Benefit of Betaseron confirmed.

The July 1995 issue of Neurology published additional data on the experience of people taking high-dose Betaseron in the large clinical trial that led to its FDA approval. The data confirm the effect of treatment and show that the benefit continues. Data now cover a four- to five-year period in which people on the drug averaged a 30% reduction in the number of MS relapses, as compared to people who took the placebo (an inert look-alike).

Increased benefit for many

people

A close look at the data shows that the benefit to the majority was a 50% reduction in relapse rate. Moreover, this group - which made up 62% of those taking what is now the standard dose - showed no increase in MS lesions (or damaged areas in the brain) as seen by annual MRI exams. People on the placebo had more relapses and significantly more and larger lesions.

Some questions for others

After 18 months of treatment, 38% of people taking high-dose Betaseron developed neutralizing antibodies to the drug. Their outcomes were about the same as outcomes in the group that took inert placebo injections.

Much remains unknown about these antibodies - and the definitive meaning of the study data is unclear. The method used to determine the presence of neutralizing antibodies is controversial. The lab test used in the clinical trial is not considered foolproof or easy to do. A better test is under development, but it is not yet available.

Because Betaseron is a protein - not a conventional chemical agent - the development of antibodies was not a surprise to some experts. Something similar might be expected in any therapy based on proteins not normally found in the body.

It is clear that people who remain antibody-free do very well on Betaseron - far better than the overall trial results initially indicated. Thus, Betaseron therapy should be discussed by physicians and their patients one to one.