Daclizumab
Daclizumab is a new drug treatment under investigation for people with relapsing remitting multiple sclerosis (MS) that is taken by injection or intravenous infusion.
Other names: Zenepax
In development for: Relapsing remitting MS
Status: Phase III
Last updated: August 2011
How does it work?
Daclizumab is a monoclonal antibody licensed for prevention of kidney transplant rejection. It was designed to block the activity of interleukin 2, a chemical messenger in the immune system, and interfere with the growth of lymphocytes. Recent studies have show that it increases the activity of natural killer cells, another immune system cell.
How is it given?
Injection under the skin or intravenous infusions.
Clinical studies
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A retrospective analysis of 55 people with relapsing remitting and secondary progressive MS who had received daclizumab reported that disability scores improved or stabilised in 60% and worsened in 40%. In other studies, daclizumab showed promise in treating people who had failed to respond to beta interferon or glatiramer acetate.
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CHOICE Trial
This study investigated the effects of combining interferon beta treatment with daclizumab in people with active relapsing MS. 230 people who had been on interferon beta for at least six months, were randomly allocated to one of three groups: high dose daclizumab, low dose daclizumab, or placebo, in addition their standard interferon beta therapy. Daclizumab was given every two or four weeks over 24 weeks and participants were assessed for a further 48 weeks.
MRI scans before, after, and during treatment were used to monitor the appearance of new or larger active lesions.
The findings showed a 72% reduction in active lesions in the high dose daclizumab group and a 25% reduction in active lesions in the low dose daclizumab group compared to the placebo group. Daclizumab was generally well tolerated.
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SELECT Trial
The SELECT trial is a phase IIb, randomized, double-blind study testing daclizumab as a monotherapy versus placebo in approximately 600 patients with relapsing MS. The study is testing two dose levels, 150mg and 300mg, administered every four weeks as a subcutaneous injection. The main measure of the trial is relapse rate after 48 weeks of treatment.
Results announced in a Biogen press release showed that daclizumab reduced the relapse rate by 54% in the 150mg group and 50%in the 300mg group compared to the placebo group at one year.
Serious infections, serious cutaneous events and liver function abnormalities occurred more frequently in people treated with daclizumab than in the placebo group.
Further details of this study.
Further clinical trials
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DECIDE Trial
The DECIDE trial is a phase III study comparing daclizumab with interferon beta 1a (Avonex) in relapsing remitting MS (RRMS). Approximately 1,500 patients with RRMS in 28 countries are expected to be enrolled. All study participants will receive either an injection of daclizumab 150 mg administered subcutaneously once every four weeks and weekly injections of placebo, or weekly injections of interferon beta 1a and an injection of placebo once every four weeks.
The main measure of the trial is the effect of each treatment on relapse rate. The study will also examine the efficacy of daclizumab compared to interferon beta 1a in slowing functional decline and disability progression and in maintaining quality of life.
The DECIDE trial began recruiting in May 2010 and is due to finish in January 2014.
Further details of this study.
References
Rose JW, et al.
Daclizumab phase II trial in relapsing and remitting multiple sclerosis: MRI and clinical results.
Neurology 2007 69(8):785-789
Read abstract
Wynn D, Kaufman M, Montalban X et al.
Daclizumab in active relapsing multiple sclerosis (CHOICE study): a phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon beta
Lancet Neurol. 2010 Apr;9(4):381-90
Read abstract