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.