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Multiple Sclerosis
Unmet Needs for People with Multiple Sclerosis
a report by
David Bates
Professor of Clinical Neurology, University of Newcastle-upon-Tyne
It has been 15 years since the first disease-modifying therapy (DMT) for of the disease inevitably carry a potential danger. There is risk of toxicity, the
multiple sclerosis (MS) was licensed, and 14 years since it became possibility of opportunistic infections and the long-term fear of neoplasia.
available in Europe. The intervening time has seen the introduction of The effectiveness of the agents will be demonstrated in trials and short-term
other DMTs and clarification of the indications for their use.
1
Physicians safety ensured, but it will be many years before overall risks can be fully
who treat MS patients can choose between four available interferons evaluated and their frequency determined. It is essential, in using the newer
(Avonex, Betaferon, Extavia and Rebif), one polymer (Copaxone) and and stronger agents, that the physician ensures the patient is not only fully
one monoclonal antibody (Tysabri) before considering the use of informed of their potential benefit, but also advised in detail about possible
cytotoxic agents. risks. People with MS are able to determine the degree of risk that they are
willing to accept, provided that they are given the necessary information.
The availability of DMTs helped focus attention on the disease and the
high cost of the biotechnical products. Together with self-injection In terms of future therapy for people with MS, most of the five
requirements, this focus has caused healthcare providers to reassess standardised DMTs – the four interferons β and glatiramer acetate – are
service provision and pharmaceutical companies to develop nursing likely to be copied by generic products within the next few years. In the
services specifically for people with MS. As a result, the help available to case of the biotechnical products such agents are called ‘bio-similars’,
MS sufferers greatly improved: MS clinics were developed and clinicians and it will be for the licensing agencies, such as the European Medicines
with expertise were identified, MS specialist nurses were established and Agency (EMEA), to determine their efficacy and safety. Information in
their numbers have multiplied, the assessment of individual patients relation to combinations of therapy with cytotoxic agents and DMTs will
became more standardised and monitored and the concept of a service become available, although the problems of summating the toxicity of
dedicated to people with MS developed. Therefore, the availability of two potentially dangerous therapies are self-evident. It is possible that
DMTs is indirectly responsible for a marked improvement in the services future therapy will include a period of induction with a major
available to most people with MS. It is evident that in those countries immunomodulating agent followed by maintenance therapy with one of
where most new therapies are available, the service provision to people the current DMTs.
with MS is most comprehensive.
Significant Unmet Needs Remain
Sadly, the provision of services and availability of DMT is not uniform. In Physicians and patients recognise that available DMTs work best during
Europe there is variation in the availability of the newer treatments, which the phase of acute inflammation and in relapsing–remitting disease.
remain expensive, and in the provision of neurological and ancillary services However, some patients taking the available DMTs still experience
to people with MS. There are national and international organisations exacerbations of the disease, representing a persistent problem. As no
working to improve conditions, and the individual national multiple current therapy completely prevents exacerbations, deciding when a
sclerosis societies together with the Multiple Sclerosis International treatment is ‘failing’ is extremely difficult. Most MS patients and their
Federation (MSIF) are collating information about service provision, access physicians perceive that a drug is failing if attacks continue and worsen or
to neurology and availability of DMTs to devise a template enabling those when disability progresses. No simple system of clinical evaluation,
countries with poorer service provision to achieve the minimum level.
2
In cerebral imaging with magnetic resonance imaging (MRI) or serological
Europe, there is the European Multiple Sclerosis Platform (EMSP), a lobby test can positively assure a physician that treatment is failing and that a
group based in Brussels that has developed a set of minimum requirements patient’s therapy should be stopped or changed. To complicate matters
for people with MS within the EU.
3
further, some forms of therapy may develop neutralising antibodies, which
may reduce treatment effectiveness. However, there continues to be
What’s New in Multiple Sclerosis? uncertainty about the extent of this effect and there is great variation from
In the near future, more DMTs will become available to help control the early
inflammatory phase of MS.
4
The first is Extavia, a rebranded version of
David Bates is a Professor of Clinical Neurology at the University of Newcastle-upon-Tyne. He
interferon beta-1b, which is a mainstay of therapy with an established
has been involved in clinical trials of multiple sclerosis (MS) for more than 20 years. His
benefit-to-risk profile. The next generation of drugs includes oral agents and
department is currently involved in six trials and is pursuing demographic studies in the north-
east of England and laboratory studies into axonal injury and damage. Professor Bates serves
monoclonal antibodies that, though given by injection, are used at
as Editor of the International MS Journal and as Chairman of the MS Forum. He trained in
infrequent intervals. Both should be more convenient for patients than medicine at Downing College, Cambridge and the Middlesex Hospital, London, and in
currently available DMTs. The drugs currently undergoing trials appear more
neurology at the University of Newcastle-upon-Tyne and the Mayo Clinic, Minnesota.
effective than those being used at present, but such improvements in E: david.bates@newcastle.ac.uk
efficacy by modifying or suppressing the immune system early in the course
© TOUCH BRIEFINGS 2008 75
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