New Study Shows Natalizumab (Tysabri) Significantly Improves Cognitive Impairment Over Three Years in MS Patients

In a study published this month, researchers in Italy found that natalizumab (Tysabri) significantly improved cognitive performance in MS patients over a three year period (Mattioli, et al). This study adds to a growing body of research that suggests the newer MS therapies may help people with MS improve in many areas, including cognitive function.

Over the past two decades, there has been an evolution in the disease modifying therapies (DMTs) available to treat MS. The first DMTs, introduced twenty years ago, were aimed at keeping the disease from getting worse. They did not cure MS, or improve symptoms, but they did slow the rate of disease progression. Clinical research on new therapies has continued to expand and newer, more effective therapies have been approved by the FDA and are increasingly used in clinical practice. These newer drugs, including natalizumab, may actually impact MS symptoms and improve function.

In this recent study, the effects of natalizumab on cognitive impairment in 24 patients with relapsing remitting MS (RRMS) were evaluated over three years. Annual relapse rate, EDSS (Expanded Disability Status Scale) scores, and performance on neuropsychological tests were assessed at baseline and then yearly. The results showed that, over the three year period, patients had improved performance on various neuropsychological tests. They also showed a decrease in annualized relapse rates, and less progression of disability as measured by ambulation. The neuropsychological assessment showed a significant improvement in memory, attention and executive function. The study concluded that natalizumab is helpful in improving cognitive performance and is likely to have a protective role with gray matter in the brain.

Earlier studies also suggested that natalizumab may improve MS symptoms. A 2013 study found that natalizumab improved ambulatory function in disabled RRMS patients and may have efficacy in secondary progressive MS (SPMS) patients as well, but this finding, will require further study (Cadavid et al).

Another 2013 study showed that natalizumab may reduce fatigue in MS patients (Svenningsson, et al). This study included 195 MS patients in a real-life rather than a clinical trial setting. Patients completed the Fatigue Scale for Motor and Cognitive functions (FSMC) questionnaire before and after 12 months of treatment. Fatigue, quality of life, sleepiness, depression, cognition and depression all showed improvement from the baseline scores. Although researchers caution that study in clinical trial setting will be needed to confirm this finding, Dr. Timothy Vollmer, Medical Director of the Rocky Mountain MS Center and Co-Director of the Rocky Mountain MS Center Clinic at University of Colorado Anschutz Medical Campus disagrees. "Real life studies of what happens to patients on MS therapies is very important and informative to both individuals dealing with MS and their care providers."

Dr. Vollmer expanded on the overall importance of these new research findings:

"These studies provide further research to demonstrate that the highly effective therapies now available are much more efficient and can keep ahead of the disease to help people improve. These therapies are essentially winning the foot race against MS and that is a significant and encouraging shift. It is important to note that starting treatment as early as possible is key to help ensure maximum impact."

The following data compiled from European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2010 posters also helps to show the recovery of function on Tysabri:

 

Area of Improvement

Observations

Fatigue

Superior to Interferon (INF) and Glatiramer Acetate (GA)

Memory, Cognition

All components

Disease Free State

68% year 1, 88% year 2, 96% year 3

EDSS, walking distance

3.4-3.1, 1185 m to 1391 m

Quality of Life

Superior to INF and GA

Employability, Work Capacity, Cost of Disease

Superior to INF and GA