New England Journal of Medicine Study Shows that Early Drug Treatment Can Reduce the Rate of Development of MS
October 25, 2000
DALLAS, Oct. 24 /PRNewswire/ -- Ophthalmologists can play a crucial role in diagnosing the earliest signs of multiple sclerosis (MS) and even delaying the onset of the disease, researchers said today during the "Hot Topics" session at the annual meeting of the American Academy of Ophthalmology (AAO) in Dallas. According to a study published last month in the New England Journal of Medicine, early treatment with AVONEX(R) (Interferon beta-1a) significantly reduces the rate at which individuals at high-risk for MS develop clinically definite multiple sclerosis (CDMS). Treatment with AVONEX in this group of patients reduced the rate of development of CDMS by 44 percent versus treatment with placebo. A large percentage of people with MS first experience symptoms that could be identified by ophthalmologists.
The first indication that a person may have MS is a single, clinical, demyelinating event of the optic nerve, spinal cord, or cerebellum/brain stem. A clinically definite case of MS is not considered until someone has had two clinical demyelinating events, separated by time and location in the central nervous system. High-risk individuals often first experience damage to the optic nerve, which presents as blurry or lost vision.
"Nearly 50 percent of individuals who are eventually diagnosed with MS first present with optic neuritis, a eye condition that often leads people to see their ophthalmologists," CHAMPS researcher Steven Galetta, M.D., Director, Neuro-Ophthalmology Service and Professor of Neurology/ Ophthalmology at the University of Pennsylvania Medical Center, told ophthalmologists at the AAO meeting. "Therefore, it is essential that ophthalmologists recognize the early symptoms of the disease and refer at-risk patients to a neurologist. These high-risk patients should be identified and treated early with AVONEX, because there is now evidence that we can delay the onset of the disease and slow its progression."
The CHAMPS study was a randomized, double blind, placebo-controlled, Phase III clinical trial involving 383 patients determined to have a high probability of developing CDMS based on brain MRI changes and clinical events consistent with MS. Participants received weekly intramuscular injections of either 30 mcg of AVONEX or placebo. The study was conducted at 50 clinical centers in the U.S. and Canada.
The primary study outcome was the development of CDMS, which was defined as the occurrence of either 1) a new neurological event (optic neuritis, spinal cord syndrome, or brain stem syndrome) or 2) progressive neurological deterioration. Brain MRI results were the secondary outcome.
The CHAMPS study yielded the following results:
Over 200 new cases of MS are diagnosed each week in the United States alone. Many more individuals are at risk of developing the disease, which is the most common neurological disorder affecting young people in this country.
"To date, there are no accepted guidelines for treating patients who have experienced a single MS-like attack but who have not yet developed clinically definite MS," Dr. Galetta said. "This study is extremely important because it indicates that initiating therapy with AVONEX in high-risk patients at the first sign of optic neuritis, or other neurological symptoms, with silent MRI lesions can significantly delay the development of the disease."
AVONEX is the leading treatment for multiple sclerosis worldwide. It was launched in the U.S. in 1996 for the treatment of relapsing forms of MS to slow the accumulation of physical disability and to decrease the frequency of clinical exacerbations. More than 93,000 patients worldwide are now on AVONEX therapy, which is marketed internationally in more than 60 countries.
MS is a chronic, inflammatory disease of the CNS in which most patients incur disability over time. MS affects approximately one million people worldwide, 400,000 of whom are in the United States and two-thirds of whom are women. Disease onset typically occurs in young adults between the ages of 20 and 40.
The disease is caused by the destruction of myelin by the immune system. Myelin is the fatty tissue that surrounds and protects central nervous system nerve fibers and facilitates the flow of nerve impulses to and from the brain. The loss of myelin disrupts the conduction of nerve impulses, producing the symptoms of MS.
In addition to historical information, this press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Reference is made in particular to statements regarding the implications of the study on the treatment of MS. These statements are based on the Company's current beliefs and expectations as to such future outcomes. Factors which could cause actual results to differ materially from the Company's current expectations include the risk that obstacles may arise in connection with regulatory approval for an expanded label. In addition, AVONEX potential in this area could be affected by the impact of competitive products, changes in the level of customer acceptance, and any unexpected negative results from clinical trials as well as the other risks and uncertainties described from time to time in the Company's periodic reports filed with the Securities and Exchange Commission.
Biogen, Inc., winner of the U.S. National Medal of Technology, is a biopharmaceutical company principally engaged in discovering and developing drugs for human healthcare through genetic engineering. Headquartered in Cambridge, MA, the Company's revenues are generated from international sales of AVONEX(R) (Interferon beta-1a) for treatment of relapsing forms of multiple sclerosis, and from the worldwide sales by licensees of a number of products, including alpha interferon and hepatitis B vaccines and diagnostic products. Biogen's research and development activities are focused on novel products to treat inflammatory and autoimmune diseases, neurological diseases, cancer, fibrosis and congestive heart failure. The Company maintains active clinical research programs in protein therapeutics, small molecules, genomics and gene therapy. For copies of press releases and additional information about the Company, please consult Biogen's Homepage on the World Wide Web at http://www.biogen.com.
Jacobs LD, Beck RW, Simons JH, et al. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. N Engl J Med 2000;343;898-904.
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