The Food and Drug Administration (FDA) has given full approval to Olumiant®(baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Previously, the treatment had only been authorized for emergency use.
The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 ACTT-2 (ClinicalTrials.gov Identifier: NCT04401579) and COV-BARRIER (ClinicalTrials.gov Identifier: NCT04421027) studies, which evaluated the efficacy and safety of baricitinib 4mg in hospitalized adults with COVID-19. The ACTT-2 study compared baricitinib plus remdesivir with placebo plus remdesivir. The COV-BARRIER study compared baricitinib with placebo.
Results from the ACTT-2 study showed that for the overall population, the median time to recovery (defined as discharged from hospital or hospitalized but not requiring supplemental oxygen or ongoing medical care) was 7 days for baricitinib plus remdesivir and 8 days for placebo plus remdesivir (hazard ratio [HR], 1.16; 95% CI, 1.01-1.33; P =.035). Patients in the baricitinib plus remdesivir arm also achieved a better clinical status (according to an 8-point ordinal scale) at day 15 compared with those treated with placebo plus remdesivir (odds ratio, 1.26; 95% CI, 1.01-1.57; P =.044).
Among patients treated with baricitinib plus remdesivir, 23% died or progressed to noninvasive ventilation/high-flow oxygen or invasive mechanical ventilation by day 29 compared with 28% of those who received placebo plus remdesivir (odds ratio, 0.74; 95% CI, 0.56-0.99; P =.039). The proportion of patients who died by day 29 was 4.7% in the baricitinib plus remdesivir arm and 7.1% in the placebo plus remdesivir arm (Kaplan Meier estimated difference in day 29 probability of mortality: -2.6%; [95% CI, -5.8, 0.5]; HR, 0.65 [95% CI, 0.39-1.09]).
In the COV-BARRIER study, results showed that the estimated proportion of patients who died or progressed to noninvasive ventilation/high-flow or invasive mechanical ventilation (primary endpoint) was lower in the baricitinib arm compared with the placebo arm (27.8% vs 30.5%), but this effect was not statistically significant (odds ratio, 0.85; 95% CI, 0.67-1.08; P =.180).
The proportion of patients who died by day 28 (key secondary endpoint) was 8.1% for the baricitinib arm and 13.3% for the placebo arm (estimated difference in day 28 probability of mortality, -4.9% [95% CI, -8.0, -1.9]; HR, 0.56 [95% CI, 0.41-0.77]).
According to a prespecified exploratory analysis of the COV-BARRIER study, the proportion of patients requiring invasive mechanical ventilation or ECMO at baseline who died by day 28 was 39.2% for the baricitinib arm and 58% for the placebo arm (estimated difference in day 28 risk of mortality, -18.8% [95% CI, -36.3, 0.6]; HR, 0.54 [95% CI, 0.31-0.96]).
The recommended dosage of Olumiant is 4mg orally once daily for 14 days or until hospital discharge, whichever comes first.
Baricitinib will remain authorized for emergency use for the treatment of COVID-19 in hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or ECMO.
Olumiant, a Janus kinase (JAK) inhibitor, is also indicated for the treatment of rheumatoid arthritis.
- FDA approves Lilly and Incyte’s Olumiant®(baricitinib) for the treatment of certain hospitalized patients with COVID-19. News release. Eli Lilly and Company and Incyte. Accessed May 11, 2022. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lilly-and-incytes-olumiantr-baricitinib-treatment
- Olumiant. Package insert. Eli Lilly and Company; 2022. Accessed May 11, 2022. https://pi.lilly.com/us/olumiant-uspi.pdf?s=pi