Treatment of Multiple Sclerosis at the First Demyelinating Event 
Delays Progression: Presented at ANA

By Paula Moyer

CHICAGO, IL -- October 12, 2006 -- Patients with multiple sclerosis 
(MS) who start treatment with interferon beta-1b (Betaseron) at the 
time of their first demyelinating event have a longer time to 
progression than patients treated with placebo, according to a 
research presented here at the American Neurological Association 
(ANA) 131st Annual Meeting.

"This is the first early treatment study to use the McDonald criteria 
and show that interferon beta-1b delays the development of McDonald 
MS," said principal investigator Hans-Peter Hartung, MD, professor of 
neurology, Heinrich-Heine University, Dusseldorf, Germany, in a 
presentation on October 9th.

The McDonald criteria were published in 2001 and consist of standards 
for assessing the MS severity.

In previous studies, subcutaneous injections of 250 mcg of interferon 
beta-1b every other day in patients with relapsing-remitting MS 
reduced the frequency and severity of relapses as well as the 
development of brain lesions. Therefore, a multinational team of 
investigators led by Dr. Hartung conducted the Betaseron in Newly 
Emerging multiple sclerosis For Initial Treatment (BENEFIT) study.

In this multicenter, double-blind trial, the investigators recruited 
patients who had had a first demyelinating event, experienced as a 
clinically isolated syndrome, and at least 2 clinically silent brain 
lesions identified by magnetic resonance imaging.

The 468 patients in the study were randomized to receive either 250 
mcg of interferon beta-1b or placebo every other day, while 292 
patients in the treatment group and 176 in the placebo group. The 
double-blind period was to last 24 months or until diagnosis of 
clinically definite MS (CDMS).

At the end of the double-blind period, patients were given the 
opportunity to participate in a 12-month open-label study.

Treatment with interferon beta-1b was associated with delayed 
progression to CDMS by both the Poser and McDonald criteria (P < .
0001 and P < .00001, respectively). In the treatment group, the risk 
of CDMS was reduced by 50% and of McDonald MS by 46%.

A McDonald MS diagnosis is characterized by progression that discerns 
MS from a clinically isolated syndrome.

When the investigators analyzed disability outcomes, they found no 
significant change in the patients' Expanded Disability Status Scale 
(EDSS) scores from baseline in either treatment group.

Multiple Sclerosis Functional Composite (MSFC) Z-scores improved from 
baseline to the end of the study in both treatment arms. However, the 
investigators documented a greater improvement in treated patients (P 
= .039). They noted that this difference was largely influenced by 
changes in the cognitive subtest (P < .001). They documented no 
significant difference in patient-reported outcome measures.

The findings show that treatment with 250 mcg of interferon beta-1b 
every other day slows progression of MS and has favorable effects, by 
some criteria, on disability status in patients with clinically 
isolated syndrome, the researchers concluded. Therefore, the findings 
show that patients would benefit from early initiation of treatment 
with interferon beta-1b, they say.

The study was funded by Schering AG, which developed Betaseron.


[Presentation title: Betaseron in Newly Emerging Multiple Sclerosis 
for Initial Treatment (BENEFIT): Disability Outcomes. Abstract M-10]