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Concept
Daclizumab
Résumé
Daclizumab (trade name Zinbryta) is a therapeutic humanized monoclonal antibody which was used for the treatment of adults with relapsing forms of multiple sclerosis (MS). Daclizumab works by binding to CD25, the alpha subunit of the IL-2 receptor of T-cells.
In March 2018, it was voluntarily withdrawn from the market by Biogen and Abbvie after reports of autoimmune encephalitis in Europe.
Daclizumab was used to treat adults with relapsing forms of multiple sclerosis. It is administered subcutaneously.
In clinical trials, decreases of 45% in annualized relapse rate have been reported, as well as a 41% reduction in the proportion of patients who relapsed, and a 54% reduction in the number of new lesions. A 2013 Cochrane systematic review concluded that there was insufficient evidence to determine the efficacy of daclizumab relative to placebo in people with relapsing-remitting MS and, prior to its being discontinued, the need to investigate longer lengths of treatment and follow-up.
Daclizumab was approved and used to prevent acute rejection of kidney transplant, along with cyclosporine and corticosteroids. For that indication, side effects with a frequency of at least 10% included sleeplessness, tremor, headache, arterial hypertension, dyspnoea, gastrointestinal side effects and oedema. In rare cases, the drug could cause severe anaphylaxis.
In the US, daclizumab (while approved) was contraindicated in people with liver impairment, including significantly elevated liver enzymes (ALT, AST) and autoimmune hepatitis.
The European Medicines Agency (EMA) originally approved the drug without any contraindications apart from known hypersensitivity, but required Biogen to implement a hepatic risk management guide for physicians. In July 2017, the EMA has issued a provisional contraindication for patients with pre-existing liver disease or liver impairment. The marketing authorisation was withdrawn in the EU on 27 March 2018. An EMA review concluded that the medicine poses a risk of serious and potentially fatal immune reactions affecting the brain, liver and other organs.
Source officielle
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