All About Multiple Sclerosis

More MS news articles for June 2004

Results of Antegren trial for acute relapses

Tuesday June 22, 2004
Hollie Schmidt
Boston Cure Project

The experimental MS drug natalizumab (aka Antegren, made by Biogen Idec and Elan Pharmaceuticals) is currently undergoing clinical trials as a long-term disease modifying therapy. Because of its proposed mode of action (blocking the migration of T cells across the blood-brain barrier), a team of researchers hypothesized that it may also be helpful in resolving acute relapses. To test this hypothesis, they conducted a multicenter trial involving 180 MS subjects in the US and Canada.

Recruited subjects had relapsing-remitting or secondary progressive MS, had been experiencing symptoms of an acute relapse for at least 24 hours, had an EDSS of less than or equal to 5.5 before the relapse, and had an EDSS of more than 3.0 at the time of the relapse. Subjects were randomized to receiving 1 or 3 mg/kg of natalizumab, or placebo, and were monitored for 14 weeks. Gd-enhanced MRIs and clinical assessments were performed at a number of follow-up periods.

Analysis of the clinical assessments for EDSS improvement over time revealed no difference between the three groups. On average, the subjects' EDSS improved by approximately 1 point one week after treatment and by 1.6 points after eight weeks, with no significant difference between placebo and treatment arms. However, the natalizumab groups did show a reduction in Gd-enhancing lesion volume during the first three weeks after treatment.

These results show that natalizumab does not appear to speed clinical recovery after acute relapses -- or if it does have an effect, it was too small to be distinguished from the unaided recovery that the placebo subjects experienced. However, the reduction in lesion volume in the natalizumab-treated subjects is consistent with the drug's proposed mechanism of action and helps support the idea of its use as a long-term treatment in MS.

Copyright © 2004, Boston Cure Project