Manufacturing companies Biogen and AbbVie have voluntarily recalled Zinbryta (daclizumab) from the market after it was connected with eight cases of autoimmune encephalitis, or serious brain inflammation.

These cases were reported in Europe, with the European Medicine Agency called for an urgent review of Zinbryta for the potential autoimmune encephalitis risk. This urgent warning came the same day the voluntary market withdrawal was announced, with seven patients reporting autoimmune encephalitis or meningoencephalitis in Germany and one patient reporting complications in Spain.

Encephalitis is described as the inflammation of brain tissue, while meningitis is described as the inflammation of the membranes covering the brain. Encephalitis is typically caused by a bacterial or viral infection, but can be caused by an autoimmune disorder.

Patients suffering from encephalitis typically suffer from flu like symptoms that can last up to three weeks, but some cases can be potentially fatal.

“Given the nature and complexity of adverse events being reported, characterizing the evolving benefit/risk profile of Zinbryta will not be possible going forward given the limited number of patients being treated. [T]herefore, Biogen and AbbVie believe it is in the best interest of patients to voluntarily withdraw worldwide marketing authorizations for Zinbryta.” the companies stated.

The European Medicines Agency stated it would contact healthcare professionals shortly after the announcement was made, but advised that doctors do not prescribe Zinbryta to any new patients. Doctors should also contact current patients, warning them against signs of autoimmune encephalitis including:

• Inflammation
• Fever
• Seizures
• Behavioral changes
• Confusion
• Disorientation

While there is treatment for autoimmune encephalitis, the process must be prompt and aggressive, with the National Institutes of Health calls for blood brain barrier antibiotics.

Even with the concern of Zinbryta autoimmune encephalitis, the European Medicines Agency stated patients should not stop their prescription without consulting their physician. In addition, patients enrolled in a Zinbryta clinical trial should reach out to their physician to discuss the concern.

Overview of Zinbryta Autoimmune Encephalitis

Zinbryta was approved by the FDA on May 27, 2016, to treat adult patients with severe multiple sclerosis (MS). This medication is typically prescribed to treat MS patients who have not reasoned well to two or more alternative multiple sclerosis treatment drugs.

Multiple sclerosis is a condition in which the body’s immune system attacks the protective layers around nerve cells and the central nervous system, which is the connection between the brain and spinal cord.

Zinbryta works by connecting immune cells and reducing activity levels in cells that are attacking the immune system.

Even with the drug’s unique treatment mechanism, the FDA strictly regulates Zinbryta due to its “complex safety profile.” Soon after Zinbryta’s release, a black boxing waring was added to the drug’s warning label stating it could put patients at risk for serious liver damage and other immune system related complications.

The voluntarily market withdrawal was announced on March 2, 2018, with at least 12 cases of Zinbryta autoimmune encephalitis. Three of those cases have been fatal, which has spurred major concern in the medical community.

Zinbryta has been prescribed to thousands of patients across the world and is an effective treatment option for the millions of patients who suffer from multiple sclerosis. However, its recent association with autoimmune encephalitis has caused major hesitation in prescribing Zinbryta.