Copaxone

This summary has been prepared by the Multiple Sclerosis Society of Canada and reviewed for accuracy by the national medical advisor.

Copaxone (glatiramer acetate) is a synthetic protein made up of a combination of four amino acids that chemically resemble a component of myelin (the insulating material that protects nerves and helps them work properly). Copaxone induces the production of immune cells that are less damaging to myelin.

INDICATIONS AND USE
Health Canada approved Copaxone in 1997 for the treatment of people with relapsing-remitting MS who are ambulatory (able to walk) to reduce the frequency of attacks and to reduce the number and volume of active brain lesions identified on MRI. Relapsing-remitting MS is characterized by recurrent attacks followed by complete or incomplete recovery.

Health Canada approved Copaxone in 2009 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 and overall disease burden on MRI. Before Copaxone 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 Copaxone is 20 mg per day.

ADMINISTRATION
Copaxone is self-injected every day under the skin (subcutaneously). Copaxone is available in pre-filled syringes that are ready for injection.

SIDE EFFECTS
The most common side effects of Copaxone therapy are injection-site reactions. Less common side effects include some of the following symptoms immediately after an injection: flushing, chest pain, palpitations (irregular beating of the heart), anxiety, and difficulty breathing. However, these symptoms are usually temporary and do not require specific treatment.

NEUTRALIZING ANTIBODIES
GA-reactive antibodies are not neutralizing and do not alter the principal immunological effects of GA.

DRUG IDENTIFICATION NUMBER (DIN)
02245619

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 Copaxone Assistance Program is available to provide financial help for people with insurance or government program co-payments or deductibles. For more information, contact Shared Solutions at
1-800-283-0034.

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: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

Phase III Trial of Copaxone

In this clinical trial, 251 persons with relapsing-remitting MS were randomized to receive either Copaxone or placebo for 2 years. Study participants treated with Copaxone showed a 29% reduction in relapses compared to placebo.¹
[Johnson et al. Neurology 1995; 45: 1268-1276]

European/Canadian MRI Study

This study examined the effect of Copaxone on disease activity in 239
(continued) persons with relapsing-remitting MS. Patients were monitored by 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. Results of the study showed that treatment
with Copaxone was associated with fewer MRI brain lesions than was placebo. The relapse rate was also reduced by one-third with Copaxone compared to placebo.² [Comi et al. Neurology 2001; 49: 290-297]

Clinical Trials: Single Event Suggestive of MS

PreCISe trial in Clinically Isolated Syndrome (CIS)

This study examined whether Copaxone could delay the 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 brain lesions on MRI. A total of 481 were treated
with Copaxone or placebo for up to 3 years. According to the pre-planned
interim analysis, the probability of developing clinically definite MS was
43% with placebo compared to 25% with Copaxone, for an absolute risk
reduction of 18% and a relative risk reduction of 45%.³ [Comi G. Abstract LBS.003, AAN 2008.]

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
Teva Neuroscience 999 Boul. de Maisonneuve W., Suite 550 Montreal, Quebec H3A 3L4

FURTHER INFORMATION
Further information for persons with MS is available by contacting Shared Solutions at 1-800-283-0034.

References

Johnson KP, Brooks BR, Cohen JA, et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebocontrolled trial. The Copolymer 1 Multiple Sclerosis Study Group. Neurology 1995; 45: 1268-1276.

Comi G, Filippi M, Wolinsky JS. European/ Canadian multicenter, double-blind, randomized, placebocontrolled study of the effects of glatiramer acetate on magnetic resonance imaging-measured disease activity and burden in patients with relapsing multiple sclerosis. European/ Canadian Glatiramer Acetate Study Group. Ann Neurology 2001; 49: 290-297.

Comi G. Treatment with glatiramer acetate delays conversion to clinically definite multiple sclerosis (CDMS) in patients with clinically isolated syndromes. Abstract LBS.003. 60th annual meeting of the American Academy of Neurology, Chicago IL, April 12-19, 2008.

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).