Best-practice recommendations for the selection and management of patients with multiple sclerosis (MS) who may benefit from, or are receiving treatment with TYSABRI® (natalizumab) were published today in a supplement to the medical journal Multiple Sclerosis. The panel provided recommendations focusing on appropriate patient selection and patient management. The recommendations, which recognize the significant efficacy of TYSABRI and the need to adequately treat patients who exhibit continued disease activity, are based on U.S. prescribing information and the panel’s vast clinical experience in treating MS patients with TYSABRI. Recommendations not only take into account the need to adequately treat patients who exhibit continued disease activity, but also the need to weigh the treatment’s benefit with potential risks.
“These best-practice approaches have been developed to ensure appropriate use of this highly-effective therapy, especially with MS patients who present with continued disease activity,” said Patricia K. Coyle, MD, professor and acting chair, department of neurology, Stony Brook University Medical Center and, director, Stony Brook MS Comprehensive Care Center, Stony Brook, New York. “The benefits of TYSABRI are evident in that it can significantly reduce relapse rates, improve cognitive and physical disability and provide freedom from disease activity for many patients, when measured by clinical and radiological measures.”
One of the expert panel’s recommendations encourages earlier and more rapid transition from first-line treatment to TYSABRI. The recommendations also seek to lower the threshold with physicians for treating unacceptable disease activity seen in their patients. According to the panel, factors such as the nature and frequency of relapses, the location of new or unresolved MRI lesions, MRI activity in the spinal cord, rapid or persistent changes in physical disability and functional deficits in cognition should be evaluated and weighed when determining the appropriate patients to treat with TYSABRI.
The panel developing the recommendations, which was selected by Biogen Idec, included U.S. academic and community neurologists who, combined, have approximately 2,000 patient-years experience with TYSABRI. The panel members were: Dr. Coyle; John F. Foley, MD, director, Rocky Mountain MS Clinic, Rocky Mountain Neurological Associates; Edward Fox, MD, director, MS Clinic of Central Texas, and clinical assistant professor, University of Texas Medical Branch; Douglas R. Jeffery, MD, PhD, associate professor, department of neurology, Wake Forest University Baptist Medical Center; Frederick E. Munschauer III, MD, professor and chairman, department of neurology, State University of New York at Buffalo, and chief, The Jacobs Neurological Institute; and Carlo Tornatore, MD, associate professor, department of neurology, and director, Multiple Sclerosis Center, Georgetown University Medical Center.
The paper entitled “Best Practice Recommendations for the Selection and Management of Patients with MS Receiving Natalizumab Therapy” is one of four articles that are part of a supplement being published in the journal Multiple Sclerosis. The other papers are “Introduction to Best Practice Recommendations for the Selection and Management of Patients with MS on Natalizumab,” “Clinical Efficacy and Benefit of Natalizumab” and “Clinical Vigilance for PML in the Context of Natalizumab.” The supplement was funded by Biogen Idec and Elan Corporation, plc.
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.
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 are listed on the New York and Irish Stock Exchanges. For additional information about the company, please visit http://www.elan.com.
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