ACTT-2 trial: Baricitinib has significant effect on recovery time in COVID-19 patients requiring Oxygen
Baricitinib in combination with Remdesivir has reduced time to recovery and improved clinical outcomes for patients with COVID-19 infection compared with Remdesivir.
This finding was part of additional efficacy and safety data from ACTT-2 ( Adaptive COVID-19 Treatment Trial ) sponsored by the National Institute of Allergy and Infectious Diseases ( NIAID ), part of the National Institutes of Health ( NIH ).
The largest benefits were observed in patients requiring supplemental Oxygen ( grade 5 on the eight-point ordinal scale ) and those who required high-flow Oxygen / non-invasive ventilation ( grade 6 ) at baseline.
As previously reported, ACTT-2 achieved the primary endpoint, demonstrating that the overall patient population treated with Baricitinib in combination with Remdesivir has improved the median time to recovery from 8 to 7 days in comparison to Remdesivir, a 12.5% improvement ( incidence rate ratio: 1.16; 95% CI: 1.01, 1.32; p=0.04 ).
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 pre-specified secondary endpoint. Using the ordinal scale that ranged from recovered to death, the odds of improvement in clinical status at day 15 were 30% greater in patients being treated with Baricitinib in combination with Remdesivir compared with Remdesivir ( odds ratio, OR 1.3; 95% CI: 1.0, 1.6; p=0.04 ).
A numerical decrease in death ( 35% ) through day 29 was observed in patients treated with Baricitinib plus Remdesivir compared to Remdesivir in the overall population ( 5.1% vs 7.8%, respectively; hazard ratio, HR 0.65; 95% CI: 0.39, 1.08; p=0.09 ).
The reduction in mortality was more pronounced for patients receiving Oxygen, as mortality at day 29 was 60% lower and 43% lower for the OS5 and OS6 subgroups respectively.
No new safety signals were observed for Baricitinib-treated patients in this study.
Baricitinib ( Olumiant ) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor ( TNF ) antagonist therapies. ( Xagena )
Source: Lilly, 2020