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Results Published from a Phase 3 Trial of Daclizumab High-Yield Process (DAC HYP) in Relapsing MS

October 20, 2015

Summary

  • A Phase 3 study involving 1,841 people with relapsing-remitting MS showed that Daclizumab high-yield process (DAC HYP) reduced the rate of relapses by 45% compared to Avonex® (interferon beta-1a, Biogen), and also reduced disease activity observed on MRI scans over the course of 2 to 3 years.
  • Participants were randomly assigned to receive either DAC HYP injected under the skin every 4 weeks or Avonex injected once weekly for up to 144 weeks. Participants also received placebo versions of Avonex or DAC HYP as a control measure.
  • The team was led by Ludwig Kappos, MD, at the University Hospital, Basel, Switzerland, and the results have been published in the New England Journal of Medicine (2015; 373:1418-142).

Background: Daclizumab is a laboratory-created monoclonal antibody that targets a receptor (docking site) for a key immune signaling chemical called interleukin-2 (IL-2). IL-2 is required to activate the immune T cells that are involved in MS attacks. DAC HYP, a highly concentrated liquid formulation of Daclizumab, is an experimental immune-modulating therapy taken by injection every 4 weeks. Results of previous phase 2 trials of DAC HYP suggested potential benefits for reducing relapses or MRI-detected disease activity in people with relapsing MS.

The Study: In this trial, 1,841 participants with relapsing-remitting MS were randomly assigned to receive either DAC HYP injected under the skin every 4 weeks or Avonex injected once weekly for up to 144 weeks. Participants also received placebo versions of Avonex or DAC HYP as a control measure. The primary endpoint of the study was to determine if DAC HYP was effective for reducing the rate of relapses. Secondary endpoints included disease activity as observed on MRI scans and clinical measures such as the EDSS scale of disability (confirmed at 12 weeks).

Compared to Avonex, DAC HYP significantly reduced the relapse rate and reduced the number of new lesions observed on MRI scans. A similar proportion of participants in each group worsened as measured by the EDSS scale of disability. Serious infections, skin rash, and abnormalities in liver enzymes occurred more often in the group taking DAC HYP. Four deaths occurred in the Avonex group, and one death occurred in the DAC HYP group, none of which was considered to be related to the treatments.

The results were announced in a June 18, 2014 press release from Biogen and AbbVie and have now been published in the New England Journal of Medicine (2015; 373:1418-142).

Next Steps: Biogen and AbbVie Biotherapeutics have applied to regulatory agencies in the U.S. and Europe to obtain marketing approval for the use of DAC HYP to treat people with MS.

“We look forward to hearing the results of the FDA’s review of the safety and effectiveness of this medication,” says Dr. Bruce Bebo, Executive Vice President, Research, at the National MS Society. “Increasing treatment options is an important way to identify solutions that work for everyone living with MS.”

Read more about Treating MS.

Avonex is a registered trademark of Biogen.
 

About Multiple Sclerosis

Multiple sclerosis, an unpredictable, often disabling disease of the central nervous system, interrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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