Updated May 21, 2013:
Based on the results reported below, Biogen Idec announced in a May 21 press release that it has submitted an application to the FDA for approval of peginterferon beta-1a for the treatment of relapsing forms of MS.
Biogen Idec announced that a phase III study of peginterferon beta-1a, injected under the skin either every two or four weeks, reduced the relapse rate significantly more than placebo in a study of 1500 people with relapsing MS, reaching the primary goal of the study. Peginterferon is a new formulation of the interferon beta-1a molecule which enables it to maintain effects in the body for longer periods of time. More data from this ongoing study, also called the ADVANCE study, will be presented at the American Academy of Neurology Annual Meeting in March (read more here). According to a press release, the company is planning to file for regulatory approval in the United States and European Union in 2013.
Avonex® (interferon beta-1a, Biogen Idec) is approved by the U.S. Food and Drug Administration for the treatment of people with relapsing forms of MS to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Peginterferon beta-1a is a “pegylated” form of the interferon beta-1a molecule. Pegylated molecules are attached to a molecule of polyethylene glycol, which enables them to maintain effects in the body for longer periods of time. Previously, the formulation has been tested in healthy individuals in two phase I clinical trials.
For this phase III, two-year trial, investigators worldwide recruited 1516 people with relapsing MS who were randomly assigned to one of three groups: placebo, peginterferon bet-1a 125 mg delivered subcutaneously (under the skin) every two weeks, or peginterferon beta-1a 125 mg delivered subcutaneously every four weeks. The primary objective of the study was to determine the effects of the drug versus placebo on the annualized relapse rate at one year. Secondary objectives included the effects on central nervous system damage as observed on MRI scans, quality of life, and disease progression as measured by the EDSS scale.
According to the press release, the annualized relapse rate was reduced significantly more that placebo, by 35.6% in the two-week dosing group, and by 27.5% in the four-week dosing group. Similar reductions occurred in the proportion of patients who experienced relapses. The risk of disability progression (confirmed over 12 weeks), as measured by the EDSS scale, was reduced by 38% in both peginterferon groups. Disease activity on MRI scans was reduced by 67% in the two-week dosing group and by 28% in the four-week dosing group.
The most common adverse events were infections, occurring in 1% or fewer people in all three treatment groups. The most commonly reported adverse events associated with the peginterferon groups were redness at the injection site and flu-like illness. Quality of life results were not included in the press release.
The ADVANCE Study is still ongoing to finish two years. After the first year of the trial, those on placebo were transitioned into one of the active treatment arms for the second year of the study. Study participants then will have the option of enrolling in an open-label extension study called the ATTAIN study, during which they are being followed for up to four years.
“We look forward to seeing the complete data from this study,” says Timothy Coetzee, PhD, Chief Research Officer of the National MS Society. “Having additional treatment options is important for people with MS, since everyone responds to therapies differently.”
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