Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Biogen Idec and Elan have reported data from a Phase III study showing that Tysabri significantly increased the proportion of disease-free patients with multiple sclerosis.
Subscribe to our email newsletter
The proportion of disease-free patients in the Affirm (Antegren safety and efficacy in relapsing-remitting multiple sclerosis) study was determined based upon clinical and MRI criteria. The proportion of disease-free patients over 2 years was significantly higher in the Tysabri-treated group compared with the placebo group, regardless of how disease free was defined.
Clinically, disease free was defined as no relapses and no progression of disability (as defined by > or =1.0-point increase in expanded disability status scale (EDSS) score from a baseline score of > or =1.0, or a > or =1.5-point increase from a baseline score of 0.0, sustained for 12 weeks) over 2 years. MRI disease free was defined as no gadolinium-enhancing lesions and no new or enlarging T2-hyperintense lesions.
Eva Havrdova, director of the center for demyelinating diseases at the First School of Medicine, General University Hospital, Charles University, said: “These data demonstrate the dramatic effect Tysabri can have on critical measures of multiple sclerosis. In addition to the impact on individual clinical and MRI outcomes, it is striking that more than one-third of patients were free of relapses, disability progression and MRI activity after two years of treatment. This suggests that Tysabri may offer patients freedom from many of their MS symptoms.”