Raptiva

Psoriasis Drug Raptiva Linked to Risk of Life-Threatening Infections 

Serious, life-threatening infections leading to hospitalization and death have been reported in patients taking Genentech’s psoriasis medication Raptiva. 

Raptiva (efalizumab) is a prescription drug approved in 2003 for the treatment of moderate to severe plaque psoriasis. Psoriasis is an inflammatory skin disease.  Plaque psoriasis is the most common form of the disease affecting approximately 2.3 million Americans and is characterized by patches of skin or “lesions” that become inflamed and covered by silvery white scale, commonly appearing on the scalp, knees, elbows and trunk. 

Raptiva is administered by once-weekly, under-the-skin injection in adults who are candidates for systemic (whole body) therapy or phototherapy (light therapy) to control their psoriasis. It works by suppressing the immune system to reduce flare-ups of psoriasis.  However, by suppressing the body’s natural defense system, Raptiva can also increase the risk of serious infections and cancer.

Raptiva Pulled From the U.S. Market

In a statement released April 8, 2009 Genentech, the manufacturer of Raptiva, announced a voluntary, phased withdrawal of the drug from the U.S. market. Patients who have used Raptiva are at potential risk to develop progressive multifocal leukoencephalopathy (PML). PML is a rare but serious neurological disease caused by a virus that affects the central nervous system.

PML generally occurs in those people whose immune systems are severely weakened and often leads to an irreversible decline neurological function, eventually leading to death. At this point there is no known treatment for PML that is considered to be effective.

FDA Issues Black Box Warning for Raptiva 

On October 16, 2008 the FDA announced labeling changes for Raptiva including a black box warning--the strongest warning a drug can receive--regarding the risk of serious, life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukencephalopathy (PML) and other opportunistic infections. 

Though not approved for children under the age of 18, the label also includes data from juvenile animal studies in mice (age equivalent between 1 and 14 years old) indicating a potential risk for permanent suppression of the immune system with repeat administration of Raptiva in this age group.   

On December 12, 2008 Health Canada also issued a warning regarding the risk of serious infections, including PML, in patients treated with Raptiva. 

Signs and Symptoms of Progressive Leukoencephalopathy (PML)

There have been two deaths from PML reported in the United States in psoriasis patients treated with Raptiva. Both cases involved patients over the age of 70 who received Raptiva for approximately four years. According to a company press release issued November 18, 2008, based upon the medical information available for the two cases of PML, Genentech believes that Raptiva likely increases the risk of PML and that prolonged exposure to Raptiva and older age may further increase this risk.

PML is a rare, progressive disease of the central nervous system caused by the reactivation of a latent virus which results in progressive damage or inflammation of the brain. In a healthy adult, the virus usually stays dormant.  PML occurs almost exclusively in people with severe immune deficiency who are more susceptible to infection. 

Signs and symptoms of Progressive Leukoencephalopathy (PML) may include: 

• Confusion
  
• Dizziness
  
• Progressive weakness
  
• Loss of balance or coordination
  
• Difficulty talking or walking
  
• Visual impairment
  
• Partial paralysis
  
• Seizures
  

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