Betaseron® (interferon beta-1b)
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 it.
- The BENEFIT trial evaluated the impact of Betaseron on patients with CIS. The risk for developing clinically definite MS (CDMS) was reduced by approximately 50 percent at two years versus placebo-treated patients. The risk for confirmed progression of sustained disability was reduced by 40 percent at three years (but not at five years) in those receiving Betaseron from the onset of CIS, versus those people whose treatment was delayed. Positive cognitive effects were maintained at five years.
- Follow-up data after 16 years from Betaseron's initial Phase III trial of RRMS show continued effectiveness and safety. The results suggest that early treatment was more effective when given early in the course of the disease.
- In the BECOME study, new MRI techniques compared Betaseron to Copaxone in RRMS. The study found that enhancing lesions and clinical data were similar, but that there were fewer hypointense lesions ("black holes") in the Betaseron-treated patients.
- The BEYOND study compared Betaseron versus double-dose Betaseron versus Copaxone in early RRMS patients. All were well tolerated, and dramatically and equally reduced 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.
- The Phase IV BETAPATH study of 800 individuals and the related SEPLUS study of 70 patients are evaluating strategies to improve adherence to therapy. This includes the use of a personal digital assistant (PDA) and participation in the BetaPlus mentoring program.
- A Phase IV telephone interview study began in September 2009 and was scheduled for completion in April 2010. In this study, 372 individuals who had participated in the original pivotal Betaseron study, at 20 years after treatment, were interviewed. The primary outcome measure is to determine mortality EDSS (those who reached 10 on the EDSS scale), cognition, resource use, rate of conversion from RRMS to secondary-progressive MS (SPMS), and employment history by length of exposure to Betaseron.
- Preliminary data from the Betaseron Pregnancy Registry includes information on 69 women who became pregnant while exposed to Betaseron; there were 59 live births, eight spontaneous abortions, and two stillbirths. Among the live-born infants, birth defects were reported in three, a frequency consistent with that of the general population. These data do not suggest an increased risk for birth defects; however, caution is urged until the study is completed.