week at home. The medication is meant to be taken continuously to maintain the results; in clinical studies, some patients took Raptiva for as long as two years.
"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, said in a press 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 psoriasis patient's symptoms by targeting specific cells in the immune system. The biologic drug revolution is generating valuable new choices for those living with this incurable disease."
As a new class of treatment for people with psoriasis and psoriatic arthritis, biologic therapy offers needed new options for dermatologists and patients. Biologics are a class of drugs engineered from proteins produced by living cells; they disrupt the immune-system processes that drive the disease. Other treatments for psoriasis and psoriatic arthritis, particularly those used in moderate to severe cases, are effective but can have a widespread impact on the immune system.
In January 2003, Amevive (pronounced AM-uh-veev), manufactured by Biogen, became the first biologic medication to be approved for treating psoriasis.
Other biologics are on their way:
- Amgen's Enbrel is already on the market for treating psoriatic arthritis, rheumatoid arthritis and juvenile rheumatoid arthritis, and it is now being reviewed by the FDA for the treatment of psoriasis.
- Centocor's Remicade is already on the market for rheumatoid arthritis and Crohn's disease; additional late-stage clinical studies in psoriasis and psoriatic arthritis are ongoing.
More than 5 million Americans and their families are affected by psoriasis and/or psoriatic arthritis. Moderate psoriasis is defined as affecting between 2 percent and 10 percent of the body's surface, and psoriasis covering more than 10 percent of the body is considered severe. (The area of skin that can be covered by the palm of the hand is considered to be 1 percent of the body.)
How is Raptiva different?
Raptiva is an antibody that blocks the activation of certain immune cells, called "T cells," and the migration of those cells into the skin. T cells are a type of white blood cell in the body that normally help us ward off foreign invaders and fight infection. In psoriasis, however, these T cells are mistakenly activated and trigger other immune responses that fuel the development of psoriasis lesions.
How will patients use it?
Raptiva is given by injection under the skin; patients give themselves a shot once per week at home. Genentech recommends that patients use it as a continuous treatment for best results.
How effective is Raptiva?
Researchers presented findings that 44 percent of patients treated continuously with Raptiva for 24 weeks saw the severity of their psoriasis improve by 75 percent or more. A longer study monitored patients for 21 months who had improved significantly and continued to take Raptiva weekly. Of those patients, 67 percent of patients achieved a 75 percent improvement in psoriasis severity.
What are the side effects?
The most common side effects reported from the phase III studies were:
- headache
- infections (usually upper respiratory infections)
- chills
- nausea
- flu syndrome
- fever
- back pain
- acne
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Safety Study
Genentech is currently recruiting for a general safety study of Raptiva. They hope to target over 200 investigational sites with up to 1200 patients nationwide. Patients with moderate to severe psoriasis who have not been in previous Raptiva clinical studies are eligible. Visit the study page for more information. |
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