Recommended patient population for baricitinib therapy are patients that are hospitalized, aged >2 years old with lab confirmed moderate-severe SARS-CoV-2 infection requiring supplemental oxygen (high-flow oxygen or non-invasive mechanical ventilation)
Study Review:
For more detailed information, see the Clinical Trials/Comparative Efficacy section.
Based on evaluation of ACCT-2 trial and the COV-BARRIER studies, it is reasonable to consider baricitinib as a part of COVID treatment. ACTT-2 patients had faster time to recovery, that was statistically significant, however patient progression to death or mechanical ventilation by Day29 was not statistically significant. COV-BARRIER allowed patients to remain on standard of care treatment for COVID. The estimated proportion of patients who died or progressed to non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation was lower in patients treated with baricitinib (27.8%) compared to the placebo group (30.5%); however, this effect was not statistically significant (odds ratio 0.85, 95% CI 0.67-1.08; p=0.18). The 28 day all-cause mortality was 8% for baricitinib compared to 13% for placebo corresponding to a 38.2% reduction in mortality (hazard ratio [HR] 0.57, 95% CI 0.41-0.78; p=0.0018). The 60-day all-cause mortality was 10% for baricitinib and 15% for placebo (HR 0.62 [95% CI 0.47–0.83]; p=0.0050).
Furthermore, current studies do not show that adding baricitinib to standard of care increases the occurrence of major severe adverse events but monitoring of baseline lab values and for infection is still recommended.