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Among the three “litigants”, the fourth enjoys: in the war over who will produce the most effective vaccine, a drug which could reduce mortality and improve the clinical picture of patients with coronavirus. It is baricitinib, already marketed and used for the treatment of rheumatoid arthritis.
What is it about
While Pfizer, Moderna and AstraZeneca (the most “advanced” companies) are testing and beginning to produce their own vaccine (however, there is no green light from the competent authorities), the hope of curing Covid-19 patients comes from baricitinib, which gave excellent results in the most seriously ill patients who had not responded to the first line of care. The research, in which Italian researchers from the University of Pisa also participated, was recently published in Science Advances. “There is a 71% reduction in mortality (95% CI 0.15-0.58) in 83 patients with moderate or severe SARS-Cov-2 pneumonia with few drug-induced adverse events, including a large cohort of elderly (average age 81 years). Another 48 cases with mild to moderate pneumonia recovered without problemi “, reads the introduction to the study. In the group treated with the drug, therefore, mortality was 71% lower than in those who received standard therapies. And if 35% of the patients not treated with baricitinib died or needed to be intubated, the percentage of those who received the drug dropped to 17%.
This is how the drug works
The study was carried out together with researchers from Imperial College London, the Karolinska Institute in Stockholm and the University of Albacete, Spain. “The intuition of this molecule was born from a study carried out by artificial intelligence: Imperial College engineers put thousands of molecules into software and, based on the mechanisms that the virus uses to enter the cell as receptors and proteins, it turned out that this molecule could be useful for the treatment of Covid “, one of the study authors, Prof. Marco Falcone, researcher in infectious diseases at the University of Pisa, dependent on the Aoup Operative Unit for Infectious Diseases and member of the board of directors, explained to us exclusively of Simit (Italian Society for Infectious and Tropical Diseases). “From here we move on to the evaluation of the sick, initially for compassionate use. In Pisa we started this treatment for some patients in whom all other therapies failed and we have seen that many of These patients, with the use of this drug, responded positively, improving the respiratory condition and returning to a dull condition. e better blood oxygenation. “Professor Falcone told us. This hospital drug is used in patients who have deteriorated and who have not responded to treatment with other first-use therapies such as standard steroids, remdesivir, and heparin.
The difference with other drugs. Collaboration between the different centers then began: “the London and Stockholm laboratories simulated human cells in vitro, called organoids, and it has been proven that this drug, born for rheumatoid arthritis, in addition to having an anti-inflammatory effect, is capable of blocking the entry of the virus into cells ”, said Falcone. But how does it differ from other drugs that are already used to alleviate the suffering of the most serious patients? The researcher explained that when a patient begins to progress, the anti-inflammatory baricitinib manages to block what is called a “cytokine cascade”, that is, the inflammation of the lung that turns ‘white’ and the patient does not breathe any more. This inflammatory phenomenon is not caused by the virus but by the inflammatory response of the subject that causes the complication that leads the patient to be intubated. “This drug, like others that are being studied, serves to block the uncontrolled inflammatory response.” .
Another plus. Compared to others, this drug has a very sophisticated mechanism that to block upstream mechanisms that then lead to inflammation that causes rheumatoid arthritis, arthritis, and inflammatory diseases. Since even with Covid there is inflammation, it is very effective. “The advantage also compared to other medications is that you take one tablet a day, orally, and it has a half-life of 12 hours: therefore, if you have an adverse effect, stopping the tablet also suspends any toxic effects. On the other hand, for other drugs with which a single intravenous injection is made whose effects last weeks or months, any adverse effect can also last for weeks, ”said Professor Falcone.
Contraindications. The effects collaterials refer to people with kidney failure below a certain limit and are contraindicated if you suffer from liver failure. Being an immunosuppressive drug that reduces immune defenses, it can cause secondary infections. “In our series we have not seen this phenomenon, however, it must be considered in a particular context such as that of patients who do not respond to first-line therapies.”
The OK of the Fda. The US Food and Drug Administration, which deals with the regulation of food and pharmaceuticals, has given the green light to the use of the drug which, among all the other options being tested for Covid, is the most promising. “The message that needs to be conveyed is that, pending the vaccine that is likely to solve the problem on a large scale, we must test molecules that are capable of cure, today, the sick. The research tries to improve the prognosis of this disease that still, to date, has a significant mortality, “said Falcone. For the moment, however, Ema (European Medicines Agency) and Aifa (Italian Agency) of the medicine) it has not ruled unlike the FDA which granted an emergency authorization. “What does this mean? That the studies are still few and the regulatory body will not say that the drug (or the vaccine) will be 100% effective or safe but that in a situation of serious difficulty it authorizes its entry into the market which will be monitored. In the United States, the drug is already operational to be used to treat Covid ”, the researcher told us.
The new Cts guidelines
While waiting to know if baricitinib treatment will also be authorized in Europe and Italy, our Scientific Technical Committee has approved the guidelines for the care of patients with Covid at home. First of all, the situation should be carefully evaluated before choosing drugs for home therapy against Covid: the cortisoneFor example, it can be seen after at least three days of symptoms and if the oxygen saturation in the blood worsens. L ‘heparin it should not be used except for those who are forced to stay in bed for a long time while vitamins and supplements, in this context, do not serve to improve the patient. On the other hand, the importance of oximeter, which in a normal situation marks a figure higher than 95% but that the acceptable saturation limit, also taking into account the margin of error of domestic instruments, must be 92%. When a doctor cares for people with few symptoms at home, they should measure oxygenation frequently, treat fever with acetaminophen, and make sure the patient hydrates and eats.
“We have the virus now.” While the new year is expected to bring a lot of good news (vaccines), it is of fundamental importance that science continues to search for cures that can block the advance of the virus. “You don’t have to encourage drugs, like hyperimmune plasma or monoclonal antibodies, but you have to be realistic: the majority of the population will not be able to be vaccinated in January-February, we may have doses only for health personnel and some categories particularly at risk. To have vaccination coverage, you will need at least spring and summer, “concludes Professor Falcone.” From now until summer we will have a very high number of people with Covid, we must have weapons now, the sick are now and people are dying now. The vaccine is the possibility, but Covid now, all treatments must be tried as soon as possible. In the coming months we must discover new strategies to reduce mortality ”.
