Addition of Baricitinib to Usual Therapeutic Regimen in Hospitalized Patients with Severe Covid-19: A Prospective Cohort Study

Abstract

Background-Purpose: The ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has affected our everyday lives for the last three years, leading to in numerous patient hospitalizations all over the world and a plethora of therapeutic interventions being implemented in an effort to combat the disease. Baricitinib is an oral selective Janus kinase (JAK) inhibitor approved for the treatment of rheumatic disease that was hypothesized to bear positive effect on the more severe forms of the novel coronavirus disease 2019 (COVID-19) based on its antiviral and anti-cytokine properties. The purpose of the current prospective cohort study was to study the effect of adding baricitinib to the usual drug regimen of patients hospitalized with severe COVID-19 in the infectious disease unit of a third-level hospital. Patients-Methods: The current prospective cohort study was conducted at the Infectious Disease Unit of the 401 General Military Hospital of Athens, recruiting a total of 74 patients who were hospitalized with severe COVID-19 based on the COVID-19 severity index. Relevant demographic data, personal and family medical history and turnout of the cases was documented. Laboratory examinations as well as arterial blood gases (ABGs) were recorded and analysed both upon admission and discharge of the patients. An oral dose of 4 mg baricitinib daily (or an adjusted dose of 2 mg daily in cases of renal disease) was added to the usual therapeutic regimen of the patients. Results: For the purpose of the current study, we recruited 74 patients (male sex 81.1%, mean age 52,8±17,2 years old). Six patients (8.1%) were fully vaccinated and 32 patients (43.2%) presented at least one comorbidity (chronic cardiovascular disease, chronic liver disease, chronic kidney disease, immunosuppression, diabetes mellitus or obesity). Mean hospitalization time reached 10.9 ± 5.8 days while mean time of baricitinib administration was 9.2 ± 2.9 days. Regarding outcomes of hospitalizations, 12 patients (16.2%) needed to be transferred to the intensive care unit (ICU), with 6 of them finally succumbing to the disease. Administration of the drug led to a statistically significant drop of inflammatory markers as well as a statistically significant improvement of respiratory function as evaluated by ABGs. No serious adverse events were recorded. Conclusion: The addition of oral baricitinib to the standard drug regimen of hospitalized patients with severe COVID-19 proved safe and efficacious in managing symptoms of the disease, leading to swift clinical complaint and laboratory profile improvements.