Researchers Report First Evidence that Drug Therapy Slows the Rate of Brain Shrinkage in Multiple Sclerosis

Brain Atrophy in MS Occurs Earlier in Disease than Previously Thought

Apr 21, 1999, 01:00 ET from The Cleveland Clinic Foundation

    TORONTO, April 21 /PRNewswire/ -- Researchers from the Cleveland Clinic
 Foundation today presented findings that show that the brains of people with
 multiple sclerosis (MS) atrophy, or shrink, much earlier in the course of this
 disease, than neurologists previously thought and demonstrating for the first
 time that the rate of brain shrinkage can be significantly reduced with drug
     Brain shrinkage, or atrophy, is irreversible and is associated with
 various symptoms, such as loss of memory, inability to walk and slurred
 speech, that are frequently experienced by people with multiple sclerosis.
     According to the study, patients receiving AVONEX(R) (Interferon beta-1 a)
 over a two year period experienced a 55 percent reduction in the rate of brain
 atrophy in the second year of treatment compared to patients who received
 placebo.  The data were presented today by Richard Rudick, M.D., director of
 the Mellen Center for Multiple Sclerosis Treatment and Research at the
 Cleveland Clinic Foundation, at the annual meeting of the American Academy of
 Neurology (AAN) in Toronto.
     "Our study shows MS patients continually lose brain tissue, even in the
 early stages of the disease, when physical symptoms are still very mild," says
 Dr. Rudick, principal investigator of the study.  "However, those patients
 treated with AVONEX(R) had a significantly lower rate of cerebral atrophy
 -- less than half after the first treatment year -- compared with placebo
     In the double-blind, placebo-controlled study, the magnetic resonance
 image (MRI) scans of 140 MS patients who participated in the two-year
 AVONEX(R) Phase III study were reevaluated by Dr. Rudick and his team to
 determine the amount of brain atrophy that had occurred, calculated as the
 loss of brain tissue volume relative to the cranial volume.  The MRI scans
 were analyzed using a new image analysis method called brain parenchymal
 fraction (BPF), which was developed by Dr. Elizabeth Fisher, a biomedical
 engineer at the Cleveland Clinic Foundation.  BPF calculates the amount of
 brain tissue as a ratio of the total brain volume.  Upon study entry, the
 baseline MRIs showed a significantly reduced BPF in the MS patients when
 compared to 16 healthy controls, indicating significant brain atrophy at entry
 into the study.
     The placebo-controlled group showed a significant reduction in BPF -- or
 increased loss of brain tissue -- during the first year (-0.75%) and second
 year (-0.53%) of observation.  AVONEX(R) treatment (30 mcg injected
 intramuscularly once a week) had no effect on brain atrophy during the first
 year of observation; however, there was a statistically significant 55 percent
 reduction in the rate of atrophy compared with placebo recipients during the
 second year.
     Multiple sclerosis is a disease of the central nervous system in which
 most patients suffer physical disability over time.  An estimated 300,000
 Americans have MS, with nearly 200 new cases diagnosed every week.  The
 disease most often strikes people in their 20s and 30s. Women develop MS more
 frequently than men. MS symptoms vary widely and may include, fatigue, muscle
 weakness, incontinence, temporary blindness or double vision, and cognitive
 impairment, among others.
     The study was supported in part by grants from the National Institute of
 Neurological Diseases and Stroke (NINDS) of the National Institutes of Health
 (NIH), the National Multiple Sclerosis Society, and Biogen, Inc. AVONEX(R),
 approved by the FDA in 1996, was developed by Biogen, Inc.

SOURCE The Cleveland Clinic Foundation