Relapsing multiple sclerosis: Plegridy, a Pegylated Interferon beta-1a, approved by FDA
The FDA ( Food and Drug Administration ) has approved Plegridy ( Peginterferon beta-1a ) as a new disease-modifying therapy for people with relapsing forms of multiple sclerosis.
This new version is designed to maintain the effects of Interferon in the body for a longer period of time.
Peginterferon beta-1a is a pegylated form of Interferon, meaning that polyethylene glycol is attached to the Interferon molecules, which enables them to maintain biologic effects in the body for longer periods of time and allows for less frequent dosing. Plegridy is given by subcutaneous injections once every two weeks.
Plegridy was shown after one year of a two-year phase III clinical trial to reduce the relapse rate significantly more than placebo in a study of 1500 people with relapsing multiple sclerosis, reaching the primary goal of the study. ( Lancet Neurology, 2014 ).
For the ADVANCE trial, 1512 patients with relapsing multiple sclerosis were randomly assigned to one of three groups: placebo, Peginterferon beta-1a 125 mcg delivered subcutaneously every two weeks, or Peginterferon beta-1a 125 mcg 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 after 48 weeks. Secondary objectives included the effects on central nervous system damage as observed on MRI scans, and disease progression as measured by the EDSS disability scale.
After the first year, patients on placebo were re-assigned to receive Peginterferon every two or four weeks, and those already on therapy remained in their respective groups.
Results for the first year of the study showed that the annualized relapse rate was reduced significantly more than placebo, by 35.6% in the two-week dosing group, and by 27.5% in the four-week dosing group.
New lesions on MRI scans were reduced by 67% in the two-week dosing group and by 28% in the four-week dosing group. The risk of disability progression ( confirmed over 12 weeks ), as measured by the EDSS scale, was reduced by 38% in both Peginterferon groups.
In this study Peginterferon was not compared to other Interferon medications, or other MS therapies,
Safety and adverse events appeared to be consistent with other forms of Interferon. The most common adverse reactions are injection site reactions, flu-like illness, fever, headache, muscle pain, chills, injection site pain, weakness, and joint pain.
Most adverse events were of mild or moderate severity.
A greater proportion of participants taking Peginterferon had increased liver enzymes compared with those in the placebo group, but these did not result in discontinuation of treatment. ( Xagena )
Source: National Multiple Sclerosis Society, 2014
XagenaMedicine2014
