Through a double-blind, randomized and placebo-controlled study (called SAVE-MORE) an Italian-Greek research team determined that the anti-inflammatory drug Anakinra, used to fight rheumatoid arthritis, can bring down mortality in severe Covid patients up to to 80 percent. An extraordinary result that can revolutionize the fight against the pandemic. The EMA will make a ruling by October.
L’Anakinra, a anti-inflammatory drug used to treatrheumatoid arthritis and other pathologies, can break down the mortality in patients Covid until’80 percent according to a new study published in Nature. It is an extraordinary achievement, which makes it one of the most valuable weapons we have in the fight against pandemic from COVID-19. Since it broke out, doctors and scientists have worked hard to fight it, both through drugs already available approved for other diseases (use off-label) than researching new molecules e active principles. Within a few months, several medicines were promoted as a “panacea against all evil”, only to collapse inexorably, under the weight of the results of the clinical studies. L’hydroxychloroquine is the most fitting example, but also theivermectina which had given good results in preclinical tests proved ineffective (despite the narrative antivaccinista). Col. plasma iperimmune did not give the desired results, not reducing the mortality and the risk of progression to severe infection. One of the drugs that was initially “snubbed”, the corticosteroid dexamethasone, on the other hand, it has proved to be one of the most useful in treating patients infected with the coronavirus SARS-CoV-2, reducing mortality by 30 percent. Now Anakinra, an experimental drug developed by Swedish Orphan Biovitrum, seems to demonstrate even greater efficacy: in the new clinical study the mortality of patients with COVID-19 (moderate or severe) was in fact reduced by up to 80 percent, in those who had probably developed the cytokine storm, a serious complication potentially fatal.
Determining the enormous potential of Anakinra in the fight against COVID-19 was an international research team led by Greek scientists from the National and Koper University of Athens and the Hellenic Institute for the Study of Sepsis, who collaborated closely contact with colleagues from the Department of Tropical Infectious Diseases and Microbiology of the IRCSS Sacro Cuore Hospital – Negrar, of the Immunology, Rheumatology, Allergies and Rare Diseases Unit (UnIRAR) of the IRCCS San Raffaele Hospital, of the Vita-Salute San University Raffaele di Milano, the Policlinico San Martino IRCCS Hospital, the Department of Health Sciences of the University of Genoa, the General Hospital Tzaneio del Piraeus and other institutes. The scientists, coordinated by Professor Evangelos J. Giamarellos-Bourboulis, came to their conclusions after conducting an in-depth study in double blind, randomized e checked (called SAVE-MORE) to verify theeffectiveness and the safety of the Anakinra. They have been involved approx 600 patients at risk of progression torespiratory failure; almost all (85.6 percent) were treated precisely with dexamethasone.
One month after administering the drug, the scholars write, the odds of having one worse clinical status after administration of Anakinra compared to placebo, were 0.36 (with 95% confidence interval, 0.26-0.50). In percentage terms, thanks to the anti-inflammatory drug “the percentage of patients who have fully recovered has exceeded 50 percent and the number of patients who remained with one severe illness has been reduced by 54 percent”, The scientists continued. “The majority of the study population had severe COVID-19 at baseline, and 85.9 percent were receiving standard-of-care treatment that included dexamethasone. The relative reduction in mortality was 55 percent and reached 80 percent for patients likely to have a cytokine storm, ”concluded Giamarellos-Bourboulis and colleagues.
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Anakinra is technically a drug “biological response modifier”(BRM), a interleukin 1 (IL1) receptor antagonist. Put simply, actively counter this cytokine, one of inflammatory protein molecules which can accumulate in the body as a result of certain conditions, such as rheumatoid arthritis (for which Anakinra is thought of) and COVID-19. As you know, SARS-CoV-2 coronavirus infection can trigger a impaired immune response with exaggerated production of inflammatory molecules, the aforementioned cytokine storm (o cytokine storm), which in turn can lead toARDS (acute respiratory distress syndrome) et al death of the patient. Precisely because it is a cytokine antagonist, medical scientists have thought about using Anakinra to fight COVID-19. And the results of the study SAVE-MORE they have given them ample reason.
Several experts welcomed them with optimism, among them also Guido Rasi, the former executive director of the European Medicines Agency (EMA) and among the advisors of General Francesco Paolo Figliuolo, who told AdnKronos: “The Anakinra seems to be among the most promising, given that it has given good results, and it could soon come out of the experimental phase to be used on patients in advanced stages of the disease “. The teacher Antonella Viola, professor of general pathology at the Department of Biomedical Sciences of the University of Padua and scientific director of the Institute of Pediatric Research (IRP-Città della Speranza), told Repubblica: “It is an excellent result, partly expected given the role key to interleukin 1 in inflammation and severe pathology caused by SARS-CoV-2. Research continues to show that the immune system is the best target to reduce Covid mortality19 ”. The scientist added that it is a drug for serious patients, so Anakinra is a drug to save lives “but not to block the virus, for this, it takes the vaccine”, Professor Viola commented. The European Medicines Agency (EMA) will decide on the Anakinra by October, the AIFA should follow it shortly. The details of the research “Early treatment of COVID-19 with anakinra guided by soluble urokinase plasminogen receptor plasma levels: a double-blind, randomized controlled phase 3 trial” have been published in the authoritative scientific journal Nature Medicine.