fbpx

,

#065: Glatiramer Acetate (Copaxone) for relapsing remitting multiple sclerosis

This time I am presenting glatiramer acetate, which is known as Copaxone, Brabio or other tradenames and is one of the approved disease-modifying drugs for relapsing forms of MS. It was one of the first drugs to be approved as a preventive therapy for MS patients and was an accidental discovery. Originally intended to induce MS in mice for research purposes, it was suddenly discovered to have a protective effect.
Like the fumarates already presented, it has a more broad-based mechanism of action. I will try to give a good overview below without going into absolute depth. And as always, please seek specific advice from MS specialists who know your individual situation, wishes, fears and overall state of health.

Klicken Sie auf den unteren Button, um den Podcast zu laden.

Podcast laden

Table of Contents

General Information

To get a good overview of the major topic of therapy decisions, I recommend that you first listen to episode 58: Immunotherapy in MS. A guide to efficacy and choice with Prof. Tjalf Ziemssen. There you will find out why:

  • You can only compare the various disease-modifying drugs to a limited extent.
  • It is important to start an effective therapy quickly.
  • MRI and other examinations are important for assessing progression and provide information about effectiveness.
  • Therapies should be changed as little as possible, but of course if they are not effective enough.
  • In most cases, it is better to start with a highly effective therapy and only switch to a lower category at an advanced age.
  • In the case of highly active MS, it may be more important to start immunotherapy quickly and tackle rehabilitation as a second step.
  • Generics and biosimilars are being used more and more and which approval requirements they have to fulfill.
  • The risks and side effects of a therapy must be differentiated into unpleasant side effects at the start of therapy and rare possible risks. And these must be set in relation to the usually irreversible effects of untreated MS in the long term.
  • It is important to honestly discuss your opinion, wishes, goals and fears with your neurologist in order to make treatment decisions together that both sides can agree on.
  • It is advantageous to be cared for by MS specialists and to stay informed yourself in order to benefit from new findings and treatment options.
  • Contribute to a favorable prognosis with your own healthy lifestyle.

Another general note

The approval studies for the individual drugs were carried out at very different times. Thirty years ago, you had to be more severely affected or more advanced in the course of the disease to receive a reliable diagnosis of multiple sclerosis. Less severely affected people were probably not diagnosed or not diagnosed at first. With ever-improving examination methods, such as MRI, even small lesions in the central nervous system can now be seen better. Furthermore, 30 years ago it was not yet known that neuromyelitis optica spectrum diseases, NMOSD for short, are separate diseases that require their own therapies and sometimes even react negatively to MS medication. They were previously thought to be multiple sclerosis and MS therapies did not alleviate the disease activity.

How is glatiramer acetate (Copaxone and generics) classified in immunotherapies?

There are currently three different therapeutic approaches to preventive, i.e. disease-modifying therapy (DMT) for multiple sclerosis. The most unspecific is immunomodulation, which includes glatiramer acetate. In migration inhibition, certain immune cells are prevented from traveling further in the body. And in depletion, developing immune cells die off. The DMTs are listed in alphabetical order:

  1.  Immunomodulation – the therapies weaken the immune system. They have a very broad effect via various factors (e.g. on Th1/T17 – Th2/Treg, antigen presentation) as well as on different signaling pathways and possibly via other mechanisms: they attempt to shift the milieu from inflammatory to non-inflammatory:
    • Dimethyl fumarate (Tecfidera and generics) & diroximel fumarate (Vumerity),
    • Glatiramer acetate (Copaxone and generics),
    • Interferons: interferon beta-1a (Avonex, Rebif), interferon beta-1b (Betaferon, Extavia), peginterferon beta-1a (Plegridy)
    • Teriflunomide (Aubagio)
  2. Migration inhibition – the migration of certain immune cells is inhibited:
    • Natalizumab (Tysabri, Tyruko)
    • S1P modulators: Fingolimod (Gilenya), Ozanimod (Zeposia), Ponesimod (Ponvory), Siponimod (Mayzent)
  3. Cell depletion – developing immune cells die off
    • Depletion of T-cells, B-cells, NK-cells and monocytes: Alemtuzumab (Lemtrada, Campath)
    • T- and B-cell depletion: Cladribine (Mavenclad, Leustat, Litakin)
    • B-cell depletion: ocrelizumab (Ocrevus), ofatumumab (Kesimpta, Bonspri), rituximab (Mabthera, Rituxan), ublituximab (Briumvi)

What is glatiramer acetate approved for?

Glatiramer acetate is approved for the treatment of relapsing forms of multiple sclerosis. The German Multiple Sclerosis Competence Network (KKNMS) and the German guideline recommend their use in mild or moderate forms of the disease. This might differ from country to country.

What is the situation for special patient groups?

Children and Teenagers

Glatiramer acetate is approved from the age of 18 based on the registration studies. Furthermore, it appears to be as safe for adolescents aged 12 to 18 as it is for adults. Please consult a MS specialist to receive individual advice.

Pregnancy and Breastfeeding

There is also no approval for pregnant women. Glatiramer acetate can be taken until the onset of pregnancy. Animal studies and data from the German MS and Fertility Register, DMSKW for

short (as of June 2024), with 513 pregnancies under glatiramer acetate (Copaxone, Brabio) show no increased risk. Continuation during pregnancy should be assessed according to the individual benefit-risk. Please speak to your neurologist or seek advice from MS experts in the field of pregnancy.

During breastfeeding, glatiramer acetate is approved by the EMA without restriction; the FDA recommends weighing up the benefits and risks on an individual basis.

Recommendation of the European (EMA) and American regulatory authorities (FDA)

As a precautionary measure, the use of glatiramer acetate (Copaxone and generics) should be avoided during pregnancy unless the benefit to the mother outweighs the risk to the fetus.

According to the FDA, glatiramer acetate (Copaxone, Brabio) can be used while breastfeeding after individual risk-benefit assessment. The EMA has already approved glatiramer acetate (Copaxone, Brabio) for use during breastfeeding without restriction.

Who should avoid glatiramer acetate?

Persons with hypersensitivity or allergies to glatiramer acetate or other components of the preparation.
There is insufficient information to recommend treatment with glatiramer acetate for children under twelve years of age; it should therefore not be used in this age group. However, the safety profile in teenagers aged twelve to 18 years seems to be comparable to that of adults.

How does glatiramer acetate work?

The mechanism of action of glatiramer acetate is not yet fully understood. The activity states of various immune cells change in the patients in whom it is effective.

In MS, the inflammatory process predominates if untreated; glatiramer acetate balances this effect and even changes it for the better. Special glatiramer acetate T-cells are created. It acts more like an antigen therapy. Antibodies are produced, which decrease again after three months of regular administration. However, only some patients respond to the therapy. For those in whom these changes occur in the immune cells, glatiramer acetate (Copaxone and generics) also has a clinical and long-term effect, even after ten years. And nerve growth factors (neuroprotection) are also promoted in this patient group. The immunomodulatory balance is restored. In addition, glatiramer acetate presumably supports remyelination and axonal protection through the formation of new oligodendrocytes.

The effect occurs after approximately twelve weeks.

How is it taken?

Glatiramer acetate (Copaxone and generics) is injected subcutaneously by itself. Either 3 times/week at a dose of 40 mg or 20 mg daily.

Injection aids and ready-to-use pens are available.

The duration of therapy is currently not limited. Tolerance and risk-benefit assessment should always be taken into account. With increasing age, the immune system changes, so that a situation can arise where the effect of the medication only brings little or no benefit, while side effects persist. MS patients have completely different courses of the disease, so there is no general recommendation, but an individual decision must be made.

How effective is glatiramer acetate (Copaxone and generics)?

Gavin Giovannoni, an MS expert from the UK, has ranked his MS-Selfie Cards from one to ten, with one being slightly effective and ten being maximally effective. In his estimation, glatiramer acetate scores 2 for relapse prevention and 1 for long-term disability.

It should be noted that glatiramer acetate is only effective in some patients. The assessment would therefore be shifted if only responders were assessed.

In the pivotal study, glatiramer acetate led to 29% fewer relapses compared to placebo. Significantly more patients receiving glatiramer acetate showed an improvement in EDSS, while more patients on placebo deteriorated.

MS-Selfie Card for Glatiramer Acetate, Tradename: Copaxone, Brabio from Prof. Dr. Gavin Giovannoni, London, UK

Risks and side effects of glatiramer acetate (Copaxone and generics)

In general, glatiramer acetate is a safe medicine. Mild side effects occur in more than one in ten patients.

The most common side effect is a local reaction at the injection site. This can range from reddening of the skin, pain, wheal formation, itching with local inflammation to a skin allergy.

More rarely, there may be a cosmetically unfavorable local reduction of the subcutaneous fatty tissue. Careful disinfection of the injection site can reduce local injection reactions.

Immediately after the injection, a so-called post-injection reaction with at least one of the following symptoms may occur: Vascular expansion, chest pain, shortness of breath and palpitations. These reactions can occur within minutes of a glatiramer acetate injection and usually subside spontaneously and without further consequences.

Safety precautions – lab parameters

A complete blood count is performed before the start of treatment and after three months. The liver values are checked before the start, after the third month, after the sixth month and from then on every six to twelve months. The same procedure applies to the kidney function test. It is carried out before the start, after three and six months and then only every six to twelve months.

Before starting treatment with glatiramer acetate, an acute inflammation must be ruled out by a urine test.

You do not need to worry about this. This will be checked for you. However, please take the examinations seriously and make up for them if you are unable to keep an appointment and do not skip them altogether.

On the MS selfie card mentioned earlier, the side effects are rated on a scale from one for few or rare to ten for many or frequent as follows:

  • Regular side effects at nine
  • Long-term side effects at zero
  • Cancer risk at one

Glatiramer acetate receives the following rating in the MS-Selfie Card overview of the impact of the therapy

  • Clinic visits: many
  • Family planning: compatible
  • Vaccinations: good response

Vaccinations

All vaccinations are permitted during therapy with glatiramer acetate (Copaxone and generics). However, live vaccines should only be given after a thorough risk-benefit assessment. There are no warnings for newborns whose mothers have taken glatiramer acetate during pregnancy.

Vaccination against herpes zoster, which leads to shingles, is recommended for patients with immunotherapy from the age of 50. In this case, vaccination with the inactivated Shingrix vaccine is recommended.

Sources

I used the following sources to create the content:

Final note

Please remember, there is no one great medication that helps everyone, but it must always be weighed up what suits a particular person best. Other illnesses, personal goals and preferences must also be taken into account. Your neurologist and MS nurse are the right persons to talk to and can make individual recommendations. This article is for information purposes only and does not constitute a recommendation. What helps one person may not help another.

I hope that, together with your neurologist and MS nurse, you will quickly find the right immunotherapy for you. And that you can lead a fulfilled, happy and self-determined life with MS, supported by a healthy lifestyle and a dose of fortune.

See you soon and try to make the best out of your life,
Nele

For more information and positive thoughts, subscribe to my newsletter for free.

Click here for an overview of all podcast episodes published so far.

And at many more places.

* This text contains affiliate links. This means that I get a small compensation if you buy the product recommended by me through the link. For you nothing changes in the price of the product. And it helps me to pay for the blog and to write new posts.

Teile diesen Beitrag

Ähnliche Beiträge

Portraitbild Nele Handwerker

Nele Handwerker

Blogger & Patient Advocate

I show you how to make the best of your life with MS from family to career to hobbies. Thanks to science and research, a lot is possible nowadays.

Nele Handwerker

Newsletter

Do you want to understand MS better?

Then get 11 impulses for a positive course as a gift and receive important information about the disease.

My favorites
Explore
English