Atlanta, Ga. – Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced interim results from an ongoing, one-year longitudinal health-outcomes study in which patients reported significantly higher levels of treatment satisfaction after three infusions with TYSABRI® (natalizumab) when compared to multiple sclerosis (MS) therapies used previously.
The findings from the study, which were reported by patients on therapy, further demonstrate the benefits of TYSABRI in treating MS and are helping to redefine successful treatment of the disease. The study, which was performed in conjunction with HealthCore Inc., a health-outcomes research company, is being presented in a poster today during the 23rd Annual Meeting of the Consortium of Multiple Sclerosis Centers.
“The patients in this study reported significantly greater satisfaction with TYSABRI when compared to their previous MS treatments, which makes these data even more compelling for patients who may not be satisfied with their current treatment,” said William Stuart, M.D., medical director of the Multiple Sclerosis Center of Atlanta. “When coupled with previously reported data from this ongoing study that showed overall improvement in quality of life measures, we have a clearer picture of the real-world impact of TYSABRI on MS patients’ lives. The success of TYSABRI over the past three years should be an encouragement to move this drug to the forefront of treatment options in many select MS patients.”
About the Study
This ongoing study, which is the first attempt to evaluate patient experiences with TYSABRI in usual-care settings, will continue to assess health outcomes from the patients’ perspectives, with subsequent data collections, after the sixth and 12th TYSABRI infusions. A total of 1,275 patients were enrolled in the study. Of these patients, 702 completed the third infusion assessment at the time of the analysis. Of the 1,275, there were 224 patients who were still being contacted or had not yet reached their third infusion. Of the initial 1,275; 43 chose to no longer participate in the study, 60 had already received a fourth infusion, 53 were unable to be contacted and 193 discontinued or had never started TYSABRI treatment.
These patient-reported outcomes paint a broad picture of MS patients’ ongoing treatment experience, which helps us to measure the effectiveness of MS treatments and expand our understanding of their everyday impact. A majority of the patients in the study are female (78.4%) with a mean age of 45.3 years and mean disease duration of 10 years. Almost all (97%) patients had used at least one MS drug prior to receiving TYSABRI.
Patient satisfaction with treatment was assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM) with higher scores indicating higher satisfaction.
In the study, patients’ attitudes towards MS drugs, with respect to effectiveness, convenience and overall satisfaction, at baseline (n=681) were compared to their attitudes to the same measures after three TYSABRI infusions.
As compared to other MS drugs, patients reported statistically significant higher levels of satisfaction after three infusions of TYSABRI with respect to:
* effectiveness of treatment (baseline 43.9 vs. 63.5 at the third infusion; p< 0.001);
* convenience of treatment (baseline 58.9 vs. 80.0 at the third infusion; p< 0.001); and
* global satisfaction (baseline 61.5 vs. 73.8 at the third infusion; p< 0.001).
The poster Treatment Satisfaction with Natalizumab in Multiple Sclerosis Patients (S63) will be available for viewing begining on Thursday, May 28, 2009, 8:00 a.m EDT.
TYSABRI is a treatment approved for relapsing forms of MS in the U.S. and relapsing-remitting MS in the European Union. According to data that have been 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 compared to placebo and reduced the relative risk of disability progression by 42-54 percent (p<0.001).
In early 2008, TYSABRI was approved in the U.S. to induce and maintain clinical response and remission in adult patients with moderately to severely active Crohn’s disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha. According to the U.S. full prescribing information, among patients who responded to TYSABRI, 54 percent sustain their response through every visit for one year compared to 20 percent of patients receiving placebo (p< 0.001), for a treatment difference of 34 percent.
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Cases of PML have been reported in patients taking TYSABRI who were recently or concomitantly treated with immunomodulators or immunosuppressants, as well as in patients receiving TYSABRI as monotherapy. Other serious adverse events that have occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis) and infections. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Herpes infections were slightly more common in patients treated with TYSABRI. In MS and CD clinical trials, the incidence and rate of other serious adverse events, including serious infections, were similar in patients receiving TYSABRI and those receiving placebo. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash. Other common adverse events reported in TYSABRI-treated CD patients include respiratory tract infections and nausea. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting.
TYSABRI is approved in more than 40 countries.
For more information about TYSABRI please visit www.tysabri.com, www.biogenidec.com or www.elan.com or call 1-800-456-2255.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec’s significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit http://www.elan.com.