Rheumatoid Arthritis Drug Helps Reduce Hospitalized COVID-19 Mortality

Vanderbilt University Medical Center issued a press statement today disclosing that hospitalized patients with COVID-19 who received the rheumatoid arthritis drug baricitinib (Olumiant), in combination with the standard of care, including corticosteroids, died less often than those receiving only the standard of care.

This study was published in The Lancet Respiratory Medicine on September 1, 2021, 

Principal investigator professor E. Wesley Ely, MD, MPH, stated in a press release, “Hospitalized patients with the SARS-CoV-2 infection (which causes COVID-19), often develop an intense hyperinflammatory state that can lead to dysfunction of multiple organs, including acute respiratory distress syndrome, septic shock, and death."

“Despite treatment advances with remdesivir, dexamethasone, and tocilizumab, reducing mortality among hospitalized patients remains a crucial unmet need."

“It is increasingly evident that treatment with baricitinib may help prevent death in some of the most critically ill COVID-19 patients and that this class of medications represents an important treatment advance for this vulnerable group of patients in the constantly evolving pandemic,” Ely said.

Baricitinib is an inhibitor of Janus kinases (JAK) 1 and 2, which “calms down your immune system,” Ely said.

“A huge computer analysis was done early in the pandemic, trying to figure out what drugs were the best to repurpose for COVID anti-viral effects."

“Anti-inflammatory effects are also important for sicker, hospitalized patients."

"JAK inhibitors selectively hit signaling via the JAK receptors, blocking transduction pathways that lead to inflammation,” he said. “Drugs like baricitinib stop multiple pathways of the inflammatory cascade to hold down the inflammation that COVID would usually start.” 

Ely added that the COV-BARRIER study data show that the sicker patients were at the time of enrollment, the greater the reduction in mortality.

Data from a COV-BARRIER addendum, which included hospitalized patients with COVID-19 on mechanical ventilation and ECMO (extracorporeal membrane oxygenation) at the time of enrollment, showed an even greater improvement in survival in the group given baricitinib, Ely said.

COV-BARRIER is a phase 3, double-blind, randomized, placebo-controlled trial; enrolled participants from 101 centers across 12 countries in Asia, Europe, North America, and South America.

One surprising finding in this study is that although the drug reduces death, some patients still progress in their severity of illness.

“When COVID hits your body, and the train is leaving the station, we did not find that this medication stopped the progress of the disease process entirely,” Ely said.

“If you were already sick, you continued to get a little sicker. The train keeps going a little bit, but adding baricitinib keeps you from going over the cliff into death.” 

Baricitinib was identified in February 2020 as a potential intervention for the treatment of COVID-19.

The U.S. FDA granted Emergency Use Authorization (EUA) to the drug in November 2020, to be given in combination with the drug remdesivir, then amended the EUA later to allow baricitinib to be given with or without remdesivir.

Indiana-based Eli Lilly and Company, the producer of Baricitinib, is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. In addition, in May 2021, Lilly announced an initial donation of 400,000 baricitinib tablets to the Indian government for eligible hospitalized COVID-19 patients in India.

Olumiant (Baricitinib) is a Janus kinase inhibitor that blocks a specific family of enzymes, interfering with the pathway leading to inflammation. Its active substance, baricitinib, blocks the action of Janus kinases that play an important role in immune processes that lead to inflammation.

Note: Lilly funded this phase 3 study, and no research conflict of interest was disclosed.