Tuesday June 22, 2004
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