Friday, October 13, 2006
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]