TA103 Psoriasis - efalizumab and etanercept: information for the public

Efalizumab

The European Medicines Agency (EMEA), the European Union (EU) body which is responsible for monitoring the safety of medicines, has recommended that marketing authorisation be suspended for Serono's psoriasis drug efalizumab (raptiva) over possible links between the drug and a rare but deadly brain infection.

The EMEA's Committee for Medicinal Products for Human Use (CHMP) said the benefits of efalizumab no longer outweigh its risks, because of safety concerns, notably the occurrence of progressive multifocal leukoencephalopathy (PML) in patients taking the medicine. The EMEA has advised that patients who are currently taking efalizumab should consult their doctor or pharmacist at a convenient time to discuss their treatment.  The EMEA has advised patients should not stop efalizumab treatment abruptly as this could lead to the disease coming back or getting worse. Their doctor will discuss the most appropriate replacement treatment with them.

As a result of the EMEA's decision, NICE has temporarily withdrawn its guidance on the use of efalizumab for the treatment of adults with psoriasis. Guidance on the use of etanercept for the treatment of adults with psoriasis remains the same and in force. NICE will continue to review the status of its guidance in light of any further changes to efalizumab's marketing authorisation.

Further information on the EMEA's decision is available from its website.