Rebif
This summary has been prepared by the Multiple Sclerosis Society
of Canada and reviewed for accuracy by the national medical
advisor.
Rebif (interferon beta-1a) is a beta-interferon that is produced
from mammalian cells using recombinant DNA techniques (a series
of procedures used to join together DNA segments). Beta-interferon
is a protein that occurs naturally in the human body in response
to initiating factors such as viruses. In MS, the main effects
of Rebif are to block the activity of certain immune system cells
and to
reduce the passage of these immune cells into the central nervous
system, where they cause inflammation and damage to myelin (the
insulating material that protects nerves and helps them work properly).
INDICATIONS AND USE
Health Canada approved Rebif in 1998 for the treatment of relapsing
forms of MS (in which persons still experience recurrent
attacks, such as relapsing-remitting MS and secondary-progressive
MS with relapses)
to reduce the number and severity of attacks, slow the progression
of physical disability, reduce the need for steroids and the
number of hospitalizations due to MS, and to reduce the number
of brain lesions seen on magnetic resonance imaging (MRI).
Relapsing-remitting MS is characterized by recurrent attacks
followed by complete or incomplete recovery. About one-half
of people with relapsing-remitting MS start to worsen within
10 years of diagnosis, with the possibility
of increasing levels of disability and continued relapses.
This is known as secondary-progressive MS.
Although Rebif did not affect progression of disability in
SPMS, clinical
trials have shown that people with SPMS with relapses experience
benefits
with respect to relapses and MRI disease activity compared
to those
receiving placebo.
DOSAGE
The usual dose of Rebif is 44 mcg three times per week. It
is also available in a dose of 22 mcg three times per week.
ADMINISTRATION Rebif is self-injected three times per week
under the skin (subcutaneously). Rebif is available in a pre-filled
syringe.
SIDE EFFECTS
The most common side effects of Rebif therapy include flu-like
symptoms (fatigue, chills, fever, muscle aches, and sweating)
and injection site reactions (swelling, redness, discolouration,
and pain). Most of these symptoms
tend to improve over time.
Less common side effects include some liver, blood and thyroid
problems,
as well as allergic reactions and depression.
NEUTRALIZING ANTIBODIES
Some people taking a beta-interferon therapy develop neutralizing
anti- bodies (NAb). It is not known if NAbs completely “neutralize” the
clinical benefits of therapy. Some research has found that
a higher NAb level may be associated with a lesser treatment
effect. Studies are continuing in this area, as is the development
of a standardized NAb test.
DRUG IDENTIFICATION NUMBER (DIN)
Rebif 22 mcg 02237319
Rebif 44 mcg 02237320
Rebif Initiation Pk 02281708
Rebif 66 mcg Multi-dose 02318253
Rebif 132 mcg Multi-dose 02318261
COST REIMBURSEMENT
Much of the cost can be reimbursed through private and group
health plans for people who meet the prescribing criteria,
and through provincial drug programs for individuals who
meet the prescribing criteria.
In addition, a program called the Multiple Support Program
is available
to assist persons in obtaining funding for Rebif therapy. For
more information
on this program, contact 1-888-677-3243 (English) or
1-877-777-3243 (French).
REIMBURSEMENT CRITERIA
Assistance with treatment costs varies among provinces and
private insurance companies. In most cases, to be reimbursed
an individual must have active relapsing-remitting MS (at
least 1 or 2 MS attacks in the 1 or 2 years prior to starting
treatment) and be ambulatory. The exact definition of “ambulatory” varies
among the provincial drug programs and private/group insurance
plans. For more information on reimbursement,
please contact your nearest division office at 1-800-268-7582,
or your
provincial government program office (telephone numbers are
listed under Provincial
Drug Programs - Contact Information).
CLINICAL TRIAL RESULTS
Clinical Trials
Note: Numerous clinical trials have been conducted for each
of the disease-modifying therapies. The clinical trials included
in this summary are those that have led to Health Canada approval
for the therapy to be prescribed and sold in Canada, or that
have led to provincial health ministries agreeing to reimburse
the cost of that therapy or to make a significant change to
the reimbursement criteria.
Clinical Trials in Relapsing-Remitting MS
PRISMS Study PRIS
MS: Prevention of Relapses and Disability by Interferon beta-1a
Subcutaneously in Multiple Sclerosis
The PRISMS study compared the effects of Rebif at two doses
(44 mcg and 22 mcg, three times per week) with placebo (a treatment
that has no active medication) in 560 persons with relapsing-remitting
MS. At 2 years, both doses of Rebif were shown to be more effective
than placebo in reducing the number and frequency of relapses.
With the higher dose of Rebif, the number of relapses was reduced
by about one-third. Rebif also delayed the progression of disability,
and a larger proportion of people were relapse-free with treatment
compared to placebo.1 [PRISMS
Study Group. Lancet 1998; 352: 1498-1504] A separate report
on MRI results found that Rebif reduced the number of brain
lesions compared to placebo.2 [Li
et al. Ann Neurol 1999; 46: 197-206]
Clinical Trials: Single Event Suggestive of MS
ETOMS Study
ETOMS: Effect of Early Treatment on Conversion to Definite
MS
This study examined the effects of Rebif on the occurrence
of MS attacks in 308 persons who were at risk of developing
clinically definite MS, but who were not yet diagnosed with
the disease. After 2 years of treatment, fewer persons in the
Rebif group developed clinically definite MS (34%) compared
to those in the placebo group (45%), which represents a 24%
reduction in risk. Rebif was also found to have a positive
effect on the relapse rate and MRI measures compared to placebo.3 [Comi
et al. Lancet 2001; 357: 1576-1582]
Clinical Trials in Secondary-Progressive MS
SPECTRIMS Study
SPECTRIMS: Secondary-Progressive Efficacy Clinical Trial of
Recombinant Interferon beta-1a in MS
In the SPECTRIMS study, 618 persons with secondary-progressive
MS were treated with either Rebif or placebo for 3 years. The
study found that Rebif did not slow disease progression in
people with secondaryprogressive MS. Rebif treatment was associated
with fewer relapses.4 [SPECTRIMS
Study Group. Neurology 2001; 56: 1496-1504] Rebif was also
associated with fewer brain lesions as measured by MRI.5 [Li
et al. Neurology 2001; 56: 1505-1513]
CURRENT CLINICAL TRIALS
A number of clinical trials involving the five disease-modifying
therapies are underway. The studies are examining the effectiveness
at different doses and the possible benefits of combining therapies.
For more information about clinical trials, please visit the
MS Society of Canada website by going to www.mssociety.ca and
click on Research.
PHARMACEUTICAL COMPANY
EMD Serono Canada Inc. 1075 North Service Rd W., Suite 100
Oakville, Ontario L6M 2G2
FURTHER INFORMATION
Further information for persons with MS is available through
the Multiple Support Program at 1-888-677-3243 (English)
or 1-877-777-3243 (French).
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References
- PRISMS
Study Group. Randomised double-blind placebo-controlled study
of interferon beta-1a in relapsing/remitting multiple sclerosis.
Lancet 1998; 352: 1498-1504.
- Li DKB,
Paty DW, and the UBC MS/MRI Analysis Research Group and the
PRISMS Study Group. Magnetic resonance imaging results of the
PRISMS trial: a randomized, double-blind, placebo-controlled
study of interferon-beta1a in relapsing-remitting multiple
sclerosis. Ann Neurol 1999; 46: 197-206.
- Comi
G, Filippi M, Barkhof F, et al. Effect of early interferon
treatment on conversion to definite multiple sclerosis: a randomised
study Lancet 2001; 357: 1576-1582.
- SPECTRIMS
Study Group. Randomized controlled trial of interferon beta-1a
in secondary progressive MS. Neurology 2001; 56: 1496-1504.
- Li DKB,
Zhao GJ, Paty DW, et al. Randomized controlled trial of interferon
beta-1a in secondary progressive MS: MRI results. Neurology
2001; 56: 1505-1513.
The drug information contained in this publication
has been obtained from the manufacturers’ product monographs.
Consult the package insert for more
detailed information about the product’s indications, contraindications,
medical use and side effects. If you are taking any of the medications
listed above, do not change the dose or stop taking your medication
without consulting your physician first.
Avonex® is a registered trademark of Biogen Idec Canada Inc.
Betaplus® is a registered trademark of Bayer HealthCare Pharmaceuticals
Betaseron® is a registered trademark of Bayer HealthCare Pharmaceuticals
Copaxone® is a registered trademark of Teva Neuroscience
Extavia® is a registered trademark of Novartis Pharmaceuticals
Canada Inc.
Gilenya® is a registered trademark of Novartis Pharmaceuticals
Canada Inc.
Gilenya GO Program® is a registered trademark of Novartis Pharmaceuticals
Canada Inc.
MS Alliance® is a registered trademark Biogen IDEC Canada
Rebif® is a registered trademark of EMD Serono Canada Inc.
Multiple Support Program® is a registered trademark of EMD Serono
Canada Inc.
Shared Solutions® is a registered trademark of Teva Neuroscience
Tysabri® is a registered trademark of Biogen Idec Canada Inc.
and Elan Pharmaceuticals
Tysabri Care Program® is a registered trademark of Biogen Idec
Canada Inc. and Elan Pharmaceuticals
© 2010, National Multiple Sclerosis Society
This resource has been adapted by the Multiple Sclerosis Society of Canada with
permission of the National Multiple Sclerosis Society (USA).
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