Betaseron® (interferon beta 1-b)

• 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 therapy leads to a decreased number of exacerbations (attacks) of MS, increases time between exacerbations, and generally less severe exacerbations as compared to those taking a lower dose or no medications, and stabilization of the total lesion area as compared to those without treatment.


• Interferons may affect the immune system by decreasing damaging cells, while increasing cells that suppress inflammation. They may also reduce the transport of potentially damaging immune-system cells from entering the brain.


• The BENEFIT trial evaluated the impact of Betaseron on patients with CIS; over the three-year period, the risk for confirmed progression of permanent disability was reduced by 40 percent, while patients were 41 percent less likely to progress to clinically definite MS (CDMS).


• 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.


• 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.


• The BECOME study is using new MRI techniques to compare Betaseron versus Copaxone in RRMS; enhancing lesions and clinical data were similar, while MRI black-hole data favored Betaseron.


• The BEYOND study compared Betaseron versus double-dose Betaseron versus Copaxone. All were well-tolerated, and dramatically and equally reduced relapses (primary outcome). 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.