In Poland, about 50 thousand people suffer from multiple sclerosis. people. They are more often women. And while treatment options for this disease have improved in recent years, not all patients can benefit from drug programs. Prof. dr hab. n. med. Halina Bartosik-Psujek, a neurologist, explains the biggest problems with treating MS in Poland.
- Multiple sclerosis (MS) is an autoimmune disease that affects young people, usually between the ages of 20 and 40
- It is estimated that within approx. 6-9 years from diagnosis, approx. 50% patients will begin to feel a distinct disability
- Thanks to new drugs and improved care, people with MS are now living longer than they used to be
- You can find more such stories on the TvoiLokony home page
Journalists for Health Association: What is multiple sclerosis (MS)?
Prof. dr hab. n. med. Halina Bartosik-Psujek: It is an inflammatory degenerative disease of the central nervous system in which nerve cells are damaged as a result of many complex pathomechanisms. The essence of multiple sclerosis is an impaired immune response.
Do we know the immediate causes of this disease?
We do not know. We only know that its development is influenced by genetic and environmental factors, such as the level of vitamin D in the blood serum, sunlight, excess salt and childhood obesity. These are not causative factors, but only parameters that are more often associated with this disease than others.
The diagnosis is made on the basis of the assessment of neurological symptoms, such as limb paresis, disturbances in vision, balance, sensation or urination. The diagnosis is confirmed by magnetic resonance imaging of the nervous system.
What forms does MS have?
The first and most common form is relapsing, that is, there are periods when new symptoms appear, followed by relative stabilization until further worsening. After the relapsing period, the course of the disease in most of these patients changes to slowly progressive (the so-called secondary progressive form).
The second is the primary progressive form, which consists in systematically increasing progression of symptoms from the onset of the disease. Most patients, about 70-75%, have relapses and remissions, in about 20%. we recognize the secondary progressive form, and about 8-10 percent. of patients has a primary progressive form.
is a neurologist, Head of the Department of Neurology with the Department of Stroke Treatment of the Clinical Hospital of the Provincial Hospital No. st. Jadwiga Królowej in Rzeszów, chairwoman of the MS and Neuroimmunology Section of the Polish Neurological Society
What stages of the disease can be distinguished?
The first is the preclinical phase. Its symptoms are not visible, but patients begin to feel them (e.g. pain syndromes – backbone, headache, excessive fatigue) and sometimes abnormalities can be detected in an MRI. The second stage is the relapses and remissions phase, and the third stage is the progression phase, in which we either still observe relapses or they are gone, but the neurological deficit is systematically increasing and new symptoms appear.
Even when the patient feels well and stable, inflammatory processes are still taking place in the brain, causing new foci to emerge and damage to nerve cells, leading to brain atrophy or cerebral atrophy. So we have a systematic progression of disability.
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What is the prognosis for patients?
We predict that in the period between 6–9 years after the onset of the disease, approximately 50% patients will begin to feel a distinct disability. After the next years, there will be problems with independent walking, after a dozen or so – the need to walk with support until there is a complete walking impairment and a clear neurological deficit. Regardless of this, a significant part, up to 75 percent. patients, has cognitive and depressive disorders, and severely decreased exercise tolerance.
How many people in Poland suffer from multiple sclerosis?
Depending on the counting methods, it is estimated that 45–51 There are 1600–1750 new cases each year, and these rates have remained constant for 10 years.
Among people eligible for treatment with the relapsing-remitting form, i.e. those meeting the NHF criteria, over 75% are treated. However, if you look at all MS patients in Poland, only 38-40 percent are covered by treatment.
Women get sick 2-3 times more often than men and this trend is increasing. Cases occur most often at the age of 20–40. Improving medical care and the fact that people with MS live much longer than they used to mean that more than half (55 percent) of people with MS are over 45 years of age, which significantly impacts treatment.
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How is MS treated?
There are three main lines of treatment. The first is treatment of the relapse, the second is symptomatic treatment, and the third is treatment that affects the natural course of the disease.
A relapse is an exacerbation of neurological symptoms that last a minimum of 24 hours. We treat him with high doses of steroids, which reduces the severity of the relapse, but does not affect the course of the disease.
Symptomatic treatment may include pharmacological treatment, rehabilitation or diet (there are no clear results confirming its effectiveness, but it certainly improves the patient’s well-being and general condition). In addition, it is recommended to avoid stress and fatigue.
Treatment that affects the natural course of the disease should be introduced immediately after diagnosis, because it can change the activity of the disease (reduces the frequency of relapses, limits changes in MRI, slows down the progression of disability).
What else does the choice of therapy depend on?
From the form of the disease, its activity and the consideration of comorbidities. The choice of the patient himself is also important, because it translates into better cooperation with the doctor. The possibility of reimbursement of a given drug is also extremely important.
What is the reimbursement of drugs for multiple sclerosis in Poland?
For the treatment of forms with relapses and remissions, we have a dozen or so preparations, which are recommended depending on the activity of the disease. In turn, for patients with the primary progressive form, a monoclonal antibody has recently been available. This drug has proven efficacy in inhibiting disease progression and is administered intravenously. On the other hand, we do not have any medicine in the NHF for the treatment of secondary progressive disease. An oral formulation that has undergone clinical trials and we already know that it is effective in patients with the secondary progressive form is waiting for the reimbursement decision. Another drug intended for patients with relapses and remissions is also waiting for a similar decision.
How does this translate into drug programs?
We have a first line program dedicated to people with an active form of the disease. In order for a patient to be included in the treatment, he or she must have at least one relapse or active foci in MRI. These drugs have proven effectiveness in inhibiting relapsing activity and this drug program is widely used in Poland.
The second-line treatment program is intended either for active MS, i.e. people with a much higher relapse rate, or after ineffective first-line treatment. In the 4nd line program, we have 2 preparations: 2 monoclonal antibodies and XNUMX immunosuppressive preparations. They are definitely stronger than those used in the first line, they have much greater clinical efficacy and a much greater proven inhibition of disease activity. Unfortunately, in order for a patient treated ineffectively with the first line to move to the second line, he must meet strict criteria that limit the possibility of using the drug and delay effective treatment.
What exactly is this problem?
According to the assumptions of the NHF drug program, in order for a patient with MS to switch to the second line of treatment, he or she must have 2 or more relapses and new foci of brain damage on MRI. And according to the recommendations of the Polish Neurological Society (not to mention American or European societies), 1 disease flare and 1 new focus in the MRI is enough, because this already indicates that the patient does not respond to the treatment and needs to change the therapy. Otherwise, we will not fully protect him against relapsing activity and, consequently, against the rapid development of disability and new symptoms. This is a simple reference to the so-called the therapeutic delay hypothesis.
What is this hypothesis?
It appeared a few years ago and concerns the late initiation of treatment. She says that if we start treating a patient early, the natural course of the disease may be inhibited and its activity stabilized at a certain level. If we start treatment later, when the patient already has some disability, even starting treatment that slows down the progression of the disease will not make him do what could have been achieved by acting earlier. These patients will have to contend with their greater disability because treatment will no longer be able to rebuild the therapeutic delay.
What activities are undertaken by the MS and Neuroimmunology Section of the Polish Psychiatric Association so that Polish patients have better access to diagnostics and treatment? Are there any chances for changes?
The MS and Neuroimmunology section of the PTN conducts extensive training activities in the treatment of multiple sclerosis, addressed to both doctors and patients. We issue opinions or develop new drug programs or changes to the current ones. In addition, we systematically report the need to change the rules of transition from the first to the second line of treatment, both in the Ministry of Health and the National Health Fund. We have developed these new rules and are talking about them at various conferences. At the same time, we work with patients to bring about the fastest possible implementation of new methods of treating MS in Poland.
Authorized press interview prepared by the Journalists for Health Association in connection with the 2020th Polish National Conference “Polish Woman in Europe” XNUMX
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