Biological treatment in rheumatic diseases

Among the diseases classified as rheumatic there are various diseases that have different causes and course. The most common six groups of diseases are mentioned. Nearly 9 million Poles suffer from it.

Rheumatic diseases can be divided into:

1. Inflammatory diseases of the jointsThese include rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA) and juvenile idiopathic arthritis (JIA).

2. Non-inflammatory diseases of the jointsthe most common of which is osteoarthritis.

3. Diseases of the joints due to metabolic abnormalitieswhere gout reigns.

4. Non-inflammatory diseases of the spine manifested by low back pain.

5. Regional disorders and generalized painwhich include carpal tunnel syndrome and fibromyalgia.

6. Systemic diseases of connective tissuethe most common of which are lupus, Sjogren’s syndrome, myositis, vasculitis, and systemic scleroderma.

Rheumatic diseases are very different. Some people have a very turbulent course, others have long periods of remission and short periods of exacerbation. However, without effective treatment, mainly in inflammatory diseases of the joints, patients are doomed to progressive disability that inevitably leads to disability. Living with such diseases every day is not easy, because each day begins with unbearable pain that often lasts throughout the day. An additional difficulty is the stiffness of the joints, which often makes it difficult or even impossible to perform the simplest activities.

Biological drugs

Contrary to popular belief, biological drugs have nothing to do with drugs used by natural medicine. Biological drugs are classified as proteins because this is their chemical structure. Biological in this case means produced by living organisms using their genetic material. This is how perfect drug molecules are created, compatible with each amino acid, which can act within the immune system.

Disease-modifying drug (DMARD) therapies considered traditional today are not effective in 30-40% of patients. sick. Hope for these people are biological drugs that have been used in Poland for 7-8 years. They are given to people who find traditional treatment ineffective or cause many side effects. In the case of patients with high disease activity and failure of classical methods of treatment, the standard is to use biological drugs. In Poland, the percentage of patients who use biological drugs is only about 1%, which is the lowest rate in Europe. In most European countries, the percentage of biologically treated patients is much greater and in some of them it reaches even 20-30%. In Poland, biological treatment is currently used in 2570 people with RA, 1261 people with AS, 516 patients with JIA and 581 people with PsA. It is a drop in the ocean of needs.

Drug programs

In Poland, biological treatment of rheumatic diseases is carried out in four drug programs, two of which are dedicated to the treatment of RA.

The criteria for qualifying, assessing the effectiveness and continuation of treatment currently in force in drug programs are in many places inconsistent with the recommendations of scientific societies, drug registration and guidelines published by the national consultant for rheumatology in Poland in 2013.

In Poland, qualification for programs as well as monitoring of the effectiveness and safety of treatment is carried out through an electronic application, and the doctor qualifying the patient for treatment in the program must obtain the consent of the Coordination Team for Biological Treatment in Rheumatic Diseases.

But the problems of the sick and the doctors who look after them do not end there. The biggest accusation against decision-makers is the system of qualifying for the program and monitoring the course of treatment. This works to the detriment of patients because those who perform well and whose health has improved are removed from the program. If the disease remains low or in remission for 6 months, the administration of the drug is obligatorily suspended. Currently, there are over 1000 people in this situation.

According to the patients

From the perspective of the sick, effective treatment of rheumatic diseases does not pay off, because too good results throw the patient out of the way.

In many surveys and studies, patients emphasize that they would like to see biological therapies as one of the treatment options for inflammatory connective tissue diseases – on an equal footing with other available therapies. However, they indicate many barriers in accessing biological treatment. The most acute problem is the difficult access to specialists and tests that facilitate the correct diagnosis. Only 13 percent. people were diagnosed in less than 3 months, but as much as 42,6 percent. It took more than two years to be diagnosed. These results differ far from the world standards and recommendations. But the problems of the sick do not end there. They are accompanied by severe pain every day. With active disease, joint deformities progress quickly and frequently. When the diagnosis is finally made, it is too late for a treatment that allows you to stay fit and independent.

Discrepancies in the assessment of the effectiveness of biological therapies are also a serious problem. 65 percent of patients claims that after biological treatment they feel a significant improvement in well-being. People treated traditionally with drugs that modify the course of the disease see only 35% of the improvement in health. However, this does not convince the decision makers.

Social effects of rheumatic diseases

Locomotor system diseases are the second most common cause of absenteeism (after injuries and poisoning). Pain, stiffness in the joints or spine, and restriction of their mobility make it difficult to perform many activities at home and at work. During exacerbations, patients usually require a medical certificate.

According to the Social Insurance Institution (ZUS) data, in 2012 rheumatoid arthritis caused 560 days of sick leave, and 330 sick leave forms were issued for this reason. If we take into account all inflammatory diseases of the locomotor system – the number of days off work is over one million two hundred thousand, and the number of sick leaves – nearly 35 thousand.

Absence from work generates high costs not only in the social insurance system, but also in individual workplaces, as the costs of the first 30 days of leave a year are borne by the employer.

Based on scientific data and the official population and economic indicators of Poland, a model was built to illustrate economic phenomena related to the productivity and costs of treating patients suffering from moderately active and aggressive form of rheumatoid arthritis. The collected data show that a patient not treated with DMARDs or biological drugs generates the lowest GDP in their lifetime. This is due to the fact that although the costs of his treatment are negligible, due to the rapid progression of the disease, he cannot work and he goes on a disability pension around the age of 50.

Patients treated with DMARDs work longer, and drugs are more effective in inhibiting disease progression. The cost of disease-modifying drugs is moderate, with patients retiring at around 60 years of age.

Patients treated with biological drugs achieve the highest therapeutic effect, which translates into significantly higher productivity. Despite the significant cost of biological therapy, the economic result is much better than in the case of other types of therapy.

What do we need?

For every chronically and terminally ill person, and this group includes patients suffering from rheumatic diseases, it is extremely important to maintain independence and maintain ability to work. Unfortunately, not everything depends on the sick themselves. In order for this group to work as long as possible, it is necessary to establish an early diagnosis, to promptly introduce classic disease-modifying drugs (DMARDs), the most common of which is methotrexate, to establish and discuss a treatment strategy with the patient, and not only to reduce pain temporarily. Another problem is adjusting the treatment, i.e. increasing the dose of the drug, introducing a different DMARD and a biological drug in people who have not achieved remission or low disease activity within a certain period of time. But that’s pure theory because it’s actually hard to achieve.

According to the latest reports, Poland is the only country in Europe where, prior to biological treatment, it is necessary to use classic disease-modifying drugs (DMARDs) for at least a year, despite their ineffectiveness. We are also the only country where, for administrative reasons, treatment should be discontinued six months after achieving remission or low disease activity, as it is no longer reimbursed. None of the European countries have recommendations that 6 months after reaching the therapeutic target, treatment should be discontinued and restarted after the next exacerbation of the disease. In this way, the long-term therapeutic effect is lost, i.e. inhibiting the progress of structural changes in the joints. But this is a problem of the patients themselves, who, without effective treatment, are doomed to pain and progressive disability.

Tekst: Anna Jarosz

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