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Title: No Differences Found Between Interferon Beta-1b and Glatiramer for Multiple Sclerosis: Presented at ECTRIMS

"No Differences Found Between Interferon Beta-1b and Glatiramer for Multiple Sclerosis: Presented at ECTRIMS"

By Chris Berrie PRAGUE, CZECH REPUBLIC -- October 16, 2007 -- Treatment with interferon beta-1b (IFNbeta-1b) or the polypeptide glatiramer acetate appear to have similar efficacies in the first head-to-head study to compare the effect of the two drugs on magnetic resonance imaging (MRI) outcomes for patients with relapsing-remitting (RR) multiple sclerosis (MS). Coprincipal investigator Leo Wolansky, MD, Chief MRI Professor of Radiology, Department of Radiology, University of Medicine and Dentistry of New Jersey, New Jersey Medical School, Newark, New Jersey, presented the results of the study on behalf of the Betaseron(R) versus Copaxone(R) in MS with triple-dose gadolinium and 3-T MRI Endpoints (BECOME) Investigators here on October 12 at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Dr. Wolansky noted, however, that previous placebo-controlled comparisons of these two drugs indicate that IFNbeta-1b is more active than glatiramer in reducing inflammation in MS, in terms of its effects on the enhancing lesions seen on scans. This study was designed to use the primary outcome measure of mean number of combined active lesions (CALs) per MRI scan. The definition of CALs here includes the number of enhancing lesions plus the number of new T2/FLAIR lesions not associated with enhancement. The secondary outcomes of CALs/month and new enhancing lesions/month were also monitored. To achieve this, 75 subjects with MS were stratified by absence or presence of enhancing lesions at baseline and randomized either to IFNbeta-1b (n = 36; mean age, 36 years; male, 25%), 250 microg SC every other day, or to glatiramer acetate (n = 39; mean age, 36 years; male, 36%), 20 mg SC daily. The baseline clinical characteristics of these patients showed no significant differences between the IFNbeta-1b and glatiramer acetate treatment groups, with the measures of: CAL (0, 28% vs 31%; ·1, 72% vs 69%); mean CAL (5.1 vs. 3.1); MS sub-type (RR, 86% vs 77%; clinically isolated syndrome, 14% vs 23%); mean time since MS onset (1.0 vs 1.2 years); median annualized relapse rate (2.0 vs 2.0); and median expanded disability status scale (EDSS; 2.0 vs 2.0). For the primary outcome of CALs/scan, there was no significant difference either within the first year of treatment (median, 0.63 vs 0.67; [P =.62) or over the full 2 years (median, 0.78 vs 0.62; P =.45).

Similarly, there were no significant differences seen between these two treatments for the secondary outcomes of CALs/month (months 1-12, median, 0.63 vs 0.67, P =.54; months 1-24, median, 0.60 vs 0.38, P =.24) and new enhancing lesions/month (months 1-12, median, 0.41 vs 0.25, P =.40; months 1-24, median, 0.39 vs 0.27, P =.20).

However, further analysis did reveal one difference between these IFNbeta-1b and glatiramer acetate treatments: only the IFNbeta-1b treatment resulted in a significant drop in CAL for the comparison between the two pretreatment MRI scans and the scans at 12 months from start of treatment: IFNbeta-1b, mean drop, 2.25, P =.0035; glatiramer acetate, mean drop, 1.38, P =.12.

"MRI is known to be a very good surrogate for active inflammation in individual foci of the brain, [such that] what we see on the scan represents the disease actively hurting the brain," Dr. Wolansky said. So the implication of this study is that the superiority of IFNbeta-1b over glatiramer acetate for reducing the incidence of active inflammation in MS may have been overestimated.

Funding for this study was provided by a contract grant from Bayer Healthcare Pharmaceuticals.

[Presentation title: Betaseron vs. Copaxone in MS With Triple-Dose Gadolinium and 3-T MRI Endpoints (BECOME): Announcement of Final Primary Study Outcome. Abstract P206]

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