1. health and fitness
2. disease

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Fifth edition March 2012
Revised March 2013
06
MS
Essentials
For people living with MS
This publication is available in large print (22 point) and audio CD
Call 020 8438 0799 or email [email protected]
Disease
modifying
drugs
Contents
02 Introduction
What disease modifying
drugs are currently
licensed?
Are all these drugs
available on the NHS?
How do I know which
drug is for me?
03 Avonex, Rebif, Betaferon,
Extavia and Copaxone
Key information
Side effects
Frequently asked questions
12 Tysabri
Key information
Side effects
Frequently asked questions
16 Gilenya
Key information
Side effects
Frequently asked questions
19 Other treatments available
20 Further information
21 Useful organisations
If you have relapses with your MS, disease modifying drugs
(DMDs) might be a suitable treatment for you. They’re not
a cure for MS, but they can reduce the number of relapses
you experience. It’s not yet known if any of the drugs can
slow the rate of disability in the long term.
In the first part of this booklet we look at the drugs that are
currently licensed for MS in the UK, including the eligibility
criteria and whether they are available on the NHS. You
might need to choose between several drugs and this
booklet may help when you are discussing your options
with a neurologist or an MS nurse.
The second section (page 19) looks at other drug treatments
that might be used to reduce relapses, but which aren’t
licensed specifically for MS.
There are also a number of new DMDs currently in
development. For information on any of these potential
new drugs, visit the MS Society website or contact the
UK Information Team. You can also read more in the MS
Society’s research magazine Research Matters. For copies
contact the UK Information Team.
Through the booklet, we refer to a number of organisations
that can help with particular issues – just look for the i .
Their details are listed at the back of the booklet in the
‘Useful organisations’ section (page 21). Contact details
for the UK Information Team are listed under ‘Further
Information’ on page 20.
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Introduction
What disease modifying
drugs (DMDs) are
currently licensed?
There are currently seven DMDs licensed in the UK:
•
Avonex (beta interferon-1a)
•
Rebif (beta interferon-1a)
•
Betaferon (beta interferon-1b)
•
Extavia (beta interferon-1b)
•
Copaxone (glatiramer acetate)
•
Tysabri (natalizumab)
•
Gilenya (fingolimod)
There’s more information on how the drugs work, how they’re
taken, possible side effects and other issues in the later sections
of this booklet.
Are all DMDs available
on the NHS?
When a drug is licensed, it does not automatically mean that it will be
available on the NHS. Licensing means that it can be used in the UK.
For a drug to become widely available on the NHS, it would normally
need to have been recommended by the National Institute for Health
and Clinical Excellence (NICE) in England, Wales and Northern
Ireland, or the Scottish Medicines Consortium (SMC) in Scotland.
Their role is to assess a drug on the basis of its effectiveness and
cost, and decide whether it represents good value for money. i
The NICE/ SMC decisions about each of the licensed drugs are
covered in the sections below.
Disease modifying drugs © MS Society 03/13
How do I know which
drug is for me?
2
This is a decision you will need to make in discussion with your
neurologist. Each of the drugs has eligibility criteria for it, usually
based on the number of relapses you have had. Most neurologists
follow guidelines issued by the Association of British Neurologists
(ABN) when prescribing DMDs. These guidelines bring together the
different recommendations from NICE or the SMC on which drugs
should be used, and represent a consensus on the best use of
DMDs to treat MS. i
There are other things you will need to think about – such as how
the drug fits in with your lifestyle. For example, most of the drugs
need to be injected, although depending on the drug this can vary
from once a day to once a week.
There’s more information on the criteria for each drug, as well as
other things you may need to think about before choosing a drug,
in later sections of the booklet. If you are online, the MS Decisions
website may also help you to choose between the different drugs:
www.msdecisions.org.uk
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Avonex, Rebif, Betaferon, Extavia
and Copaxone (beta interferon
and glatiramer acetate)
Key information
Who are these drugs
recommended for?
The ABN guidelines recommend that Avonex, Rebif, Betaferon,
Extavia and Copaxone be prescribed for:
•
people with relapsing remitting MS who have experienced at least
two ‘clinically significant’ relapses in the last two years
•
people with secondary progressive MS who are still experiencing
relapses, and where these relapses are the predominant cause of
their increasing disability
The guidelines also say they may be recommended for:
•
people with ‘clinically isolated syndrome’ (a set of symptoms
which may well be due to damaged myelin around nerve fibres,
but where there have been no other attacks), when MRI scans
show a high likelihood that they will go on to develop MS
•
children and young people with relapsing remitting MS
There’s more information about relapses in the MS Society
booklet Managing a relapse. Our booklet What is MS? explains
more about the different types of MS.
Avonex, Rebif, Betaferon and Copaxone
In 2001, NICE decided that these drugs did not provide enough
benefit, given their cost, for them to be available on the NHS.
However, challenges to this decision led to an agreement between
the Government and the drug companies to make the drugs
available through what is known as the Risk Sharing Scheme.
Why is it called the Risk Sharing Scheme?
The ‘risk’ in the title refers to a shared financial risk – if the
drugs do not prove to be as effective as was promised, then
the drug companies could be required to reduce the price
of the drugs to the NHS.
The Risk Sharing Scheme uses a version of the ABN guidelines from
2001. Since then, the guidelines have been updated, most recently
in 2009, and some of the recommendations have changed. The
Department of Health has issued guidance stating that the Risk
Sharing Scheme is still current. In addition, the drugs can be
prescribed on the NHS to people outside the ABN guidelines where
it is judged clinically necessary. So, if your neurologist thinks you are
Disease modifying drugs © MS Society 03/13
Are they available
on the NHS?
3
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eligible for treatment according to the 2009 ABN guidelines,
the drugs should be funded by the NHS.
Extavia
Extavia was not licensed until 2009, and so does not come within
the Risk Sharing Scheme. Although it has not been assessed by
NICE or the SMC, it is available as a prescribed drug on the NHS.
How are they taken?
Avonex, Rebif, Betaferon, Extavia and Copaxone are all selfinjected, between one and seven times a week, depending on
which drug is used. The table opposite has more information
about injection frequency.
How effective are they?
Several clinical trials have shown that the different drugs are equally
effective for those eligible, with around a 33 per cent reduction in
the number of relapses experienced over two years (compared
to what would be expected if no treatment was taken). They may
also reduce the development of disability, although this benefit was
found to be modest at best and some trials did not show any benefit.
There is no clear research evidence for long-term benefits.
Studies have shown that these drugs are safe to use to treat MS
in people under the age of 18.
How do they work?
Interferons are proteins produced naturally in the human body.
There are different types of interferon, including ‘alpha’, ‘beta’
and ‘gamma’. In the immune system, they help fight viral
infections. It’s thought that beta interferon can reduce (and might
prevent) inflammation which can damage nerve fibres in MS.
The different beta interferon drugs are named 1a and 1b because
of differences in how they are manufactured. The branded drugs
Avonex and Rebif are beta interferon-1a, and Betaferon and
Extavia are beta interferon-1b.
Disease modifying drugs © MS Society 03/13
Copaxone (glatiramer acetate) acts like a part of the myelin
coating around nerve fibres. It seems that it works by attaching
itself to the immune cells that target myelin, which stops them
from attacking the real myelin and causing damage.
4
How do I know which
drug is best for me?
Although all of the drugs are equally effective, there are
differences in frequency, preparation and storage of Avonex,
Rebif, Betaferon, Extavia and Copaxone. These are summarised
in the table opposite.
You may find it helps to discuss the options with your neurologist
and, if you have one, your MS nurse. They will be able to
talk about experiences others have had, and about medical
considerations over which drug is suitable. But your choice
will also depend on your own preference about, for example,
how often you want to inject and what will suit you best.
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Drug name
How often is
it injected?
Where is
it injected?
Is the drug
pre-mixed,
ready to inject?
How should it
be stored?
Avonex (beta
interferon 1a)
Once a week
Into the muscle
It is available
in two versions:
one is pre-mixed
and ready to
inject; the other
needs to be
mixed each time
The pre-mixed
version generally
needs to be kept
in the fridge (2–8°C),
but can be kept at
room temperature
for up to a week
before use. The
unmixed version
can be kept at
room temperature
for up to two
years
Rebif (beta
interferon 1a)
Three times
a week
Under the skin
Yes, it is
pre-mixed
Generally needs
to be stored in
the fridge (2–8°C),
but can be stored
at room temperature
(15–25°C) for
up to 14 days
Betaferon (beta
interferon 1b)
Alternate days Under the skin
No, it needs
to be mixed
each time
At room
temperature, for
up to two years
Extavia (beta
interferon 1b)
Alternate days Under the skin
No, it needs
to be mixed
each time
At room
temperature, for
up to two years
Copaxone
(glatiramer
acetate)
Every day
Yes, it is
pre-mixed
Generally needs
to be stored in
the fridge (2–8°C),
but can be stored
at room temperature
(15–25°C) for
up to a month
before use
Under the skin
Disease modifying drugs © MS Society 03/13
Comparing these drugs
5
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What am I commiting to?
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Taking any of these DMDs involves a long-term commitment.
They are intended to reduce the number and severity of relapses
over several years, so they need to be taken regularly for some
time. While taking a disease modifying drug, you will have regular
review appointments with your MS nurse, if you have one, and an
annual assessment by a neurologist at the prescribing centre.
Possible side effects
Most people tolerate these drugs well, but, as with any treatment,
there can be side effects. If you take any of these drugs, you will
be monitored to check for any side effects.
Your neurologist or MS nurse can tell you more about the possible
side effects covered here, but if you notice unusual or unexpected
effects, you should contact them – even if you have been taking
the drug without problems for some time.
Skin reactions
Betaferon, Copaxone, Extavia and Rebif are all injected under the
skin. DMDs injected under the skin commonly cause reactions at
the site of the injection (reddening, hardening, bruising or itching).
Your MS nurse, if you have one, can help you develop good
injection technique.
Avoiding site injection problems
Disease modifying drugs © MS Society 03/13
Good practice includes washing your hands thoroughly and
then cleaning the skin where you will inject – though there is no
particular cleaning method recommended for this. Applying an
ice pack just before cleaning the skin or after injecting can help
reduce painful skin reactions. Also, it is advisable to keep the
injecting needle ‘dry’ – avoid discharging any liquid medication
onto the outside of the needle before you inject. Allowing the
medication to warm to room temperature also helps. Rotating
injection sites is important, too, as is injecting where there
is sufficient body fat. MS nurse support when you start
treatment and throughout your treatment should make
injecting manageable.
6
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Flu-like symptoms
Avonex, Betaferon, Extavia and Rebif may cause periods of flu-like
symptoms, such as muscle ache, fever, chills or headache –
generally for no longer than 48 hours. These are usually worse in
the first three months and often (though not always) lessen over
time. Ibuprofen or paracetamol can prevent or improve these
symptoms. Injecting immediately before going to bed and taking
ibuprofen or paracetamol at that time can alleviate the flu-like
symptoms – you may sleep through the worst of these. Some
people find drinking more fluids on the day of the injection can
help reduce the headache.
Changes in menstrual
periods
Some women taking Avonex, Betaferon, Extavia or Rebif
experience irregular, early or late periods. If you are concerned,
you should ask for a referral to a gynaecologist. This is not a
common side effect of these drugs. It affects only around one
per cent of people taking them.
Mood changes
Depression is relatively common in people with MS. It has been
suggested that Avonex, Rebif, Betaferon or Extavia can make it
worse, though it is not certain that this is the case. Before you
start on any disease modifying drug, your neurologist or MS nurse
will ask if you have been prone to mood changes. If you have
been diagnosed with depression in the past, you might not be
prescribed Avonex, Rebif, Betaferon or Extavia, though Copaxone
may still be a suitable option. This would all be assessed on
an individual basis, so having a history of depression does not
automatically rule out being prescribed one of these drugs.
Neurological symptoms
Rarely, people taking beta interferon experience a ‘flare-up’ of their
MS symptoms following injection. This normally lasts no more than
48 hours. Some people notice their muscles get stiff during this
time. This flare-up of symptoms could be because the drugs have
caused a mild fever – many people with MS notice their symptoms
get worse when their body temperature rises like this. This side
effect, if it occurs at all, usually lessens over the months and years
of taking the drug. As with the flu-like symptoms, ibuprofen or
paracetamol can help.
Disease modifying drugs © MS Society 03/13
Less commonly, some people injecting under the skin experience
a condition at injection sites called ‘lipoatrophy’, in which the fat
is lost in small areas under the skin. This leaves dents in the skin,
which, if they occur, are usually permanent. The problem can be
kept to a minimum by looking out for early signs of dents and
avoiding sites which have been affected, rotating injection sites
for every injection.
7
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A few people using Copaxone experience chest pain or tightness
immediately following the injection, which can be accompanied
by anxiety, flushing, sweating, palpitations or a perceived difficulty
in breathing. These side effects do not happen often, but can
be unpredictable – they might happen the first time you take the
drug, or after many doses. They usually only last a short time
and although unpleasant, have not been linked to permanent
or serious harm. They are not a reason to have to stop taking
Copaxone.
Anyone taking Avonex, Rebif, Betaferon and Extavia will have
regular blood tests to check liver function and blood cell count.
Occasionally, they can cause problems such as mild anaemia,
liver abnormalities or a reduction in white blood cell count. Liver
abnormalities are actually quite common in people taking these
drugs, but are usually mild, settle down on their own and only
very rarely mean the person must stop taking the drug.
Liver function and
blood count
Frequently asked questions
Who prescribes
these drugs?
A neurologist based at one of the regional prescribing centres.
There is one of these centres in most large towns or cities.
If your neurologist is not based at a centre which prescribes these
drugs, they may refer you to your nearest centre for this. You can
still choose to see your existing neurologist for other matters. This
is something to discuss with them when they make the referral.
Disease modifying drugs © MS Society 03/13
Are there any reasons
why I might have to
stop taking the drugs?
8
As long as the drug seems to be having a positive effect (for
example, if your relapses are less severe or less frequent than
before) it should continue to be prescribed. However, there
might be circumstances in which you decide, together with your
neurologist, to stop taking a disease modifying drug, such as:
•
if you or your health care team notice signs of a serious side
effect or adverse reaction
•
if you find the side effects intolerable
•
if you are planning to get pregnant
•
if you develop an increased number and severity of relapses
•
if you do not see a reduction in the number of relapses compared
to the one to two years before you started taking it
•
if you develop ‘neutralising antibodies’ (see opposite)
•
if you develop secondary progressive MS and can no longer walk
•
if a more suitable treatment becomes available
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What are neutralising antibodies?
Sometimes, the body’s immune system begins to react against beta
interferon, by producing antibodies which might prevent the drug
from being effective. This can be checked by a blood test. Experts
disagree about how much these antibodies can affect the way the
drugs work. In some cases, levels of antibodies go down over time.
Sustained, high levels of neutralising antibodies might suggest that
the drug is no longer effective, and can be a factor in choosing to
stop treatment.
Guidance issued by the Department of Health stresses that anyone
being prescribed these drugs should only come off them for clinical
reasons. Treatment on the NHS should not be stopped for financial
reasons.
Can I switch drugs?
Yes, if you need to, you can switch to another of the drugs that you are
eligible for. You would need to discuss any planned change with the
prescribing neurologist. People’s reactions to drugs vary and if, for
example, you get continuing side effects which prove intolerable,
you might want to change drugs. Note that if you switch from a beta
interferon (Avonex, Rebif, Betaferon or Extavia) because of neutralising
antibodies, it only makes sense to switch to Copaxone (glatiramer
acetate) because the antibodies will neutralise other forms of interferon
as well.
Do I have to inject
myself?
These drugs do need to be injected, but most people, even many
who were afraid of needles, find that they soon get used to it. None
of the drugs are injected into a vein. Instead, they are injected just
under the skin or into the muscle. The drugs are available with ‘autoinject’ – a system which means you don’t need to see the needle
going in, and where the action of injecting comes down to the click
of the ‘pen’ holding the syringe.
One of the drugs, Rebif, is available with an injecting device known
as ‘RebiSmart’. This device uses pre-filled syringe cartridges which
only need loading once a week. It allows for changing needles and
injecting without having to see the needle itself, and also keeps
a record of when the injections happen. The speed and depth of
the injection can also be controlled, so you can set it to your own
comfort level.
Disease modifying drugs © MS Society 03/13
If your MS becomes more active and you become eligible for another
drug, this might be a reason to discuss changing treatments with
your neurologist. None of the drugs are licensed for combination
with any of the other DMDs, so you would stop taking one drug
before beginning the other.
9
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When you are prescribed any of these drugs, a nurse will go
through good injection technique with you. Most people find
they are able to do the injections themselves, which gives them
independence over when and where to do it, but it is possible
for a family member or friend to be given this training so they
can do it for you. It is also sometimes possible for injections
to be given by a practice nurse at a local clinic.
How do I store the
drugs and syringes?
Different drugs have different storage requirements, as shown
in the table on page 5. Most need to be kept in the fridge, and
you would also need to have a safe space to store syringes and
discarded needles. The drug company will supply a box for these
discarded ‘sharps’. An MS nurse can help with storage ideas and
how to approach family or friends who you might want to explain
things to.
Do these drugs affect
pregnancy or breast
feeding?
It is not known whether Avonex, Rebif, Betaferon, Extavia or
Copaxone present a risk to a baby or foetus. If you are trying
to conceive or are already pregnant, it is important to discuss all
your medications with your doctor. Women are advised to stop
taking a disease modifying drug if they are trying to conceive, are
pregnant or breastfeeding. You should discuss all these matters
with your doctor.
What about travelling
with the drugs?
Taking these drugs should not prevent you from travelling,
though you might need to plan well in advance.
Keeping the drugs cool
When you start treatment, you will be given a travel bag, with ice
packs, to make it easier to keep the drugs cool and the syringes
safe when you travel. All of the drugs can all be stored at room
temperature for a limited amount of time. This ranges from one
week to two years. It is recommended that you transfer the drugs
to a fridge or equivalent cool place as soon as you reach your
destination.
In case of delays
Disease modifying drugs © MS Society 03/13
You may want to take a few more doses than you would normally
need when you travel – in case of unexpected delays.
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Air travel
For air travel, it’s advisable to keep syringes and drugs in the
cabin, rather than in your standard luggage. Temperatures can
get extremely low in the baggage hold of an aircraft.
The Department for Transport says that syringes are prohibited
in hand luggage unless required for medical reasons, and that
in general, airport managers and aircraft operators have the
discretion to refuse any potential weapon. You should contact both
the airport and your individual airline to let them know you will be
bringing the medication with you in your hand luggage and ask for
any special instructions. For security reasons, the crew may lock
them in a special locker in the cabin for the duration of the flight.
Ensure you have documentation with you to establish why you
need to travel with the drug – for example, a letter from your
neurologist, MS nurse or GP. The makers of each drug may be
able to provide paperwork to help with travel.
Eurostar and Eurotunnel
If you’re travelling on Eurostar or through the Eurotunnel, you
should carry a letter with you from your neurologist, MS nurse
or GP stating that you need to travel with the drug. At the time
of writing, you do not need to tell the travel operator in advance
that you will be carrying these items, but it’s a good idea to always
check with them before travelling in case of any changes to
the security situation.
Avonex and Rebif both contain animal products. Betaferon and
Extavia do not contain animal product, but contain human ‘serum
albumin’, a protein found in our blood and produced by the liver.
Copaxone is synthetic and does not contain human or animal
material. As with many other licensed drugs, they have all been
tested in animals.
Disease modifying drugs © MS Society 03/13
Are these treatments
vegan-friendly or
vegetarian-friendly?
11
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Tysabri (natalizumab)
Key information
Who is Tysabri
recommended for?
Is Tysabri available
on the NHS?
The ABN guidelines recommend that Tysabri be prescribed for:
•
people with ‘aggressive multiple sclerosis’ – who have had two
or more disabling relapses in one year, and an increase in lesions
as shown on an MRI scan
•
people who have had an increase in the number or severity
of relapses while taking one of the other drugs (Avonex, Rebif,
Betaferon, Extavia or Copaxone)
Yes. NICE and SMC recommend Tysabri, using the same criteria
as the ABN guidelines.
If you and your neurologist feel you meet the criteria for Tysabri,
it should be available to you on the NHS. At the moment, however,
this is not always the case. The MS Society has produced a guide
to campaigning for access to MS medicines, which may help if
you feel you meet the criteria for Tysabri but you have been
denied it. Contact the UK Information Team for a copy or visit the
MS Society website: www.mssociety.org.uk
How is it taken?
Tysabri is given by a health care professional as a monthly
infusion into a vein, lasting about an hour. This usually happens
at the neurology unit of a hospital.
How effective is it?
A two-year study showed that, on average, people taking Tysabri
had a 67 per cent reduction in the number of relapses (compared
to what would be expected if no treatment was taken).
Tysabri also slowed the accumulation of disability over two years.
Only 17 per cent of people taking the drug had worse disability,
compared with 29 per cent of people taking a placebo (dummy
treatment).
Disease modifying drugs © MS Society 03/13
We do not yet know if Tysabri can deliver long-term benefits.
12
There have not been studies to show whether Tysabri is safe
for people under 18, so it is not normally prescribed for children
or young people.
How does it work?
Tysabri is an ‘antibody’, just like those found naturally in the
immune system (where antibodies help fight infection). By
attaching itself to receptors on the outside of certain immune
cells, Tysabri prevents these cells from leaving the blood stream
and entering the brain and spinal cord where, in MS, they can
cause inflammation and damage.
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Possible side effects
Most people taking Tysabri tolerate it well, but there can be side
effects – including a very rare, but potentially fatal infection called
PML (see below).
Everyone taking Tysabri is monitored closely. Each month, when
you visit the clinic for your infusion, the doctor or nurse will ask if
you have any lasting medical problems which are getting worse,
such as changes to eyesight, your memory or thinking, or balance.
They will also ask specific questions about any reactions you
might have noticed after the last infusion of Tysabri, or any fever
or infection.
During or shortly after
the infusion
During the infusion of Tysabri, and up to an hour afterwards, some
people shiver, or feel sick or dizzy. These effects are usually mild
and normally pass before the end of the infusion. They are not
usually a reason for having to stop the treatment.
Around one in 25 people who take Tysabri have a more serious
allergic reaction to taking it, either during the infusion or in the
hour following. These allergic reactions can include an itchy rash,
swelling of the face, lips or tongue or difficulty breathing.
Other signs of an allergic reaction might be picked up by health
care professionals, such as an increased body temperature,
decreased blood pressure and a faster pulse. The health care
team would give medical attention if this reaction occurs, to
manage the symptoms.
Treatment with Tysabri has to be stopped for anyone who has
an allergic reaction to it.
Common side effects
Common side effects include joint pain, fever, tiredness, a runny
or blocked nose, sore throat, feeling or being sick, headache or
dizziness.
PML
(progressive multifocal
leukoencephalopathy)
Because of the way that Tysabri works, it can leave the immune
system more open to infections. PML is a viral brain infection. It
can cause severe neurological symptoms, which may at first be
mistaken for MS relapses. But the symptoms rapidly worsen and
may lead to death or disability. Several people treated with Tysabri
have died because of PML.
Disease modifying drugs © MS Society 03/13
Fewer than ten per cent of people taking Tysabri experience these
side effects, but these milder side effects are far more common
than, for example, liver problems or PML.
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Analysis of the number of cases of PML suggests that the overall
risk is about 1 in every 500 people treated with Tysabri. However,
there are factors which appear to affect a person’s risk of
developing PML:
•
The length of time they’ve been taking Tysabri – there have not
been any recorded cases in a person who’s been taking it for
less than a year.
•
Previous use of another immunosuppressant drug, such as
mitoxantrone (Avonex, Rebif, Betaferon, Extavia and Copaxone
are not considered to be immunosuppressants).
•
Testing positive for the ‘JC virus’. This is a common virus that
affects around 70 to 90 per cent of the general population,
usually without any symptoms. However, in people who are taking
immunosuppressants or have weakened immune systems it may
cause PML.
Disease modifying drugs © MS Society 03/13
Any hospital prescribing Tysabri must ensure that everyone –
professionals and patients – is aware of the risks, the early signs
of PML to look out for and what to do if they notice these signs.
14
Liver problems
Serious liver problems for people taking Tysabri are also very rare
and ought to be picked up in routine blood tests. Early signs of
liver problems include the skin or whites of the eyes turning
slightly yellow, and urine turning unusually dark.
Long-term side effects
It is too soon to know about possible long-term side effects from
Tysabri, but people taking the drug are being monitored, which
should give a better picture for the future.
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Frequently asked questions
Who prescribes
Tysabri?
Tysabri can be prescribed on the NHS by any neurologist, just
like any other prescription drug – with the same considerations
around suitability, potential benefits and possible side effects.
A neurologist would be guided in their decision to prescribe
by the NICE/ SMC guideline for the drug. Because of rare but
potentially very serious side effects (see page 13), anyone taking
Tysabri needs to be carefully monitored, with regular check-ups.
How long will I be
prescribed the drug?
There are no formal guidelines for stopping treatment with
Tysabri. You could expect to take it for as long as you and your
neurologist agree it seems to be working. If the side effects
become a problem, or blood tests show early signs of health
problems, these would be reasons to stop.
Occasionally, the immune system begins to act against Tysabri
and stop it working. If this occurs at all, it is normally in the first
six months of treatment, when it would show up with a blood
test. This can sometimes be a reason to stop taking Tysabri.
How will taking Tysabri
affect any other
treatments?
Because of the way it works, Tysabri is not suitable for people
with weakened immune systems, so it cannot be combined
with treatments which alter the way the immune system works,
such as the other DMDs.
People taking Tysabri can still receive short courses of steroids
to treat relapses.
Does Tysabri affect
pregnancy or breast
feeding?
As with the other licensed DMDs, it is not known if Tysabri
presents a risk to the foetus and babies. If you are trying to
conceive, are pregnant or breastfeeding, you are advised to
stop taking Tysabri. Speak to your neurologist for further
advice on this.
Disease modifying drugs © MS Society 03/13
Is Tysabri vegan-friendly Tysabri is made by combining DNA from mouse and human
or vegetarian-friendly?
cells, to create an antibody similar to those in the human immune
system. As with other licensed drugs, Tysabri has been tested
in animals.
15
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Gilenya (fingolimod)
Key information
Who is Gilenya
recommended for?
Gilenya was licensed in 2011 for treating rapidly evolving
relapsing remitting MS. This means that it is suitable for people
who still have relapses despite taking Avonex, Rebif, Betaferon or
Extavia, or who have had two or more relapses in the past year.
Is Gilenya available
on the NHS?
Yes. Both NICE and SMC have recommended the use of Gilenya
on the NHS for the treatment of adults with highly active relapsing
remitting MS.
This means that people with MS who have regular relapses or
increased relapse rates (compared to the previous year), despite
taking beta interferon (Avonex, Rebif, Betaferon or Extavia),
will be eligible for the treatment on the NHS.
If you have only ever taken Copaxone (glatiramer acetate), and
have no evidence of taking any of the beta interferons, then you
are not likely to be considered eligible for Gilenya. You need to
have taken, and failed to respond to, beta interferon in order
to be considered eligible.
If you and your neurologist feel you meet the criteria for Gilenya,
it should be available to you on the NHS. However, this is not
always the case. The MS Society has produced a guide to
campaigning for access to MS medicines, which may help if
you feel you meet the criteria for Gilenya but have been denied it.
Contact the UK Information Team for a copy or visit the MS
Society website: www.mssociety.org.uk
How is it taken?
Gilenya is taken once a day, in tablet form.
How effective is it?
A two-year study comparing Gilenya to a dummy treatment
showed that it reduced relapse rates by 54 to 60 per cent,
and reduced disability progression by about 30 per cent.
Disease modifying drugs © MS Society 03/13
A one-year study showed that it reduced relapse rates by 53 per
cent compared to beta interferon-1a.
16
How does it work?
A specialised type of immune cell, called a T-cell, is thought to be
responsible for much of the damage caused in relapsing remitting
MS. Gilenya acts by grabbing these T-cells from the bloodstream
and trapping them inside organs in the body called lymph nodes.
This prevents these T-cells from getting into the brain and causing
damage.
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Possible side effects
Gilenya is generally well-tolerated, although some people may
experience side effects, some of them potentially quite serious.
Lowered heart rate
When you first take Gilenya it can cause your heart rate to slow
down or become irregular. This may make you feel dizzy or tired.
You will be expected to stay under medical supervision for six
hours after taking the first dose, to check for any serious side
effects. Irregular heart rate should return to normal within a day,
and a slow heart rate can take up to a month to return to normal.
If it doesn’t, or if you notice a change after you’ve been taking
Gilenya for a while, then you should speak to your neurologist
or MS nurse.
Following a safety review in 2012, the European Medicines Agency
updated their prescribing guidelines for Gilenya. They now
recommend that doctors should not prescribe Gilenya to people
with a history of heart disease or problems with blood supply to
the brain (such as stroke), or who are taking medication that
affects their heart rate.
Increased risk
of infections
Gilenya lowers the numbers of white blood cells in your blood.
As white blood cells fight infection, you may find that you pick
up illnesses and infections more easily while taking Gilenya. Any
infection that you already have may get worse, and could become
serious. Speak to your doctor if you have an infection or fever,
particularly if it seems to be getting worse.
Macular oedema
Very rarely, Gilenya can cause a problem with your vision, known
as macular oedema. It’s caused by leaking blood vessels causing
fluid to build up in the macular (part of the retina at the back of
your eye). Symptoms of macular oedema can be similar to optic
neuritis (inflammation of the optic nerve), and can include blurring
or a blind spot in the centre of your vision, or problems seeing
colours or fine detail. Sometimes you may not notice any
symptoms.
Because macular oedema is more likely to develop in the first
few months of taking Gilenya, you may need to have an eye
examination after about three or four months. Some people who
are at a higher risk of developing macular oedema, for example
Disease modifying drugs © MS Society 03/13
However, even in these circumstances, the guidelines say that if
your neurologist considers treatment with Gilenya necessary then
they can still prescribe it to you. You would need to stay under
medical supervision at least overnight following your first dose of
Gilenya, and you may also have ongoing monitoring of your heart.
17
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people with diabetes or anyone who’s had an eye infection known
as uveitis, may need extra monitoring. If you notice any changes
in your eyesight at any point, let your neurologist or MS nurse
know as it may be a sign of macular oedema.
Liver problems
Serious liver problems for people taking Gilenya are also very
rare and ought to be picked up in routine blood tests. Early signs
of liver problems include the skin or whites of the eyes turning
slightly yellow, and urine turning unusually dark.
Common side effects
Common side effects of Gilenya include headache, diarrhoea,
back pain, cough and dizziness. These milder side effects affect
around one in ten people taking Gilenya.
Long-term side effects
It is too soon to know about possible long-term side effects
from Gilenya, but people taking the drug are being monitored,
which should give a better picture for the future.
Disease modifying drugs © MS Society 03/13
Frequently asked questions
18
Who prescribes Gilenya?
Gilenya can be prescribed on the NHS by any neurologist, just
like any other prescription drug – with the same considerations
around suitability, potential benefits and possible side effects.
A neurologist would be guided in their decision to prescribe by
the NICE/ SMC guideline for the drug.
How long will I be
prescribed the drug?
There are no formal guidelines for stopping treatment with
Gilenya. You could expect to take it for as long as you and your
neurologist agree it seems to be working. If the side effects
become a problem, or tests show early signs of health problems,
these would be reasons to stop.
How would taking
Gilenya affect any
other treatments?
Because of the way that Gilenya affects the immune system, you
would not be able to take it with any of the other DMDs. Similarly,
if your immune system is weakened already, Gilenya would not be
a suitable drug for you.
Does Gilenya affect
pregnancy or breast
feeding?
As with the other licensed DMDs, it’s not known whether Gilenya
can cause harm to an unborn baby. If you’re trying to conceive,
or you are pregnant or breastfeeding, you would be advised to
stop taking Gilenya. Speak to your neurologist for further advice
on this.
Is Gilenya vegan-friendly
or vegetarian-friendly?
The active ingredients in Gilenya are contained within a capsule
made from gelatine, which is of animal origin. As with other
licensed drugs, Gilenya has been tested in animals.
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Other treatments available
In the first part of this booklet, we looked at drugs licensed
specifically for MS. There are also other treatments that NICE
or the ABN guidelines mention might be used for treating MS,
but which aren’t licensed specifically for treating MS.
Mitoxantrone
The drug mitoxantrone (brand name Novantrone) is approved in
the US for treating secondary progressive MS and worsening
relapsing remitting MS (when there is not complete remission
between relapses). Mitoxantrone is currently licensed in the UK
as a cancer-fighting drug. It is not licensed for MS, but it is
prescribed for some people with MS (on an individual ‘named
patient basis’). It is given by drip, at a hospital.
Treatment with mitoxantrone is limited to courses ranging from six
months to two years. This is because, above a certain cumulative
dose, it can be toxic to the heart. People taking mitoxantrone also
have an increased risk of developing a potentially fatal leukaemia.
A neurologist can explain more fully the potential benefits and risks.
A number of small studies have found that a combination of
a short course of mitoxantrone followed by Copaxone can
significantly reduce relapse rates and disability progression
while also limiting possible side effects from the mitoxantrone.
The drug azathioprine (Imuran) is sometimes used to help prevent
rejection during transplantation and it is also used in a variety of
diseases where the immune system is at fault, like MS. Although not
licensed for MS, it has been used in MS since the 1960s – although
not commonly in the UK. There have not been many trials looking
at azathioprine, but a recent review of the available evidence
found that it can help to reduce the number of relapses. There
are concerns with possible side effects, but these can be reduced
by limiting both the overall dose and the number of years that
someone takes the drug.
IVIg
IVIg (intravenous immunoglobulin) is a blood product given by
infusion. You would need to go into hospital for the treatment,
which can take several hours. It is not a standard treatment for
MS. But some neurologists argue that it has a place for reducing
a woman’s risk of having a relapse in the three months after giving
birth – a time when, if she breast feeds, she would be advised
against taking currently licensed DMDs. These potential benefits
remain unproven.
Disease modifying drugs © MS Society 03/13
Azathioprine
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Further
information
UK Information Team
020 8438 0799
[email protected]
National offices
– see back cover
www.mssociety.org.uk
Page 20
Read more
Our free booklets help explain MS, look at its practical and
emotional effects, and help you find your own ways to manage
life with MS. Titles are available in large print, audio format and
a number of languages.
We can help you find and borrow other books, research articles
and DVDs about living with MS. Search online or call the UK
Information Team.
Find out more online
Get the latest on research, campaigns and MS news. Chat online
with our message boards and Facebook. Follow us on Twitter,
see the MS community at Flickr and watch us on YouTube.
Children and teenagers can find out more and link up through
our YoungMS site: www.youngms.org.uk
Join us
Receive local and national magazines and newsletters, and
get involved locally and nationally. Be as involved as you like.
Just by being a member you strengthen the voice of all people
with MS, and help us continue our vital work. Join online, or call
020 8438 0759 or your national office.
Get in touch
The freephone MS Helpline offers confidential emotional support
and information for anyone affected by MS, including family,
friends and carers. Information is available in over 150 languages
through an interpreter service. 0808 800 8000 (weekdays 9am9pm) or [email protected] Contact the UK Information
Team or your national office if you have any questions about MS.
Near you
Disease modifying drugs © MS Society 03/13
Our volunteers run over 300 local branches and support groups.
They provide information about MS and local services, and a
chance to meet others affected by MS and take part in a range
of activities.
20
In many parts of the country, you can pick up our booklets at MS
Society Info Points. Larger information centres – including ones
in our national offices in London, Belfast, Cardiff and Edinburgh
(Newbridge) – can help you with information about MS and
services in your area.
Or come along to our local and national events and learn more
about MS from expert care professionals, researchers and other
people with the condition. Find out more online or call your
national office.
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Page 21
Useful organisations
Association of British Neurologists
Ormond House
27 Boswell Street
London WC1N 3JZ
Telephone 020 7405 4060
www.abn.org.uk
National Institute for Health and Clinical Excellence
MidCity Place
71 High Holborn
London WC1V 6NA
Telephone 0845 003 7780
www.nice.org.uk
Scottish Medicines Consortium
Delta House (8th floor)
50 West Nile Street
Glasgow G1 2NP
Telephone 0141 225 6989
www.scottishmedicines.org.uk
Disease modifying drugs © MS Society 03/13
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Further reading
MS Decisions
Funded by the Department of Health, this online decisions
tool aims to help people consider whether disease modifying
treatment is the right option for them and, if so, which of the
available drugs might suit them best.
www.msdecisions.org.uk
References
Disease modifying drugs © MS Society 03/13
A list of references is available on request, and all cited articles
are available to borrow from the MS Society library (there may
be a small charge). Contact the UK Information Team, or visit
www.mssociety.org.uk/library
22
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Page 23
Authors and contributors
First edition written by Debbie Reeves
This edition edited by Jude Burke
With thanks to Dr Alasdair Coles, Kerry Mutch, Bernadette Porter
and the rest of the MS Nursing Team at the National Hospital for
Neurology and Neurosurgery, and all those affected by MS who
contributed to this booklet.
Disclaimer: We have made every effort to ensure that information
in this publication is correct. We do not accept liability for any
errors or omissions, and policy and practice may change. Seek
advice from the sources listed.
Suggestions for improvement in future editions are welcomed.
Please send them to [email protected]
© Multiple Sclerosis Society, 2013
First edition, August 2004
Fifth edition, March 2012
Revised, March 2013
This title will be reviewed within three years.
The MS Society provides this information free of charge but if
you would like to help cover the cost, which will help towards our
essential work, please call 0800 100 133 or visit the fundraising
section of our website to make a donation. Anything you can
give will be greatly appreciated.
Disease modifying drugs © MS Society 03/13
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MS Society
Multiple sclerosis (MS) is the most common disabling
neurological disorder affecting young adults and we estimate
that around 100,000 people in the UK have MS. MS is the result
of damage to myelin – the protective sheath surrounding nerve
fibres of the central nervous system. This damage interferes with
messages between the brain and other parts of the body.
For some people, MS is characterised by periods of relapse
and remission while, for others, it has a progressive pattern.
For everyone, it makes life unpredictable.
The MS Society is the UK’s largest charity dedicated to supporting
everyone whose life is touched by MS. We provide a freephone
MS Helpline; grants for home adaptations, respite care and mobility
aids; education and training; support for specialist MS nurses;
and a wide range of information.
Local branches cater for people of all ages and interests and are
run by people with direct experience of MS.
The MS Society also funds around 80 vital MS research projects
in the UK.
Membership is open to people with MS, their families, carers,
friends and supporters. You can help the work of the MS Society by:
•
•
•
becoming a member
making a donation
offering your time as a volunteer
Contact information
MS National Centre
372 Edgware Road
London NW2 6ND
Telephone 020 8438 0700
[email protected]
MS Society Scotland
National Office, Ratho Park
88 Glasgow Road
Ratho Station
Newbridge EH28 8PP
Telephone 0131 335 4050
[email protected]
MS Society Northern Ireland
The Resource Centre
34 Annadale Avenue
Belfast BT7 3JJ
Telephone 028 9080 2802
[email protected]
MS Society Cymru
Temple Court
Cathedral Road
Cardiff CF11 9HA
Telephone 029 2078 6676
[email protected]
National MS Helpline
Freephone 0808 800 8000
(weekdays 9am-9pm)
www.mssociety.org.uk
Multiple Sclerosis Society.
Registered charity
nos 1139257 / SC041990.
Registered as a limited
company in England and
Wales 07451571.
ES06/0313