Copaxone (glatiramer acetate injection) is a disease-modifying treatment widely approved for adults with relapsing forms of multiple sclerosis (MS). The therapy helps reduce the relapse rate, and there is evidence that it may delay progression of the disease.
The name-brand medication is marketed by Teva Pharmaceuticals. Generic versions of Copaxone also are widely available and include Glatopa by Sandoz (a Novartis company) and Glatiramer Acetate Injection by Mylan Pharmaceuticals, now part of Viatris.
MS is caused by the body’s immune system erroneously attacking healthy cells in the nervous system. In particular, the autoimmune attack in MS targets myelin — a fatty substance that wraps around nerve fibers like a sheath, and is critical for helping send electrical signals (nerve impulses).
The active agent in Copaxone, glatiramer acetate, is a synthetic (man-made) protein that is designed to mimic a piece of myelin. It consists of four amino acids, the building blocks of proteins, that make up myelin basic protein, a major component of the myelin sheath.
Copaxone was discovered when researchers were seeking a way to induce an MS-like autoimmune response in animal models. However, research first published in the 1970s showed that, contrary to expectations, treating mice with the compound actually prevented the disease from developing. This accidental finding led to Copaxone being developed as a therapy for MS.
The exact mechanisms of how Copaxone works in MS remain poorly understood. Broadly, the medication is thought to modulate the activity of a number of different types of immune cells — particularly T-cells and antigen-presenting cells — to induce a less inflammatory state, thereby lessening the inflammatory attack that drives MS. Some studies suggest that Copaxone also directly acts on nerve cells to help protect them from damage.
Copaxone was approved by the U.S. Food and Drug Administration in 1996 for treating adults with relapsing forms of MS, which include clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS).
The therapy now is approved in more than 50 countries worldwide, including Canada, all European countries, Australia, and Russia, among others.
People with known hypersensitivity to glatiramer acetate (the active ingredient in Copaxone) or mannitol (an inactive ingredient) should not take Copaxone.
Copaxone is administered via subcutaneous (under-the-skin) injection. Two dosages are approved:
The doses are not interchangeable. Both options are provided as a single-dose, prefilled syringe with a plunger — a white plunger holds the 20 mg dose and a blue plunger, the 40 mg. An optional, compatible autoinjector device also can be used.
Copaxone should be self-administered subcutaneously — in the fatty layer under the skin — and is given in areas such as the arms, abdomen, hips, and thighs. The prefilled syringe should be taken from the refrigerator and left to stand at room temperature for 20 minutes before administration, to allow the solution to reach ambient temperature. These syringes are designed for single use only. Copaxone 40 mg/mL should be given on the same three days each week, at least 48 hours apart.
The first dose of Copaxone should be given under the guidance of a healthcare professional. Patients should be instructed in the proper injection technique, and injection sites should be rotated with each administration to avoid injecting the same area multiple times.
The key clinical trial that led to Copaxone’s approval for marketing was carried out in the 1990s. The Phase 3 trial enrolled 251 patients with RRMS, who received either Copaxone (20 mg) or a placebo daily, for two years. It was a randomized, double-blind, placebo-controlled study, which means that neither the participants nor the researchers knew which patients had been randomly selected to receive the medication, and who was given a placebo.
Initial results from the trial, published in 1995, showed that participants receiving Copaxone experienced significantly fewer MS relapses, a reduction by 29%, over the course of the trial.
Results also suggested that Copaxone-treated participants were significantly more likely than those given a placebo to experience an easing of disability, as measured by the expanded disability status scale (EDSS). By contrast, participants given a placebo were more likely to experience worsening disability.
Following the original placebo-controlled study, participants had the option to enter an open-label extension trial, in which all patients received the active medication and were monitored for safety and efficacy.
Trial results showed that, after 10 years of Copaxone treatment, most patients (62%) had EDSS scores that either were stable or had improved. Additionally, while participants had reported slightly more than one relapse per year on average before starting treatment, after a decade on Copaxone, these patients were, on average, only experiencing one relapse every five years.
Another Phase 3 trial, called PreCISe (NCT00666224), launched in 2004, enrolled 481 people with CIS who were randomly selected to receive daily Copaxone (20 mg) or a placebo for up to three years. Copaxone significantly lowered the risk of progression to clinically definitive MS by about 45%, trial results showed.
More recently, Teva sponsored a randomized Phase 3 trial, called GALA (NCT01067521), to investigate the effectiveness of a higher dose of Copaxone — specifically, 40 mg three times weekly instead of 20 mg daily. The trial recruited 1,404 RRMS patients worldwide, who were randomly assigned to receive the less frequent dosing regimen of Copaxone or a placebo for one year, with the option to then enroll in an open-label extension study.
Results from GALA indicated that the higher dose formula had a similar safety and efficacy profile to the original formulation, and follow-up data at seven years continued to indicate that the higher dosage could lessen relapse rates and delay disability progression.
The most common side effects associated with Copaxone in clinical trials include:
Copaxone carries warnings for chest pain and other reactions after injection. These reactions may include flushing, palpitations or racing heart, anxiety, throat constriction, shortness of breath, and/or hives. They usually resolve on their own in time.
Tissue damage to the skin can occur, so it is important that people using Copaxone know how to properly administer the medication. Copaxone also may modify immune responses, and it has been associated with liver injury in some cases — treatment discontinuation might need to be considered in the presence of signs or symptoms of hepatic (liver) impairment or dysfunction.
Copaxone has not been rigorously studied during pregnancy or while breastfeeding, though available data indicate Copaxone appears to be safe in both situations. Nonetheless, the therapy’s U.S. label states that people should inform their healthcare provider if they are pregnant, or have plans to become pregnant; the same is applicable to patients breastfeeding or who intend to breastfeed.
Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
Copaxone’s approval in December 1996 was for the treatment of adults with relapsing-remitting MS, followed by a change to the current indication of relapsing forms of the disease — which include clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. A higher and less frequently administered formulation (40 mg/mL) of Copaxone was approved in January 2014.
According to animal data, treatment with Copaxone results in no adverse effects on the fetus or offspring development; however, there are no well-controlled studies in pregnant women. Copaxone’s U.S. label indicates that patients should inform their healthcare team if they are pregnant or have plans to become pregnant.
No known interactions exist between Copaxone and alcohol consumption. However, given that alcohol can interfere with some medications and disease symptoms, patients should discuss this topic with their healthcare provider.
According to Teva Pharmaceuticals, which markets Copaxone, patients taking the therapy usually see results at one year.
During clinical trials, hair loss and weight gain were not reported as side effects associated with Copaxone use. There are, however, some isolated reports of unusual weight gain in some cases and weight loss in others. Patients are advised to talk with their healthcare team if they experience any such issues.
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