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New MS Treatments and the Importance of Maintaining Therapy | MS Watch
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New MS Treatments and the
Importance of Maintaining
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Understanding the
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There is normal
tiredness and then
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MS
How to Survive the
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Sclerosis
MS Patient Stories
That Will Inspire You
New MS Treatments
and the Importance
of Maintaining
Therapy
Your Guide to MS
Treatment Approval
8 Questions You Need
to Ask About Clinically
Isolated Syndrome
(CIS)
MS and Vitamin D
The MS and Migraine
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How to Survive the
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How to Live Well with
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Looking into the future of MS treatment
The future approval of emerging therapies for multiple sclerosis
(MS) is exciting, and that is just one reason to maintain control
over your MS until then. Think about personal milestones your
own future may hold for you. If you decide to continue with
your MS therapy and wait for more data on the new therapies,
how would that benefit you? How would it help you if you gave
up your current MS therapy in the hope that another option is
about to become available?
Physicians who care for people with MS are almost as eager to
see new therapies become available as you are. The potential is
out there – all that’s needed is a reasonable track record of
safety and success. Your physician has a commitment to “do no
harm”; that is why he or she will want to take a careful
approach to prescribing new therapies.
Go with what you know
Delaying or preventing the onset of physical disability is a major
goal of treating MS with a disease modifying therapy (DMT).
Intramuscular (IM) (Avonex®) and subcutaneous interferon
beta IFNb-1a (Rebif®), IFNb-1b (Betaseron ®), and glatiramer
acetate (Copaxone®) represent the main self-injectable DMTs
for patients with relapsing–remitting MS (RRMS).
A second beta interferon-1b called Extavia ® was approved for
treatment of MS in 2009, and became available in Canada in
May 2010. Extavia® is identical to Betaseron®. Natalizumab
(Tysabri ®) is the most recently introduced novel treatment
option, and a variety of new therapies are expected to become
available over the next few years. When you are looking into
your treatment options, you will notice that the newer the
therapy, the less we know about its long-term tolerability and
benefits.
Over 15 years of experience treating MS with the IFN betas and
Copaxone ® has provided a good understanding of what to
expect from currently approved therapies. It has been shown
that taking a disease modifying therapy soon after a diagnosis
http://www.mswatch.ca/en/MS-today/new-MS-treatments-and-the-importance-of-maintaining-therapy.aspx[18/04/2011 1:24:14 PM]
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New MS Treatments and the Importance of Maintaining Therapy | MS Watch
of MS or CIS (Clinically Isolated Syndrome) reduces relapses by
one-third. Just as importantly, DMT delays progression of the
disease and the disability it leads to over the long term.
Keep up with new developments
By paying attention to treatment developments in MS, you are
taking an active role in managing your MS. It’s important to
stay up to date, so that you can make the best choices for your
long term wellbeing. That’s where patience may be a virtue.
Until we have more experience with emerging treatments, you
can choose to continue with your DMT for its proven long-term
benefits. All your treatment decisions should be well informed
and thoroughly considered.
Aspects of MS treatments to consider
Quality of life
All drug therapies have both positive (efficacy) and negative
(safety considerations and adverse events) effects. It will
continue to be important to have informed conversations with
your physician about treatment options best suited to you.
What’s new in MS treatment?
Several new therapies are likely to become available for the
treatment of MS in Canada over the coming years. Efficacy and
safety data from advanced development trials (Phase III) are
now available for the two emerging oral (i.e. taken by mouth)
medications, cladribine and fingolimod. Barring any unforeseen
safety concerns, these two medications are expected to be
approved for MS within about a year, while another oral
therapy, laquinimod, is completing Phase III trials. Other
emerging treatments have completed, or are in the process of
completing Phase III trials.
An overview of emerging oral MS
therapies
The following table is an overview of specific oral therapies
based on their respective clinical development programs. Once
approved, the Canadian product will be the most accurate
source of information.
FINGOLIMOD
Generic names: FTY720 or fingolimod
Brand name: Gilenia®
First of a new class of sphingosine modulators originally
targeted for undergoing organ transplantation.
Oral therapy taken once-daily.
Efficacy
FTY720 reduced the relapse rate by 54% for the 0.5-mg
dose 60% for the 1.25-mg dose compared with placebo, in
the 2-year, Phase III FREEDOMS study.
Efficacy as well as adverse effects may be dose dependent.
Adverse effects
Slowed heart rate and irregular heart beat (which can
range from mild to severe) have occurred when the
medication is started; macular edema (which affects the
eyes), elevated liver enzymes, and mild elevations in blood
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New MS Treatments and the Importance of Maintaining Therapy | MS Watch
pressure.
CLADRIBINE
Generic names: Cladribine, 2-chlorodeoxyadenosine
and 2-CdA
Brand name: Movectro ®
Purine nucleoside analog developed as a selective
lymphocytotoxic agent for the treatment of leukemia.
Cladribine Tablets are oral therapy, requiring as little as 2
cycles of 5 consecutive days each at the beginning of the
first and second month of treatment for the first full year of
therapy.
Efficacy
Disease-activity-free status (patients with no relapses, no
sustained disability progression and no new MRI lesion
activity) over the 96 weeks CLARITY Study, was
experienced by 46% of patients treated with a high-dose of
cladribine, and 44% of patients randomized to a low- dose
regimen compared with 16% of placebo patients (P<0.001)
in the Phase III (CLARITY) clinical trial of an oral
formulation of cladribine.
Adverse effects
Lymphopenia (low levels of white blood cells), herpes
zoster, malignancies, and infections.
LAQUINIMOD
Modulator of key processes of the immune system, and
may have an immunomodulating effect within the central
nervous system (CNS); developed for treatment of RRMS.
Two randomized, placebo controlled Phase III trials of
laquinimod are currently underway.
Efficacy
In Phase II trials, laquinimod 0.3 mg reduced the mean
cumulative number of active lesions by 44% compared with
placebo.
Adverse effects
Nasopharyngitis (inflammation of the nose and throat
causing cold-like symptoms), back pain, and headache;
dose-dependent, reversible elevation of liver enzymes.
Keep the faith
Keep the faite in yourself and your ability to make wise choices
to maximize your long-term health. If your approved DMT for
MS is working for you, you can feel confident knowing that it
has a proven long term record of safety and effectiveness.
Medications only work when you take them as prescribed.
Recent studies have shown that skipping doses or taking a
“drug holiday” can lead to a setback in your control over MS.
Not taking your DMT, even for a relatively short period of time,
can increase the risk of having a relapse.
Perseverance has its benefits
A recent study in MS showed that greater levels of adherence to
therapy (i.e. taking it as prescribed) are associated with lower
chances of relapse. And in addition, increasing levels of
http://www.mswatch.ca/en/MS-today/new-MS-treatments-and-the-importance-of-maintaining-therapy.aspx[18/04/2011 1:24:14 PM]
New MS Treatments and the Importance of Maintaining Therapy | MS Watch
adherence to treatment were associated with lower overall
costs, even though the medication costs to the healthcare
system increased along with adherence levels.
Thinking ahead
You know what it’s like to live with uncertainty when you have
MS. While you look forward to the availability of new therapies,
think about your own future. Try to imagine your life in one
year, three years or five years, and how things might be
different if you continue taking a disease modifying therapy, or
if you decide to stop treating your MS. The proven benefits of
our current DMTs in terms of delayed disability can not be
regained – when disease modifying treatment is stopped, the
disease will continue to progress. When you consider your
options, be sure you understand as much as possible how they
may affect not only your disease, but your overall long-term
wellbeing.
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