Seattle, Wash. – April 29, 2009 – Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced results from an ongoing, one-year longitudinal health outcomes study (n=1275) in which patients who received three infusions of TYSABRI(R) (natalizumab) reported reduced fatigue, as well significant improvements in general and disease-specific measurements of quality of life (QoL) and cognitive function. 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 results from this study are being presented today in two separate posters at the 61st Annual Meeting of the American Academy of Neurology.
“MS is a debilitating disease that significantly reduces the quality of patients’ lives. In this study, a majority of patients said they were less tired, thought more clearly, and had a better overall quality of life,” said Dr. William Stuart, M.D., medical director of the Multiple Sclerosis Center of Atlanta. “Data from the pivotal trial has shown that TYSABRI not only results in a significant reduction in relapses, but also showed an improvement in quality of life. These new patient-reported outcomes expand our understanding of the real-world impact of TYSABRI on different aspects of the lives of MS patients.”
The ongoing one-year follow-up study will assess health outcomes from patients’ perspectives before starting TYSABRI and after the third, sixth, and 12th infusions of TYSABRI, respectively. A majority of the patients in the study are female (78.4%) with mean age of 45.3 years and mean disease duration of 10 years.
Quality of Life Study Results
As early as after the third infusion of TYSABRI, patients reported statistically significant improvement in:
- general health-related QoL, as measured by the 12-item Short Form Scale (SF-12), with higher scores indicating better QoL
- MS-specific QoL, as measured by the 29-item Multiple Sclerosis Impact Scale (MSIS-29), with lower scores indicating better QoL
Both scales report the physical and psychological aspects of QoL in two summary scores. SF-12 physical component summary (baseline 34.03 vs. 36.02 at the 3rd infusion; p<0.001) and the SF-12 mental component summary score (baseline 43.17 vs. 47.22 at the 3rd infusion; p<0.001) showed statistically significant improvements from baseline.
For the MSIS-29 subscales, there were statistically significant improvements from baseline for both the physical (baseline 48.25 vs. 40.19; p<0.001) and psychological (baseline 43.70 vs. 34.80; p<0.001) impact scores.
The results of the current study are consistent with those reported in clinical trials and an earlier cross-sectional study in which patients reported significant improvements in functional status, disability and overall QoL after three TYSABRI infusions. The cross-sectional study also found that TYSABRI patients who had the disease for less than five years had higher magnitudes of improvement in functional status and overall QoL as compared to patients who had the disease for more than five years. Findings from this study will also be reported in the peer-reviewed journal The Patient: Patient-Centered Outcomes Research later this quarter.
The poster Change in Health-Related Quality of Life in Multiple Sclerosis Patients Receiving Natalizumab (P05.144) will be available for viewing on Wednesday, April 29, 2009, 11:30 a.m. PDT.
Cognition and Fatigue Study Results
After three infusions of TYSABRI, patients reported both:
- improvements in cognitive functioning
- lower impact of fatigue on daily functioning
Cognitive functioning was assessed by Medical Outcomes Study Cognitive Functioning Scale (MOS-Cog Scale) with higher scores indicating improved cognition. Impact of fatigue on daily functioning was assessed by short version of Modified Fatigue Impact Scale (MFIS-5) with lower scores indicating lower fatigue.
On average, MOS-Cog scores increased by statistical significance from baseline (baseline score 24.48; 3rd infusion score 26.29, p<0.001) and MFIS scores decreased by statistical significance from baseline (baseline score 12.46; 3 rd infusion score 10.29, p<0.001).
The poster Early Effects of Natalizumab on Patient Reported Fatigue and Cognitive Function (P02.142) will be available for viewing on Wednesday, April 29, 2009, 11:30 a.m. PDT.