What is Raptiva?
Raptiva, manufactured by Genentech, is used for the treatment of chronic plaque psoriasis– thick, red patches of skin topped with silvery or white scales. The company has reported that upwards of 46,000 patients have used Raptiva since it was approved by the FDA in 2003. It is given via injection, usually once a week.
It has been reported that it can lead to the potentially fatal disease called progressive multifocal leukoencephalopathy. In October 2008 Raptiva’s prescribing information was updated to include a boxed warning on the risk of serious infections, including progressive multifocal leukoencephalopathy. The prescribing information was further updated in March 2009 to include additional information on the risk of progressive multifocal leukoencephalopathy. On April 9, 2009, Genentech announced that it would be pulled from the market due to the risk of progressive multifocal leukoencephalopathy.
What is progressive multifocal leukoencephalopathy?
Progressive multifocal leukoencephalopathy is typically found only in patients who have a compromised immune system, such as cancer patients, AIDS patients, or organ transplant patients. An ordinarily harmless virus called polyomavirus JC (or JC virus) is carried by a majority of people but rarely harmful. But Raptiva is believed to activate the virus, and the infection leads to the loss of white matter in the brain. White matter contains myelin, the material which surrounds and protect the nerves in the brain, and the breakdown of myelin prevents nerves from transmitting signals to the body.
Symptoms of progressive multifocal leukoencephalopathy include:
- Mental deterioration
- Loss of vision
- Muscle weakness or loss of muscle coordination
- Impaired speech
- Memory failure
- Paralysis
- Coma
- Seizures
The condition progresses until it leads to disability or death. Diagnosis requires a brain biopsy or the detection of white matter lesions on an MRI and detection of the JC virus in spinal fluid. For some patients, the only treatment is reversing their immunodeficiency, which in transplant patients may mean rejection of the transplant. In HIV patients, anti-retroviral therapy will help.
The disease usually lasts for months and 80 percent of patients die from it within the first 6 months. Those who survive can be left with severe neurological disabilities.
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