Real-Life Effectiveness and Safety of Baricitinib as Adjunctive to Standard-of-Care Treatment in Hospitalized Patients With Severe Coronavirus Disease 2019

Abstract

Background Therapeutic options for hospitalized patients with severe coronavirus disease 2019 (sCOVID-19) are limited. Preliminary data have shown promising results with baricitinib, but real-life experience is lacking. We assessed the safety and effectiveness of add-on baricitinib to standard-of-care (SOC) including dexamethasone in hospitalized patients with sCOVID-19. Methods This study is a 2-center, observational, retrospective cohort study of patients with sCOVID-19, comparing outcomes and serious events between patients treated with SOC versus those treated with SOC and baricitinib combination. Results We included 369 patients with sCOVID-19 (males 66.1%; mean age 65.2 years; median symptom duration 6 days). The SOC was administered in 47.7% and combination in 52.3%. Patients treated with the combination reached the composite outcome (intensive care unit [ICU] admission or death) less frequently compared with SOC (22.3% vs 36.9%, P = .002). Mortality rate was lower with the combination in the total cohort (14.7% vs 26.6%, P = .005), and ICU admission was lower in patients with severe acute respiratory distress syndrome (29.7% vs 44.8%, P = .03). By multivariable analysis, age (odds ratio [OR] = 1.82, 95% confidence interval [CI] = 1.36–2.44, per 10-year increase), partial pressure of oxygen/fraction of inspired oxygen ratio (OR = 0.60, 95% CI = .52–0.68, per 10 units increase), and use of high-flow nasal cannula (OR = 0.34; 95% CI, .16–0.74) were associated with the composite outcome, whereas baricitinib use was marginally not associated with the composite outcome (OR = 0.52; 95% CI, .26–1.03). However, baricitinib use was found to be significant after inverse-probability weighted regression (OR = 0.93; 95% CI, .87–0.99). No difference in serious events was noted between treatment groups. Conclusions In real-life settings, addition of baricitinib to SOC in patients hospitalized with sCOVID-19 is associated with decreased mortality without concerning safety signals.

A review of clinical efficacy data supporting emergency use authorization for COVID‐19 therapeutics and lessons for future pandemics

“…Further data from the pre‐EUA COV‐BARRIER study of hospitalized patients showed baricitinib in addition to standard of care (SOC) led to a 38.2% relative reduction in 28‐day all‐cause mortality ( p = 0.0018). 67 Similarly, studies of baricitinib in combination with SOC, remdesivir, and dexamethasone, respectively, found decreased ICU admissions (22.3% vs. 36.9%, p = 0.002) 68 and invasive mechanical ventilation was avoided in 90% of patients 69 (Table S2.2 ).…”

Insights into CD24 and Exosome Physiology and Potential Role in View of Recent Advances in COVID-19 Therapeutics: A Narrative Review

“…Other important members of this category are the Janus kinase inhibitors [ 63 , 64 ]. Among them, baricitinib showed promising results in hospitalized patients, especially those receiving high flow oxygen or noninvasive ventilation [ 65 , 66 ].…”

Baricitinib in the Treatment of COVID-19

“…A retrospective cohort study conducted by Tziolos et al [43] in Athens, Greece assessed the role of baricitinib (4 mg/day for 14 days or discharge) as an add-on therapy to the standard of care in 369 hospitalized patients with COVID-19 which included dexamethasone (6 mg/day), remdesivir (200 mg/day on day 1 followed by 100 mg/day for subsequent days) and low molecular weight heparin for thromboprophylaxis apart from antimicrobials as per the physicians discretion. The standard of care regimen was provided to 47.7% of the patients and the remaining received baricitinib as an add-on.…”