PsoriasisNet Article
Efalizumab Patients: Transition, Don't Just Stop

If you are treating your psoriasis with efalizumab, recent news may make you wonder if you should stop treatment immediately. This is not what dermatologists generally recommend.

For the estimated 2,000 patients in the United States treating psoriasis with efalizumab, this is what dermatologists advise:

  1. Do not immediately stop treating with efalizumab. Suddenly stopping can be dangerous. It can cause such a severe psoriasis flare that you may need to be hospitalized.
     

  2. If you do not already have an appointment, make an appointment to see the doctor who prescribed efalizumab. The U.S. Food and Drug Administration (FDA) “strongly recommends that patients taking efalizumab work with their health care professional to transition to other alternative therapies for psoriasis.”

    To give patients time to transition to other treatments, efalizumab will be available in the United States until June 8, 2009.
     

  3. Seek immediate medical care if you experience any warning signs. While the risk of developing a life-threatening infection seems remote, it is important to know these warning signs:

  • Confusion or difficulty thinking

  • Difficulty walking or talking

  • Weakness

  • Loss of balance or coordination

  • Sudden vision change

These can be signs and symptoms of progressive multifocal leukoencephalopathy (PML), the rare and often life-threatening infection that developed in 3, and possibly 4, patients taking efalizumab.

As efalizumab also increases the risk of infections in general, you should tell your dermatologist right away if you have any signs or symptoms of an infection. These include fever, cough, flu-like symptoms, feeling especially tired, chills, muscle aches, and a stiff neck.

Why is the company voluntarily removing efalizumab from the U.S. market?
The company says its decision to voluntarily remove efalizumab reflects its commitment to patient safety. Three confirmed cases of PML developed in patients who had been taking efalizumab to treat psoriasis. PML is an extremely rare infection of the brain. One more patient treating with efalizumab developed neurological problems. All 4 patients had been treating with efalizumab for more than 3 years. The patients’ ages ranged from 47- to 73-years-old. Three of the 4 patients died.

Why did the FDA approve efalizumab?
Before the U.S. Food and Drug Administration (FDA) approved efalizumab, this medication underwent several clinical trials. During these clinical trials, not one person developed PML. About 46,000 people worldwide have treated their psoriasis with efalizumab.

Each Biologic Medication Unique
All medications have possible side effects. Efalizumab belongs to a class of medications called the biologics. Other biologic medications have been approved for the treatment of psoriasis and a few have been approved for the treatment of psoriatic arthritis. It is important to know that each biologic is unique, so each works in a slightly different way. If taking a biologic concerns you, be sure to talk with your dermatologist. Knowing the facts and speaking about your concerns with your dermatologist can help you make an informed decision.

References:
U.S. Food and Drug Administration. “FDA Statement on the Voluntary Withdrawl of Raptiva From the U.S. Market.” Statement issued April 8, 2009. Last accessed April 10, 2009.

U.S. Food and Drug Administration. “FDA Advises Public of Serious Adverse Event with Psoriasis Drug Raptiva.” Public Health Advisory issued February 19, 2009. Last accessed April 10, 2009.

All content solely developed by the American Academy of Dermatology

 

 

On April 8, 2009, the manufacturer of efalizumab announced that it has begun voluntarily withdrawing this psoriasis medication form the U.S. market. By June 8, 2009, efalizumab will no longer be available in the United States.


 
 

 

 

 

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Page last updated 5/1/09

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