A new study in the prestigious British journal The Lancet showed significant survival benefits of the drug baricitinib in patients hospitalized with moderate to severe COVID-19 pneumonia. The study confirms the recent findings of the National Institutes of Health-sponsored trial, ACTT-2, led by Andre Kalil, MD, of UNMC.
Combined, these studies found that baricitinib provides faster clinical recovery and a significant reduction in the progression to mechanical ventilation and death in COVID patients, said Dr. Kalil, professor in UNMC’s Department of Internal Medicine Division of Infectious Diseases.
In the recent issue of The Lancet, Respiratory Medicine, Dr. Kalil published an editorial discussing the findings of an international study led by Vincent Marconi, MD, professor in the Division of Infectious Diseases at the Emory University School of Medicine. The study with 1,525 patients in 101 centers from 12 countries, was sponsored by Eli Lilly and Company.
"This new randomized, double-blind, placebo-controlled trial demonstrated significant survival benefits with this immunomodulatory agent in hospitalized patients with COVID-19 infection," Dr. Kalil said. "This is remarkable because it brings a new and effective treatment to persons affected by this terrible infection and it shows the critical importance of high-quality scientific studies in order to discover truly effective and safe new therapies."
Dr. Kalil said hospitalized patients with SARS-CoV-2 infection often develop an intense inflammatory and immune dysregulation that can lead to multiple organ dysfunction, including acute respiratory failure, shock and death.
He said many potential drugs and treatments have been tested in hospitalized patients with COVID-19, but few have shown benefits in rigorously done studies.
"Despite significant treatment advances with anti-viral drugs such as remdesivir, reducing the immune defense dysfunction-related mortality among hospitalized patients remains a crucial unmet need."
Baricitinib is in a class of drugs called immunomodulators, which modulate the immunological response that can become dysregulated during a severe COVID-19 infection.
Dr. Kalil said the results of the new and rigorous study are significant and clinically relevant for patients at UNMC and around the world, but as with any good study, there are limitations.
"The main limitation is that the new study didn’t detect the same speed of clinical recovery as previously demonstrated by the ACTT-2 study," Dr. Kalil said. "Considering the substantial clinical care differences among the study hospitals from many different countries, it is possible that this made it more difficult to detect clinical recovery differences. However, it is important to note that the magnitude of survival benefits provided by baricitinib was consistent and similar between both studies."
As a result of the baricitinib studies, Dr. Kalil said, the FDA issued an Emergency Authorization Use, and the drug is recommended as part of the standard treatment of hospitalized patients with COVID-19 by major American medical guidelines and is standard of care at Nebraska Medicine.
Great job Andre