AN IMMUNOMODULATOR WITH DEMONSTRATED EFFICACY1

COPAXONE® (glatiramer acetate injection) has a clinical profile demonstrated across 5 clinical trials.1 Select 1 of the 5 trials to view study data, or scroll down.

Khan 2013 GALA

A 12-month, double-blind, placebo-controlled, multinational study. Patients with RRMS were randomized to receive 3-times-a-week COPAXONE® 40 mg/mL (n=943) or placebo (n=461). The primary endpoint was total number of confirmed relapses.1,2

Baseline Patient Characteristics2
Prestudy number of relapses, mean over 1 year (±SD)

Placebo (n=461)

1.3 (0.6)

COPAXONE® 40 mg/mL (n=943)

1.3 (0.6)

T2 lesion volume, mean (±SD)

Placebo (n=461)

17.4 mL (17.4)

COPAXONE® 40 mg/mL (n=943)

19.7 mL (20.7)

Number of T1-enhancing lesions, mean (±SD)

Placebo (n=461)

1.4 (3.7)

COPAXONE® 40 mg/mL (n=943)

1.7 (4.7)

3-times-a-week COPAXONE® 40 mg/mL significantly reduced relapses at 1 year.1,2

Clinical study results for COPAXONE® treatments of 40mg/mL 3-times-a-week.

3-times-a-week COPAXONE® 40 mg/mL significantly reduced T1 lesions at 1 year.2

Clinical study results for COPAXONE® treatments of 40mg/mL 3-times-a-week.

3-times-a-week COPAXONE® 40 mg/mL significantly reduced the number of new or enlarging T2 lesions at 1 year.2

Clinical study results for COPAXONE® treatments of 40mg/mL 3-times-a-week.

Comi 2009 PreCISe

A 3-year, multi-country, multicenter, randomized, placebo-controlled, double-blind study in which 481 subjects with clinically isolated syndrome (CIS) were equally randomized into 2 parallel treatment groups: COPAXONE® 20 mg/mL (n=243) or matching placebo (n=238) administered once daily as a subcutaneous (SC) injection. The primary endpoint of the intent-to-treat analysis was time to conversion to clinically definite MS.1,3

Baseline Patient Characteristics3
Number of GdE lesions per patient, mean (±SD)

Placebo (n=238)

1.6 (2.9)

COPAXONE® 20 mg/mL (n=243)

1.3 (2.8)

Number of T2 lesions, mean (±SD)

Placebo (n=238)

29.9 (26.3)

COPAXONE® 20 mg/mL (n=243)

33.0 (34.4)

In CIS, COPAXONE® significantly delayed time to second clinical event by more than a year (386 days).3

Clinical study results for COPAXONE® 20mg/mL daily treatments.

Secondary endpoint: 42.4% reduction in patients experiencing a second clinical event within 36 months among patients taking COPAXONE® compared to those taking placebo (24.7%, n=243 vs 42.9%, n=238, respectively; P<0.0001)1.

In CIS, COPAXONE® significantly reduced new T2 lesions.3

Clinical study results for COPAXONE® 20mg/mL daily treatments.

Comi 2001

A double-blind, placebo-controlled study to determine the effect of COPAXONE® on the cumulative number of enhancing lesions found on monthly MRI in patients with RRMS (N=239; 119 COPAXONE®, 120 placebo) for 9 months. The primary outcome measure was the total number of enhancing lesions on T1-weighted images.1,4

Baseline Patient Characteristics4
Number of GdE lesions per patient, mean (±SD)

Placebo (n=120)

4.4 (7.1)

COPAXONE® 20 mg/mL (n=119)

4.2 (4.8)

T2 lesion volume (mL), mean (±SD)

Placebo (n=120)

20.5 (18.8)

COPAXONE® 20 mg/mL (n=119)

20.0 (17.2)

In RRMS, COPAXONE® significantly reduced disease activity as measured by T1 GdE lesions.4

Clinical study results for COPAXONE® 20mg/mL treatments.

Johnson 1995

Double-blind, randomized, placebo-controlled, multicenter trial of glatiramer acetate in patients with RRMS (N=251; 125 COPAXONE®, 126 placebo).1,5

Baseline Patient Characteristics5
Duration of disease, mean years (±SD)

Placebo (n=126)

6.6 (5.1)

COPAXONE® 20 mg/mL (n=125)

7.3 (4.9)

EDSS score, mean (±SD)

Placebo (n=126)

2.4 (1.3)

COPAXONE® 20 mg/mL (n=125)

2.8 (1.2)

Prior exacerbation rate, mean over 2 years (+/-SD)

Placebo (n=126)

2.9 (1.1)

COPAXONE® 20 mg/mL (n=125)

2.9 (1.3)

In RRMS, COPAXONE® reduced relapses.1,5

 Clinical study results for COPAXONE® 20mg/mL treatments.

Bornstein 1987

A 2-year, single-center, randomized study in which 50 subjects received daily doses of either COPAXONE® 20 mg/mL SC or placebo (COPAXONE®: n=25; placebo: n=25).1,6

Baseline Patient Characteristics6
Duration of disease, average years*

Placebo (n=25)

6.1

COPAXONE® 20 mg/mL (n=25)

4.9

DSS score, average

Placebo (n=25)

3.2

COPAXONE® 20 mg/mL (n=25)

2.9

Prior exacerbation rate, average over 2 years*

Placebo (n=25)

3.9

COPAXONE® 20 mg/mL (n=25)

3.9

In RRMS, COPAXONE® significantly reduced relapses.6

Primary endpoint: 56% of COPAXONE® patients were free of relapse at 2 years vs 28% of placebo patients (P=0.085).1

Clinical study results for COPAXONE® 20mg/mL treatments.

Review safety data for COPAXONE®.

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Click on a link or scroll down to see the studies.

Indication

COPAXONE® is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Important Safety Information

Contraindication: COPAXONE® is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.

Immediate Post-Injection Reaction: Approximately 16% of patients exposed to COPAXONE® 20 mg per mL compared to 4% of those on placebo, and approximately 2% of patients exposed to COPAXONE® 40 mg per mL compared to none on placebo experienced a constellation of symptoms that may occur immediately (within seconds to minutes, with the majority of symptoms observed within 1 hour) after injection and included at least 2 of the following: flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, throat constriction, and urticaria. In general, these symptoms have their onset several months after the initiation of treatment, although they may occur earlier, and a given patient may experience 1 or several episodes of these symptoms. Typically, the symptoms were transient and self-limited and did not require treatment; however, there have been reports of patients with similar symptoms who received emergency medical care.

Chest Pain: Transient chest pain was noted in 13% of COPAXONE® 20 mg per mL patients compared to 6% of placebo patients, and approximately 2% of COPAXONE® 40 mg per mL patients compared to 1% on placebo. While some episodes of chest pain occurred in the context of the Immediate Post-Injection Reaction described above, many did not. The temporal relationship of this chest pain to an injection was not always known. The pain was usually transient, often unassociated with other symptoms, and appeared to have no clinical sequelae. Some patients experienced more than 1 such episode, and episodes usually began at least 1 month after the initiation of treatment.

Lipoatrophy and Skin Necrosis: At injection sites, localized lipoatrophy and, rarely, injection site skin necrosis may occur. Lipoatrophy may occur at various times after treatment onset (sometimes after several months) and is thought to be permanent. There is no known therapy for lipoatrophy.

Potential Effects on Immune Response: Because COPAXONE® can modify immune response, it may interfere with immune functions. For example, treatment with COPAXONE® may interfere with recognition of foreign antigens in a way that would undermine the body’s tumor surveillance and its defenses against infection. There is no evidence that COPAXONE® does this, but there has not been a systematic evaluation of this risk.

Common Adverse Reactions: In controlled studies of COPAXONE® 20 mg per mL, the most common adverse reactions with COPAXONE® vs placebo were injection site reactions (ISRs), such as erythema (43% vs 10%); vasodilatation (20% vs 5%); rash (19% vs 11%); dyspnea (14% vs 4%); and chest pain (13% vs 6%).

In a controlled study of COPAXONE® 40 mg per mL, the most common adverse reactions with COPAXONE® vs placebo were ISRs, such as erythema (22% vs 2%).

ISRs were one of the most common adverse reactions leading to discontinuation of COPAXONE®. ISRs, such as erythema, pain, pruritus, mass, edema, hypersensitivity, fibrosis, and atrophy, occurred at a higher rate with COPAXONE® than placebo.

Please see full Prescribing Information for COPAXONE®.

Injections for 3-times-a-week COPAXONE® 40 mg must be at least 48 hours apart.

References: 1. COPAXONE® (glatiramer acetate injection) Current Prescribing Information. Teva Neuroscience, Inc. 2. Khan O, Rieckmann P, Boyko A, Selmaj K, Zivadinov R; for the GALA Study Group. Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis. Ann Neurol. 2013;73(6):705-713. 3. Comi G, Martinelli V, Rodegher M, et al. Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial. Lancet. 2009;374(9700):1503-1511. 4. Comi G, Filippi M, Wolinsky JS; and the European/Canadian Glatiramer Acetate Study Group. European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging-measured disease activity and burden in patients with relapsing multiple sclerosis. Ann Neurol. 2001;49(3):290-297. 5. Johnson KP, Brooks BR, Cohen JA, et al; and the Copolymer 1 Multiple Sclerosis Study Group. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind, placebo-controlled trial. Neurology. 1995;45(7):1268-1276. 6. Bornstein MB, Miller A, Slagle S, et al. A pilot trial of Cop 1 in exacerbating-remitting multiple sclerosis. N Engl J Med. 1987;317(7):408-414.

CI, confidence interval; CIS, clinically isolated syndrome; DSS, Disability Status Scale; EDSS, Expanded Disability Status Scale; GdE, gadolinium-enhancing; LOV, last observed value; RRMS, relapsing-remitting multiple sclerosis; SD, standard deviation.

*Average reported without SD in study.†Kurtzke DSS utilized in study; average reported without SD.

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