BARI, ITALY -- December 10, 2001 -- The use of interferon beta-1a (Avonex®) for the treatment of relapsing-remitting multiple sclerosis (RRMS) stabilizes the disease by delaying progression of patient disability, according to an independent study presented at the 17th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2001) in September.
The study found that Avonex, when compared to interferon beta-1b (Betaseron® in United States; Betaferon outside the U.S.), might also favorably impact the quality of life of patients with multiple sclerosis (MS).
The study found that both Avonex and Betaseron demonstrated efficacy in reducing relapses associated with RRMS. Avonex dosed once weekly reduced relapses by 65 percent, compared to 59 percent in the Betaseron group dosed every 48 hours.
"This study confirms that treatment with both interferon beta therapies is well tolerated and effective for patients with relapsing-remitting MS," said Professor Maria Trojano, Neurologist in charge of the MS Center, at the Department of Neurological and Psychiatric Sciences, directed by Professor Paolo Livrea, University of Bari, Bari, Italy, and lead investigator of the study. "However, patients treated with interferon beta-1a may have a better compliance rate than patients treated with interferon beta-1b due to the infrequency of adverse events."
Patients treated with Avonex experienced a lower incidence of side effects during treatment initiation. In the first three months of treatment, patients treated with Betaseron experienced more clinical and hematologic side effects compared with Avonex patients.
Even though the incidence of side effects declined during the first year of treatment, patients treated with Betaseron continued to experience more injection-site reactions. Fewer Avonex patients discontinued treatment during the trial than did patients treated with Betaseron (9 percent versus 19 percent).
The population-based surveillance study was conducted to evaluate the efficacy and safety of Avonex and Betaseron in RRMS patients. Relapse rates, Expanded Disability Status Scale (EDSS) scores, adverse events, and study dropouts were evaluated every three months during the two-year study. Of the patients enrolled, 408 patients completed two years of treatment with either Avonex (177 patients) or Betaseron (231 patients). Patients in both treatment groups had significant reduction in relapse rates at all time points compared with baseline. While no differences were shown in mean relapse rates or mean EDSS scores from baseline to year two, patients in the Avonex treated group experienced no significant change in EDSS scores, which measure physical disability, compared to a significant increase over baseline in the Betaseron- treated group.
The study, led by researchers at the University of Bari in Bari, Italy and conducted through a network of 16 specialized MS Centers throughout southern Italy, enrolled 1,033 patients with RRMS. Results also showed that age at treatment onset and the pre-treatment disease duration and relapse rate are all factors influencing the clinical response to treatment. These findings suggest that the earlier patients start on treatment, the better they will respond to therapy.
The most common side effects experienced by enrollees treated with Avonex compared to Betaseron included fever (50 percent vs. 70 percent), depression (6 percent vs. 14 percent), leukopenia (increased risk of infection) (6 percent vs. 22 percent), anemia (reduction in the concentration of red blood cells) (5 percent vs. 18 percent), and thrombocytopenia (reduction in the number of platelets) (1 percent vs. 4 percent).
Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 Americans and about one million individuals 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 disease is believed to be 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.
SOURCE University of Bari
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