Copaxone (glatiramer acetate)


Copaxone (glatiramer acetate) is a disease modifying drug (DMD) for relapsing remitting MS.

You self-inject Copaxone under the skin either daily or three times a week to reduce the number and severity of relapses. It reduces the number of relapses by about one third (30%).

Common side effects include injection site reaction.


What is Copaxone used for in MS?

Copaxone is a disease modifying drug (DMD) for relapsing remitting MS. You have fewer relapses than you might have had with no treatment and any relapses you do have should be less severe.

Copaxone is a moderately effective (category 1.1) DMD; in clinical trials people taking Copaxone had about 30% fewer relapses than people taking placebo. In clinical trials, MRI scans showed people taking Copaxone had fewer, smaller or no new areas of active MS (lesions).

Who can take Copaxone?

Copaxone can be prescribed for adults with active relapsing remitting MS.

Copaxone taken daily has been approved for use on the NHS since 2002. Copaxone three times a week has been approved since 2015. It can only be prescribed by a neurologist.

Conception and pregnancy

The prescribing advice for Copaxone during pregnancy and breastfeeding is appropriately cautious.  However, pregnancy registers and clinical experience have shown no increased risk to the health of mother or baby with Copaxone.

If you are trying for a family, talk to your MS nurse or neurologist about whether you should continue to take Copaxone until you are pregnant.

If you become pregnant while on Copaxone, your neurologist or MS nurse may recommend you stop taking it, depending on how active your MS has been and the benefits and risks to you and your baby. Women usually experience fewer relapses during pregnancy, so continuing to take Copaxone may not be necessary.  However, if Copaxone is stopped during pregnancy, it will take several months to reach full effectiveness when restarted and may not reduce relapses during the first few months after childbirth.

Pregnancy guidelines consider that it is safe to take Copaxone during breastfeeding if required.

How do I take Copaxone?

You self-inject Copaxone under the skin. Two doses are available: one for daily injections and another for three times a week injections. Copaxone is supplied in single-use, pre-filled syringes. An automatic injection device is also available to make injections easier.

Your MS nurse will show you how to do the injections, discuss the practicalities and offer advice or training and ongoing support if you should need it.

What side effects could I get with Copaxone?

Overview

Common side effects include injection site reactions such as lipoatrophy (leading to permanent indentations in the skin), redness, swelling, itching or some pain at the site.

Occasionally, some people may experience a reaction, known as the immediate post-injection reaction (IPIR), shortly after injection.  This may cause flushing, chest tightness, shortness of breath and palpitations.  This reaction can last 15-30 minutes, will ease without any treatment and doesn't cause long-term problems.  If symptoms last longer than 30 minutes, contact your doctor immediately or go straight to the A&E department of your nearest hospital.

Common side effects (affecting more than 1 person in 100)

  • injection site reactions
  • lipoatrophy (indentations in the skin)
  • headache
  • depression, anxiety
  • nausea
  • feeling weak
  • chest pain, pain
  • swollen lymph nodes
  • gastrointestinal changes

Less common side effects (affecting less than 1 person in 100)

  • blood cell changes
  • extra heartbeats
  • thyroid changes
  • dilation of blood vessels
  • immediate post-injection reaction (IPIR)

A full list of side effects is included in the manufacturer's Patient Information Leaflet.

Assessment before treatment

Blood tests are not generally required before starting treatment with Copaxone.

Assessment during treatment

There is no need for routine blood tests during treatment, but your MS nurse will arrange regular appointments to review how you are coping with Copaxone.

How does Copaxone work?

Copaxone is a synthetic combination of four amino acids, resembling the myelin protein surrounding nerve fibres. It is thought to act as a chemical decoy which diverts an immune attack away from your myelin.

Copaxone research

Copaxone has been studied extensively since the early 1990s. The following study first demonstrated the effectiveness of Copaxone:

  • Copolymer 1 Multiple Sclerosis Study Group - 1995 - Copaxone compared to placebo

In this clinical trial, 251 people with relapsing remitting MS took either Copaxone or placebo for two years. The main measure of the study was the number of relapses per year - Copaxone reduced this by 29% compared to placebo. Over the two year study, more people taking Copaxone had improved or unchanged disability (measured as a 1 point change in EDSS) and more people taking placebo had worsened disability.

More recently, the three times a week dosing pattern has been evaluated:

  • GALA - 2013 - Copaxone three times weekly compared to placebo

1404 people with relapsing remitting MS took either Copaxone three times weekly or placebo for one year. Compared to placebo, Copaxone reduced relapses by 34%. MRI results showed that Copaxone significantly reduced the number of lesions compared to placebo.

  • Risk Sharing Scheme - 2018 - long-term effectiveness of beta interferons and Copaxone

This study was set up in 2002 to evaluate the long-term benefits of beta interferons and Copaxone(glatiramer acetate). More than 5000 people taking either Avonex, Betaferon, Copaxone or Rebif were recruited at study centres around the UK and their disability levels (EDSS) monitored for 10 years. At the end of the study, changes in disability levels were compared to those recorded from an untreated group.

The study found that the DMDs delayed the need to use a walking stick (EDSS 6.0) by four years.

Find out more

References
National Institute for Health and Care Excellence (NICE).
Beta interferons and glatiramer acetate for treating multiple sclerosis.
NICE technology appraisal guidance TA527
Full guideline (link is external)
Johnson KP, et al.
Copolymer 1 reduces relapse rate and improves disability in relapsing remitting multiple sclerosis: results of a phase III multicenter, double-blind, placebo-controlled trial. The Copolymer 1 Multiple Sclerosis Study Group.
Neurology 1995;45(7):1268-76.
Summary (link is external)
Khan O, et al.
Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis.
Annals of Neurology 2013;73(6):705-13.
Summary (link is external)
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