Drugs Xagena
Raptiva ( Efalizumab ) is an immunosuppressive, humanized monoclonal antibody indicated for treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or who have a contraindication to, or are intolerant to other systemic therapies including Ciclosporin, Methotrexate and PUVA.
In September 2008, a case of progressive multifocalleukoencephalopathy ( PML ) was reported in a patient with plaque psoriasis receiving Efalizumab in the post-marketing setting.- In this case Raptiva had been given as monotherapy for approximately4 years.-
The case underlines the importance of continued clinical vigilance, prompt discontinuation of Raptiva when PML is suspected with subsequent appropriate evaluation, including magnetic resonance imaging ( MRI ) scan and lumbar puncture.-
Further information on safety concern
Progressive multifocal leukoencephalopathy ( PML ) is a rare, progressive and demyelinatingdisease of the central nervous system that usually leads to death or severe disability. PML is caused by activation of JC virus, a polyoma virus that resides in latent form in up to 80% of healthy adults. JC virus usually remain latent, typically only causing PML in immunocompromised patients. The factors leading to activation of the latent infection are not fully understood.
There have been one confirmed case of PML and one case with symptoms suggestive of PML inpatients receiving Raptiva. The recent case of PML has been reported in a 70-year-old man who received Efalizumab for longer than 4 years for treatment of plaque psoriasis. He was not receiving other systemic immunosuppressants concomitantly to Raptiva. The patient also suffered from coronary artery disease and hyperlipidemia. PML was diagnosed based on the detection of JC viral DNA in the CSF, clinical symptoms, and MRI findings. The patient died about two months after his first neurological symptoms started.
The second case refers to a patient who developed progressive degenerative neurological symptoms suggestive of progressive multifocal leukoencephalopathy; however, a final diagnosis was not made and progressive multifocal leukoencephalopathy was not confirmed.
These cases emphasise the importance of clinical vigilance in the management of patients treated with Raptiva. The overall exposure to date, since Raptiva was first approved in the United States in October2003, is estimated at approximately 47,000 patient-years worldwide, of which approximately 15,000patient-years correspond to the exposure in the European Union.
The absolute risk of progressive multifocal leukoencephalopathy in patients treated with Raptiva cannot be precisely estimated.
Further information on recommendations to healthcare professionals
If a patient develops progressive multifocal leukoencephalopathy, Raptiva must be permanently discontinued. Raptiva must be prescribed in compliance with the Summary of Product Characteristics ( SPC ).Patients must be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of progressive multifocal leukoencephalopathy ( such as impaired cognition, visual disturbances, hemiparesis, altered mental state or behavioural changes ). If progressive multifocal leukoencephalopathy is suspected, further dosing must be suspended until PML has been excluded. The clinician should evaluate the patient to determine if the symptoms are indicative of neurological dysfunction and, if so, whether these symptoms are possibly suggestive of progressive multifocal leukoencephalopathy. If any doubt exists, further evaluation, including magnetic resonance imaging ( MRI ) scan preferably with contrast, cerebrospinal fluid ( CSF ) testing for JC viral DNA and repeat neurological assessment, should be considered. Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Source: Medicines and Healthcare product Regulatory Agency MHRA, 2008
XagenaMedicine_2008
