Biogen's Tysabri Improves Walking Speed In Patients With MS

Biogen Idec reported data from a post hoc analysis from the AFFIRM study showing that TYSABRI (natalizumab) significantly increased the proportion of relapsing-remitting multiple sclerosis (RRMS) patients. The analysis confirmed that Tsyabri improved patients’ walking speed compared to placebo at two years.

AFFIRM was a randomized, multi-center, placebo-controlled, double blind, two-year study involving 942 patients with RRMS. AFFIRM evaluated the effect of TYSABRI on the rate of clinical relapses and progression of physical disability. Treatment with TYSABRI increased the percentage of patients with CIWS at year two by 79 percent compared to placebo. Moreover, observed effects were more significant and took place earlier in patients with more advanced disability. CIWS in these patients were reported to increase by as much as five-fold compared to placebo at one year.

Additional data from observational registry studies showed that the risk of future relapses and treatment discontinuation was decreased when patients switched to TYSABRI after experiencing a multiple sclerosis relapse while taking interferon beta (IFNβ) or glatiramer acetate (GA).

Multiple sclerosis affects 2.5 million around the world, according to the Multiple Sclerosis Foundation. More than 400,000 people in the U.S. are afflicted with MS. While the course of the disease is unpredictable, common symptoms include fatigue, weakness, spasticity, and balance problems.

Alfred Sandrock, group SVP and CMO at Biogen Idec, said, “We know that MS has a significant impact on ambulation – a key concern for many people living with this disease – which is why we analyzed data from AFFIRM to evaluate the potential impact of TYSABRI on walking speed. TYSABRI was associated with a 20 percent increase in walking speed, a clinically relevant improvement, in a significantly greater number of patients compared to placebo.”

TYSABRI is indicated as a monotherapy for patients with relapsing forms of multiple sclerosis. The drug is approved in over 65 countries. In the EU, TYSABRI is indicated as a single disease modifying therapy in highly active relapsing-remitting MS (RRMS) for adult patients who have high disease activity in spite of undergoing treatment with a beta interferon or glatiramer acetate or for patients with rapidly evolving severe RRMS.

The company presented the data from the AFFIRM trial at the 66th American Academy of Neurology (AAN) annual meeting in Philadelphia, Pennsylvania.