Germany recently informed the European Medicines Agency (EMA) that seven patients with multiple sclerosis (MS) had developed immune-mediated inflammation of the brain (encephalitis) during treatment with daclizumab beta (Zinbryta). Three of these patients also had a severe allergic reaction (drug reaction with eosinophilia and systemic symptoms [DRESS] syndrome).
Six patients had brain biopsies and all showed inflammation of the brain (with B- and T-cell infiltrates), but three also contained areas of eosinophilic inflammation which is not usually found in MS. One patient has died and most of the others are significantly disabled despite treatment with steroids and/or plasmapheresis.
Three more patients with immune-mediated encephalitis have been reported from Spain and the United States. Two of these patients have also died.
The marketing authorisation holder of Zinbryta (Biogen Idec Ltd) has decided to withdraw this product from the European Union to protect public safety. The product will also be recalled.
Doctors in the EU will be contacted directly in the coming days with further information. Until then the EMA advises that doctors should not start new patients on Zinbryta. They should also review patients currently treated with drug and initiate alternative therapy as soon as possible.
Patients must not stop their medication without discussing it with their doctor first. Patients who have any questions should talk to their doctor.
The company has also informed EMA of its decision to stop ongoing clinical studies with Zinbryta in the EU. Patients in clinical studies who have any question should contact the doctor treating them in their study.
It is important to note that Zinbryta has only been used by a small number of patients in the UK and it is estimated that there are fewer than 100 patients receiving Zinbryta at the moment. There have been no reported cases of immune-mediated inflammation of the brain in the UK.