Contents
In line with its mission, the Editorial Board of MedTvoiLokony makes every effort to provide reliable medical content supported by the latest scientific knowledge. The additional flag “Checked Content” indicates that the article has been reviewed by or written directly by a physician. This two-step verification: a medical journalist and a doctor allows us to provide the highest quality content in line with current medical knowledge.
Our commitment in this area has been appreciated, among others, by by the Association of Journalists for Health, which awarded the Editorial Board of MedTvoiLokony with the honorary title of the Great Educator.
The introduction of biological therapies to treatment has raised great hopes in chronically ill patients. And although biological drugs do not provide a chance for a complete cure, after using them, the quality of life of patients is incomparably better.
Biological therapies are used in many fields of medicine, including in dermatology, rheumatology, gastrology, in the treatment of diseases of the immune system as well as in oncology. In Poland, they are most often used when classic treatment does not give the expected results.
Biological drugs are large proteins produced with the use of genetic engineering and molecular biology that replace, remove, supplement natural proteins produced in the human body, thanks to which it is possible to treat many diseases. Biological drugs are commonly known erythropoietin, recombinant insulin, human growth hormone, coagulation factors, low molecular weight heparins or monoclonal antibodies used in oncology, gastroenterology, rheumatology and hematology. The great complexity of these drugs is evidenced by the comparison, often quoted by specialists. A biological medicine is a jet plane that requires over 200 parts, and an ordinary chemical drug (such as the proverbial aspirin) is a bicycle that consists of about 120 parts.
The most valuable feature of biological drugs is that, thanks to their unique structure, they can modify immune responses in the body in accordance with the therapeutic goal.
When are biologics used?
Biological therapies are most often used to modify diseases that have an immunological basis. Used in the treatment of e.g. rheumatoid arthritis (RA), ankylosing spondylitis (AS), lupus erythematosus, atopic dermatitis, psoriasis, inflammatory bowel disease (ulcerative colitis and Crohn’s disease). They are also used by oncologists to fight colorectal cancer, lymphomas and breast cancer.
In the world, treatment very often begins at the very beginning of the disease in order to prevent its consequences. In Poland, most often only when traditional methods of treatment fail.
Biological drugs improve the patient’s well-being quite quickly. Their administration allows to significantly shorten the hospital stay, and also to discontinue additional treatment or reduce the doses of other drugs used, e.g. glucorticosteroids, or finally – as is the case in rheumatic diseases – to avoid surgical repair of joints deformed by inflammation.
How it works?
Biological drugs work mainly by inactivating certain molecules that are overproduced by the immune system and which, in the course of disease, damage the patient’s tissues. Thanks to this, it is possible to influence the course of the disease, alleviate its symptoms or lead to long-term remission, i.e. calming the troublesome symptoms.
The main cause of health problems in people with a malfunctioning immune system is TNF-alpha, a tumor necrosis factor. In the case of rheumatic diseases, this substance accumulates in the synovium and synovial fluid of the inflamed joints and leads to their destruction. Administration of a biological drug inhibits the damaging effects of TNF-alpha. TNF-alpha inhibitors, as this group of biological drugs are called, are used in the treatment of RA, AS, inflammatory bowel disease, psoriatic arthritis and arthritis in the course of chronic inflammatory bowel diseases. Research is also underway to introduce drugs that lower TNF-alpha levels in the treatment of other inflammatory diseases, including sarcoidosis, psoriasis and iritis.
Biological drugs are administered subcutaneously or intravenously in the form of drips. Depending on the type of drug and the patient’s body weight, the dose of the drug is always selected individually.
Not for everyone
Unfortunately, from a medical point of view, biological drugs cannot be used in all patients. The patient is qualified for each biological therapy after performing many tests. Generally speaking, the use of biological drugs excludes:
– moderate / severe infectious disease,
– tuberculosis (even latent),
– chronic and opportunistic infections,
– severe / moderate cardiovascular, respiratory, liver, kidney failure, neoplastic diseases (except for registration indications of a specific biological drug),
– autoimmune diseases (except for biological drug registration),
– neurological diseases (e.g. multiple sclerosis),
Biologics are generally well tolerated, but side effects can occur with any therapy. Their intensity or nature may be different. Common side effects of biological drugs include skin reactions at the injection site, upper respiratory tract infections, mycoses, and weakening of the cardiovascular system. Latent tuberculosis, i.e. previously latent tuberculosis, may be revealed in people treated with biological drugs. The therapy may increase the level of liver enzymes. Biological intolerance can also be manifested by chills, fever, muscle aches, loss of appetite, nausea, vomiting and diarrhea. They can, although very rarely, even cause shock. Each of the biologically authorized drugs has a different effect on the immune system, therefore it is difficult to establish a single list of contraindications and side effects for all biological drugs.
It almost makes a difference
The use of biological drugs is an expensive treatment. According to the report “Biological treatment in rheumatic diseases in Poland” prepared by Dr. Marcin Stajszczyk, the annual cost of therapy, for example in a RA patient weighing 70 kg with adalimumab, is PLN 49. The high cost of therapy limits access to treatment with biological drugs. It is also limited by a complicated system of qualifying for treatment. Therefore, biological treatment is used in Poland by just over 488 thousand. sick.
It would seem that the fate of patients will change because the patent protection for innovative (reference) biological drugs has expired. Biosimilar drugs, which in their structure and function are similar to the reference drugs, have entered and will be introduced to the market.
Unfortunately, it is impossible to equate biological and biosimilar medicines. Proponents of biosimilars say they are almost like biologics but, as is usually the case, “almost” makes a difference. Even generics are not exact copies of the original chemical drugs. According to the guidelines of the European Medicines Agency, which read “Due to the complexity of biological products, the approach to generic (biosimilar) drugs is not appropriate”. This means that biosimilars should not be named or treated as generic chemical drugs. But it may soon turn out, because these are ministerial plans, that doctors will not be able to administer biological drugs because, due to the high price, hospitals will not order them. The place of reference biological medicines will be taken by cheaper biosimilars.
What might this mean for patients? It is difficult to answer that right now. A biosimilar medicine will always be different from the reference medicine. The reason for the differences will be that the manufacturers of a different cell line use a different manufacturing and purification process than the manufacturer of the reference medicine did. Therefore, a different effect of these drugs on the human immune system can be expected, which will require increased monitoring of the treatment course.
Currently, there are no legal provisions in Poland that regulate all aspects of the use of biological drugs, including the safety of therapy. All the more so, the use of biosimilar drugs will require special care, both by doctors and patients themselves.
Increased monitoring
The new European regulations indicate that “biological medicines, including biosimilar medicinal products, are a priority for pharmacovigilance”. In order to increase the safety of Polish patients, the European directive on pharmacovigilance was implemented into our pharmaceutical law, according to which biological drugs approved for marketing after January 1, 2011, including biosimilars, were deemed to require special monitoring and marked with a black triangle. This symbol is placed on the packaging and on the leaflet attached to the medicine. The black triangle on the drug is intended to raise the alertness of doctors and patients. Pursuant to the new law, patients gained the right to self-report any adverse effects. In the past, such a procedure could only be implemented by a doctor. Any side effects during therapy with biological and biosimilar drugs can be reported at http://dzialanianiepozadane.urpl.gov.pl/
Tekst: Anna Jarosz
Health Expert: dr hab. n med. Piotr Albrecht pediatrician gastrologist Department of Gastroenterology and Nutrition for Children Medical University of Warsaw