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Asthma is an increasingly common respiratory disease. The number of patients is systematically growing, but at the same time, thanks to the progress of science, there are more and more options for effective treatment of the disease. One of them, extremely valuable for patients with the most severe form of the disease, severe asthma, is biological treatment.
The World He alth Organization estimates the number of people suffering from asthma at over 235 million. About 400,000 die from it annually. The greatest number of cases, affecting approx. 20% of the population, occurs in developed countries, incl. Great Britain, Australia, Sweden, Finland, and the lowest (1%) among Inuit and Japanese. About 4 million people suffer from illness in Poland. 11% are children aged 6-14 and about 9-10% of the population are adults. However, these statistics are only estimates as many cases of the disease remain undiagnosed.
Asthma comes in several forms that experts call phenotypes. The most severe form of asthma is severe asthma, which, according to statistics, affects 3.7% of the asthmatic population. Severe asthma very often prevents normal functioning due to frequent exacerbations and hospitalization. It is a serious burden for the he alth care system and patients' families.
We talk toprof. extra dr hab. n. med. Maciej Kupczykfrom the Department of Internal Diseases, Asthma and Allergy, Medical University of Lodz, President-Elect of the Polish Society of Allergology.
- According to epidemiologists in Poland, up to 15,000 people could qualify for biological treatment of severe asthma. people. Currently, only about 1 thousand are treated in this way. patients. Why is this happening?
Prof. Maciej Kupczyk:We could certainly treat more patients than today, but the limited number of patients receiving biological therapies is influenced by several aspects. First of all, the criteria for inclusion in the therapeutic program in Poland are slightly more stringent than it is provided for in the characteristics of the medicinal product, i.e. the recommendations for which group of patients the drug is dedicated.
Secondly, we must remember about logistical aspects, because therapies are conducted by selected specialized centers that are notevenly distributed throughout the country. This is a good rule, because these centers have appropriate diagnostic facilities and experience in the diagnosis, differentiation and management of seriously ill people. But the location of the centers in academic cities makes it difficult for many patients to reach them for the administration of the next dose of the drug.
Another problem is the under-recognition of severe asthma. Unfortunately, it is still widely accepted that the patient has frequent exacerbations of the disease, that he must periodically take systemic steroids, i.e. oral steroids.
Meanwhile, according to the latest global recommendations of the Global Initiative for Asthma (GINA) regarding the treatment of asthma, in the fifth stage of treatment, i.e. in cases of severe asthma, the patient should be referred to a specialized center, where doctors will consider starting biological treatment. But this is not always the case, so there is certainly a group of patients that has not yet been referred for biological treatment. We are still looking for such patients and we are trying to introduce biological treatment in them.
And the last reason for the limited access to biological treatment - economic. Therapeutic programs are a heavy financial burden for specialist centers. Overall, the programs are under-financed by the payer. There are centers that can take care of a few or a dozen patients, but this is where their financial possibilities end.
In addition, many facilities lack staff to supervise and treat patients with severe asthma. Patients with severe asthma need a lot of attention and care from medical staff, and this is constantly lacking, because hospitals do not have the money to hire more employees.
- Until now, the drug program forced patients with severe asthma to visit hospitals frequently. Depending on the drug administered, the patient would come to the hospital every two weeks or once a month. On November 1, the Ministry of He alth introduced a change that allows the dispensing of biological drugs for 3 months for self-administration at home.
M.K.:Less frequent visits to the hospital will certainly benefit patients. However, medical personnel is still burdened with excessive so-called reporting. But they will not reduce the obligations that result from the need to constantly monitor the course of treatment and to monitor possible complications of the disease itself.
Self-administration of a drug is one thing, but supervision of treatment requires the involvement of doctors, nurses and support staff. It is also worth remembering that a lot depends on the specificity of the drug administered. They are among biological drugsthose having a patient-friendly administration schedule, e.g. every two months. This reduces the number of visits to a specialist center necessary, but does not solve all problems.
- What is the essence of biological treatment?
M.K.:Biological therapy is a very modern method of treatment that uses monoclonal antibodies. They are created in laboratories and target the immune mechanisms that underlie the development of the most severe forms of asthma.
Let's look at severe allergic asthma. The mediator that determines the development of the disease is the IgE antibody. If we recognize this asthma phenotype, we can use the monoclonal antibody omalizumab, which will work against IgE. This means that we will stop the main culprit of the disease.
If we are dealing with eosinophilic asthma (severe asthma) there are many drugs available that inhibit the inflammation in the airways dependent on IL-5. We know that IL-5 contributes to the development of severe inflammation in the airways. So we give drugs that inhibit these mediators, thanks to them the inflammation is extinguished.
- Biological treatment is intended only for patients with severe asthma or can it also be used by COPD patients?
M.K.:Modern medicine has dozens of biological drugs that are used in many fields. As part of therapeutic programs, biological drugs are administered to oncological patients.
There are programs for dermatology or allergology, e.g. in cases of spontaneous urticaria, atopic dermatitis. Biologists and rheumatologists also use biological drugs.
When it comes to COPD, no biological drug in the world is registered for the treatment of this disease. The development of the disease is mainly influenced by smoking, but it is not affected by monoclonal antibodies.
- Severe asthma is a disease that often deprives the patient of independence and makes the patient quit studying or working. Does biological treatment change the fate of patients?
M.K.:Severe bronchial asthma is extremely stressful for the patient, his family, and also for the he alth care system. Direct and indirect costs are extremely high, which - fortunately - is getting more and more attention. To put it somewhat poetically, biological treatment is magic.
Of course, for this to be the basis, it is necessary to properly qualify the patient for treatment, i.e. to recognize the mechanisms that contribute to the development of the disease. In order not to make a mistake and individually select the drug forthe patient is phenotyped, i.e. looking for a factor determining the development of the disease. This requires specialized equipment, knowledge and experience of specialists.
When we choose the right drug, most of our patients' he alth improves spectacularly. The number of troublesome symptoms during the day and at night is reduced, and the tolerance of physical exertion improves. A sick person can play sports, return to work or study. It can function like a he althy person. And most importantly - the number of exacerbations of the disease decreases, so also the number of hospital stays, unplanned medical visits, and emergency medical services.
From my point of view, it is extremely important that the patient less often has to use emergency treatment, i.e. frequent use of systemic steroids. They are good drugs, but their long use carries a risk of significant complications.
Cushing's syndrome may develop, symptoms of which include obesity on the trunk, puffed face with puffy eyelids, pink stretch marks on the skin. Long use of systemic steroids promotes osteoporosis, thromboembolism and bacterial superinfections. By choosing the right biological treatment, we can protect patients against such complications, or at least reduce the risk of their occurrence.
- You said biological treatment is magic. Does it also have a dark side?
M.K.:Apart from some logistical difficulties with reaching patients at specialized centers, especially when the treatment regimen involves administering the drug every two weeks, we do not observe significant adverse symptoms of biological treatment. This is due to the extraordinary diligence in the development and production of biological drugs, which are therefore very safe.
Yes, there are isolated cases of a generalized allergic reaction. But only a few cases of side effects are described in the world literature. This does not mean that when administering biological drugs, we completely trust the belief that they are safe. After administering the first dose, we observe each patient for two hours. We observe the next doses for half an hour.
The only disadvantage of biological therapy for the patient is the need to regularly reach the hospital. Doctors will be burdened by bureaucracy and the so-called reporting. Payer high medical costs. But in the long run it pays off anyway, as spending on frequent and expensive hospitalizations, ambulance visits, and finally the costs of sick leave and benefits is reduced.
- How long is biological treatment applied?
M.K.:The duration of biological treatment depends on the form of the disease. The decisive factor in asthma is the patient's age. Pediatricians who deal with the treatment of severe asthma in children, in many cases observe the complete disappearance of the symptoms of the disease, which, however, does not always mean complete recovery from asthma.
In adults who have persistent disease, allergy or asthma, things vary. Some patients take biologics for two years. After this period, we discontinue them and observe the state of he alth. There is also a group of patients who need longer treatment, possibly even chronic.
- In adults, do comorbidities affect the course of treatment?
M.K.:Contrary to COPD, comorbidities are of less importance in the course of asthma. This is due to, inter alia, from the fact that, in general, asthma is a disease of younger people.
Asthma most often begins in childhood and continues throughout life. The average age of our patients is 40-60 years. They are people free from multiple diseases. Of course, obesity should be considered a comorbid disease, which in the case of asthma and other respiratory diseases is a very aggravating factor.
- The standard treatment of asthma includes inhaled steroids, bronchodilators, and systemic steroids during exacerbations. Does biological treatment discontinue these groups of drugs?
M.K.:No. It's not like that. A patient with severe asthma usually takes inhaled steroids and a bronchodilator. Inclusion in the therapeutic program is not associated with the discontinuation of basic medications. They need to be taken regularly.
In some patients it is possible to significantly reduce the doses of medications taken, but the most important thing in biological therapy is that we can reduce the dose of systemic steroids, which - as I said - have a lot of side effects.
Inhaled steroids do not pose such a threat. Patients with severe asthma use them chronically, without the risk of complications. Importantly, inhaled steroids are administered in doses several dozen times smaller than systemic steroids. The safe administration of inhaled steroids does not depend on the active substance, but on the type of inhaler. Modern inhalers have a better deposition, i.e. they allow the drug to be administered to the lower respiratory tract.
- Biological treatment in Poland is available as part of the severe asthma drug treatment program conducted in highly specialized centers. There are about 50 of them in Poland. What belongsto do to get into the program?
M.K.:First of all, you need to know that there are such options for treating severe asthma in Poland. This is where patient education, as well as primary care physicians, bows down. To qualify for biological treatment, you must be diagnosed with severe uncontrolled asthma. The administrative condition is a referral from the attending physician.
- Severe asthma is treated in Poland according to world standards, although the number of patients in therapeutic programs is not yet impressive. What tools in the fight against severe asthma are still waiting for specialists?
M.K.:We are waiting for new modern drugs, including modern inhalation drugs with anticholinergic properties. They are registered but not yet approved for reimbursement. So they are not available to our patients.
They would be very useful because the so-called Dual bronchodilation, i.e. the simultaneous use of two drugs with different mechanisms of action in patients with severe disease, would bring many benefits for patients.
We are also waiting for the possibility of prescribing three drugs to patients, which will be in one inhaler. These are modern inhalers that facilitate the proper intake of inhaled steroids.
I would like to add that an extremely important change introduced to drug programs is the reduction of the waiting period for changing a biological drug. In Poland, when a patient was administered a wrong biological drug and it was necessary to switch to another, a six-month break had to be observed, although there are no medical indications for such treatment. In the world, it is the doctor who decides when to change the drug. This time was reduced to three months, which is extremely important for patients with severe asthma. In other countries, such distant treatment intervals are not used.
We are happy that we can treat our patients as part of therapeutic programs. After enrolling in the program, the patient does not pay a dime for expensive treatment. Without programs, biological treatment would be available to a handful of patients. This is a huge advantage of therapeutic programs.
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