Early data from a phase 3 trial showed that baricitinib combined with remdesivir improved recovery in patients hospitalized with COVID-19 compared with remdesivir alone.
Baricitinib (Olumiant; Eli Lilly) in combination with remdesivir reduced time to recovery in hospitalized patients with coronavirus disease 2019 (COVID-19) when compared with remdesivir, according to initial data from the Adaptive COVID-19 Treatment Trial (ACTT-2).
The phase 3 ACTT-2 trial, which is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), included more than 1000 patients to assess the efficacy and safety of a 4-mg dose of JAK1/JAK2 inhibitor baricitinib plus antiviral therapy remdesivir versus remdesivir alone in hospitalized patients with COVID-19.
According to the result, study investigators determined an approximate 1-day reduction in median recovery time for the overall patient population treated with baricitinib plus remdesivir versus those treated with remdesivir alone, which was statistically significant. Recovery was defined as the participant being well enough for hospital discharge, meaning the participant either no longer required supplement oxygen or ongoing medical care in the hospital or was no longer hospitalized at day 29. The key secondary end point was also met, which compared patient outcomes at day 15 using an ordinal 18-point scale ranging from fully recovered to death.
An independent data and safety monitoring board met regularly throughout the trial to review safety data. Additional analyses are ongoing in order to understand other clinical outcome data, including mortality and safety data. NIAID is expected to release full details of the study in a peer-reviewed journal.
“These findings from ACTT-2 are another step as we improve the care of these patients,” principal investigator Andre Kalil, MD, professor at the University of Nebraska Medical Center, said in a statement. “These data may help us better understand baricitinib’s potential role in the treatment of COVID-19.”
Based on this data, Eli Lilly plans to discuss the potential for emergency use authorization with the FDA.
Baricitinib is currently indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). The US prescribing information for the approved use of baricitinib includes boxed warnings regarding its use, including warnings about the risk for developing blood clots and serious infections.
In a statement, Lilly said it will continue to create adequate supply for patients with RA an ensure baricitinib remains available in countries where it is approved.
Baricitinib in Combination with Remdesivir Reduces Time to Recovery in Hospitalized Patients with COVID-19 in NIAID-Sponsored ACTT-2 Trial. News release. Eli Lilly; September 14, 2020. Accessed September 15, 2020. https://investor.lilly.com/news-releases/news-release-details/baricitinib-combination-remdesivir-reduces-time-recovery