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 and individuals with CIS.


• Betaseron reduces the number and severity of exacerbations (attacks) of MS. It also stabilizes the total lesion area as compared to those without treatment.


• Interferons appear to reduce inflammation by modulating a favorable balance between cells that increase inflammation and cells that decrease it.


• The BENEFIT trial evaluated the impact of Betaseron on patients with CIS. The risk for developing clinically definite MS (CDMS) was reduced by 41 percent at two years versus placebo-treated patients. The risk for confirmed progression of sustained disability was reduced by 40 percent at three years in those receiving Betaseron from the onset of CIS, versus those people whose treatment was delayed. A positive effect on cognition has also been demonstrated over the five years of the study.


• Follow-up data after 16 years from Betaseron's pivotal placebo-controlled trial of RRMS, which led to marketing approval of the drug, show continued effectiveness and safety. The results suggest that early treatment was more effective when given at the first sign of the disease than if treatment is delayed.


• A new, thinner-gauge needle and autoinjector provide for greater satisfaction and comfort. These improvements are associated with fewer injection-site reactions, which can enhance compliance and increase comfort.


• Combination and Comparative studies: The BRIGHT study of the relative tolerability of Betaseron versus Rebif favored Betaseron. Rebif has been reformulated but this newer formulation is not yet available in the United States; it may become approved in the near future.


• In the BECOME study, new MRI techniques compared Betaseron to Copaxone in RRMS. The study found that enhancing lesions and clinical data were similar.


• The BEYOND study compared Betaseron versus double-dose Betaseron versus Copaxone. All were well tolerated, while dramatically and equally reducing relapses. The T2-lesion volume MRI data favored Betaseron. As a result of this study, double-dose Betaseron will not be pursued since it was no more effective than the standard dose of Betaseron or Copaxone in clinical outcomes.