Betaseron

Betaseron (interferon beta-1b) is a beta-interferon that is produced from bacterial 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 Betaseron 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 Betaseron in 1995 for the treatment of people with relapsing-remitting MS who are ambulatory (able to walk) to reduce the frequency of attacks. Relapsing-remitting MS is characterized by recurrent attacks followed by complete or incomplete recovery.

Betaseron was approved by Health Canada in 1999 for the treatment of secondary-progressive MS to slow the progression of disability and to reduce the frequency of MS attacks. 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.

Health Canada has also approved Betaseron for the treatment of people at risk of developing clinically definite MS (CDMS) accompanied by at least two lesions on MRI to delay the progression to clinically definite MS. Before Betaseron is initiated, alternative diagnoses must be ruled out.

DOSAGE
The recommended dose of Betaseron for both relapsing-remitting and
secondary-progressive MS is 250 mcg every other day.

ADMINISTRATION
Betaseron is self-injected every other day under the skin (subcutaneously). Betaseron is available in a diluent pre-filled syringe. A diluent is a diluting agent. With Betaseron, the syringes are pre-filled with a salt-water solution to mix with the active medication, which is in a powder form.

SIDE EFFECTS
The most common side effects of Betaseron 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)
02169649

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 Bridging the Gap is available to provide
financial help for people with insurance or government program copayments
or deductibles. For more information, call 1-800-977-2770.

REIMBURSEMENT CRITERIA
Assistance with treatment costs varies among provinces and private CRITERIA 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 provincial health ministries
to agree to reimburse the cost of that therapy or to make a significant
change to the reimbursement criteria.

Clinical Trials in Relapsing-Remitting MS

Interferon Beta Multiple Sclerosis Study Group

In this clinical trial, 372 people with relapsing-remitting MS received
Betaseron at a dose of either 1.6 MIU or 8 MIU, or placebo (a treatment that has no active medication) for 2 years. Compared to placebo, Betaseron reduced the annual attack rate by about 30%.¹ [The IFNB Multiple Sclerosis Study Group. Neurology 1993; 43: 641-643]. Betaseron also reduced disease activity, as measured by magnetic resonance imaging (MRI), by 80% compared to placebo.²[Paty & Li. Neurology 1993; 43(4): 662-667] MRI is a powerful tool that provides images of the brain, spinal cord, or other areas of the body. It is often used in MS to identify areas of inflammation.

Clinical Trials in Secondary-Progressive MS

European Study in Secondary-Progressive MS

In this study, 718 people with secondary-progressive MS received either
Betaseron or placebo for up to 3 years. Compared to placebo, Betaseron
delayed progression of disability for 9-12 months. Betaseron
the attack rate by 31%.³ In this study, 718 people with secondary-progressive MS received either Betaseron or placebo for up to 3 years. Compared to placebo, Betaseron delayed progression of disability for 9-12 months. Betaseron also reduced the attack rate by 31%.⁴ [Miller et al. Ann Neurol 1999; 46:
850–859] The final analysis (mean 35 month follow-up) of this study
confirmed the benefits of Betaseron over placebo with respect to
progression and relapses.⁵ [Kappos et al. Neurology 2001; 57: 1969-1975]

North American Study in Secondary-Progressive MS

The North American study of Betaseron involved 939 individuals with
secondary-progressive MS. In this trial, treatment with Betaseron failed to show a significant difference in the time to progression compared to placebo, although there were improvements in relapses and MRI brain lesions.⁶ [North American Study Group on Interferon Beta-1b in Secondary Progressive MS. Neurology 2004; 63: 1788-1795]

Clinical Trials: Single Event Suggestive of MS

BENEFIT trial

BENEFIT: Betaferon in Newly Emerging Multiple Sclerosis for Initial Treatment
This study examined whether Betaseron could reduce conversion to clinically
definite MS in people who had a first clinical event suggestive of MS (an event involving the optic nerve, brain stem/cerebellum, or spinal cord) and at least two clinically silent brain lesions on MRI. A total of 468 were treated with Betaseron or placebo for up to 2 years. The probability of developing clinically definite MS over 2 years was 45% with placebo compared to 28% with Betaseron, for an absolute risk reduction of 17% and a relative risk reduction of 38%.⁷ [Kappos et al. Neurology 2006; 67: 1242-1249]

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
Bayer HealthCare Pharmaceuticals 77 Belfield Rd. Toronto, Ontario M9W 1G6

FURTHER INFORMATION
Further information for persons with MS is available through MS Pathways at 1-800 977-2770.

Back to top

References

1. The IFNB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology 1993; 43: 641-643.


2. Paty DW, Li DK. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. II. MRI analysis results of a multicenter, randomized, double-blind, placebo-controlled trial. UBC MS/MRI Study Group and the IFNB Multiple Sclerosis Study Group. Neurology 1993; 43: 662-667.


3. European Study Group on Interferon Beta-1b in Secondary-Progressive MS. Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary-progressive multiple sclerosis. Lancet 1998; 352: 1491-1497.


4. Miller DH, Molyneux PD, Barker GJ, et al. Effect of interferon-beta1b on magnetic resonance imaging outcomes in secondary progressive multiple sclerosis: results of a European multicenter, randomized, double-blind, placebo-controlled trial. Ann Neurol 1999; 46: 850–859.


5. Kappos L, Polman C, Pozzilli C, et al. Final analysis of the European multicenter trial on IFNbeta-1b in secondary-progressive MS. Neurology 2001; 57: 1969-1975.


6. North American Study Group on Interferon Beta-1b in Secondary Progressive MS. Interferon beta-1b in secondary progressive MS: results from a 3-year controlled study. Neurology 2004; 63: 1788-1795


7. Kappos L, Polman CH, Freedman MS, et al. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinical isolated syndromes. Neurology 2006; 67: 1242-1249.

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).

Back to top