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 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
- 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.