CHAMPIONS To Be Extended To 10 Years
September 22, 2003
Source: Biogen, Inc.
Biogen, Inc. announced today that Avonex® (Interferon beta-1a) was shown to alter the long-term course of multiple sclerosis (MS) in patients who began treatment immediately after their initial MS attack compared to initiation of treatment more than two years after onset of symptoms. The patients studied were considered at risk of suffering additional MS attacks because of the presence of brain MRI scan abnormalities. The study, known as CHAMPIONS (Controlled High Risk Avonex Multiple Sclerosis Prevention Study In Ongoing Neurological Surveillance), was designed to determine whether the effect of early treatment with Avonex in delaying relapses and reducing the accumulation of MS brain lesions could be sustained for up to five years. These five-year data were presented at the European Committee for Treatment and Research in MS (ECTRIMS) meeting in Milan, Italy.
In addition, Biogen announced today that the CHAMPIONS study will be extended for an additional five years, which will determine if the effects of early treatment can be sustained for up to 10 years.
"These CHAMPIONS data show that therapy should be initiated as early as possible," said lead study investigator R. Philip Kinkel, M.D., Director of the Multiple Sclerosis Center at Beth Israel Deaconess Medical Center in Boston, MA and Associate Professor of Neurology at Harvard Medical School. "This study confirms for me that Avonex works well for patients over the long term. I am very pleased that Biogen has decided to extend this important MS research in order to gain further insight on how patients treated very early with Avonex do over a 10-year period."
About the Study
CHAMPIONS is an open-label extension of CHAMPS, a randomized, double- blind, placebo-controlled Phase III clinical trial involving 383 patients who had just experienced their first MS attack and who had brain MRI scan abnormalities characteristic of MS. In CHAMPS, Avonex-treated patients experienced a 44% decrease in the rate of developing a second attack when compared to placebo over a three-year period. Based on the CHAMPS results, the U.S. Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) approved Avonex to be used in patients who have experienced a first clinical episode if they have brain MRI scan abnormalities consistent with MS.
The 203 MS patients who enrolled in the CHAMPIONS study were followed for a total of five years after their initial attack. Patients who began treatment with Avonex immediately after their first attack had a 35% decrease in the rate of developing a second attack and a 42% reduction in the median number of new or enlarging T2 hyperintense lesions, when compared to patients who began treatment with placebo. All of the patients in the CHAMPIONS study had received Avonex or placebo in the CHAMPS study. At the start of CHAMPIONS, 154 patients were continuing Avonex treatment, 14 patients were taking another treatment, and 35 patients were not on any therapy.
"MS is a chronic disease that requires therapies which can be used over a patient's lifetime," said Burt Adelman, M.D., Executive Vice President, Research and Development, Biogen. "Avonex is the first treatment to be approved in the United States and Europe for patients with MS at its earliest stage. Now we have even more data demonstrating that early initiation with Avonex can have a positive impact on the lives of people with MS."
MS is a chronic disease of the central nervous system that affects approximately 400,000 people in North America and approximately 1 million people worldwide. It is a disease of young adults, mostly women, with onset typically between 20 and 40 years of age. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.
The first sign that a patient may have MS is a single, clinical event, such as blurred vision, loss of balance, numbness, extreme fatigue, poor coordination, slurred speech or tremors. Until recently, the standard practice has been to treat MS only after patients experience at least two clearly defined events.
Avonex is the leading treatment for relapsing forms of multiple sclerosis worldwide, with more than 120,000 patients on therapy. It was launched in the U.S. in 1996 and later in Europe for the treatment of relapsing forms of MS to slow the progression of disability and reduce relapses. Avonex is marketed internationally in more than 65 countries. Avonex was the first treatment approved for MS patients who have their first clinical MS attack and have a brain MRI scan that suggests MS; this use was approved in Europe in 2002 and in the U.S. in 2003.
The most common side effects associated with Avonex treatment are flu-like symptoms including myalgia, fever, fatigue, headache, chills, nausea, vomiting, pain and asthenia.
Avonex should be used in caution with patients with depression or other mood disorders and in patients with seizure disorders. Avonex should not be used by pregnant women. Patients with cardiac disease should be closely monitored. Patients should also be monitored for signs of hepatic injury. Routine periodic blood chemistry and hematology tests are recommended during treatment with Avonex. Rare cases of anaphylaxis have been reported. Please see complete prescribing information available at http://www.Avonex. com.
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