Copaxone (Glatiramer Acetate) - Summary

COPAXONE SUMMARY

COPAXONE

COPAXONE® is the brand name for glatiramer acetate (formerly known as copolymer-1). Glatiramer acetate, the active ingredient of COPAXONE®, consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively.

COPAXONE® Injection is indicated for reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis.

See all Copaxone indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Copaxone (Glatiramer)

Multiple Sclerosis More Common In Black Women Than White
Source: Multiple Sclerosis News From Medical News Today [2013.05.07]
Multiple sclerosis (MS) is more common in black women than in white women, according a new study. The research was conducted by Kaiser Permanente and was published in the journal Neurology. The results contradict the widely believed notion that black people are less vulnerable to the disease. The electronic health records of over 3...

Peli1 Identified As Pivotal Actor In Animal Model Of Multiple Sclerosis
Source: Multiple Sclerosis News From Medical News Today [2013.05.06]
Scientists have identified an influential link in a chain of events that leads to autoimmune inflammation of the central nervous system in a mouse model of multiple sclerosis (MS). An international team of researchers led by scientists in The University of Texas MD Anderson Cancer Center Department of Immunology reported their results in an advance online publication in Nature Medicine...

Atrophy In Key Region Of Brain Associated With Multiple Sclerosis
Source: Multiple Sclerosis News From Medical News Today [2013.04.25]
Magnetic resonance imaging (MRI) measurements of atrophy in an important area of the brain are an accurate predictor of multiple sclerosis (MS), according to a new study published online in the journal Radiology. According to the researchers, these atrophy measurements offer an improvement over current methods for evaluating patients at risk for MS...

Shrinkage of Brain Region May Signal Onset of Multiple Sclerosis
Source: MedicineNet Multiple Sclerosis Specialty [2013.04.23]
Title: Shrinkage of Brain Region May Signal Onset of Multiple Sclerosis
Category: Health News
Created: 4/23/2013 10:35:00 AM
Last Editorial Review: 4/23/2013 12:00:00 AM

Multiple Sclerosis
Source: MedicineNet Amyotrophic Lateral Sclerosis Specialty [2013.04.16]
Title: Multiple Sclerosis
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 4/16/2013 12:00:00 AM

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Published Studies Related to Copaxone (Glatiramer)

Interferon beta-1b and glatiramer acetate effects on permanent black hole evolution. [2011.04.05]
OBJECTIVE: To compare interferon beta-1b (IFNbeta-1b) and glatiramer acetate (GA) on new lesion (NL) (gadolinium-enhancing, new T2) evolution into permanent black holes (PBH)--a marker of irreversible tissue damage--in patients with relapsing-remitting multiple sclerosis (RRMS)... CONCLUSION: IFNbeta-1b affected PBH development to a similar or better extent than GA. IFNbeta-1b favorably influences an MRI outcome indicative of permanent tissue destruction in the brains of patients with multiple sclerosis. Classification of evidence: This study provides Class III evidence that IFNbeta-1b is associated with a reduction in MRI PBH formation and evolution compared with GA between years 1 and 2 of treatment.

Phase III dose-comparison study of glatiramer acetate for multiple sclerosis. [2011.01]
OBJECTIVE: To evaluate the safety, tolerability, and efficacy of glatiramer acetate (GA) 40 mg compared to a 20mg dose... INTERPRETATION: In relapsing-remitting MS patients, both the currently-approved GA 20 mg and 40 mg doses were safe and well-tolerated, with no gain in efficacy for the higher dose. Copyright (c) 2010 American Neurological Association.

Tolerability and safety of novel half milliliter formulation of glatiramer acetate for subcutaneous injection: an open-label, multicenter, randomized comparative study. [2010.11]
Daily glatiramer acetate (GA) 20 mg/1.0 mL is a first-line treatment for relapsing-remitting multiple sclerosis (RRMS). To reduce the occurrence of injection pain and local injection site reactions (LISRs), a reduced volume formulation of GA was developed.

Continuous long-term immunomodulatory therapy in relapsing multiple sclerosis: results from the 15-year analysis of the US prospective open-label study of glatiramer acetate. [2010.03]
The ongoing US Glatiramer Acetate (GA) Trial is the longest evaluation of continuous immunomodulatory therapy in relapsing-remitting multiple sclerosis (RRMS). The objective of this study was to evaluate up to 15 years of GA as a sole disease-modifying therapy... There were no long-term safety issues.

Effect of oral antihistamine on local injection site reactions with self-administered glatiramer acetate. [2010.02]
Patients with multiple sclerosis often use injectable medication such as glatiramer acetate or interferons to treat their disease. Subcutaneous injections may be associated with local injection site reactions (LISRs), which can include itching, pain, swelling, or redness... Because there were no statistically significant differences on the primary end point between patient groups taking cetirizine and those taking placebo prior to glatiramer acetate injections, cetirizine use as a strategy to reduce LISRs in patients on glatiramer acetate therapy cannot be recommended at this time.

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Clinical Trials Related to Copaxone (Glatiramer)

Effects of Copaxone in the Retinal Function in Diabetic Patients After Panphotocoagulation [Active, not recruiting]
The purpose of this study is to evaluate the effects of Copaxone injections in retinal function and integrity in diabetic patients who underwent pan-retinal photocoagulation.

Treatment of Multiple Sclerosis With Copaxone and Albuterol [Active, not recruiting]
The purpose of this study is to determine the effects of glatiramer acetate (Copaxone) alone compared to Copaxone plus albuterol in patients with Multiple Sclerosis (MS).

MS is thought to be an autoimmune disease of the central nervous system. Certain white blood cells of the immune system become abnormally active and mistakenly attack the myelin of nerve fibers. Myelin is a fatty sheath that surrounds nerve fibers and insulates the nerve like insulation around an electrical wire. Without proper myelin insulation, messages sent between the brain and other parts of the body may be confused or fail completely. Damage to myelin causes the symptoms of MS. The most common form of MS is known as relapsing-remitting (RR), where partial or total recovery occurs after attacks. Four therapies are currently approved for the treatment of MS. These therapies, however, are only moderately effective and can cause undesirable side effects. For this reason, there is a need to find new therapies that have minimal side effects and may stop the disease from getting worse.

Efficacy and Safety of GTR in Comparison to Copaxone� [Recruiting]
The purpose of this study is demonstrate that efficacy and safety of Synthon's glatiramer acetate (GTR) is equivalent to Copaxone® (Teva) in patients with relapsing remitting multiple sclerosis

Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate Therapy to Glatiramer Acetate Monotherapy for MS [Recruiting]
The purpose of this study is (1) to determine if rituximab induction therapy followed by glatiramer acetate (GA) is substantially superior to placebo induction followed by GA for the treatment of clinically isolated syndrome (CIS) or relapsing forms of multiple sclerosis (RMS) and (2) to explore the changes in lymphocyte populations in the CNS as a consequence of treatment with rituximab followed by chronic GA therapy.

A Double Blind Placebo Control Study to Assess the Safety,Tolerability and Efficacy of Copaxone in Crohn's Disease [Recruiting]
phase 2 study. Target disease: Crohn's disease.

Rational and relevance to IBD patients:

Copaxone is known for its high safety profile and for acting as an effective immunomodulatory agent for the treatment of MS. . In experimental models of IBD, a beneficial effect of Copaxone was demonstrated where significant amelioration of macroscopic colonic damage, preservation of the microscopic colonic structure, reduced weight loss, and improved long-term survival in treated compared with untreated mice was demonstrated. In addition, Copaxone suppressed the proliferation of local mesenteric lymphocytes to syngeneic colon extract, significantly reduced the overall secretion of TNF-α and induced the secretion of transforming growth factor (TGF)-β. The ability of Copaxone to effectively modulate the clinical manifestations and the detrimental immune response involved in experimental colitis, together with its high safety profile support its potential effect as a new treatment for CD.

Patients: patients with moderately active Crohn's disease as indicated by a CDAI 220 - 450,

whose diagnosis was done more than 3 months before enrollment.

Study objectives: to test the efficacy and safety of Copaxone in CD patients.

Study design: This will be a single center, randomized, double blind placebo controlled phase 2 study.

Subjects will be assessed for study eligibility 1 to 2 weeks prior to baseline Eligible patients will be enrolled into the study after signing an informed consent form and allocated in a 1. 5: 1 ratio to receive either Copaxone or placebo. A total of 50 patients will be recruited.

Subcutaneous injections (Copaxone or Placebo) will be administered daily through week 12. Patient assessment of safety and efficacy will be made at weeks 0,4,8,12 and 16.

At week 12 non-responders would be offered an open label arm with daily Copaxone 20mg for the next 12 weeks

more trials >>

Reports of Suspected Copaxone (Glatiramer) Side Effects

Multiple Sclerosis Relapse (136),  Dyspnoea (107),  Urticaria (69),  Injection Site Pain (52),  Convulsion (51),  Nausea (48),  Injection Site Reaction (46),  Flushing (44),  Chest Pain (42),  Immediate Post-Injection Reaction (41), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Copaxone review by 49 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		relapsing/remitting multiple sclerosis
Dosage & duration:		20 mg taken every day for the period of 7 years
Other conditions:		osteoporosis, migraine headache, spastic bladder
Other drugs taken:		Ditropan 15 mg, Wellbutrin 300 mg
		Reported Results
Benefits:		It reduces the frequency of episodes of relapsing/remitting multiple sclerosis.
Side effects:		The most common side effects are reactions at the injection site, which I have had, especially at the beginning of treatment. These are redness, a lump or firmness, soreness, or itching at the site of injection. Once I developed a permanent depression at an injection site, which is caused by a localized destruction of fat tissue. Some patients (I never have) develop a short term reaction experienced immediately after injecting this medicine. This reaction includes a feeling of warmth and/or redness known as flushing, chest tightness or pain with heart palpatations, anxiety, and trouble breathing. These symptoms may last a few minutes then go away by themselves without any further problems. Each package of Copaxone contains a complete list of possible side effects, or you may obtain this list from your doctor or pharmacist.
Comments:		Each single use blister pack of Copaxone contains one prefilled syringe containing 20 mg of Copaxone (glatiramer acetate) which the patient self administers subcutaneously, in the fatty layer of skin, once a day. It is important to rotate injection sites daily.

Copaxone review by 28 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Multiple Sclerosis
Dosage & duration:		20mg taken once a day/everyday for the period of 2 months
Other conditions:		endometriosis, migraines
Other drugs taken:		Ambien, celexa
		Reported Results
Benefits:		Peace of mind that I am doing something to decrease the MS progression.
Side effects:		Site reactions: pain, redness, lumps, flush of heat, itchiness
Comments:		I was on copaxone over a year ago and quit because I found the reactions unbearable. My health has declined and I changed doctors and now that I have found the confidence to accept my disease and become more proactive, I have begun applying heat to the site prior to injection. The pain from the shots have practically disappeared. I actually purchased a massager (heart massager from pure romance) that self heats and I don't have to do so much work prior to injection. I still get large red lumps if I don't put ice on it after the injection.

Copaxone review by 28 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Multiple Sclerosis
Dosage & duration:		20mg taken once a day/everyday for the period of 2 months
Other conditions:		endometriosis, migraines
Other drugs taken:		Ambien, celexa
		Reported Results
Benefits:		Peace of mind that I am doing something to decrease the MS progression.
Side effects:		Site reactions: pain, redness, lumps, flush of heat, itchiness
Comments:		I was on copaxone over a year ago and quit because I found the reactions unbearable. My health has declined and I changed doctors and now that I have found the confidence to accept my disease and become more proactive, I have begun applying heat to the site prior to injection. The pain from the shots have practically disappeared. I actually purchased a massager (heart massager from pure romance) that self heats and I don't have to do so much work prior to injection. I still get large red lumps if I don't put ice on it after the injection.