MULTIPLE SCLEROSIS

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OPTIC NEURITIS

New England Journal of Medicine Study Shows that Early Drug Treatment with Interferon Beta-1a, Avonex®, Can Reduce the Rate of Development of Multiple Sclerosis  in identifying early signs of multiple sclerosis (MS) and even delaying the onset of the disease.

Nearly 50% of individuals developing MS presented optic neuritis as their initial event, which underlines the importance that ophthalmologists recognize the early symptoms of the disease and refer at-risk patients to a neurologist.

According to a new study published recently in the New England Journal of Medicine, early treatment with the MS therapy interferon beta-1a, or Avonex®, can significantly reduce the rate at which individuals at high-risk for the disease actually develop clinically definite multiple sclerosis (CDMS).

In the study, the rate of development of CDMS was 44 percent lower in the treated group than in the placebo-treated group.

FOR IMMEDIATE RELEASE

EARLY RECOGNITION OF SYMPTOMS BY OPHTHALMOLOGISTS COULD HELP DELAY THE ONSET OF MULTIPLE SCLEROSIS IN HIGH-RISK PATIENTS

New England Journal of Medicine Study Shows that Early Drug Treatment Can
Reduce the Rate of Development of MS

(Dallas, TX - October 24, 2000) -- 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® (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.

Early Recognition of Symptoms by Ophthalmologists Could Help Delay the Onset of MS

"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:

* The rate of development of CDMS was 44 percent lower in the AVONEX-treated group than in the placebo-treated group.
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* The increase in brain MRI T2 lesion volume was 91 percent lower in the AVONEX-treated group than in the placebo-treated group.
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* With the results of this study showing a strong benefit of AVONEX treatment at the time of the first clinical event, there is added justification for obtaining brain MRIs at the earliest symptoms of MS. Previously, MRIs were considered useful in predicting the possibility of developing CDMS but were not considered necessary because they would not affect treatment and patient management.

Study Suggests New Course of Action for At-Risk Individuals

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."

Early Recognition of Symptoms by Ophthalmologists Could Help
Delay the Onset of MS

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