New ACTT-2 findings show notable promise for a combination of the rheumatoid arthritis drug and the EUA-approved antiviral therapy.
Combination baricitinib and remdesivir provided a reduction in time to recovery among patients hospitalized with coronavirus 2019 (COVID-19), according to initial data from the Adaptive COVID-19 Treatment Trial (ACTT-2).
In new findings from the double-blind, randomized, controlled trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), investigators reported a combination of 4mg JAK1/JAK2 inhibitor baricitinib (Olumiant) plus antiviral therapy remdesivir resulted in a statistically significant reduction of 1 day in median recovery time for COVID-19 hospitalization versus lone remdesivir.
More commonly used for the treatment of adults with moderately to severely active rheumatoid arthritis, baricitinib’s prescription use in the US also includes boxed warnings regarding patient risk for developing blood clots and serious infections. However, it is among the more promising inflammation-targeting therapies being considered for severe COVID-19 treatment.
Lilly Bio-Medicine now intends to consider submission for an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) based on the ACTT-2 findings, as well future clinical assessments of baricitinib in hospitalized COVID-19 patients.
The company is currently planning to review this new data against preliminary findings from its phase 3 COV-BARRIER trial—a randomized, double-blind, placebo-controlled trial comparing baricitinib versus background therapy in hospitalized patients across the US, Europe, Asia, and Latin America, initiated in June.
In ACTT-2, investigators defined COVID-19 recovery as a patient recovering well enough to be discharged from the hospital—or, no longer requiring supplemental oxygen nor ongoing hospital medical care. Recovery was also distinguished by those no longer hospitalized after 29 days.
Baricitinib plus remdesivir also met a key secondary endpoint in 15-day improvement on the ordinal eight-point scale gauging patient status from fully recovered to death, versus lone remdesivir.
The study was overseen by an independent data and safety monitoring board, and additional analyses are continuing to properly interpret all of the clinical outcome data, including mortality and safety findings, as how they pertain to current COVID-19 care understanding. The NIAID is anticipated to fully publish the ACTT-2 findings in a peer-reviewed journal.
In the meantime, principal ACTT study program investigator Andre Kalil, MD, professor at the University of Nebraska Medical Center, expressed hope for what these findings deliver immediately—as well as what they could imply for future hospital COVID-19 care.
“These findings from ACTT-2 are another step as we improve the care of these patients," Kalil said in a statement. "These data may help us to better understand baricitinib's potential role in the treatment of COVID-19.