Biogen Idec, Elan Publish Tysabri Results
Biogen Idec and Elan announced the publication of results of Phase III studies of Tysabri in the Annals of Neurology, demonstrating that patients with relapsing forms of multiple sclerosis treated with the drug showed significant improvement in health-related quality-of-life measures when compared with placebo.
According to Biogen and Elan, 2,113 patients participated in the two-year, randomized, double-blind, placebo-controlled, multicenter Phase III clinical trials, AFFIRM and SENTINEL.
Published results from the AFFIRM included:
- A statistically significant improvement in physical wellbeing beginning at week 24 and all subsequent time points, compared with a decline in the placebo-treated group;
- A statistically significant improvement in me at week 104, compared with a decline in the placebo-treated group;
- Statistically significant benefits using the visual analogue scale — a measure of wellbeing as assessed by the patient — when compared with placebo at weeks 52 and 104; and
- Sustained improvement from baseline quality-of-life measures, not just a slowing down of quality-of-life deterioration.
Improvements on quality-of-life measures were also observed in the SENTINEL study, in which Tysabri was added to Avonex (interferon beta-1a), the article added.