Betaseron
Interferon beta-1b - Information provided by Berlex, makers of Betaseron
What Is It And How Does It Work?
Betaseron is a type of protein called interferon. Several types of interferons are produced naturally by the body, and work with your immune system - your natural defense system that protects against infection and disease.
Research shows that Betaseron works to influence the immune response caused by MS. Betaseron was the first drug shown effective in the treatment of relapsing-remitting MS, setting the standard for MS therapy. Only Betaseron studies collected data for five years, on patients being treated with Betaseron and those not receiving the drug.
The MS Clinic, London Health Sciences Centre, University of Western Ontario, London, Ontario, Canada has also recently finished a 12 year study on the long-term efficacy and tolerability of Interferon beta-1b (Betaseron). "Favorable long-term tolerability, depression of MRI T2 lesion burden, and the disappearance of neutralizing antibodies (NABs) are reassuring to patients who have begun long-term treatment programs with interferon beta-1b. These factors may explain a treatment compliance of 61% after almost 12 years, which we consider remarkable for such a treatment", said Dr George Rice, director of the London Health Sciences Centre MS Clinic.1
What Kind of Results Can I Expect with Betaseron Therapy?
In a two-year, double blind study for Betaseron, neither the 372 patients nor their physicians knew who was receiving Betaseron or no treatment at all.Three groups of patients received subcutaneous injections (under the skin) every other day.
123 patients received a placebo (an inactive treatment)
125 patients received 0.05 mg (50mcg) of Betaseron
124 patients received .25mg (250mcg) of Betaseron
Results showed that patients on Betaseron had fewer attacks (exacerbations). When patients had an attack, the rate of the severe attacks was 51% less than the untreated patients. A reduction in the severity of an attack may make a difference in your ability to maintain normal daily activities.
Highlights from the Two-Year Study of Betaseron
When compared to those taking placebo, patients taking high-dose Betaseron (250mcg) had the following results:
31% fewer MS attacks or relapses per year
51% less frequent severe attacks
56% less moderate or severe attack days
20% fewer days of steroid treatment to help treat their attacks
48% fewer hospitalizations related to MS
Magnetic Resonance Imaging (MRI) results in the 372 patients showed:
A reduction in the total amount of brain lesion area (scar tissue) was seen in the treated group (250mcg dosage) compared to an increase in brain lesion area seen in the untreated group over 2 years.
In a subset of 52 patients, in which scans were done every six weeks, a reduction in the amount of new or expanding lesions was found over 2 years when compared to untreated patients.
In an independent study:
Patients were followed for a minimum of 7 months by monthly MRI and then began treatment.
Patients were treated with 250 mcg of Betaseron every other day.
93% of these patients had a significant reduction in the total or new amount of enhancing lesions.
Because of these results, 250mcg every other day is the recommended dose of Betaseron.
Taken every other day, it maintains a constant level of drug to fight your disease.
What Are Some of the Most Common Side Effects?
Flu-like symptoms are common, but usually dramatically decrease over time. Not all patients experience flu-like symptoms with Betaseron therapy. Reactions at the injections site are common. These, too, may decrease over time. Shortness of breath, menstrual disorders, and injection-site reactions (redness, pain, swelling) have also been reported.
Serious side effects include depression, suicide, suicidal ideation, and injection-site necrosis (skin breakdown, drainage of fluid, and tissue destruction), which has been reported in 5% of patients in a controlled MS trial. You should be aware of the important of rotating areas of injection with each dose, and of consulting with your physician if you experience any of the above signs or symptoms.
What Is MS Pathways?
Berlex Laboratories, makers of Betaseron, have created MS Pathways to support patients on Betaseron. It includes a training program, home express delivery service, personal patient assistant (PPA), Beta Advantage program for free injection supplies, reimbursement counselors, a website (http://www.betaseron.com), educational materials and a newsletter. It also includes an MS Pathways nurse, who is available 24 hours a day, 7 days a week to answer any questions you may have about side effects. The toll-free number is 1-800-788-1467.
1Forefronts of Neurology, Pub: Ithaca Center for Postgraduate Medical Education, Ithaca, NY, November 2001.
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