More MS news articles for June 2001

WCN: High-Dose Interferon Beta-1a Decreases Relapse Rate in Multiple Sclerosis

By Richard Robins
Special to DG News

LONDON, ENGLAND -- June 22, 2001 -- High-dose interferon beta-1a decreases the relapse rate in multiple sclerosis compared to standard dosing, according to a study presented at the 17th World Congress of Neurology in London, June 17-22 2001.

The study was the first head-to-head comparison between two brands of interferon beta-1a, Rebif, dosed at 44 mcg three times weekly by subcutaneous injection, and Avonex, dosed at 30 mcg once weekly by intramuscular injection. Unlike Avonex, Rebif is not available in the United States and this FDA-approved trial is meant to position the drug for approval prior to the expiration of Avonex's orphan drug status in 2003.

Lead investigator Patricia Coyle, Professor of Neurology at the School of Medicine, Stony Brook, New York, outlined the trial and presented the results. She and colleagues in nine countries enrolled 677 patients with relapsing-remitting MS, including 440 in the USA. Patients had to be interferon-naive, with at least two relapses in the past two years. Assessments included biweekly patient interview to determine occurrence of relapse, the primary endpoint of the study, as well as monthly MRI scans. While patients knew which drug they were receiving, assessing physicians did not.

After six months, 75 percent of Rebif patients and 63 percent of Avonex patients remained relapse-free, a difference significant at the p=0.0005 level, Dr. Coyle reported. The average number of relapses for the study period was also significantly fewer for Rebif, with 0.29, versus 0.40 for Avonex. MRI activity was correlated with these outcomes, with about one half of Rebif patients, and one third of Avonex patients, showing no new disease activity during the study.

Correlated with the increased number of injections, Rebif patients had more injection-site reactions and elevated liver enzymes. Ninety-five percent of all patients completed the study, however, with no significant difference between the two treatments.

Based on the strength of these study results, Dr. Coyle said, the manufacturer, Serono Laboratories, will be submitting the data to the FDA in an effort to gain approval for marketing Rebif in the United States.