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Disease modifying treatments
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Disease modifying
treatments
Disease modifying treatments (DMTs) are
medications which modify the disease
course. They target inflammation and are
designed to reduce the damage caused
by relapses. By doing this, the number
and severity of relapses decreases. Some
of these drugs have been found to delay
the long-term progression of MS and
reduce the number of new lesions
forming.
Not everyone with MS will benefit from
DMTs in the same way. New guidance
was issued in 2015 by the Association of
British Neurologists (ABN) setting out the
eligibility criteria for the prescribing of
these drugs. The ABN also states that
treatment should start as early as possible
in eligible patients, before the person with
MS shows any disability or sustains
damage to their nerve cells. Some
treatments are licensed for use in
Clinically Isolated Syndrome (CIS) and
these are sometimes given before MS has
been made as a definitive diagnosis. The
guidelines also state that ‘people with MS
will face complex choices and must play
an active role in treatment decisions’.
There are currently a number of disease
modifying treatments available
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Beta Interferon 1a (avonex, rebif
and plegridy)
Beta Interferon 1b (betaferon and
extavia)
Copaxone (glatiramer acetate)
Gilenya (fingolimod)
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Tecfidera (dimethyl fumerate or
BG-12)
Aubagio (teriflunomide)
Lemtrada (alemtuzumab, campath)
Tysabri (natalizumab)
An MS specialist neurologist should
assess your eligibility and suitability for
DMTs. Once treatment has started,
patients should remain under the
supervision of a specialist MS
neurologists and nurses.
The recommendations for starting disease
modifying treatment as stated in the ABN
guidance are as follows:
Eligible patients will normally be ambulant
(maximum EDSS 6.5). There are no
treatments licensed for use during
pregnancy.
The currently list of licensed disease
modifying drugs are divided broadly into
two classes:
Drugs of moderate efficacy
(‘category 1')
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Beta Interferons
Copaxone
Aubagio
Tecfidera (more effective)
Gilenya (more effective)
Drugs of high efficacy (‘category 2’)
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Lemtrada
Tysabri
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Relapsing remitting
multiple sclerosis (RRMS)
More active relapsing
remitting MS
Patients with relapsing remitting MS who
have had two or more clinical relapses in
the previous two years are considered to
have ‘active’ disease that warrants
consideration of disease modifying
treatments. Increasingly, clinicians are
starting treatments in people whose
disease is judged ‘active’ because of a
single recent relapse and/or on
radiological grounds, including both
patients newly diagnosed according to the
2010 ‘MacDonald criteria’, and those with
longer established disease who develop
new MRI lesions without clinical relapse.
Patients may be classified as having more
active MS by frequent clinical relapses
and/or MRI activity either when untreated
or whilst on a Category 1 drug. The formal
criteria for high-disease activity despite
beta interferon or Copaxone requires one
relapse in the previous year on beta
interferon and either a) gadolinium
enhancing MRI lesions or b) at least nice
T2-hyperintensive lesions on a cranial
MRI. It is recommended that patients with
more active disease use on of the
Category 2 drugs, either Tysabri or
Lemtrada. Both have similar efficacy.
The European Medicines Agency has
explicitly recognised that disease activity
may be established on radiological or
clinical grounds (in its licensing of
Alemtuzumab).
More information can be found in the full
ABN guidance, see link above.
All people with active relapsing remitting
MS should be considered for treatment
and most are likely to start treatment with
a Category 1 drug.
To read more about when each drug is
likely to be used over another see the full
ABN guidance here:
http://www.theabn.org/resources/abnpublications/m/ms-guidelines2015.html
Secondary & Primary
progressive multiple
sclerosis (SPMS & PPMS)
None of the current disease modifying
treatments are recommended in ‘nonrelapsing’ secondary progressive MS or in
primary progressive MS. Some people
with relapsing secondary progressive MS,
whereby relapses are their main cause of
increasing disability, may benefit from a
disease modifying treatment.
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Clinically Isolated
Syndrome (CIS)
Clinically Isolated Syndrome is used to
describe a first neurologic episode that
lasts at least 24 hours, and is caused by
inflammation/demyelination in one or
more sites in the central nervous system.
This is sometimes diagnosed before a
formal diagnosis of MS can be made.
Those with CIS who show abnormalities
on MRI scans within one year, may be
offered treatment with a DMT. Currently
only the Beta interferons and Copaxone
are licensed for clinically isolated
syndrome.
People aged under 18
years
The ABN guidance states that minors
aged between 16-18 years should be
treated according to the above guidelines.
Children with MS aged under 16 should
be treated in specialist clinics, preferably
under a combined team including adult
and paediatric neurologists with a
particular interest in MS.
For further information on stopping
disease modifying treatments see the full
ABN guidance here:
http://www.theabn.org/resources/abnpublications/m/ms-guidelines2015.html
What is a relapse?
The National Institution for Care
Excellence (NICE) published guidelines in
October 2014 for the management of
multiple sclerosis. In these guidelines a
relapse can be diagnosed by a GP or
neurologist if:
‘The person with MS has developed new
symptoms or has a worsening of existing
symptoms, and these symptoms have
lasted for more than 24 hours in the
absence of infection or any other cause
after a stable period of a least one month.’
What are the disease
modifying treatments?
Interferon Beta-1a (Avonex, Rebif &
Plegridy)
How does it work?
Interferons are proteins, produced
naturally by the body that help us to fight
infection. There are currently three
interferon beta-1a DMTs available –
avonex, rebif and plegridy.
Interferon beta-1a blocks the action of one
type of protein called gamma interferon. It
reduces the autoimmune reaction that
causes inflammation and destruction of
myelin.
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How can it help?
It has been shown to reduce the rate of
relapse by about one-third in people with
relapsing remitting MS. It also reduces the
severity of relapses that occur.
Other less common side effects can be
mood swings (mainly from avonex), fever
and blood abnormalities. Most people find
these effects reduce over a three month
period of taking the drug. If they persist, a
conversation with an MS nurse or
neurologist would be recommended.
How is it administered?
Avonex must be injected into the muscle
once a week and should be stored in the
fridge.
Rebif must be injected under the skin
three times per week and should be
stored in the fridge. Rebif comes in two
dosages – 22mcg and 44mcg.
Plegridy must be injected under the skin
every 2 weeks and should be stored in the
fridge.
Who manufactures it?
Avonex – Biogen.
Rebif – EMD Serono.
Plegridy – Biogen.
What type of MS is it prescribed for?
All types of interferon beta-1a are classed
as ‘Category 1’ drugs therefore they are
used in those diagnosed with relapsing
remitting MS.
Interferon Beta-1b (Betaferon and
Extavia)
How does it work?
Both Betaferon and Extavia are thought to
block the action of one type of immune
cell, called a T-cell and reduce the
autoimmune reaction that causes
inflammation and destruction of myelin.
How can it help?
Both have been shown to reduce the rate
of relapse by about one-third in people
with relapsing remitting MS and also
reduce the severity of relapses that occur.
How is it administered?
Betaferon and Extavia must be injected
subcutaneously (under the skin, into body
fat) every other day. They do not need to
be stored in the fridge, but must be mixed
before use.
Who manufactures it?
What are the side effects?
The most common side effect
experienced when taking interferon beta1a is flu-like symptoms after injecting.
Injection site irritations may also occur,
such as redness, swelling, itching.
Betaferon – Schering.
Extavia – Novaratis.
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What type of MS is it prescribed for?
Who manufactures it?
Both types of interferon beta-1b are
classed as ‘Category 1’ drugs therefore
they are used in those diagnosed with
relapsing remitting MS.
Teva.
What are the side effects?
The most common side effects
experienced with Betaferon and Extavia
are flu-like symptoms after injecting and
injection site reactions. They can also
cause changes in menstruation, blood
abnormalities and mood swings; however,
again these symptoms are less common.
Copaxone (glatiramer acetate)
What type of MS is it prescribed for?
It is classed as a ‘Category 1’ drug and
therefore licensed for relapsing remitting
multiple sclerosis and some people with
clinically isolated syndrome.
What are the side effects?
Common side effects are injection-site
reactions and lipotrophy (indentations
under the skin). Less commonly, it can
also cause chest tightness,
breathlessness, anxiety, flushing and
palpitations after injection.
How does it work?
Gilenya (fingolimod)
Copaxone acetate works differently from
the interferons in that it is a synthetic
combination of four amino acids which
resemble the myelin protein. It is thought
to work by preventing the production of
immune cells that attack myelin.
How can it help?
The rate of relapse in people taking
Copaxone is generally reduced by onethird.
How does it work?
Gilenya is an immuno-modulating drug,
which attaches to the surface of certain
white blood cells (known as lymphocytes),
causing a number of them to retained
within the body’s immune system. As a
result less lymphocytes get into the blood
stream and fewer reach the central
nervous system. The potential for immune
attack on the cells of the brain and spinal
cord is reduced.
How is it administered?
How can it help?
It needs to be injected subcutaneously
(under the skin). There are two doses,
one for daily injections and another for
three time a week injections (only
approved in 2015). It needs to be stored in
the fridge.
Gilenya was shown to reduce the risk of
relapses by 67% compared to a placebo
in trials.
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How is it administered?
It is taken in the form of a capsule, orally,
once a day.
Who manufactures it?
Novartis.
What type of MS is it prescribed for?
Gilenya is classed a ‘Category 1’ drug
although listed as ‘more effective’ rather
than moderately effective. It is licensed for
adults with highly active relapsingremitting MS. Such people have a high
disease activity as characterised as one
relapse in the previous year despite being
on another disease modifying therapy,
such as interferon for at least 12 months.
In June 2014, NHS England published
new guidelines to allow a switch to
fingolimod for those patients with highly
active RRMS, if they met the following
criteria:
with RES RRMS without them having to
have taken any previous medication.
Gilenya is also undergoing trials for
potential use in people with primary
progressive MS. Some research evidence
points to the drug being neuroprotective
and also repairing myelin. The INFORMS
study is looking into whether the drug can
reduce progression in people with PPMS.
What are the side effects?
Possible side effects include changes to
liver function, macular edema (an
accumulation of fluid in the macular area
of the eye -- the central area of vision –
that sometimes causes blurred vision),
headache, respiratory tract infection,
shortness of breath, diarrhoea and
nausea. Gilenya can cause a decrease in
heart rate so the first dose will be
monitored in hospital for six hours
Tecfidera (Dimethyl fumerate or BG-12)
How does it work?
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Patients whose relapse rate is
unchanged, or has increased
compared to the previous year,
while on any of the beta interferons
or glatiramer acetate (Copaxone)
Patients who are receiving
natalizumab (Tysabri) and are at a
high risk of developing PML
Additionally in October 2014 the Scottish
Medicines Consortium (SMC) licensed
fingolimod as a first-line treatment for
people with rapidly evolving severe
relapsing remitting MS (RES RRMS). This
means Gilenya can be offered to people
Tecfidera may have an anti-inflammatory
effect on the immune system.
How can it help?
Studies have shown that Tecfidera
reduces the annual MS relapse rate by
around one-half. During trials, MRI scans
showed fewer, smaller or no new active
lesions. Some studies also showed a
significant reduction in the progression of
the disease.
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How is it administered?
progression (sustained for 12 weeks) by
30%.
Tecfidera is taken as a tablet, twice a day.
How is it administered?
Who manufactures it?
Aubagio is taken as a tablet, once a day.
Biogen.
Who manufactures it?
What type of MS is it prescribed for?
Genzyme.
Tecfidera is a ‘Category 1’ drug and
therefore it is prescribed for people with
relapsing remitting MS. It is listed as ‘more
effective’ rather than ‘moderately
effective’.
What type of MS is it prescribed for?
Aubagio is a ‘Category 1’ DMT, licensed
for relapsing remitting MS.
What are the side effects?
What are the side effects?
Common side effects reported are
flushing and feeling hot, gastrointestinal
upset and headaches.
Common side effects are gastrointestinal
upset, hair thinning and changes in liver
function. Aubagio should not be taken by
women considering pregnancy because of
potential risks to the unborn baby. A
woman of child-bearing age considering
Aubagio must take a pregnancy test and
ensure adequate contraception is in place
before starting the drug.
Aubagio (teriflunomide)
How does it work?
Aubagio inhibits the function of specific
immune cells that have been implicated in
MS. It can inhibit a key enzyme required
by white blood cells (lymphocytes) – which
in turn reduces the T and B immune cells
that are active in MS, from multiplying.
As well as this, it has shown to have other
anti-inflammatory and immune-modulating
actions.
The drug stays in the body for a long time
and if a woman taking Aubagio suspects
pregnancy, she must immediately contact
her GP and, if a pregnancy is confirmed,
Aubagio can be ‘flushed out’ of the body
by taking activated charcoal or
cholestyramine over several days.
Lemtrada (alemtuzumab, campath)
How can it help?
How does it work?
Studies showed that Aubagio reduced
relapses by one-third. In trials the higher
dose reduced the risk of disability
Lemtrada was originally licensed for the
treatment of leukemia. It is an anti-CD52
monoclonal antibody which kills T-cells, a
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type of lymphocyte involved in the MS
immune response. Once the T-cells are
killed, the immune system repopulates,
leading to a modified immune response
that no longer regards myelin and nerves
as foreign, and therefore stops attacking
them.
Lemtrada was also shown to have a
positive effect on MS progression, with 8
percent of people taking Lemtrada
reporting a worsening of their EDSS
scale, compared to 11 percent of people
on interferon during the two-year trial.
How is it administered?
How can it help?
Two two-year trials looked at the effect of
Lemtrada: one trial enrolled people
recently diagnosed with relapsing
remitting MS, who had not taken any other
disease modifying drugs, and another trial
looked at people with relapsing remitting
MS, who still had relapses despite being
on an interferon.
Lemtrada is delivered by two infusions,
twelve months apart. The first infusion is
delivered over five days, and the second
over three days. Infusions take place in a
hospital or infusion clinic.
Who manufactures it?
Genzyme.
In the first trial of people recently
diagnosed with RRMS, Lemtrada reduced
relapses by 55 percent compared to
people taking interferon beta 1a. In the
group of people taking Lemtrada, 78
percent did not experience a relapse
during the two years of the trial.
What type of MS is it prescribed for?
The people in the Lemtrada group also
demonstrated that the drug had a greater
effect on reducing the progression of MS,
compared to the interferon group.
Side effects reported for Lemtrada include
one-third of people reporting changes to
their thyroid function, which while
treatable, can mean lifelong medication
was necessary. One percent of people
reported a blood clotting disorder called
Immune Thrombocytopenic Purpura (ITP).
While serious, ITP can be treated
effectively. Other adverse effects reported
related to kidney function, reactions at the
infusion site and respiratory infections.
In the second trial of people who had
been on interferons previously, Lemtrada
reduced relapses by 49 percent compared
to interferon beta-1a (Rebif). In one of the
trials, 65 percent of people taking
Lemtrada did not have relapse in the two
years of the trial, compared to 49 percent
of people taking interferon.
Lemtrada is listed as a ‘Category 2’ drug
and therefore is licensed for more active
forms of relapsing remitting MS.
What are the side effects?
More common side effects reported were
flu-like symptoms after the infusion was
given.
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Tysabri (Natalizumab)
What type of MS is it prescribed for?
How does it work?
Tysabri is listed as a ‘Category 2’ drug
and therefore is effective when treating
highly active forms of relapsing remitting
MS.
A monoclonal antibody that works in a
different way to injectable therapies,
Tysabri binds to specific adhesion
molecules within the immune cells. This
stops the cells from crossing the blood
brain barrier and entering the central
nervous system, thereby reducing
inflammation and damage.
How can it help?
Studies have shown that people with
rapidly evolving severe relapsing remitting
MS (RES) showed a decrease of 81% in
relapses when taking Tysabri. In addition,
the rate of their disease progression was
slowed by approximately two thirds and
the accumulation of new lesions that could
be detected by MRI was reduced. People
with relapsing remitting MS also showed a
reduction of around two thirds in the
number of relapses, fewer MS lesions
detected during MRI scans and a
significantly reduced rate of disease
progression.
How is it administered?
Tysabri has to be given by intravenous
infusion every 4 weeks at either an
infusion centre or a hospital.
What are the side effects?
Side effects can include dizziness,
nausea, joint pain, shivering and
sometimes inflammation of the nose and
throat. Tysabri increases the risk of
developing a serious infection called
Progressive Multifocal
Leukoencephalopathy (PML), which is a
rare but sometimes fatal brain infection
that affects the central nervous system.
The manufacturers of Tysabri state that
the risk is less than three cases in a
thousand, although there is a slightly
increased risk for patients who remain on
the therapy for more than two years. PML
is caused by a virus called the JC virus
(JCV). A blood test is now available to
check whether you are positive for JCV
and this can help to establish the risk of
developing PML. Patients who have been
on immune suppressants prior to
treatment also have an increased risk
factor. Despite these factors, the benefits
of the drug continue to outweigh the risks
for many people with highly active
relapsing remitting MS.
Who manufactures it?
Biogen.
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Choosing a disease
modifying drug
Alternatively, it is recommended that you
take paracetamol or ibuprofen two hours
before the injection to ease the symptoms.
Once diagnosed with MS, your neurologist
will talk to you about any medication you
may require and be eligible for. They will
discuss with you all your possible options.
One thing to consider when looking at
these medications is your lifestyle and
how the administration of these drugs will
fit into your day-to-day living.
If you suffer from injection-site reactions,
you could try using Emla cream which
numbs the area prior to the injection.
Always rotate the injection site – avoid
injecting the same area each time. It may
also help to ensure the drug is at room
temperature and also warming the skin
before injecting may also help make your
injection more comfortable.
There are a number of factors you may
want to consider, and discuss with your
family and neurologist. For example, what
are the benefits of a DMT in the short-,
mid- and long-term? What are some of the
common side effects? How is the therapy
administered – tablet, injection or
infusion? Is this right for my lifestyle?
Openly discuss all the options with your
MS nurse and/or neurologist to come to a
decision as to what is the best course of
treatment for you.
Coping with side effects
The side effects of these drugs are
different per therapy. It is important to talk
to your MS nurse or neurologist about
what side effects the drug may cause.
Side effects are generally not severe and
there are various ways to manage them.
If you are on any of the oral therapies, ask
your MS nurse how to manage any side
effects you are experiencing.
If the side effects become severe or you
feel unable to cope with them, contact
your MS nurse or neurologist who will be
able to advise you further. Contact our
helpline on 0800 783 0518 to find your
nearest MS nurse.
Drugs in development
All drugs need to be licensed and go
through regulatory procedures before they
are made available. Many drugs are
currently being developed to treat multiple
sclerosis. The list below contains drugs
that are either currently in trials or have
completed their trials, but are not yet
licensed. Some have been put forward for
European licensing.
If you suffer from flu-like symptoms after
injecting, try changing the time of day you
take your injection; possibly to just before
bedtime so you can sleep through the
side-effects.
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ATX-MS-1467
Who manufactures it?
How does it work?
Apitope and Merck Serono.
ATX-MS-1467 is a peptide-based drug
consisting of four amino acids obtained
from myelin basic protein (MBP).
What type of MS is it under trial for?
It is believed to protect myelin by reducing
the immune system’s harmful response to
the nerve’s coating. It does this through
the inhibition of the T-cell’s response to
myelin basic protein (MBP). A T-cell is
type of white blood cell or lymphocyte.
The drug is currently in early stages of
testing for RRMS and SPMS. It is
currently in Phase II testing.
The drug is currently in trial for relapsing
remitting MS and secondary progressive
MS.
What are the side effects?
Currently there have been no side effects
reported from trials.
Biotin (MS1003)
How does it work?
How can it help?
In the phase I trials, a small number of
people with secondary progressive
multiple sclerosis were injected with
increasing doses of the drug every one to
two weeks. This group showed a
reduction in the response of the T-cells to
MBP.
In the phase II trials, people with
relapsing-remitting multiple sclerosis were
given increasing doses of the drug 2
weeks’ apart. In this group, there was a
significant reduction in the number of
lesions seen on the MRI.
How is it administered?
It is given by injection under the skin every
2 weeks.
Biotin is one of the B-group vitamins
(vitamin B7), also known as vitamin H or
coenzyme R. It is an important component
of enzymes in the body that help to break
down certain substances like fats,
carbohydrates and others. It is necessary
for cell growth and is involved in the
production and synthesis of myelin. Very
high doses of biotin may be effective in
MS by promoting myelin repair.
How can it help?
MD1003 is a highly concentrated form of
biotin and in trials the intake of biotin was
10,000 times the recommended amount.
Therefore classing it as a pharmaceutical
preparation rather than a food
supplement.
An improvement in disability was seen in
some small scale trials. Further trials
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looking into the effect MD1003 may have
on optic neuritis are under way.
How is it administered?
How is it administered?
Daclizumab is administered via injection
under the skin every four weeks.
A capsule is taken three times a day.
Who manufactures it?
What type of MS in it under trial for?
Biogen.
So far it has been trailed in secondary and
primary progressive MS.
What type of MS is it under trial for?
What are the side effects?
No side effects have been currently
reported.
Daclizumab
How does it work?
Daclizumab is a monoclonal antibody that
blocks the activity of the chemical
messenger interleukin 2, in the immune
system. It also helps prevent the growth of
lymphocytes. The drug helps to prevent
the activation and growth of lymphocytes
that is involved in the immune attack that
takes place in MS. Studies have shown
that the activity of natural killer cells is
increased by this drug, strengthening the
body’s immune system.
It is currently in trial for relapsing remitting
MS.
What are the side effects?
In trials the common side effects were
infections, serious skin infections and
changes in liver function.
Laquinimod
How does it work?
Laquinimod affects the level of certain
cytokines (substances released by
immune cells) and reduces the passage of
immune cells into the brain and spinal
cord. Studies have also suggested that
this drug may have a protective effect on
the nervous system and anti-inflammatory
actions.
How can it help?
How can it help?
In trials, Daclizumab reduced the
annualised relapse rate by 54 percent
when given as 150mg, and 50 percent
when given as 300mg injections,
compared to a placebo.
In studies Laquinimod was shown to
reduce relapses by 23% as well as a
reduction in disability progression and
brain volume loss.
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How is it administered?
How is it administered?
By tablets, once a day.
It is taken by tablet twice daily.
Who manufactures it?
Who manufactures it?
Teva and Active Biotech.
AB Science.
What type of MS is it under trial for?
What type of MS is it under trial for?
It is in trial for primary progressive MS and
relapsing remitting MS.
Secondary and primary progressive MS.
What are the side effects?
What are the side effects?
The studies show that some people
experience an increase in liver enzyme
levels, and suffer from back pain and
headache.
Masitinib seems to be well tolerated
according to trials. Most common side
effects rash, nausea, oedema, diarrhoea
and asthenia (loss of strength and/or
energy).
Masitinib
Ocrelizumab
How does it work?
How does it work?
Masitinib blocks some of the biochemical
processes involved in the body’s
inflammation and immune responses,
leading to a reduction in these processes.
The drug targets mast cells – a type of cell
involved in allergy and inflammation.
Ocrelizumab is a monoclonal antibody
that attacks specific target markers on the
surface of B cells, which are thought to
influence the abnormal immune response
that causes the immune system to attack
myelin.
How can it help?
How can it help?
In trials, those taking the drug had an
improvement in their MS Functional
Composite (MSFC) score after a 3-month
period. The score assesses walking
ability, hand and arm coordination and
cognitive function.
Early results from trials indicate that
ocrelizumab is twice as effective as
current disease modifying treatments for
relapsing remitting MS, with reductions in
lesions seen on an MRI being 85 – 96
percent compared to the placebo. It is
given as an infusion every six months.
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How is it administered?
How can it help?
It is administered by intravenous infusion
every 6 months.
The phase II trials were conducted on
participants with relapsing remitting
multiple sclerosis. The trial focused on
different delivery mechanisms of
Ofatumumab: intravenous infusion and
subcutaneous injection. Phase II
participants, who received the drug by
infusion at different doses, showed a
reduction in B-cell activity and a total
suppression of new lesions.
Who manufactures it?
Genentech.
What type of MS is it under trial for?
Relapsing remitting and primary
progressive MS.
What are the side effects?
In the Phase II trial one patient in the high
dose group died due to brain oedema
(swelling) after developing systemic
inflammatory response syndrome.
However, the connection between
Ocrelizumab and this particular death is
unclear. The trials also showed that
people taking Ocrelizumab had more
infusion-related adverse events than
those in the placebo group.
Phase II participants who received the
drug as an injection at different doses,
showed a 65% reduction in new active
lesions on an MRI after 12 weeks for all
doses.
How is it administered?
The trial is moving forward with
Ofatumumab being administered as a
subcutaneous injection, or via intravenous
infusion.
Ofatumumab (Arzerra)
Who manufactures it?
How does it work?
GlaxoSmithKline and Genmab.
Ofatumumab is currently used to treat
leukaemia. It is an immune-suppressing,
monoclonal antibody that reduces the
number of B-cell lymphocytes, a type of
white blood cell. B-cells are believed to be
part of the body’s abnormal immune
response to myelin. Ofatumumab targets
these B-cells and destroys them.
What type of MS is it under trial for?
Relapsing remitting MS.
What are the side effects?
Side effects in the phase II trials were
linked to injection sites.
Helpline: 0800 783 0518
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Simvastatin
How does it work?
Simvastatin comes from the class of drugs
used to treat high cholesterol. The drug is
said to have anti-inflammatory and
neuroprotective properties which led it to
being studied as a potential treatment for
MS.
How can it help?
The MS-STAT trial results were published
in The Lancet in 2014; 140 people with
secondary progressive MS took a high
dose (80mg/day) of simvastatin for two
years, or placebo. Out of the two groups,
those taking the simvastatin were found to
have significantly less reduction in brain
volume, significantly slower change in
EDSS, and significantly improved scores
on the MSIS-29 (a measure of the extent
to which MS affects daily life). More
studies are needed.
should pregnant or breastfeeding women.
Grapefruit juice should be avoided as it
can increase the risk of side effects.
Siponimod
How does it work?
Siponimod belongs to the same class of
drugs as Gilenya (fingolimod). The drug is
designed to work on certain types of white
blood cells (lymphocytes). These are cells
that are involved in the attack on myelin.
The drug causes the lymphocytes to be
retained in the lymph glands, resulting in a
reduced immune attack on nerve cells in
the brain and spinal cord.
How can it help?
In phase 2 trials for relapsing remitting
MS, sipinimod was demonstrated to
reduce the relapse rate by 58 percent,
compared to the placebo.
How is it administered?
Phase 3 trials for secondary progressive
MS are currently underway.
Statins are taken in tablet form.
How is it administered?
What type of MS is it under trial for?
A tablet taken once daily.
Secondary progressive MS.
Who manufactures it?
What are the side effects?
Novartis.
Common side effects of statins can
include nausea, digestive problems,
nosebleeds or a runny/blocked nose,
headache. Some statins can interact with
other medications. Those with liver
problems should not take statins, neither
What type of MS is it under trial for?
Secondary progressive multiple sclerosis.
Helpline: 0800 783 0518
www.ms-uk.org/choicesleaflets
What are the side effects?
In trials, the reported side effects were
dizziness, throat infections and slowing of
the heart rate.
Further reading
Drug therapies
www.ms-uk.org/choicestreatments
Tysabri
www.ms-uk.org/choicestreatments
Helpline: 0800 783 0518
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How we create our Choices leaflets
MS-UK believes we must listen to the voices of people affected by multiple sclerosis to
shape the information and support we provide. It is these people that bring us perspectives
that no one else can give.
For every Choices leaflet we produce, MS-UK consults the wider MS community to gather
feedback, and uses this to inform content. All of our Choices leaflets are then reviewed by
the MS-UK Virtual Insight Panel before they are published.
Thank you to everyone affected by MS who made this leaflet possible.
Sources
•
None cited
Keep in Touch
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MultipleSclerosisUK
www.ms-uk.org/choicesleaflets
Date: December 2015
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www.ms-uk.org/choicesleaflets