Efalizumab (Raptiva®) is no longer commercially available. The withdrawal follows concerns over progressive multifocal leukoencephalopathy (PML), a rare brain infection, occurring in patients using this treatment.
Timeline of Recent Regulatory Developments on Efalizumab
October 16, 2008 - The U.S. FDA announced labeling changes for efalizumab (Raptiva®) to include a
"black box" warning, the FDA's sternest warning, about the risk of life-threatening infections. The new
information will highlight the risk of opportunistic infections that include bacterial sepsis (an infection of the
bloodstream that can affect organs throughout the body), viral meningitis (inflammation of the brain),
invasive fungal disease, and progressive multifocal leukoencephalopathy (PML) (a rare brain infection).
The press release:
February 19, 2009 - The European Medicines Agency (EMEA) recommends suspension of the Marketing
Authorization for efalizuman (Raptiva®). The press release:
February 19, 2009 - The U.S. FDA issues a public health advisory concerning three confirmed, and one
possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients
using efalizumab (Raptiva®). The press release:
February 20, 2009 - Efalizumab (Raptiva®) has been removed from the Canadian market by the
manufacturer (EMD Serono) due to safety concerns. Read the full Health Canada Advisory at:
April 8, 2009 - Genentech announces a phased voluntary withdrawal of efalizumab (Raptiva®) from the
U.S. market. The company's decision is based on the association of Raptiva® with an increased risk of
progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous
system. FDA statement:
Efalizumab was previously approved for the treatment of patients with moderate-to-severe chronic plaque
psoriasis in adult patients (18 years or older) who were candidates for systemic therapy or phototherapy.
Efalizumab is a man-made protein (called a monoclonal antibody) that binds specifically to the surface of T lymphocytes (or T cells) and decreases their activities. By this mechanism, efalizumab subdues the body's immune response by inhibiting the migration of white blood cells into tissues and prevents the symptoms associated with psoriasis from manifesting.
How the treatment works
- Intended for use under the guidance and supervision of a health care professional
- Administered as a subcutaneous (just under the skin) injection. Patients may self-inject following proper training by a health care professional (usually a nurse) in measurement of the correct dose and injection technique.
- The prescribed dose is based on body weight
- Usually administered once a week
- Injection sites should be rotated (thigh, upper arm, abdomen, or buttocks)
- If self-injecting, proper drug handling and storage is required.
- Quick onset of action - improvement may be seen as early as 2-4 weeks after starting treatment
- Once per week injection can provide long-term control of psoriasis
- Very good safety profile
- In a limited number of patients, their psoriasis can worsen if treatment is abruptly stopped.
- Common side-effects considered mild to moderate and dose-related include flu-like symptoms, such as headache, fever, chills, nausea and muscle pain. These side-effects usually occur within the first 48 hours after an injection, and often decrease after the first few weeks of use.
- More serious side-effects include infections and worsening of psoriasis.
- Treatment with drugs that suppress the immune system, such as efalizumab, may increase the risk of developing certain types of cancer (e.g., lymphoma).
- In very rare cases, efalizumab may cause a condition called thrombocytopenia that results in a reduction in the number of certain blood cells (called platelets), which causes bleeding. Notify your doctor immediately if you notice any unusual signs of bleeding or bruising.
Comments & Suggestions
- Efalizumab is best used as a continuous therapy.
- Flu-like symptoms usually happen within the first 48 hours after an injection, and often decrease or disappear after the second or third injection.
- Blood tests to monitor treatment progress and side-effects are required once per month for the first 3 months, then once every 3 months.
- If you respond to the treatment, but you discontinue efalizumab after 12 weeks of therapy, the average time that it takes for your psoriasis to return is approximately 2 months.