Assessment of the Efficacy and Safety of Baricitinib Treatment in COVID-19 Patients: a real-world study

Abstract

Backgroud This retrospective cohort study assessed the real-world effectiveness and safety of Baricitinib (BAR) in hospitalized adult patients with severe or critical COVID-19 infection. Methods Utilizing real-world data. Propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) were applied to address imbalances in baseline characteristics. The Cox regression model was employed to assess the hazard ratio of treatment efficacy, utilizing both unmatched and matched datasets. The primary outcome focused on all-cause mortality among hospitalized patients. Results Among initially screened 2,731 adults with COVID-19 infection, 2,454 were included in this analysis (2,312 non-BAR, 142 BAR). In total, there were 39 deaths, with 36 occurring in the non-BAR group and 3 in the BAR group. Multivariable Cox regression analysis demonstrated that BAR was associated with a lower risk of all-cause mortality (hazard ratio [HR] = 0.24, 95% confidence interval [CI] 0.07–0.83, p < 0.024). Analysis based on the PSM datasets consistently showed that BAR reduced the risk of all-cause mortality in 1:1 (HR = 0.10, 95% CI 0.01–0.86), 1:2 (HR = 0.11, 95% CI 0.01–0.88, p = 0.038), and 1:3 (HR = 0.08, 95% CI 0.01–0.66) matched databases. Analysis based on the IPTW dataset also indicated that BAR reduced the risk of all-cause mortality (HR = 0.06, 95% CI 0.01–0.41, p = 0.004). The incidence of Venous Thrombosis Events (VTE) was higher in the BAR group compared to the non-BAR group (11.27% vs. 6.14%, p = 0.016). Conclusions BAR demonstrated effectiveness in reducing all-cause mortality in hospitalized COVID-19 patients, with an acceptable safety profile.