Aifa’s okay to the anti Covid drug Baricitinib is just a few hours ago, whose experimentation was made at the Grosseto hospital.
Regarding the drug, the editorial staff of Lucca Live has placed some questions to the head of internal medicine of the Versilia hospital, Dr. Plinio Fabiani, who since the beginning of the third wave of the epidemic, ie in the autumn of last year, has used the medicine, subject to the informed consent of the patient undergoing the therapy.
Vero?
“It is true. We were among the forerunners of the use of this type of drug in Sars Cov-2. Already during the first wave of Covid-19 in 2020 we used tocilizumab among the first, a monoclonal antibody used for rheumatoid arthritis, which prevents interleukin-6 from binding to its receptors, for patients with lung disease characterized by high levels of inflammatory indices, respiratory failure is some involvement of the lung tissue in the so-called CT scan ground glass (frosted glass). Among other things, this drug was approved this year by Aifa for Sars-Cov-2 patients. Starting from the end of 2020, the second and third wave of covid19 we turned to the use of another drug, baricitinib, the first case on December 28, and we managed to treat 152 patients as of May 27, 2021. The typology is that of a patient in whom there are signs of a change towards the severe form, not too early or late “.
Was the drug already known to be used for other pathologies?
“Baricitinib, like tocilizumab, is also registered for the treatment of active rheumatoid arthritis and works by blocking the action of enzymes known as Janus kinase. One wonders why drugs active on an inflammatory disease such as rheumatoid arthritis can help in coronavirus-19 disease, particularly in Sars Cov-2. Well the coronavirus-19 can give a variety of symptoms ranging from asymptomatic forms, with mild symptoms, to severe and even fatal forms, as is now well known. In the most severe forms it is mainly the type of response of the infected organism that causes the damage in what is called the cytokine storm, that is, an inflammatory response that is no longer controllable ”.
What is its real effectiveness?
“It is precisely by fitting in with this type of drug that we managed to contain the damage which recognizes the virus as primum movens, but which is subsequently due to the exaggerated response of the organism as the immune system is massively mobilized ”.
What result has it given on the reduction of the disease?
” During both the first, second and third waves, we saw that in patients who showed signs of excessive inflammation, the initial lung involvement in CT scan (ground glass appearance) the use of these drugs modified the natural history of the disease, resulting in an evident improvement and reducing the need to switch from non-invasive ventilation to oro-trachelae intubation or the transition from our department to that of intensive care ”.
Is it also effective in advanced forms of the disease?
“If the disease is too advanced, that is the respiratory insufficiency is very serious and at the pulmonary CT scan the ground glass lesions have turned into real consolidations, the chaces of success are drastically reduced. Hence the importance of its use in the right phase ”.
Did it have any side effects?
“By selecting the patients well, we did not find any particular side effects. Since these drugs are immunomodulators, they lead to a reduction in the immune response. For this reason they should not be administered in the first phase of the disease in which the viral infection is predominant, but in the subsequent phase when the viral load is strongly reduced and in these subjects, the inflammatory phase increases exponentially. For this reason, the signs of any bacterial overlap are sought that would contradict treatment with these drugs. This explains well why we switched from tocilizumab to baricitinib: the first has very prolonged effects in the patient to whom it is administered, so the risk that a subsequent infection could lead to a defenseless organism exists. Baricitinib, on the other hand, works with daily administration and when the administration is stopped it also ceases its effect on the immune system, ie it is much more manageable because its effect is rapidly reversible in case of need “.
When you, as head physician, entered the ward and proposed it to the Covid patients, what reaction did the patients have? Trust, fear of the drug?
“Since the timeliness of initiation of this therapy is essential in selected patients, it was my collaborators who, at any hour of the day or night, holidays or weekdays, kept in contact with me describing the conditions of the patients, their vital parameters, their CT scan, their inflammation indices, on which base I took the responsibility of prescribing an “off-label” drug, that is, outside its indications approved by the drug agencies, both Italian and European, because we believed we were doing the good of patients. Patients duly informed, took our trust and almost everyone accepted the treatment. I have to thank the directors of the department of medical specialists and the pharmacy of the Northwest Healthcare Company who facilitated us in obtaining the drug, making all the bureaucratic steps fluid, and for the trust they gave us. We have had to make important decisions such as off-label use of drugs, taking on considerable responsibilities, as if we were in wartime, and perhaps the comparison is not so out of place. I would say that in all no more than 3-4, the great majority adhered to the treatment “
Will this drug somehow reduce the use of the vaccine?
“Vaccine and baricitinib go into completely different stages. The vaccine aims to prevent the disease, the baricitinib to cure. And as they always say, prevention is always better than cure. Let me explain: not having the disease means that the person (we cannot speak of a patient because he is not yet sick) will not contract the disease and will continue to lead his life normally (obviously in the large percentage of cases in which the vaccine is effective ). When the percentage of vaccinated exceeds a certain threshold, the disease will not be able to spread to the population. So protection is not only individual but of the population, with clear social consequences. Baricitinib improves the prognosis of a certain percentage of patients (not all) who would undergo intensive treatment. It contains the damage in those who respond to therapy, but does not eliminate them. It is certainly one more weapon to our credit, but the enemy is still fearful ”.
Is it also effective against possible variants?
“Since it works by containing excessive inflammation, conceptually it can be used in the individual patient regardless of the underlying cause. However, it would always be better not to have to get there. And on this only vaccines can help us. Covid-19 has made it possible to refine the techniques for the production of effective vaccines “.