SAN DIEGO, CA -- May 2, 2000 -- Results from a new European study show that Betaseron® (Interferon beta-1b) for SC Injection reduces the development of hypointense T1 lesions, also known as "black holes," in the brains of patients with secondary progressive multiple sclerosis (MS). The findings were presented today by study investigator Ludwig Kappos, MD, of the University Hospital Basel, Switzerland, Department of Neurology, and member of the European study's Steering Committee, at the annual meeting of the American Academy of Neurology.
In secondary progressive MS patients, "black holes" correlate with severe tissue destruction, especially axonal loss. Destruction of axons disrupts the flow of nerve impulses within the brain, making it difficult for MS patients to perform ordinarily normal daily functions.
The Betaseron T1 black hole study was performed in five centers, using a subgroup of 95 secondary progressive MS patients participating in a placebo-controlled trial of Betaseron at 8 million international units (MIU) on alternate days. Six monthly unenhanced T1-weighted spin-echo magnetic resonance imaging (MRI) images were acquired for 36 months. Hypointense lesions were marked and quantified by blinded observers. Coordination of the study and analysis of the data were performed at the Image Analysis Center, headed by Frederik Barkhof, MD, of the Vrije University Hospital, Department of Diagnostic Radiology in Amsterdam.
"A 45 percent reduction in the development of 'black holes' clearly illustrates the efficacy of Betaseron therapy in delaying axonal damage in secondary progressive MS patients," said Dr. Kappos. "By reducing damage to axons, Betaseron is able to slow the disabling effects of secondary progressive MS. This study reinforces previous clinical findings from a European trial that indicated Betaseron slowed disease progression in people with secondary progressive MS."
In the study, compared to baseline, the median black hole volume increase was 42 percent in the placebo group at 36 months, compared to 23 percent in the Betaseron treated group (p=0.0003). Earlier studies of Dr. Barkhof's group had clearly shown that black holes correspond to areas of reduced axonal density and correlate with disease-related disability.
"Interest in studies measuring black holes is increasing rapidly. The data from this study suggest once more that an increase in disability in secondary progressive MS patients relates to axonal damage, and this can be benefited by Betaseron treatment," said Dr. Barkhof.
Betaseron was the first therapy approved in the United States to treat early stage relapsing-remitting MS (patients with Expanded Disability Status Scale scores of 0-5.5). The black hole study examined the effect of Betaseron? in the development of hypointense T1 lesions in secondary progressive MS patients.
About 50 percent of people with relapsing-remitting MS advance into the secondary progressive form. Betaseron is already approved for secondary progressive MS in Europe, Canada, and Australia. In these regions, it is the only approved therapy for the treatment of both the relapsing-remitting form as well as the more advanced, secondary progressive form of multiple sclerosis.
Betaseron was jointly developed by Chiron Corporation and Berlex Laboratories,
Inc. It is manufactured by Chiron and sold in the U.S. and Canada by Berlex.
Related Links: Betaseron (Interferon beta-1b), Chiron Corporation and
Berlex Laboratories, Inc.