Betaseron® (interferon beta-1b)

Parent company: Bayer HealthCare Pharmaceuticals

• Administered by subcutaneous injection every other day; dose is 250 mcg.
  
  
• Approved for relapsing forms of MS in 1993, and more recently, for individuals with CIS.
  
  
• Betaseron reduces the number and severity of exacerbations (attacks) of MS. It also stabilizes the total lesion area as measured by MRI, compared to those without treatment.
  
  
• Interferons appear to reduce inflammation by modulating a favorable balance between cells that increase inflammation and cells that decrease inflammation. They also prevent the transport of damaging lymphocytes into the brain. Lymphocytes are immune-system cells produced to fight infection and disease.
  
  
• Follow-up data after 21 years from Betaseron's initial Phase III trial of RRMS show continued effectiveness and safety, as well as increased longevity. The results suggest that treatment was more effective when given early in the course of the disease, and a more favorable outcome can be seen for those patients who received the active drug in the very first trials, when compared to those who initially received placebo and could later switch to any diseasemodifying therapy.
  
  
• Improved effects of early treatment were also demonstrated in a group of 468 patients with CIS who were randomized to active treatment or placebo. By five years, the treated group showed greater improvement in scores on the Paced Auditory Serial Addition Test (PASAT), a measure of cognitive function.
  
  
• The small SMART study of 25 patients with RRMS was designed to identify immune markers of Betaseron therapy. Immune markers are tendencies or indicators that are observed across a population with a particular disease state. Immune markers in this study were compared in those patients with and without relapses during the first year of treatment.
  
  
• Data from the study have now been analyzed, and the treated group showed significant changes in the levels of several immune-system markers. Twelve relapses occurred in 11 patients. A trend toward higher levels in the pro-inflammatory cytokine interleukin-17 (IL-17) was found in the relapsing group. Cytokines are small proteins that may stimulate or inhibit the function of other cells. Higher brain-derived neurotrophic factor (BDNF) levels were observed in the relapse-free group. BDNF is a protein found in the brain that helps to support nerves and their development.
  
  
• The data suggest that the mode of action of the beta interferons may involve a shift in cytokines in favor of an anti-inflammatory/regulatory profile. Findings also suggest that elevated IL-17 may correlate with having relapses, while increased levels of another cytokine, BDNF, may be protective. These findings serve as a platform for further research of biomarkers predictive of responses to interferon therapy.