Avonex

Avonex (interferon beta-1a) is a type of protein called 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 occurs naturally in the human body in response to initiating factors such as viruses. In MS, the main effects of Avonex 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 Avonex in 1998 for the treatment of relapsing forms of MS to slow the progression of disability, decrease the frequency of MS attacks, and reduce the number and volume of brain lesions seen on magnetic resonance imaging (MRI). 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.

Health Canada approved Avonex in 2003 for the treatment of people at
risk of developing clinically definite MS (CDMS), so as to delay the onset
of clinically definite MS and to decrease the number and volume of active
brain lesions on MRI. Before Avonex is initiated, people at risk of developing
CDMS must have brain lesions on MRI and other possible diagnoses
must be ruled out.

DOSAGE
The recommended dose of Avonex is 30 mcg once per week.

ADMINISTRATION
Avonex is self-injected once per week into the muscle (intramuscularly). The medication is now available as a pre-filled syringe.

SIDE EFFECTS
The most common side effects of Avonex therapy include flu-like symptoms (fatigue, chills, fever, muscle aches, and sweating). Most of these symptoms tend to improve over time. Less common side effects include injection site reactions (swelling, redness, discolouration, and pain), some liver, blood and thyroid problems, allergicreactions 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. The level of NAbs associated with the use of Avonex is lower than that seen during treatment with the other two beta-interferons. Studies are continuing in this area, as is the development of a standardized NAb test.

DRUG IDENTIFICATION NUMBER (DIN)
02237770; 02269201 for the pre-filled syringe

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.

REIMBURSEMENT CRITERIA
Assistance with treatment costs varies among provinces and private insurance companies. In most cases, to be reimbursed an individualmust 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. In Ontario and Quebec, Avonex can be reimbursed for persons at high risk of developing MS who meet specific criteria. 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

MSCRG Study

MSCRG: Multiple Sclerosis Collaborative Research Group Study

In this clinical trial, 301 people with relapsing-remitting MS were treated
with either Avonex at a dose of 30 mcg once per week or placebo (a treatment that has no active medication) for over 2 years. Results of the study showed that Avonex delayed the time to sustained progression of disability compared to placebo. The proportion of patients who progressed was reduced 37% (21.9% vs. 34.9%). Avonex reduced the annual attack rate by 18-32% compared to placebo and also reduced the number of brain lesions on MRI.¹
[Jacobs et al. Ann Neurology 1996; 39: 285-294]

Clinical Trials: Single Event Suggestive of MS

CHAMPS Study

CHAMPS: Controlled High-Risk Subjects Avonex Multiple Sclerosis Prevention Study

This study examined whether Avonex could reduce conversion to clinically definite MS in people who had a single neurological event suggestive of MS (an event involving the optic nerve, brain stem/cerebellum, or spinal cord) but who had not been diagnosed with MS. A total of 383 persons were treated with Avonex or placebo for up to 3 years. Treatment with Avonex resulted in a 44% reduction in the chance of having a second MS attack over the three-year period.² [Jacobs et al. N Engl J Med 2000; 343: 898-904]

CURRENT CLINICAL TRIALS
A number of clinical trials involving the five disease-modifying therapies are underway. The studies are examining the effectiveness at differentdoses 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
Biogen Idec Canada 3 Robert Speck Parkway Mississauga, Ontario L4Z 2G5

FURTHER INFORMATION
Further information for persons with MS is available through MS Alliance at 1-888-456-2263.

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References

1. Jacobs LD, Cookfair DL, Rudick RA, et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG). Ann Neurology 1996; 39: 285-294.


2. Jacobs LD, Beck RW, Simon JH, et al. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group. N Engl J Med 2000; 343: 898-904.
   

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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