Berlex Laboratories Inc, the U.S. affiliate of Schering AG, Germany, announced results from a study that showed its multiple sclerosis (MS) treatment Betaseron (interferon beta-1b) for SC Injection significantly reduced relapse rate and MRI disease activity in early-stage and relapsing-remitting MS patients with low levels of disability.
"Early treatment with Betaseron, even in patients with low levels of disease activity, can potentially slow the path toward disability," said lead investigator Barry Arnason, Professor of Neurology, University of Chicago MS Center. "These findings demonstrate that frequent and high doses of Betaseron, given early in the course of the disease, can reduce repeat attacks and brain lesions, helping to impact disease progression."
The study was derived from a post-hoc subgroup analysis of the Betaseron pivotal two-year study. Data were evaluated in two subgroups: patients with low levels of disability (Expanded Disability Status Scale [EDSS] score of less than or equal to 2) and patients with early-stage disease (duration of less than or equal 2 years).
In the first group, 41 relapsing-remitting MS patients with low levels of disability were treated with Betaseron 250 mcg every other day, while 49 were given a lower dose of Betaseron (50 mcg), and 43 received a placebo. Results showed that Betaseron 250 mcg significantly reduced the mean relapse rate compared to placebo (1.0 versus 1.5, p=0.013), and significantly decreased MRI disease activity as measured by the mean percentage change in lesion area at two years (a reduction of 4.0%, compared to an increase of 31.2% with placebo, p=0.0001).
In the group with early relapsing-remitting MS, 38 patients were given Betaseron 250 mcg every other day, 48 received Betaseron 50 mcg, and 48 received a placebo. The results showed that treatment with Betaseron 250 mcg significantly reduced MRI disease activity, as assessed by mean change in lesion area, compared to placebo (a reduction of 8.3% versus an increase of 31.8%, p=0.0001).