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The purpose of this material is to make it clear to a person without medical education how vast and complex the problem of multiple sclerosis is. Very often patients who undergo an MRI of the brain find themselves face to face with their problem.
Indeed, it so happens that a specialist describes an MRI and finds a suspicion of a focus of demyelination. The patient should then be examined by a doctor at the multiple sclerosis center. Alas, such centers are located only in large cities, and the patient, having no idea about what demyelination is and how dangerous it is, simply does nothing. Many years later, if a person really has multiple sclerosis, he becomes deeply disabled simply because time is lost.
The second important reason for the appearance of this material is the data of the Ministry of Health of the Russian Federation, which indicate that over the past 5 years the number of patients with multiple sclerosis has increased by 20,000 people, and last year more than 80,000 patients were registered. At the same time, the highest morbidity was registered in St. Petersburg, more than one case per 1000 population. It is extremely disturbing that 7% of patients with this diagnosis increase annually in Russia.
To a large extent, the situation is complicated by the fact that a quarter of drug tenders in Russia this year were disrupted (https://www.bfm.ru/news/422701). Patients did not receive insulin, 75% of the bidding on rabies vaccine did not take place, and in the same St. Petersburg, in which the incidence of the disease is the highest in the country, people have been unable to get medicines for multiple sclerosis for a whole year. That is, the doctor prescribes the drug, but the state cannot provide it, although it is obliged. The consequences of untimely treatment, and simply the lack of drugs can be catastrophic: disability and the frequency of exacerbations progresses.
- What is MS?
- Nerves are wires!
- How does MS manifest?
- Attention! Dangerous symptoms!
- Caution: overheating!
- How is MS diagnosed?
- Prognosis and goals of treatment
- Treating MS, or multiple sclerosis
- How are exacerbations treated?
- Methylprednisolone (Metipred, Ivepred, Solu-medrol)
- Cyclophosphamide (Endoxan, Cyclophosphamide)
- Other treatments for exacerbations
- PITRS of two lines
- First line funds of PITRS
- Low-dose interferon beta-1a for intramuscular injection (Avonex)
- High-dose interferon beta-1a for subcutaneous administration (Genfaxon, Rebif)
- Interferon beta-1b (Ronbetal, Infibeta)
- PEG-interferon beta-1a (Plegridi)
- Glatiramera acetate (Copaxone, Axoglatiran, Timexon)
- Teriflunomide – tablets (Abagio)
- Dimethyl fumarate – tablets (Tekfidera)
- Second line of PITRS
- Natalizumab (Tysabri)
- Fingolimod (Gilenia)
- Alemtuzumab (Lemtrada)
- Ocrelizumab (Ocrevus)
- Organizational features of PITRS appointment
- Conventional medicines
What is MS?
First of all, multiple sclerosis is not at all forgetfulness, that is, absent-mindedness, and not the sclerosis of the vessels, which they talk about in everyday life, complaining about memory. This is a chronic and so far incurable disease that affects the myelin sheath of the nerves and structures of the central nervous system. The process that leads to the symptoms of multiple sclerosis is demyelination, that is, the gradual breakdown of the nerve sheaths. What does this lead to?
Everyone knows that nerves, as well as bundles of nerve fibers in the spinal cord and brain, conduct different types of sensitivity: temperature, pain, tactile. Nerves carry information about the musculoskeletal feeling, thanks to which we understand the position of our arms and legs in space with our eyes closed. The cranial nerves convey to the brain all kinds of specific sensitivity, vision, hearing, smell, and a sense of balance. Command signals are sent back from the brain. This is, first of all, muscle contraction.
Nerves are wires!
Simply put, nerves are nothing more than electrical wires, only the conductor is not metal, but an electrochemical process in the membranes of nerve cells. The maximum speed of the impulse is up to 120 m per second, which is quite enough to ensure the fastest reactions. But what happens if the wire insulation is damaged? Imagine that a thick cable that powers an entire house has a poor quality outer or inner sheath. Then the wires begin to spark, and various short circuit options arise. Therefore, if a cable is damaged in a switchboard, somewhere in the basement, then these consequences can manifest themselves very far from the place of damage. So, for example, the light can be switched off selectively in several apartments, which are supplied with electricity from the affected area. As a result, it will become dark in one apartment, the washing machine will turn off in another, and the computer will stop working in the third. Much the same situation occurs with multiple sclerosis. With it, all types of sensitivity are disturbed, and later paralysis develops, which can lead to complete immobility. Multiple sclerosis has been proven to be an autoimmune disease. In the body, harmful antibodies are formed, which induce the process of inflammation, and themselves destroy the myelin sheath of their own nerve structures, considering it as foreign.
It is known that multiple sclerosis is the most common cause of disability in young people associated with nervous diseases. It is important that in multiple sclerosis, the intellect never suffers, and people are fully aware of the progression of their illness, remaining in their right mind and clear memory. Currently in Europe, more than 700 thousand people live with this diagnosis, and in the world there are more than 2.5 million patients with multiple sclerosis. How does this disease manifest itself and how does it proceed?
How does MS manifest?
This disease can proceed in different ways. In some cases, the patient periodically worsens, then improves, and then worsens again. In this case, they speak of a remitting course. Sometimes after each exacerbation, the patient returns to the previous state, and sometimes the improvement still does not reach the best results of the previous one, and each subsequent exacerbation leads to the development of new symptoms. Sometimes multiple sclerosis can proceed without any remission and improvement, that is, with a continuous and constant worsening. This is the most unfavorable situation. In this case, the course of the disease in any case is a process stretched out over many years, multiple sclerosis is a lifelong disease.
But, unfortunately, even with an accurate and certainly reliable diagnosis, neither the patient nor the doctor can predict what new symptoms will arise. They can be extremely diverse, and depend on where exactly the myelin sheath is destroyed in the structures of the central nervous system. These are the most common first symptoms of multiple sclerosis, for which the patient usually turns to a therapist, and then to a neurologist. Usually, after talking about such symptoms as a result, neurologists and prescribe an MRI of the brain.
Attention! Dangerous symptoms!
If you or your loved ones at a young or middle age have the following symptoms, then you should immediately contact a neurologist. They may indicate the process of myelin breakdown:
- paresthesia, that is, a feeling of numbness and tingling in the limbs and body, a feeling of 'crawling';
- muscle weakness on one side of the body, left or right, or periodic weakness in the limbs. It can grow;
- decreased vision, blurred vision, decreased clarity (sometimes it can be in one eye), up to transient blindness, episodic double vision;
- sometimes the debut of multiple sclerosis is associated with the presence of pain in the eye and decreased vision, the so-called retrobulbar neuritis;
- dizziness, tremors;
- spasticity and increased muscle tone;
- pelvic disorders.
More than half of all patients with multiple sclerosis have urinary disorders. Most often, these are imperative urges when you need to immediately, right now, urgently empty the bladder. The second symptom is reflex urinary retention, when you need to go to the toilet, but you cannot immediately empty the bladder, it takes some time for urine to go
Patients who develop these symptoms should be very careful from the outset with regard to high temperatures and overheating of the body. If they do not have multiple sclerosis, then such a precaution will not hurt, and if, nevertheless, multiple sclerosis is confirmed, then this tactic will avoid exacerbation, progression, and, perhaps, will postpone the appearance of signs of disability for several years.
The point is that myelin is destroyed at an increased rate at high temperatures. In such patients, exacerbation, intensification, and the appearance of new all of the above symptoms occurs after:
- prolonged exposure to the sun, including after lying on the beach;
- taking hot baths and showers;
- being in the bath and sauna.
In some cases, worsening may occur even after a bowl of too hot soup or a mug of very hot tea. It is especially dangerous for such patients to catch a cold, since fever, like an increase in body temperature, also worsens the course of the disease. Therefore, patients who have a suspicion of a demyelinating process, it is advisable to be in public places as little as possible in the midst of an epidemic, wear a disposable mask, avoid hypothermia, and even refuse vaccinations temporarily, for medical reasons. Indeed, after vaccinations, such an adverse reaction as a flu-like syndrome often occurs.
How is MS diagnosed?
In order to make or refute the diagnosis of multiple sclerosis, the following diagnostic steps are required:
- if a neurologist finds specific abnormalities in the neurological status, then he refers the patient to an MRI of the brain. Such deviations can be external internal ophthalmoplegia, nystagmus, absence of abdominal reflexes, pyramidal symptoms, talking about signs of central paralysis and other symptoms that the patient himself cannot determine;
- according to MRI of the brain with contrast, on a tomograph of at least 1.5 T, in the classic case, foci of demyelination are found in a patient, that is, the disintegration of the same myelin sheath.
- It is known that the white matter of the brain is the thick and compact bundles of nerve fibers, therefore, the favorite place for localization of demyelinating foci is the area surrounding the lateral ventricles, or periventricular location. If such changes are found, then it will be necessary to do MRI again so that doctors are convinced that these foci change their position, number and size. If the correspondence of complaints, history of the development of the disease to the clinical picture is established, and there are foci, then the diagnosis can be considered established;
- if there are no such foci, or they are not very characteristic of multiple sclerosis, then a lumbar puncture has to be prescribed in order to examine specific antibodies of the cerebrospinal fluid, the so-called oligoclonal immunoglobulins. According to the modern criteria of 2017, they can be searched earlier, this will make it possible to diagnose multiple sclerosis more accurately and reliably.
The most important thing in diagnostics is to correctly establish the type of course of the disease, since the list of drugs that are used selectively depends on this: what heals in a remitting form is not shown in a primary progressive form, for example.
Prognosis and goals of treatment
Unfortunately, despite the fact that multiple sclerosis affects several million people, in the entire more than 150-year history of the study of this disease, not a single case of independent and complete recovery is known. Multiple sclerosis works only in one direction, the patient's condition gradually worsens, and the symptoms of disability increase. But even in the most severe cases, the patient dies not from multiple sclerosis, but from complications that are associated with profound disability and immobility. These are hypostatic pneumonia, bedsores, intestinal paresis, urinary tract infection and other conditions that are familiar to everyone who cares for seriously ill patients.
However, do not despair. If the diagnosis is made early, and therapy is started promptly and correctly, then it is possible not only to make exacerbations more rare and less pronounced, but also to delay the onset of disability. In some cases, the delay of clinically expressed symptoms of disability can be done for 15, 20 years, or even longer. Therefore, the main task of treatment will be to slow down the course of the disease.
Treating MS, or multiple sclerosis
|Nomination||a place||Name of product||price|
|Medications||1||Methylprednisolone (Metipred, Ivepred, Solu-medrol)||151 RUB|
|2||Cyclophosphamide (Endoxan, Cyclophosphamide)||141 r|
|3||Other treatments for exacerbations||–|
|First line funds of PITRS||1||Low-dose interferon beta-1a for intramuscular injection (Avonex)||RUB 47,000|
|2||High-dose interferon beta-1a for subcutaneous administration (Genfaxon, Rebif)||RUB 3,200|
|3||Interferon beta-1b (Ronbetal, Infibeta)||1 246 RUB|
|4||PEG-interferon beta-1a (Plegridi)||RUB 28,985|
|5||Glatiramera acetate (Copaxone, Axoglatiran, Timexon)||RUB 8,005|
|6||Teriflunomide – tablets (Abagio)||RUB 17 490|
|7||Dimethyl fumarate – tablets (Tekfidera)||RUB 59,000|
|Second line of PITRS||1||Mitoxantrone||RUB 8,700|
|2||Natalizumab (Tysabri)||RUB 53,000|
|3||Fingolimod (Gilenia)||RUB 97,000|
|4||Alemtuzumab (Lemtrada)||RUB 615,000|
|5||Ocrelizumab (Ocrevus)||RUB 220,000|
In general, the treatment of multiple sclerosis consists of two large sections: it is planned therapy, which is indicated to the patient based on the form of the disease for a long time (MDMS drugs have been used for at least several years), and this is a kind of 'emergency therapy', or relief exacerbations of the disease.
In the treatment of multiple sclerosis, the usual medications used in neurology are also used. But these symptomatic drugs do not alter the course of the disease, and therefore they do not affect the progression of disability. In Russia, patients can also receive drugs such as Cerebrolysin, Mexidol, Cortexin, Actovegin, But all these drugs have no proven effectiveness, and if they and only they are offered to treat multiple sclerosis, then such a doctor is, at least, a charlatan.
Below we will consider drugs that really work. It should be said that full, competent treatment of multiple sclerosis with the best original imported drugs is very expensive. Therefore, in the Russian Federation there is a register of patients with multiple sclerosis, and they are entitled to free treatment if they have a confirmed diagnosis.
Naturally, in the light of modern trends, patients in pharmacies are initially offered cheap domestic analogues. MS medications also have them. But as we can see, patients sometimes do not receive even these free guaranteed domestic drugs.
How are exacerbations treated?
First, let's imagine that the patient is diagnosed with multiple sclerosis for the first time, and just against the background of the most vivid picture of the development of new neurological symptoms, that is, during an exacerbation. What should be done with exacerbation? It needs to be stopped. And since, as mentioned above, multiple sclerosis is an autoimmune disease associated with the development of specific inflammation leading to the destruction of myelin, it is necessary to suppress it with the most powerful anti-inflammatory drugs, as well as drugs from the group of cytostatics. In all cases of exacerbations, it is necessary to hospitalize the patient in a specialized neurological department, and only those 'tested' patients, whose exacerbations are well known to the doctor, and who have already been well and repeatedly stopped, can be treated in a day hospital.
Methylprednisolone (Metipred, Ivepred, Solu-medrol)
Exacerbations of multiple sclerosis are suppressed by the administration of large doses of corticosteroid hormones. This is the so-called pulse therapy. Typically, 1 gram (1000 mg) of methylprednisolone is used intravenously daily in saline for 3 days. Thus, 3000 mg of methylprednisolone is administered to the patient in 3 days. This is one of the most common regimens, but there are other ways to administer pulse therapy.
Hospitalization is necessary for the use of methylprednisolone, since a large amount of hormones is administered quickly. The patient may develop anxiety, change in appetite. There are nausea, insomnia, cardiac arrhythmias, high blood sugar, or even psychosis. High doses of corticosteroid hormones are dangerous for a patient with exacerbation of erosive and ulcerative gastritis or gastric ulcer. Therefore, to prevent the appearance of ulcers, either H2-blockers of histamine receptors or proton pump blockers, for example, Omeprazole, are prescribed together with pulse therapy.
High doses of hormones contribute to the loss of potassium and calcium, all this must be taken into account when conducting pulse therapy. Methylprednisolone not only relieves exacerbation, but can also slow the progression of specific forms of multiple sclerosis, for example, secondary progression forms. In this case, pulse therapy can be performed every 2 months in a planned manner, also for 3 days, but the dose will be half as much, 500 mg.
Of the modern methylprednisolone drugs, Pfizer's Solu-medrol is the most popular. It is not often in pharmacies, and a 250 mg injection bottle will cost 350 rubles. The drug Metypred will cost about 380 rubles for the same dosage, manufactured by Orion, Finland. Thus, for one day of pulse therapy, four such bottles are needed, and for the entire course – 12. Accordingly, the cost of Metipred for a course of pulse therapy will be 4560 rubles. for 3 days. Of course, the patient can be provided with domestic, cheaper analogues for free, but here it is necessary to think not only about the price, but also about the quality of treatment.
Cyclophosphamide (Endoxan, Cyclophosphamide)
If a patient has an unfavorable course of multiple sclerosis, in which exacerbations are too frequent, and new neurological symptoms, including movement disorders, develop rapidly, then it is advisable to combine pulse therapy with the introduction of cytostatics, such as cyclophosphamide, or to use other schemes of separate or combined use of these drugs.
Cytostatics are usually prescribed in high doses for malignant tumors, but they also stop the inflammatory autoimmune process. Cytostatic therapy for exacerbations of multiple sclerosis is prescribed to patients in significantly lower dosages than in oncology, and in shorter courses, so the side effects characteristic of them are quite rare. Cyclophosphamide is usually given in doses of 500 mg for three days, or 100 mg daily.
It should be borne in mind that the dosage is indicated in milligrams per square meter of body area, and special calculation formulas are required for the correct dose prescription. The cost of Endoxan, which is produced by the German company Baxter-Oncology, is from 200 rubles. for one package of powder for solution for intravenous administration at a dosage of 200 mg. So, for an adult man with a height of 190 cm, weighing 100 kg, the body surface area will be 2.28 square meters according to one of the formulas. Accordingly, the daily dose required to relieve an exacerbation will be just one package.
Although side effects are quite rare, it should always be borne in mind that cytostatics worsen the blood composition, cause nausea, vomiting and anorexia, increase the liver enzymes ALT and AST, sometimes there is a cardiotoxic effect, the fibrotic process in the lungs increases, and the reproductive system is disturbed synthesis of eggs and sperm.
Other treatments for exacerbations
It should be said that not all exacerbations of multiple sclerosis necessarily require the appointment of such 'heavy artillery' as pulse therapy or cytostatics. If this exacerbation is short-lived and mild, then conventional drugs can be dispensed with without pulse therapy.
Currently, plasmapheresis sessions are very helpful, when they do without drugs at all. By the way, if an exacerbation of multiple sclerosis occurs in a pregnant or lactating woman, then it can be stopped only with plasmapheresis sessions, since hormones, especially cytostatics, are categorically contraindicated.
In this case, within 15 days, the patient exchanges a total of up to one and a half volumes of blood plasma for each session, (from 3 to 5 sessions in 2 weeks). Plasmapheresis is also indicated in those patients who have no effect with the administration of corticosteroid hormones. Correctly conducted regular plasmapheresis sessions maintain remissions and can significantly reduce the manifestations of disability. Improvement with plasmapheresis, as a rule, occurs on the second – fourth day of the sessions.
PITRS of two lines
This is a Russian-language abbreviation. This means 'drugs that change the course of multiple sclerosis', MITS. Hormones and cytostatics, which are used as 'heavy artillery' in the treatment of exacerbations, themselves treat exacerbations and relieve their symptoms. But the course of multiple sclerosis itself is practically not affected by the means for stopping exacerbations. Accordingly, the timing of the onset of disability does not change. Since multiple sclerosis most often moves to disability by steps, or jerks associated with the occurrence of exacerbations, drugs have been found that prevent the occurrence of these very exacerbations.
Since they postpone the onset of disability for many years with the right treatment, they were called drugs that change the course of multiple sclerosis, or MITRS. And these drugs come in two lines, first and second line. Second-line funds are a kind of reserve, and they are prescribed to those patients who do not have the expected effect from prescribing first-line funds.
First line funds of PITRS
After the exacerbation is stopped, it is necessary to prescribe a drug from this group. If the patient was diagnosed with MS outside the exacerbation stage, then he should immediately, after full confirmation of the diagnosis and in the absence of contraindications, prescribe one of the MITRS drugs. Of course, 'right away' can only be paid: while the patient goes through all the stages of the bureaucratic machine of Russian health care, it may take more than one month, and in some cases it can be completely left without drugs.
Low-dose interferon beta-1a for intramuscular injection (Avonex)
Avonex is an imported drug of the Hungarian company Gedeon Richter. And it is indicated for intramuscular injection once a week, with this form of the disease, which is called remitting. It should be administered once a month, and it is especially good for the mild course of multiple sclerosis, including in children. Avonex reliably postpones the rate of disease progression.
Side effects include fever, the so-called flu-like syndrome, seals and inflammatory changes at the injection site, depressive conditions, and even seizures. But it is generally well tolerated.
At the beginning of treatment, the dose of Avonex is 0.25 ml at 1 week, and from the fourth week, the drug is administered intramuscularly once a week. One syringe-bottle for a single injection costs 30,000 rubles. retail, respectively, the cost of monthly treatment is 120,000 rubles. Such a high price of a drug is determined by the method of its production. This is human interferon, which is not taken from donors, but synthesized artificially. It is grown on Chinese hamster ovary cells. The human interferon genome has been introduced into these cells using recombinant technology, and hamster cells are producing it on an industrial scale. This is a very sophisticated modern technology.
High-dose interferon beta-1a for subcutaneous administration (Genfaxon, Rebif)
These drugs are indicated for the secondary progressive form, with frequent exacerbations, as well as for relapsing multiple sclerosis. The use of Genfaxon and Rebif reliably reduces the frequency of exacerbations by a third, and also slows down the period of disability. The drug is excreted subcutaneously at a dose of 44 mcg three times a week. As in the previous case, dose titration is required at the beginning of treatment, and only from 4 weeks the full dosage is administered subcutaneously.
The drug Rebif in the amount of 3 syringes for a weekly course of treatment can be purchased at pharmacies at retail, starting at a price of 6,000 rubles. Accordingly, the monthly course of treatment will be about 25,000 rubles. Genfaxon is cheaper, its monthly cost of treatment is about 8,000 rubles. Produced by Genfaxon CJSC Biotech, Russia. Rebif is an Italian drug.
Interferon beta-1b (Ronbetal, Infibeta)
Interferon beta-1B, which also refers to high-dose, is given according to the same indications as Genfaxon and Rebif, and also subcutaneously. Only the frequency of administration is higher: Ronbetal or Infibeta is given every other day. Likewise, the titer of the dose rises initially, and the full 1 ml dose begins to be administered one month after the drug is prescribed. Unfortunately, neutralizing antibodies can develop to these interferons, on average from 6 months of use to one and a half years after the start of therapy. This can reduce the effectiveness of the treatment.
Infibeta is sold as a concentrate for solution preparation: it is a bottle complete with a solvent, attached syringes, sterile napkins and disposable needles. The package contains 15 syringes designed for a monthly course every other day. The minimum cost of one package and a monthly course is 11,000 rubles. Ronbetal is a domestic drug of the Biocad company, and Infibeta is a product of the domestic company Generium JSC, a subsidiary of Pharmstandard.
PEG-interferon beta-1a (Plegridi)
This remedy is indicated for relapsing-remitting multiple sclerosis, when frequent injections are uncomfortable or the patient is afraid of injections. Plegridi is administered once every 14 days, and also reliably reduces the frequency of exacerbations by a third. However, it can have a variety of side effects, ranging from post-injection reactions and elevated liver enzymes, to fever, headaches, and nausea or vomiting. However, during treatment with this type of interferon, neutralizing antibodies interfering with therapy very rarely develop, in less than one percent of cases.
125g is injected subcutaneously, this is the full dose, and the full dose is prescribed for 3 injections, that is, one month after the start of treatment. This drug has been included in the list of medicines for the high-cost nosology program since 2018. Its advantage is that it is rarely administered, it increases patient adherence to treatment and quality of life. According to the state register of maximum selling prices of medicines in 2019, a pack of two Plegridi syringes of 125 mg each (for a month's course of treatment) cannot cost more than 20,913 rubles.
Glatiramera acetate (Copaxone, Axoglatiran, Timexon)
The next drug, Copaxone, also, unfortunately, needs to be injected subcutaneously daily at a dose of 20 mg, or in a dose twice as much, that is, 40 mg, but three times a week. It suppresses autoimmune inflammation, also reduces the frequency of exacerbations, and slows the progression of disability. Copaxone improves the MRI picture, that is, it reduces the number of demyelination foci and their spread, but only after 6 or 9 months of treatment. Copaxone is administered daily, subcutaneously at a dose of 20 mg. It is prescribed for the remitting form of multiple sclerosis. Copaxone, which is produced by the Israeli company Teva, costs from 17 to 28 thousand rubles for a set of 28 injections, 20 mg each. The set is designed for a month of use. An analogue of Copaxone, Axoglatiran is half the price.
Teriflunomide – tablets (Abagio)
In conclusion of the first-line drugs of MITRS, it is necessary to list not injections, but tablets. Teriflunomide is also indicated for relapsing-remitting multiple sclerosis, but it is not prescribed immediately, but only if the patient does not tolerate interferon injections. Why is it so? First of all, there may be more pronounced side effects, for example, impaired liver and pancreas function, diarrhea and nausea, less often – thinning and even hair loss. In the first six months of therapy, the risk of infections is increased. While taking teriflunomide, it is imperative to check liver enzymes, they should not exceed 3 times the upper limit of the norm. Abagio's package of 28 tablets, designed for a month of admission, costs 17,000 rubles at least.
Dimethyl fumarate – tablets (Tekfidera)
Dimethyl fumarate is also a tablet preparation that is taken initially at a dose of 120 mg twice a day, and then the dose is doubled: 240 mg 2 times a day. The indications are the same: remitting multiple sclerosis. This remedy is recommended for those patients who respond poorly to interferons or Copaxone. But this is ideally when the patient is not constrained in funds. Patients are given not what suits them best, but what the Ministry of Health can release for free. The drug reduces inflammation and has a suppressive effect on immunity, significantly reducing the frequency of exacerbations by 50%.
The most common adverse reactions are hot flashes, a burning sensation and heat, sweating, and diarrhea at the beginning of the intake. The drug is taken under blood control, and if the lymphocytes fall below a certain level, the drug is canceled, since the risk of such a serious complication as progressive multifocal leukoencephalopathy (PML), which can even lead to death, increases. 14 Tekfidera capsules containing 120 mg of dimethyl fumarate cost 6,000 rubles, this is a weekly course of treatment for a dose of 240 mg. Accordingly, a monthly treatment will cost four times more: about 25,000 rubles.
Second line of PITRS
Second-line drugs are prescribed if all first-line drugs are ineffective. However, if multiple sclerosis flows quickly, progresses inexorably, and the activity of the demyelinating process is high, then these drugs, in theory, can be prescribed to the patient immediately, upon establishing the diagnosis. It should be said right away that, despite the high prices of first-line drugs, they seem frivolous compared to second-line drugs from MITRS, perhaps, except for mitoxantrone. Almost all of them are monoclonal antibodies that are produced using sophisticated modern technologies.
Opens MITRS 2 lines of immunosuppressant mitoxantrone. It is surprisingly affordable, perhaps overtaking some of the first line vehicles.
It is used for aggressive and rapidly progressive forms of the disease: it reliably reduces the frequency of exacerbations and the rate of progression of disability symptoms by 60%.
To it, like cyclophosphamide, for the treatment of exacerbations, it is administered according to regimens that take into account the surface area of the body, but a dosage of 20 mg intravenously is often used, once every 3 months during the first year of therapy. Before the introduction of mitoxantrone, a preparation similar to pulse therapy is performed, 1000 mg of methylprednisolone intravenously. The cost of one bottle of 10 ml, just for one infusion, is on average 2000 rubles, and the cost of methylprednisolone, on average, is 400 rubles. Thus, the cost of treating multiple sclerosis with mitoxantrone will be 2500 rubles. for 3 months, or about 840 rubles. for a month, which is quite affordable.
Unfortunately, mitoxantrone may not be indicated for all forms of the disease. It also has side effects – nausea, baldness, accession of an upper respiratory tract infection. It is cardiotoxic and should not be used during pregnancy. But the most important side effect can be considered an increased risk of developing leukemia (malignant leukemia), and especially at high doses, at which cumulation occurs. This is a dose of 80 mg per square meter. The risk of developing blood cancer is quite high, 1%, and this limits the use of this drug. But you can use it once, in a low dosage, before starting treatment with Copaxone or Beta-interferons.
Tysabri is administered once a month intravenously, 300 mg. It is recommended for patients with high disease activity, if before that a full course of 1-line PITRS did not give the expected results. It can be used immediately, that is, as a first line medication for aggressive multiple sclerosis. In no case should it be used in patients with primary progressive or secondary progressive forms. Of course, for a person without medical education, and even for a doctor who has not passed specialization in multiple sclerosis, it is difficult to understand the features of the course, but this is extremely important for correct therapy in anticipation of an adequate response.
With the correct use of TYSABRI, it reduces the frequency of exacerbations by almost 70%, and slowing down the signs of disability by 55%. Nearly 40% of patients who received TYSABRI for 2 years did not have an increase in disease activity. The difficulty is the fact that TYSABRI infusion should be carried out only by specially trained nurses, and only in those institutions where severe allergic reactions can be urgently stopped. Undesirable side effects are PML (the main disadvantage), and opportunistic infections. The drug TYSABRI costs about 36,000 rubles per injection, equal to the cost of a monthly course.
This drug is a tablet, and you need to use it inside, no injections and infusions are required. On the one hand, this is good, and it really helps. If a patient is diagnosed with a relapsing form of multiple sclerosis and first-line drugs have not helped, then you can switch to Gilenia. It can also be used in patients with aggressive multiple sclerosis who have not received any previous treatment. The drug reduces the frequency of exacerbations and slows the progression of disability.
However, the agent can disrupt the heart rhythm, cause an increase in atrioventricular blockade, increase the risk of infections, including herpes, and decrease the number of lymphocytes. Therefore, before taking fingolimod for the first time, it is imperative to measure blood pressure and record an ECG before taking fingolimod, to identify those patients who have additional risk factors, for example, a slow heart rate and the presence of atrioventricular block, which can get serious complications.
After taking the drug, it is necessary to measure the pulse every hour, after 6 hours – to record an ECG, and only after a 6-hour hospital stay, examination and ECG monitoring, the patient can be released home. The second problem is the rather high cost of the drug. Gilenia is sold in capsules, and the monthly cost of the course is approximately 65,000 rubles.
Perhaps, at the moment, alemtuzumab is the most expensive drug for the treatment of multiple sclerosis. In the first year the Patient is given 5 infusions, and in the second year – 3 infusions. A total of 8 infusions. Considering that one bottle of concentrate for preparation costs about 550,000 rubles, then a 2-year course of treatment will cost more than 4 million rubles.
It is not prescribed for everyone, but only for those patients who have an active and aggressive disease, and Tysabri is contraindicated. Also, these are those patients with aggressive forms of multiple sclerosis who are not helped by first-line drugs for a year. Patients who are prescribed alemtuzumab include those who have been treated with Tysabri for 2 years, but they have a high risk of developing such a serious complication as progressive multifocal leukoencephalopathy. There are other indications such as persistent disease activity despite prior prior treatment with mitoxantrone.
The drug is monoclonal antibodies, and also reliably reduces the frequency of exacerbations by 50%, slows down the rate of progression of disability. As with all potent drugs, after an infusion of Lemtrada, there may be an acute reaction to the infusion, damage to the thyroid gland, and nephropathy. Therefore, especially careful monitoring is necessary in those patients who have thyroid pathology.
Finally, ocrelizumab is a second-line PITRS. or Ocrevus. It is administered intravenously once every six months if the patient has multiple sclerosis with exacerbation, namely, a remitting and secondary progressive form. It is also indicated in the primary progressive form. One of the indications will be a lack of response to line 1 MITS, a high risk of developing progressive multifocal leukoencephalopathy after two years of treatment with TYSABRI, and high disease activity after cyclophosphamide or after mitoxantrone. The drug reliably reduces the frequency of exacerbations and prolongs the patient's activity, and is expensive.
The first infusion is initially 300 mg on one day and 300 mg on day 15, totaling 600 mg in 2 weeks. If the patient tolerated the drug well, then after 6 months a dose of 600 mg is administered to him. How much is Ocrevus worth? Half of the standard dosage, that is, a concentrate containing 300 mg, will cost about 230,000 rubles, and each subsequent injection after 6 months, respectively, 450,000 rubles.
Organizational features of PITRS appointment
As the names suggest, all these drugs are not familiar to the common man, they are very specific. And even if the doctor conducted a diagnostic search and accurately established the diagnosis, the type of course and the severity of multiple sclerosis, and 'prescribed' the necessary medicine, then one should not think that the medicine will be immediately prescribed to the patient:
- the PITMS Prescribing Commission should recommend this drug;
- information must be submitted to the regional health care institution, where the patient will be put on the waiting list (!);
- a response should come from a health care institution;
- to discharge the drug, the patient is examined by a neurologist again (what if he recovered, and this is not a joke, because disabled people regularly come to the ITU to report that they still do not have a leg or an arm);
- then the prescription is written out, it is copied into the outpatient card;
- the patient is trained to perform injections, and only then he receives the drug, if the auction took place, and it appeared in this region of the Russian Federation.
But interruptions often occur, and treatment should be continued. In this case, a painful substitution of one remedy for another occurs, which the patient almost always does not tolerate. Why bad? Yes, because all the changes work in one direction for us, and the sudden purchase of an expensive imported drug, which is well tolerated, instead of a cheap domestic product, is from the realm of fantasy. There are many 'pitfalls' here. For example, a drug can be purchased by the government when its expiration date, although valid, is approaching the end. This allows you to write off unrealized balances for a tender, which are already guaranteed not to be sold, if there is an administrative resource.
Of course, sometimes it is necessary to change PITRS preparations abroad as well. Ideally, the physician should have more than one remedy at his disposal, since one drug may go to the patient and the other may not. Finally, if the course of the disease changes, then a vertical replacement will be necessary, that is, a transfer from the first line to the second. The sooner this is done, the better.
Unfortunately, financial investments in the treatment of multiple sclerosis are not limited to expensive specific drugs, although, of course, this is the most serious item of expenses, both for individuals and for public health. Patients need many common medications:
- many with multiple sclerosis have increased muscle tone, or spasticity. They are assigned Midokalm, Baclofen and Sirdalud. The anticonvulsants gabapentin are also used to treat spasticity, especially in painful forms;
- for severe spasticity, Botox or Dysport is recommended;
- in the presence of pelvic disorders and imperative urge to urinate, use Driptan, Detrusitol;
- a patient with multiple sclerosis often has pain. As with neuropathic pain, gabapentin, finlepsin, lamotrigine, clonazepam are used;
- due to limited mobility, back pain occurs, which are bathed in non-steroidal anti-inflammatory drugs;
- a large number of patients have sexual dysfunctions; in men, phosphodiesterase inhibitors, such as Viagra, Cialis and Levitra, are used to lead an active life;
- it is extremely important to fight depression, for this modern antidepressants are used.
It is possible to list medications for a very long time, but it must be remembered that not only medications are needed for patients to treat multiple sclerosis, but also physiotherapy, massage, and then, with the development of disability, various physical means of rehabilitation.
It is also extremely important to have the right mental attitude, attitude to illness, full and long sleep, which should be at least 7 hours. The patient must optimize his physical activity, and he is even allowed to play sports. Full employment at work is very important as it contributes to psychological comfort.
Of course, family support is important, since now medicine has reached such a stage of development that a woman with multiple sclerosis can become pregnant and give birth, since this does not affect the risk of exacerbation, and multiple sclerosis is not transmitted to the child. It is important to remember that with proper treatment and timely relief of exacerbations, you can postpone the symptoms of this disease for many years and live a full and active life.
Attention! This rating is subjective and does not constitute an advertisement and does not serve as a purchase guide. Before buying, you need to consult with a specialist.