Insulin’s little brother by almost a hundred years, the first immunological drug to delay the onset of type 1 diabetes was approved in November of this year. approved by the US Food and Drug Administration (FDA). Will he live up to his expectations?
The introduction of insulin was one of the greatest breakthroughs in medicine—diabetes was no longer a death sentence. However, this disease has not yet been cured. Teplizumab, registered in the US, is supposed to delay the development of type 1 diabetes. It is described as a policeman who gives T-lymphocytes, which are responsible for protecting our body, an accurate description of the pathogens they have to fight, so that they do not blindly attack their own cells. leading to incurable and life-threatening diseases like type 1 diabetes. Can they actually stop them from attacking their own body?
Teplizumab is a new drug for the treatment of type 1 diabetes.
The US Food and Drug Administration (FDA) November 17 this year. approved teplizumab, which can be used in people 8 years of age and older. Kevan Gerold, professor of immunobiology and medicine at the Yale School of Medicine, who led the research on the drug, says: even one day without this disease is a gift.
Around 9 million people around the world struggle with type 1 diabetes 24 hours a day, 7 days a week, for the rest of their lives. In Poland, almost 200 thousand. It is expected that in 2040 the number of patients will reach almost 17.5 million people.
If the disease was diagnosed before the age of 10 years, it statistically shortens the life of a diabetic by 16 years. This is an autoimmune disease, which means that our body, especially the T-lymphocytes produced in the bone marrow, begin to destroy the beta cells that are in the pancreas and are responsible for producing insulin.
Causes of the disease
Why is this happening? This is still one of the unsolved medical mysteries. So we don’t know the cause, but a hundred years ago we managed to start treating its effects by injecting patients with insulin. Without it, our cells have no chance to feed. Glucose without insulin will not penetrate our tissues. The man is slowly dying.
- We do not yet know what the causes of this disease are, if we knew this, we would know the cure. Then it could be treated like a runny nose, and probably one day it will be, says Dr. Leszek Borkowski, PhD, former president of the Office for Registration of Medicines, Health Products and Biocidal Products. .
He adds that this drug was originally studied in the case of transplantation of kidneys and pancreatic islets, the pulp of which is mainly beta cells.
– This story is similar to the one associated with Viagra, a drug that is currently used to treat potency. At first it was supposed to be used in cardiology, and then it turned out that it helps patients in other ways, says Dr. Borkowski.
The drug is supposed to prevent it from attacking the pancreas.
So, a hundred years after the invention of insulin, a drug appears (so far on the American market), the task of which is to block T-lymphocytes so that they do not attack pancreatic beta cells, but focus only on attacking dangerous pathogens. Teplizumab is a monoclonal antibody that binds to the CD3 protein of T cells. Monoclonal antibodies are a group of new drugs that are used in some serious diseases.
T-lymphocytes are immune cells produced in the bone marrow. We talked a lot about them in the context of dealing with pandemics of infectious diseases such as COVID-19. T cells of the immune system play a significant role in autoimmune inflammation of the beta-cell pancreatic islets. Pancreatic beta cells are responsible for insulin production, explains Dr. Borkowski.
The expert adds that they were looking for a monoclonal antibody that would not destroy the ability of lymphocytes to fight viruses and bacteria, but would force the bypass of pancreatic beta cells, because the attack of pancreatic beta cells by lymphocytes leads to the development of type 1 diabetes mellitus. To achieve this effect, T-lymphocytes had to be reprogrammed so that they did not see the beta cells of the human pancreatic islets as enemies to be destroyed.
“For 15-20 years they have been working on an antigen that would make T cells not attack pancreatic beta cells, but continue to attack bad bacteria and viruses. Such an antigen is the monoclonal antibody teplizumab, which binds to the CD3 protein found on the T cell. Teplizumab is to crazy T cells like a cop to overly reckless drivers. This allows them to walk, but requires caution, says Dr. Borkowski.
It’s a step in the dark forest for now
The drug is intended for people in whom the process of destruction of pancreatic beta cells is just beginning. This is difficult, because in the initial stage the disease is asymptomatic. It may take years. When it appears, it is too late for pharmacological treatment, because the pancreas no longer produces insulin or produces it in trace and disappearing amounts. Nevertheless, the drug can stop the development of the disease for an average of two years and delay the onset of severe complications.
The drug study involved people (median age 13.14 years) who had not yet been diagnosed with diabetes mellitus, but who were aggravated by the disease due to the fact that the disease appeared in the family. Participants were tested for common immune markers. If they were found to be at risk of developing the disease, they received teplizumab for 14 days. Then they checked the course of the disease in subsequent years. In a clinical trial, it was found that compared with the placebo group, the development of type 1 diabetes occurred with a delay of at least two years. In one patient, the course of the disease was slowed down to 11 years.
Teplizumab can have very serious side effects.
According to Dr. Borkowski, the approval of the drug in the US is certainly another important step in therapy. Teplizumab should be given as an intravenous infusion (over at least 30 minutes) once daily for 14 days.
“Teplizumab is a step in a dark forest. This is the first step, but my enthusiasm is limited, the expert emphasizes and points out that this drug has serious side effects. – May cause cytokine release syndrome. What is it? Everyone was convinced of the COVID-19 epidemic,” the expert says.
Cytokine release, also known as “cytokine storm”, is the process by which the immune system rebels against its own body. Instead of fighting real enemies, he attacks his own cells. This is a direct threat to life.
– In addition, the drug destroys the liver, because alanine aminotransferase (ALT) and aspartate aminotransferase (AST) increase exponentially. If it exceeds the norm by five times, and bilirubin by three times, the drug must be discontinued. In addition, it causes infections because it reduces the number of T-lymphocytes (immune cells). It can also cause bronchospasm, vascular swelling, lists Dr. Borkowski.
The expert compares the drug situation to the fact that we entered the kitchen through the side entrance, although we want to get into the room through the main entrance.
It doesn’t change the fact that monoclonal antibodies are very good drugs. However, they must be used very precisely. “Grenade is different. Not only will it not protect, it will also tear off your hands, - the expert sums up.
Source: Wprost
