Avonex® (interferon beta-1a)
Combination and Comparative Studies:
- Taken via weekly intramuscular injections;
dosage is 30 mcg (micrograms).
- The FDA approved Avonex in 1996 for relapsing
MS and more recently for individuals with
clinically isolated syndrome (CIS).
- Avonex has been shown to reduce the number
of relapses and lesions on MRI, as well as
slowing the progression of physical disability.
The drug has been shown to be both safe and
- 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 ASSURANCE study includes 15-year data
and shows that early suppression of clinical
disease activity by Avonex is a marker of
treatment response. This is associated with
significant long-term benefits for quality of life
as compared to patients who had received
placebo. These results support other
accumulating evidence that short-term
responders to Avonex also experience beneficial
- A 10-year analysis of data from the CHAMPS
trial, which treated patients with CIS and a
positive MRI, showed that although some had
characteristics of disease progression, there was
evidence of improved disease course with early
treatment. These results emphasize the value of
early treatment. This effect remained evident in
both the CHAMPIONS five- and 10-year
- The Phase III clinical trial (ADVANCE) continues
to enroll patients with relapsing-remitting MS
(RRMS) to determine the safety and efficacy of
BIIB017 (a "PEGylated" version of Avonex), as
compared to placebo. PEGylation is a chemical
modification of the interferon beta-1a (Avonex)
molecule that allows it to be given
subcutaneously (under the skin) every two or
four weeks, in contrast to the current once-aweek,
deeper, intramuscular injection. The goal
is to reduce the number of injections and the
need for deep injections, while maintaining the
positive effect of the drug.
- Of approximately 1,260 ADVANCE participants,
up to 120 will also be enrolled in a sub-study that
will involve optical coherence tomography
(OCT). This is a rapid, noninvasive, office-based
imaging technique that allows objective
evaluation of the thickness of the retinal axon
(the nerve behind the eye) and nerve layers that
atrophy (shrinking due to nerve cell death) in MS.
Preliminary evidence supports the use of OCT as
an objective tool to monitor the effectiveness of
therapy, and it is hoped that OCT may be used
as an outcome measure in future studies.
- The ongoing Phase III CombiRx trial for RRMS is
comparing three treatment arms: Avonex with
Copaxone, Avonex alone, and Copaxone alone.
The study has 1,008 participants; it began in 2005
and is scheduled for completion in July of 2012.