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Transcript
Treatments for MS:
Immunotherapy
There are currently several disease-modifying therapies approved for people with MS in
Australia. These therapies, called immunotherapies, work to reduce disease activity in the
central nervous system and reduce the frequency and severity of relapses in people with MS.
Gilenya® (fingolimod)
Gilenya belongs to a class of medications call
sphingosine 1-phosphate (s1P) receptor modulator.
The active ingredient in Gilenya is fingolimod.
Gilenya acts on certain types of white blood cells
called lymphocytes. In multiple sclerosis, these
small lymphocyte cells play a role in destroying
myelin, the protective sheath that surrounds the
nerve fibres and helps with the efficient flow of
nerve signals or messages to and from the brain
and various parts of the body.
Lymphocytes circulating in the blood and reaching
the central nervous system, which in turn reduces
damage to the nerve cells in the brain and spinal
cord.
Gilenya has been shown in clinical trials to:
 Reduce the frequency of relapses 1,2
 Delay progression of physical disability 1,2
There is also evidence it may have a direct effect in
enhancing re-myelination of damaged nerve cells.
Gilenya helps prevent lymphocytes leaving the
lymph nodes. This lowers the number of
Glatiramer acetate (Copaxone®)
Copaxone is a synthetic protein made up of a
combination of four amino acids, which are the
natural building blocks of protein in the body.
It is thought to work by connecting cells to stop them
attacking the myelin. It is administered by a daily
injection given under the skin.
In Australia, glatiramer acetate is sold under the
brand name Copaxone. My Support Team® is a
telephone helpline (call 1800 502 802) run by CSL
Biotherapies for people using this treatment.
In clinical trials Copaxone has been shown to:

reduce the frequency of relapses 3.

delay progression of physical disability 3.

delay the onset of definite MS after a first time
experience of symptoms that suggests MS 4
Glatiramer acetate is not an interferon so it does not
have any flu-like side effects. Some discomfort at the
injection site may be experienced and this can
usually be managed by the use of heat or cold packs
prior to injecting and carefully rotating injection sites.
On rare occasions, a post-injection reaction has been
experienced by some people, where they experience
a sense of panic shortly after injecting. This passes
quickly
INFORMATION FOR PEOPLE LIVING WITH MS | September 2014 | © MS Australia
Treatments for MS: Immunotherapy continued
Interferon beta (Avonex®, Betaferon®, Rebif®)
Interferons are proteins that occur naturally in the
body. They help fight viral infections and regulate the
immune system. It is thought interferon beta may
reduce immune responses directed at myelin. These
medications are given as an injection either just
under the skin or into the muscle.
In Australia, there are three different types of
interferon beta available. Each type is sold under a
different brand name:
Avonex (interferon beta-1a): An injection into the
muscle once per week. The Avonex Alliance® is a
telephone helpline (call 1800 286 639) run by Biogen
Idec Australia.
Betaferon (interferon beta-1b): An injection given
under the skin every second day. Betaplus® is a
telephone helpline (call 1800 557
960) run by Bayer Australia.
Rebif (interferon beta-1a): Injected under the skin
three times per week. Rebif Extracare® is a
telephone helpline (call 1800 073 243) run by Merck
Serono Australia.
In clinical trials interferon beta has been shown to:
 reduce the frequency and severity of relapses
5,6,7.

slow the rate of disease progression and
physical disability 6,7.

delay the onset of definite MS after a first time
experience of symptoms that suggests MS 8,9.
All the interferons may give you mild flu-like
symptoms (e.g. chills, fever, head/muscle aches and
sweating) when you don’t actually have the flu.
These side effects are usually easily managed by
taking paracetamol or ibuprofen pain relief prior to
injecting and they generally settle after a period of
time.
On rare occasions, some people may develop liver,
blood or thyroid problems, allergic reactions or
depression. Some irritation and discomfort may be
experienced at the injection site. This can be
managed by using a heat or cold pack prior to
injecting and by applying a soothing cream or lotion
after the injection if required.
Tecfidera® (dimethyl fumarate)
Tecfidera (dimethyl fumarate) - previously known
as BG-12 - is an oral treatment for Australian
patients with relapsing-remitting multiple sclerosis
(MS). The recommended starting dose of Tecfidera
is 120mg, twice daily. After 7 days the dose may be
increased to the recommended dose of 240mg
twice daily.
Tecfidera has been shown to have antiinflammatory and neuro-protective properties. It is
thought that Tecfidera works in MS by inhibiting
immune cells and molecules, and may have antioxidant properties that protect the brain and spinal
cord from damage.
gastrointestinal side-effects, effects on the kidneys
and liver, and reduced white blood cell counts.
While increased frequencies of infection were not
seen in clinical trials, it is recommended that
patients on Tecfidera have their white blood cell
counts monitored at least annually.
Tecfidera has not been tested in people under the
age of 18 or in women who are pregnant or
breastfeeding. Women who are pregnant, planning
pregnancy or breastfeeding should seek advice
from their doctor.
Clinical trials have shown it can reduce relapse
rates and delay the progression of disability in
people with relapsing remitting MS.
In clinical trials of Tecfidera, the most common
side-effects experienced were flushing, diarrhea,
nausea and abdominal pain. Less common but
more serious side-effects include more severe
INFORMATION FOR PEOPLE LIVING WITH MS | September 2014 | © MS Australia
2
Treatments for MS: Immunotherapy continued
Natalizumab (Tysabri®)
Natalizumab belongs to a class of medications called
monoclonal antibodies (MABs) which are a type of
protein.
The most common possible side effects are joint
pain, fever, blocked or runny nose, tiredness, nausea,
headache and dizziness.
Natalizumab works by attaching to the surface of
specific immune cells. It then indicates to the body
that these cells should not cross from the blood
stream into the central nervous system (the brain and
spinal cord), where they could attack the myelin
sheath. This treatment is administered through the
veins (intravenous infusion) once a month.
A rare but serious brain infection, progressive
multifocal leucoencephalopathy (PML), has occurred
in a very small percentage of people taking
natalizumab. There are tests to help determine your
individual risk of developing PML.
In Australia, natalizumab is sold under the brand
name Tysabri. Tysabri Linked Care is a patient
support program (call 1800 897 227) run by Biogen
Idec Australia.
In clinical trials, natalizumab has been shown to:

reduce the frequency of relapses 10.

slow the rate of disease progression and
physical disability 10.
Your neurologist can provide you with more
information about these tests.
To reduce the risk of people developing PML, and to
make sure that PML is picked up as quickly as
possible in people who develop the condition, there
are strict safety protocols in place which include an
observation period after your infusion.neurologist.
Teriflunomide (Aubagio®)
Teriflunomide belongs to a class of medications
called pyrimidine synthesis inhibitors. It is a film
coated tablet taken daily by mouth.
Teriflunomide acts by interrupting the lifecycle of
certain types of white blood cells, called lymphocytes.
In MS, these small lymphocyte cells play a role in
destroying myelin, the protective sheath that
surrounds nerve fibres and helps with the efficient
flow of nerve signals or messages to and from the
brain and various parts of the body.
Teriflunomide works by reducing the production of an
enzyme (a type of protein) which lymphocytes, need
to divide and mature. This lowers the number of
lymphocytes circulating in the blood and reaching the
central nervous system, which in turn reduces
damage to the nerve cells in the brain and spinal
cord.
In Australia, teriflunomide is sold under the brand
name Aubagio.
In clinical trials teriflunomide has been shown to:

reduce the frequency of relapses11,12.

delay progression of physical disability11,12.
Side effects include Nausea, abnormal liver tests,
diarrhoea and hair thinning or loss. On rare
occasions, some people may develop liver skin or
blood problems, increased blood pressure or pain.
Teriflunomide interacts with ingredients in some oral
contraceptive pills so it is important to discuss with
your doctor the type of contraceptive pill you are
taking if you are.
INFORMATION FOR PEOPLE LIVING WITH MS | September 2014 | © MS Australia
3
Treatments for MS: Immunotherapy continued
Lemtrada® (alemtuzumab)
Lemtrada® is in a class of medications called
monoclonal antibodies, which means it can bind
specifically to molecules present on the surface of
cells.
Lemtrada® works by binding to CD52 molecules
which are present on the surface of B and T cells of
the immune system and once it is bound, the
body’s own immune system destroys those cells.
Since B and T cells are known to play a role in the
disease process of MS, depleting B and T cells in
the circulation may slow the disease process in
some individuals.
Lemtrada® is used to treat relapsing forms of MS in
adults with active disease. Lemtrada® is not
recommended for patients with inactive disease or
those who are stable on their current therapy.
Lemtrada® is a liquid preparation which is given by
intravenous infusion in two treatment courses one
year apart. The first course consists of infusions
given over five consecutive days, the second
course consists of infusions given over three days.
Due to potential side effects, once you have
received Lemtrada® you will need to undergo
regular monitoring so that any side effects can be
detected and treated promptly. Monitoring must
continue for four years after the last infusion.
In clinical trials, Lemtrada® has been shown to:

Reduce the frequency of relapses when
compared with interferon beta treatment

Delay the progression of disability in some
people when compared to interferon beta
treatment. 13,14
The treatment does have side effects including
infusion-associated reactions (such as headache,
rash and nausea), lowered blood cell counts and
infections.
Serious autoimmune side effects include:

An overactive or underactive thyroid gland,
leading to thyroid-related side effects.
These side effects are treatable but can
require careful monitoring and lifelong
thyroid medication.

A blood clotting disorder known as immune
thrombocytopenic purpura (ITP), which is
caused by low numbers of platelets in the
blood. This can lead to internal bleeding.
ITP can be fatal, but monitoring strategies
enable ITP to be detected early and treated
appropriately.13, 14
There is an increase in the risk of infection with
Lemtrada treatment, though the incidence of
serious infections in clinical trials was low.
Lemtrada® has not been tested in women who are
pregnant. Women of childbearing age should use
effective birth control measures when receiving a
course of treatment with Lemtrada® and for 4
months following that course of treatment.
For more information on these treatments or other treatments in MS

Speak to your neurologist about what treatment best suits your individual circumstances.

MS Nurses also provide information, training and ongoing support in managing your immunotherapy.
Contact your state office on 1800 042 138 or visit www.msaustralia.org.au for more information.

MS Research Australia (MSRA) provides information on the latest research and clinical trials in MS.
Visit www.msra.org.au for more information.

Making Sense of MS Research provides plain language summaries of independent, high-quality
research about MS treatments. Visit www.makingsenseofmsresearch.org.au
INFORMATION FOR PEOPLE LIVING WITH MS | September 2014 | © MS Australia
4
Treatments for MS: Immunotherapy continued
For information about MS and MS Australia services:
Freecall: 1800 042 138
Web: www.msaustralia.org.au
Disclaimer: Information contained in this fact sheet is intended to provide useful and accurate information of a general nature for the
reader but is not intended to be a substitute for legal or medical advice. MS Australia is not recommending medical or legal advice and
readers must seek their own medical or legal advice as may be appropriate. Printing and photocopying this publication in its original
form is permitted for educational purposes only. Reproduction in any other form without written permission is prohibited.
References
1)
Kappos L, Raude EW, O’Connor P et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. NEJM
2010;362:387-401.
2)
Cohen JA, Barkhof F, Comi G et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. NEJM
2010;362:402-15.
3)
Johnson KP, Brooks BR, Cohen JA et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting
multiple sclerosis. Neurol 1995;45:1268-76.
4)
Comi G, Martinelli V, Rodegher M, Moiola L, Bajenaru O, Carra A et al. Effect of glatiramer acetate on conversion to clinically
definite multiple sclerosis in patients with clinically isolated syndrome. Lancet 2009;374:1503-11.
5)
Jacobs LD, Cookfair DL, Rudick R A et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple
sclerosis. Ann Neurol 1996;39:285-94.
6)
INFB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. Neurol
1993;43:655-61.
7)
PRISMS Study Group. Randomised double-blind placebo controlled study of interferon β-1a in relapsing/remitting multiple
sclerosis. Lancet 1998;352:1498-504.
8)
Jacobs LD, Beck RW, Simon JH et al. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in
multiple sclerosis. NEJM 2000;343:898-904.
9)
Kappos L, Polman CH, Freedman MS et al. Treatment with interferon beta-1b delays conversion to clinically definite and
McDonald MS in patients with clinically isolated syndromes. Neurol 2006;67:1242-9.
10) Polman CH, O’Connor PW, Havrdova E et al. A randomized, placebo-controlled trial of natalizumab for relapsing multiple
sclerosis. NEJM 2006;354:899-910.
11) O’Connor PW, Li D, Freedman MS et al. A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with
relapses. Neurol 2006:66:894-900
12) 12. O’Connor P, Wolinsky JS, Confavreux C et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis NEJM
2011; 365: 1293-303
13) Cohen JA, Coles AJ, Arnold DL et al., Alemtuzumab versus interferon beta 1a as first-line treatment for patients with
relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet. 2012;380(9856):1819-28.
14) Coles AJ, Twyman CL, Arnold DL et al., Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying
therapy: a randomised controlled phase 3 trial. Lancet. 2012;380(9856):1829-39.
INFORMATION FOR PEOPLE LIVING WITH MS | September 2014 | © MS Australia
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