Role of Baricitinib in moderate to severe COVID-19, a case control study from a South Indian tertiary care setting

Abstract

Background Baricitinib is a Janus kinase inhibitor with known anti-inflammatory effects and has been explored for beneficial outcomes in COVID-19 therapeutic management however with paucity of data on its effects on secondary infections and thrombosis. We aimed to assess the efficacy and all-cause mortality among moderate to severe COVID − 19 on a retrospective cohort of patients who received adjunct baricitinib as compared to a matched cohort who received standard of care for moderate to severe Covid 19. Methods The retrospective case control study conducted at 1300-bedded South Indian tertiary care centre from April to October 2021 recruited moderate to severe Covid patients receiving baricitinib therapy for at-least 72 hours into case group. Age and severity matched Covid patients who received standard of care without baricitinib were enrolled as control arm in 1:1 ratio. Data of the study groups on baseline characteristics, medications including antivirals, steroids, antibiotics and outcome measures were obtained. Study outcomes included all-cause mortality, daily clinical improvement assessed by ≥ 1-point improvement in WHO Ordinal Scale scores, multi-organ dysfunction syndrome, incidence of thrombotic events and secondary infections. Results Among the 527 moderate to severe COVID 19 patients in the study period, 75 patients each were recruited into case and control groups respectively. Mean age of case and control groups were 60.82 ± 13.03 and 61 ± 13.48 years respectively. 28-day mortality rate was 33.3%(n = 25) in the case group and 48%(n = 36) in the control group (p = 0.24, RR = 0.79, CI 95%). An absolute risk reduction of 16.75% was observed (NNT = 6) between the groups. All-cause mortality was 42.7%(n = 64) with 27(n = 36%) and 37(n = 49.3%) deaths in the case and control groups respectively(p = 0.09). Kaplan-Meier survival analysis revealed survival distributions to be significantly different between case and control groups (Log rank: p = 0.048). Clinical improvement assessed by decrease in WOS ≥ 1 was demonstrated to be higher in cases (n = 35,47%) than controls (n = 28,37.7%)(p = 0.32). Conclusion Our retrospective case control study revealed lower mortality and higher proportion of patients attaining clinical improvement as measured by at least one-point improvement of WHO ordinal scale in patients admitted with moderate to severe Covid 19, which did not attain statistical significance.