Despite Infection Warning, Arthritis Drug Baricitinib Will Be Tested in Seriously Ill COVID-19 Patients

Baricitinib, a rheumatoid arthritis treatment drug manufactured by Eli Lilly, will be tested in a trial of patients who are seriously ill with COVID-19.

Eli Lilly is teaming up with the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health, to kick off this arm of the Adaptive COVID-19 Treatment Trial in the U.S. this month, with plans to eventually expand to other countries in Europe and Asia. The phase 2/3 trial will take place at the University of Colorado.

Lilly also announced the advancement of LY3127804, an investigational selective monoclonal antibody against Angiopoietin 2 (Ang2), to phase 2 testing in hospitalized COVID-19 patients with pneumonia at serious risk of developing acute respiratory distress syndrome.

“Lilly is moving at top speed and using all available resources to help fight this pandemic,” said Daniel Skovronsky, MD, PhD, Lilly’s chief scientific officer and president of Lilly Research Laboratories, in a press release. “Developing potential therapeutic medicines for COVID-19 is part of our vital and humanitarian mission. To be successful, we must combine resources, data and expertise, with government, academia and other companies. We look forward to seeing the results of baricitinib and anti-Ang2 clinical studies.”

Baricitinib, marketed as OLUMIANT, comes with a boxed warning that it carries a risk for serious infections, possibly because the drug affects the body’s immune system, according to Lilly. The warning states, “Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled.”

The most commonly reported serious infections associated with the drug are pneumonia, herpes zoster, and urinary tract infection.

However, the company said in a press release, “Given the inflammatory cascade seen in COVID-19, baricitinib’s anti-inflammatory activity has been hypothesized to have a potential beneficial effect in COVID-19 and warrants further study in patients with this infection.”

Correspondence published in The Lancet earlier this year theorized that baricitinib may effectively treat COVID-19, saying the drug is “predicted to reduce the ability of the virus to infect lung cells.”

Lilly said that it does not anticipate shortages of the drug will occur and said it is prepared to “create adequate supply to support both appropriate clinical and investigational use.”