Daclizumab high-yield process in relapsing-remitting multiple sclerosis

This study (SELECTION) is the extension of the SELECT trial, the first randomised, double-blind, placebo-controlled trial of daclizumab high-yield process (HYP) given as monotherapy for relapsing-remitting multiple sclerosis.

Daclizumab is a humanised monoclonal antibody and the primary analysis showed that its administration for 52 weeks reduced disease activity.

The primary aim of the SELECTION extension study was to assess the safety and immunogenicity of extended treatment with daclizumab HYP. The secondary aim was to assess the durability of the daclizumab HYP treatment effect on disease activity. SELECTION is a multicentre, randomised, double-blind, 52-week extension trial in patients with relapsing-remitting multiple sclerosis who completed the SELECT study. Patients who received placebo in SELECT were randomly assigned (1:1) to receive 150 mg or 300 mg subcutaneous daclizumab HYP every four weeks for 52 weeks (treatment initiation group); those who had received daclizumab HYP were randomly assigned (1:1) to continue their present dose with (washout and re-initiation group) or without (continuous treatment group) a washout period of 20 weeks.

Bronchitis was the only serious infection reported: infections resolved with standard treatment. Alanine aminotransferase or aspartate aminotransferase concentrations of more than five times the upper limit of normal occurred in 11 patients (two per cent).

Except for a case of severe autoimmune hepatitis (one patient died), in which a contributory role of daclizumab HYP could not be excluded, and for some serious cutaneous events in six patients (urticaria, eczema, pityriasis rubra pilari, dermatitis), the drug was well tolerated and safe. Reductions in clinical and radiological disease activity in patients were maintained in the second year of treatment with daclizumab HYP. Disease activity at the end of the washout period was similar to the pre-treatment period, without evidence of increase above baseline levels. Re-initiation of treatment effectively restored the pharmacodynamic effects and reduced disease activity.

Authors: Giovannoni G, Gold R.
Source: Lancet Neurol. 2014 May;13(5):472-81. doi: 10.1016/S1474-4422(14)70039-0. Epub 2014 Mar 19.
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