My life with MS
A step by step guide towards
maintaining an active lifestyle
8 Long-term experience
For people newly diagnosed with MS:
1 Multiple Sclerosis – An introduction
2 Diagnosis and what happens next
3 Symptomatic treatment of MS
For people with MS on beta-interferon therapy:
4 An introduction to modern MS treatments
5 Betaferon® – Benefits of a modern MS therapy
6 Betaferon® – The convenient therapy
7 Living with MS
8 Long-term experience with Betaferon®
9 Physical exercise, well-being and MS
Bayer Schering Pharma AG · 13342 Berlin · Germany · www.ms-gateway.com
Table of contents
This brochure deals with the history of Betaferon® Introduction ...........................................4
and long-term experience with the drug. Betaferon®
was not only the first drug of its kind to be approved The dawn of a new era . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
for the treatment of multiple sclerosis (MS), it is still
one of the most widely prescribed treatments for The benefits of early treatment . . . . . . . . . . . . . . . . . . . . 8
people with MS in Europe today.
Dose-dependent efficacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Please note that this brochure is one of a series
that deals with various aspects of MS and its Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
therapy. You may also find it useful to read one
or all of the others.
Multiple sclerosis (MS) existed, of course, long before 1957 The first identification
the discovery of interferons in medicine (1957), and The first of interferons as
the emergence of Betaferon® (interferon beta-1b) of interferons
as the first interferon to be approved in MS therapy substances goes
in 1993. back to 1957.
The body produces
In fact, the first known case of what may have different types of
Figure 1: been MS was described back in the 15th century. interferon. Inter-
Historical texts St. Lidwina of Schiedam (figure 1), who lived in the feron beta plays a role in
reveal that Netherlands (1380-1433), suffered from an illness “reducing” relapse rate and
St. Lidwina of
Schiedam (1380 –
where many of the symptoms described were similar MS progression. Interferon gamma, in contrast,
1433) had a to those of MS to the extent that a retrospective may increase the activity of MS. This fundamental
condition that diagnosis of MS could be justified. This dates the difference between the two interferons became
shared many of
disease back to the 15th century. the key to interferon therapy in MS.
1985 While a study with natural beta-interferon yielded
Larger quantities promising results in the 1980s, the drug had to be
could be produced
injected into the spinal cord, which was not practical
for long-term treatment. By the mid 1980s scientists
had discovered new techniques that allowed them
to produce beta-interferon in larger quantities. At
this time scientists really began to focus their efforts
on the therapeutic potential of beta-interferon.
The dawn of a new era
16 years of clinical experience 1993 Until the 1960s, very little was known about MS and
Betaferon® how to treat it. A new era dawned when Betaferon®
1988 Betaferon® (interferon beta-1b) retained the activity first drug to
became the first drug to be approved on July 23,
The first large of native human beta-interferon, but in a more stable be approved 1993 for the treatment of people with relapsing-
and potent form. As a result, the earlier problems of remitting MS. This pioneering approval in the US
was launched availability, potency, and purity rapidly vanished and was followed by an approval in the European Union
positive data came from new trials in MS. In 1988, in 1995, and even today, Betaferon® remains one of
the first large study with Betaferon® was launched the most widely prescribed medications for MS.
in North America and the follow-up is still ongoing
today. Overall, 16 years of clinical experience have In 1999, it also became the first available treatment
been documented. This is the longest and most for the secondary progressive type of MS in the EU.
extensive collection of data on any interferon treat- Finally, in the year 2006 Betaferon® received approval
ment for people living with MS to date. for use in the very early stages of MS, i.e. as early as
after the first clinical event and MRI (magnetic
resonance imaging) features suggestive of MS.
Today Betaferon® is the MS drug with the broadest
approved spectrum for use in MS.
Since its launch, Betaferon® has shown a good
safety and tolerability profile in studies with
over 3,500 patients and a total of more than
150,000 users worldwide. This has led to
the collection of a great deal of
data confirming the long term
benefits, efficacy and the good
safety profile of Betaferon® in
many people with different
types of MS.
The benefits of early treatment Dose-dependent efficacy
Over the last few years the concept of a very early treat- In the treatment of MS, there is evidence that the
ment in MS has been recommended by MS experts efficacy of beta-interferon may be dose-dependent.
throughout the world. However, before treatment can A recent clinical trial (called OPTIMS) compared
start, a clear diagnosis of MS needs to be made. This two different doses of Betaferon® (the currently
process needs time, because the neurologist requires recommended dose and the one and a half times
information from different sources (please refer to dose). The study revealed that the higher dose
module no. 2 for further details). People get their showed greater benefits as measured by MRI with
diagnosis sometimes quite a long time after they a comparable profile.
experienced the first symptoms. The resulting uncer-
tainty not knowing ‘what’s going on with my body’, There are also signs that doubling the currently
‘what’s wrong with me’ is sometimes hard to endure. recommended Betaferon® dose might provide even
MS can now be diagnosed much earlier, because of more effective results. One of the largest MS trials
recent advances in MRI, but also due to the new (called BEYOND) to date is currently examining this
McDonald criteria which allows an question. Hopefully, the results of this study will
MS diagnosis to be made sooner and provide the answer as to whether higher doses
with a higher degree of certainty. of Betaferon® will lead to even greater benefits
for people with MS.
Evidence from the BENEFIT study has
shown that immediate treatment right Leading the way in MS research
after the first steroid-treated syndrom
indicative of MS had a positive effect Although at present there is no cure for MS, many
on the course of the disease over the present study companies and research labs around the world are
period of 3 years, providing a better outcome for those actively working to find a cure. The level of research
that received prompt treatment as compared to delayed in this field has grown exponentially in the last 20
treatment. Of course, every doctor will decide when years and a number of promising drugs are in the
each of their patients should start therapy on an indi- early stages of development. Hopefully in the next
vidual basis, as early treatment may not necessarily suit few years, one of these drugs will provide new and
every person with MS. improved options for the treatment of people with MS.
BENEFIT study: Betaferon® in Newly Emerging
Multiple Sclerosis For Initial Treatment
Beta-interferons: Can modify specific actions of
the body’s immune system and are therefore used
to treat people with MS.
BEYOND study: Betaferon® Efficacy Yielding
Outcomes of a New Dose
PPMS: The primary progressive type of MS. This form
is rare and only affects about 10% of all MS patients.
Disease progression from onset is steady. Symptoms
progressively worsen and disability gradually increases.
RRMS: The relapsing-remitting form of MS is the
most common type of the disease, affecting more
than 80% of patients. In the early phases symptoms
may be lacking, sometimes even for several years.
But attacks are unpredictable and symptoms may
occur at any time. In between relapses, there seems
to be a lack of disease progression.
SPMS: The secondary progressive course of MS
is the more advanced form of the disease. It is
considered the second stage of the disease for
more than 40% of patients initially suffering from
RRMS. After periods of attacks and remissions,
disability and symptoms continuously worsen.