1. In patients with relapsing-remitting multiple sclerosis, treatment with interferon beta-1b significantly reduced the rate of multiple sclerosis exacerbations in a dose-dependent fashion.
2. Serial magnetic resonance imaging revealed less multiple sclerosis activity in patients with increasing doses of IFNB.
3. There was no difference in disability caused by IFNB treatment.
Original Date of Publication: April 1993
Study Rundown: This landmark trial, conducted by the Interferon beta-1b (IFNB) Multiple Sclerosis Study Group, randomized patients with relapsing-remitting multiple sclerosis (MS) to low-dose IFNB, high-dose IFNB, or placebo. Patients on IFNB experienced lower rates of disease exacerbation and were found to have less activity on serial magnetic resonance imaging (MRI) compared to placebo. Moreover, patients taking the higher dose of IFNB experienced significantly lower rates of relapse and MRI activity as compared to those on the lower dose, thereby demonstrating dose-dependent effect. Over a 3 year period, however, there was no significant difference in overall disability between the three groups.
In summary, this study was able to demonstrate that IFNB treatment significantly reduced rates of disease exacerbation in patients with relapsing-remitting MS. In addition, a higher dose of IFNB was shown to have significantly greater effects than a lower dose with no appreciable increase in risk of adverse effects. This study was vital in establishing the efficacy of IFNB as a treatment for relapsing-remitting MS and it remains a commonly used medication for this disease.
In-Depth [randomized, controlled trial]: Originally published in 1993 in Neurology, this trial enrolled patients with relapsing-remitting MS from 11 medical centers across the U.S. and Canada. In order to be enrolled, patients must have been suffering from the illness for at least 1 year and must not have received any treatment for 30 days prior to enrollment. Patients were randomized to receive placebo, 1.6 million international units (MIU) IFNB, or 8 MIU IFNB. The primary endpoint was the annual exacerbation rate and proportion of patients free of exacerbations. Exacerbations were defined as the appearance of a new symptom or the worsening of an old symptom that could be clinically attributed to MS. In addition, each patient had a brain MRI at baseline and on a yearly basis afterwards.
At 3 years of follow-up, the exacerbation rates were 1.21 for the placebo group, 1.05 for the 1.6 MIU group, and 0.84 for the 8 MIU group (p=0.0004). Furthermore, MRIs at the 3-year mark demonstrated a 17.1% increase in mean lesion area for patients in the placebo group and a 1.1% increase for the 1.6 MIU group, while the 8 MIU group experienced a 6.2% decrease compared to baseline MRIs. Over the 3 year period, there was no statistically significant difference between the groups with regards to total disability, as measured by the Kurtzke EDSS score.
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