Results Further Support The Benefits Of TYSABRI For Multiple Sclerosis Patients

Main Category: Multiple Sclerosis
Also Included In: Psychology / Psychiatry;  Clinical Trials / Drug Trials
Article Date: 14 Sep 2009 - 0:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) have announced six-month results of an ongoing, one-year longitudinal, observational, patient-reported outcomes study showing multiple sclerosis (MS) patients taking TYSABRI® (natalizumab) experienced an improvement in both their physical function and psychological well-being. Findings from the study, which was performed in conjunction with HealthCore Inc., a health-outcomes research company, are the first attempt to assess patient experiences with TYSABRI in usual-care settings. The data, presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), shows patients report TYSABRI has an impact in improving their overall quality of life.

"The symptoms that an MS patient deals with on a daily basis result in significant psychological and physical effects that can adversely impact their quality of life," said William Stuart, M.D., medical director of the Multiple Sclerosis Center of Atlanta. "In a previous pivotal trial, TYSABRI not only showed a reduction in relapse rates and disability progression, but also improved quality of life. Results from this observational study further demonstrate the impact of TYSABRI on improving MS patients' well-being as reported by patients who live with this disease every day."

About the study

The study is assessing health outcomes from patients' perspectives before starting TYSABRI and after the third, sixth and 12th infusions of TYSABRI. A majority of the patients in the study are female (76.3%) with mean age of 46.6 years and mean disease duration of 10 years.

After six TYSABRI infusions, patients reported statistically significant improvement in:

• Disease-specific quality of life (QoL), as measured by the Multiple Sclerosis Impact Scale-29 (MSIS-29), which measures the physical impact of MS in terms of mobility and self care, as well as the psychological impact of MS in terms of anxiety/depression, with lower scores indicating better QoL; and
  
  
• General health-related QoL, as measured by the 12-item Short Form Scale (SF-12) health survey, which assesses the physical and mental health, with higher scores indicating better QoL.

Both scales assess patient experience of the physical and psychological aspects of QoL. For the MSIS-29 subscales, there were statistically significant improvements over time for both the physical (baseline 46.87; third infusion 39.60; sixth infusion 39.27 (p< 0.001)) and psychological (baseline 41.56; third infusion 33.77; sixth infusion 33.20 (p< 0.001)) impact scores.

SF-12 physical component summary (baseline 34.20; third infusion 36.05; sixth infusion 36.34 (p< 0.001)) and the SF-12 mental component summary score (baseline 43.25, third infusion 47.35, sixth infusion 47.92 (p< 0.001)) showed statistically significant improvements over time.

What do multiple sclerosis patients experience? Effect of natalizumab on disease-specific quality of life over time (poster P872).

About TYSABRI

TYSABRI is approved in more than 40 countries. In the U.S., it is approved for relapsing forms of MS and in the European Union for relapsing-remitting MS. According to data from the Phase III AFFIRM trial published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68 percent relative reduction (p< 0.001) in the annualized relapse rate, when compared with placebo, and reduced the relative risk of disability progression by 42-54 percent (p< 0.001).

TYSABRI is redefining success in the treatment of MS. In post-hoc analyses of the Phase III AFFIRM trial and as published in The Lancet Neurology, 37 percent of TYSBARI-treated patients remained free of their MS activity, compared to seven percent of placebo-treated patients. In addition, data has been presented showing that treatment with TYSABRI significantly increased the probability of sustained improvement in disability in patients with a baseline expanded disability status scale (EDSS) score ≥ 2.0 by 69 percent relative to placebo.

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash.

Source:
Shannon Altimari
Biogen Idec