Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN), in collaboration with EPI-Q, Inc. and Avatar International, LLC, have launched the My MS Health, a first-of-its-kind, web-based, patient-reported outcomes (PRO) research program. My MS Health is designed to track and provide instant reports on patient function and quality of life (QoL) using validated measures over time.
This outcomes research program will assess the impact of using My MS Health on patient-healthcare provider communication, and was developed with guidance from a multidisciplinary steering committee of individuals from healthcare and patient communities, as well as academia. Launched today, interested patients and healthcare providers who meet the research criteria can register for the program at www.mymshealth.org.
"My MS Health is a new research tool that may help patients and healthcare providers further communicate about important measures in the management of MS," said Alfred Sandrock, M.D., Ph.D., Senior Vice President of Neurology Research and Development at Biogen Idec. "We believe the patients' perspective on how they feel and function is vital in understanding the overall definition of efficacy in MS therapy."
The user-friendly, secure technology platform and design for My MS Health was developed by EPI-Q, Inc., an industry leader in innovative health economics and outcomes research solutions, and Avatar International, LLC, an industry leader in healthcare measurement and quality improvement. In addition, EPI-Q, Inc. and Avatar International, LLC will implement My MS Health and evaluate data collected via the web-based outcomes research program.
The multidisciplinary steering committee provided critical advice on design and implementation of My MS Health, including the choice and presentation of appropriate measures to ensure relevance to current medical practice and patient needs.
"In developing My MS Health, it was important that all voices – from medicine to academia to the patient community – were heard and that their specific needs were identified and incorporated into the program," said John F. Foley, M.D., director, Rocky Mountain Multiple Sclerosis Clinic, Salt Lake City, and a member of the My MS Health steering committee. "While clinical and radiological assessments play a primary role in patient evaluation, patient-reported outcomes can offer valuable, standardized data that can lead to more comprehensive insights into the physical, neurological and psychological dimensions of a patient's experience."
The pilot phase of My MS Health, anticipated to continue through the first half of 2011, will be available to more than 2,000 patients with relapsing-remitting multiple sclerosis (RRMS) treated with TYSABRI® (natalizumab) and to physicians who prescribe the drug in the U.S. After the pilot phase, there will be a review of intermediate study results to evaluate potential expansion to all people with MS. Interested patients and healthcare providers who meet the study criteria can register for the program at www.mymshealth.org.
My MS Health Enrollment
When people with MS enroll in My MS Health, they are prompted to complete a series of self-assessment surveys that help them track the effect of MS on their QoL. These answers are recorded and instantly translated into easy to understand reports that patients can view online to track how they feel and how they are responding to therapy over time. Information also can be shared directly via the website with registered healthcare providers, or the report can be printed and used to prompt or guide discussions at regularly scheduled appointments.
PROs are validated measures of patient perspectives and can encompass a range of measures, including health-related QoL, ability to function and perform daily activities and the impact of MS symptoms and treatment on QoL and functioning.
TYSABRI is approved in more than 45 countries. In the U.S., it is approved for relapsing forms of MS and in the European Union for relapsing-remitting MS.
Data from the Phase III AFFIRM trial highlights TYSABRI's powerful efficacy. According to that data, which was 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). In post-hoc analyses of the Phase III AFFIRM trial and as published in The Lancet Neurology, 37 percent of TYSABRI-treated patients remained free of their MS activity, based on MRI and clinical measures, compared to seven percent of placebo-treated patients.
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain. The risk of PML increases with increasing duration of use. 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.
TYSABRI is co-marketed by Biogen Idec Inc. and Elan Corporation, plc. For more information about TYSABRI, please visit www.tysabri.com,www.biogenidec.com or www.elan.com, or call 1-800-456-2255.
About Multiple Sclerosis
MS is a chronic, unpredictable and progressive disease of the central nervous system that causes inflammation and destruction of the myelin sheath – the protective layer that surrounds the body's nerve fibers. This destruction may result in cognitive impairment, physical disability and fatigue. According to the National MS Society, MS affects about 400,000 people in the United States and more than 2.5 million people worldwide. RRMS affects about 85 percent of the MS population. RRMS is characterized by clearly defined flare-ups followed by periods of partial or complete recovery or remission.
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 worldwide 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 and Irish Stock Exchanges. For additional information about the company, please visit http://www.elan.com.