Initial data were announced from the ACTT-2 study evaluating the efficacy and safety of baricitinib, a Janus kinase inhibitor, in combination with the investigational antiviral remdesivir, in hospitalized patients with coronavirus disease 2019 (COVID-19). The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
The ACTT-2 study began on May 8 and included more than 1000 patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection who had either a need for supplemental oxygen, abnormal chest X-ray, or illness requiring mechanical ventilation. Patients were randomized to receive oral baricitinib 4mg (for up to 14 days of treatment) plus intravenous (IV) remdesivir (for up to 10 days of treatment) or placebo plus IV remdesivir; if necessary, baricitinib was crushed and given through a nasogastric tube.
The primary end point of the study was time to recovery, defined as a patient no longer requiring supplemental oxygen or ongoing medical care in the hospital, or was no longer hospitalized at day 29. Patient outcomes at day 15 were also evaluated as a key secondary outcome measure using an ordinal 8-point scale ranging from fully recovered to death.
Findings from the study showed that treatment with baricitinib in combination with remdesivir led to a statistically significant reduction in median recovery time (approximately 1 day) compared with remdesivir alone. Moreover, the combination therapy met the secondary end point at day 15.
Safety data were reviewed regularly throughout the study by an independent data and safety monitoring board. Additional analyses are ongoing for other clinical outcome data, including mortality and safety data. Full study details are expected to be published by the NIAID in a peer-reviewed journal.
“These findings from ACTT-2 are another step as we improve the care of these patients,” said Andre Kalil, MD, professor at the University of Nebraska Medical Center and a principal investigator of the ACTT studies. “These data may help us to better understand baricitinib’s potential role in the treatment of COVID-19.”
Baricitinib is currently marketed under the brand name Olumiant by Eli Lilly for the treatment of rheumatoid arthritis (RA). In a statement, the Company indicated its plans to potentially seek the Food and Drug Administration’s Emergency Use Authorization (EUA) for baricitinib as a treatment for hospitalized patients with COVID-19. The EUA may potentially authorize the use of a 4mg dose for COVID-19 patients; currently a 2mg dose is approved for RA treatment.
Baricitinib in combination with remdesivir reduces time to recovery in hospitalized patients with COVID-19 in NIAID-sponsored ACTT-2 trial. https://www.prnewswire.com/news-releases/baricitinib-in-combination-with-remdesivir-reduces-time-to-recovery-in-hospitalized-patients-with-covid-19-in-niaid-sponsored-actt-2-trial-301129865.html. Accessed September 14, 2020.