Genentech announced that the company has issued a Dear Healthcare Provider letter to inform potential prescribers of a case of progressive multifocal leukoencephalopathy ( PML ) in a 70-year old patient who had received Raptiva ( Efalizumab ) for more than four years for treatment of chronic plaque psoriasis. The company will work with FDA ( Food and Drug Administration ) to update the prescribing information for Raptiva and determine if further action is needed.
The case was recently reported to the company in late September as part of Genentech's ongoing safety monitoring and surveillance program. Based on the medical information available to date, Raptiva may have had a contributory role in the development of PML in this patient. There are no other cases of confirmed PML in patients treated with Raptiva. There has been a report of a 62-year old patient treated with Raptiva who developed progressive neurologic symptoms and died of unknown cause.
Patients who are currently on Raptiva therapy or considering Raptiva should discuss the benefits and risks of Raptiva with their physicians. As described in the Raptiva package insert, some patients have had severe worsening or new forms of psoriasis while taking Raptiva or after stopping Raptiva. It is important for patients not to change or stop treatment without first talking with their physician.
Progressive multifocal leukoencephalopathy is a rare, progressive, demyelinating disease of the central nervous system that usually leads to death or severe disability. PML is caused by activation of the John Cunningham, ( JC ) virus. JC virus resides in latent form in up to 80 percent of healthy adults, typically only causing PML in immunocompromised patients. The factors leading to activation of the latent infection are not fully understood, though abnormalities in T-cells may be important for reactivation and PML. PML has been reported in the published literature in HIV-positive patients, as well as immunosuppressed cancer patients ( including patients with hematologic malignancies ), organ transplant recipients, and patients with autoimmune diseases. There are no known interventions that can reliably prevent or adequately treat PML.
Source: Genentech, 2009
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