Daclizumab

Current phase of trial: phase III

Type of MS: relapsing remitting MS

Research into: preventing damage caused by MS

How is it taken? Intravenous infusion at a hospital or in some cases injected under the skin.

• How does it work?
• Latest research
• How does it compare to current therapies?
• Further work
• When will it be available?

How does it work?

Daclizumab is a monoclonal antibody. It has been used for several years as a post-operative treatment for patients receiving kidney transplants, to help prevent the body's rejection of the donated organ.

Daclizumab binds to a molecule called CD25 on the surface of activated immune cells and reduces the number of them in the body. Activated immune cells are responsible for some of the damage to the myelin sheath in relapsing remitting MS.

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Latest research

1. In August 2011 the company that makes daclizumab released initial results from a phase II clinical trial involving more than 600 people.  The one year study showed that;

• Daclizumab reduced relapse rates by up to 54 per cent compared with a placebo (dummy treatment)
• Daclizumab reduced the number of lesions in the brain
• Daclizumab reduced the risk of disability progression at one year by 57 per cent

2. In February 2010 a phase II study reported in the journal Lancet Neurology that daclizumab, in combination with beta-interferon, may benefit people with relapsing remitting MS.

The study involved 230 people and tested the safety and effectiveness of daclizumab in combination with beta-interferon against beta-interferon alone. The study found that:

• daclizumab reduced the number of new lesions in the brain by 72 per cent
• daclizumab reduced the number of relapses experienced by people with MS by 30 per cent 

3. In November 2007 a phase II study reported in the journal Neurology that daclizumab shows benefit in people with relapsing remitting MS.

The study recruited nine people who had active lesions and relapses whilst taking beta-interferon.

Researchers treated nine people with a combination of daclizumab and beta-interferon for 5.5 months followed by daclizumab alone for a further 22 months.

Of the nine, three people had to eventually switch back to taking a combination of daclizumab and beta-interferon because they were found to have new lesions.

• daclizumab reduces the number of active lesions in the brain (as seen by MRI)
• daclizumab reduced the number of new lesions appearing in the brain by 4-fold
• daclizumab reduced the number of relapses and improved symptoms 

4. A report published in January 2009 in the journal Multiple Sclerosis looked at the effects of daclizumab treatment in 75 people with MS who had failed existing treatments.

The aim was to assess the safety of daclizumab. The most common side effects in order of likelihood were fatigue, stomach upset, rash and a general feeling of weakness.

Some of the more severe, but less common, side effects were: allergic reactions, infections, heart problems and reduced numbers of platelets.

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How does it compare to current therapies?

Daclizumab has not been directly compared to other therapies, therefore it isn't possible to draw conclusions about its relative effectiveness from these results.

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Further work

1. A phase II extension study to evaluate the safety and effectiveness of daclizumab in people with relapsing remitting MS (ClincalTrials.gov identifier: NCT01051349)

This trial will test the long-term safety of daclizumab in people with relapsing remitting MS and is currently recruiting by invitation.  It is due to complete in late 2015.

2. A phase III trial to evaluate the safety and effectiveness of daclizumab compared with beta-interferon in relapsing remitting MS (ClinicalTrials.gov identifier: NCT01064401)

This trial will test daclizumab against beta-interferon in 1500 people with relapsing remitting MS and is currently recruiting.  The trial will specifically measure the effects that daclizumab has on relapse rates and disability progression in people with MS.  It is due to complete in early 2014.

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When will it be available?

Daclizumab is already licensed for some conditions (including after operations to prevent rejection of a newly donated organ). Before use in MS, daclizumab will need to undergo phase III clinical trials to definitively test its effectiveness, which will take several years

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