Late-Stage COVID-19 Treatment Found ‘Significant’
The Adaptive COVID-19 Treatment Trial (ACTT-2), which included more than 1,000 patients to assess the efficacy and safety of a 4-mg dose of baricitinib plus remdesivir, versus remdesivir in hospitalized patients with COVID-19, reported statistically significant results.
Eli Lilly and Incyte announced on September 14, 2020, study investigators noted an approximately 1-day reduction in median recovery time for the overall patient population treated with baricitinib in combination with remdesivir, versus those treated with remdesivir (Veklury).
Recovery was defined as the participant being well enough for hospital discharge, meaning the participant either no longer required supplemental oxygen or ongoing medical care in the hospital, or was no longer hospitalized at Day 29.
The study also met a key secondary endpoint comparing patient outcomes at Day 15 using an ordinal 8-point scale ranging from fully recovered to death.
An independent data and safety monitoring board overseeing the double-blind, randomized controlled trial met regularly throughout the trial to review safety data. Additional analyses are ongoing to understand other clinical outcome data, including mortality and safety data. NIAID is expected to publish full details of the study in a peer-reviewed journal.
"We are pleased with these data from the ACTT-2 study," said Patrik Jonsson, Lilly senior vice president and president of Lilly Bio-Medicines, in a press statement. "There is an urgent need to identify COVID-19 treatments, and we will continue to work with NIAID to understand these data and next steps on baricitinib's role moving forward.”
“We appreciate NIAID selecting baricitinib for inclusion in this important study and the participants, investigators, and collaborators for the vital roles they played."
Based on the ACTT-2 data, Lilly plans to discuss the potential for emergency use authorization with the U.S. FDA and to explore similar measures with other regulatory agencies for baricitinib as a treatment of hospitalized patients with COVID-19. If authorized for use, Lilly will propose that baricitinib be available through commercial channels and will work with hospitals and governments to ensure patient access.
Lilly will continue to create an adequate supply for rheumatoid arthritis (RA) patients and ensure baricitinib remains available in countries where it is approved. In the U.S., baricitinib is approved for RA patients at a 2-mg daily dose; a EUA would potentially authorize a 4-mg dose for COVID-19.
Baricitinib, a JAK1/JAK2 inhibitor licensed to Lilly from Incyte and marketed as OLUMIANT®, is approved in more than 70 countries as a treatment for adults with moderately to severely active RA.
There are 4 known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases. OLUMIANT has greater inhibitory potency at JAK1, JAK2, and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.
Studying baricitinib in controlled trials is important in order to better characterize its potential benefits and understand the safety of its use as a COVID-19 treatment. The U.S. prescribing information for the approved use of baricitinib for RA includes boxed warnings regarding the use of baricitinib, including warnings about risk for developing blood clots and serious infections.
Lilly is also currently supporting ongoing multisite and single-site investigator-initiated trials in Europe and North America for hospitalized patients with COVID-19 infections.
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