Rebif® (interferon beta-1a)
EMD Serono, Inc. and Pfizer Inc
A German study looked at the effects of
interferons and Copaxone on pregnancy and
relapse rate. This study re-confirmed the
reduced MS relapse rate during pregnancy and
the increased relapse rate after birth. Exclusive
breastfeeding seemed to have beneficial
effects on postpartum relapse-rate reduction.
While these data also support previous findings
that the interferons and Copaxone do not
present a major risk for birth defects, anyone
who is pregnant or plans on becoming
pregnant should discuss the risks and the
benefits with her doctor before starting or
continuing any disease-modifying therapy.
- Administered by subcutaneous injection three
times weekly; dosage is 22 or 44 mcg. The 44
mcg dose appears significantly more effective
than 22 mcg, and 44 mcg is the dose most often
used in the United States.
- Approved for relapsing types of MS.
Rebif reduces the frequency of relapses and
slows the progression of disability. It has also
been shown to reduce MRI lesion area and
activity compared to placebo.
- 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.
- The REFLEX study of 517 patients is comparing
the efficacy of two dosing frequencies (once or
three times per week) of Rebif versus placebo.
The effect studied is the conversion to definite MS
in patients with clinically isolated syndrome (CIS),
which is also referred to as a "first demyelinating
event." The primary endpoint was the time to
confirmed MS using the McDonald criteria, which
is a set of guidelines used to confirm a diagnosis
ofMS. The secondary endpoint was time to
clinically definiteMS (CDMS). Rebif significantly
delayed development ofMS as compared with
placebo. This conversion was more pronounced
with the higher dose (44 mcg three times weekly).
- The Phase IV SKORE study continues to evaluate
cognition and fatigue in people with RRMS
treated with Rebif. Its primary outcome measure
is the percentage of patients with stable or
altered cognition status; secondary outcome
measures include the proportion of relapse-free
subjects and the proportion with defined EDSS
changes. "EDSS" refers to the Kurtzke Expanded
Disability Status Scale, which uses numbers from
one to 10 to measure degree of disability,
largely in terms of mobility. The study has 300
participants; it was initiated in June 2009 and is
scheduled for completion in November 2013.
- A Phase IV observational study is ongoing but is
not recruiting participants. It is evaluating the
effectiveness of Rebif therapy on quality of life,
using two health-related, quality-of-life measures.
- A multi-center, observational, 96-week Phase IV
study is evaluating whether the use of the
RebiSmart™ self-injection system improves
compliance with Rebif in subjects with relapsing
forms of multiple sclerosis.