tetano
Editor, Senior Moderator
Open Forum Infect Dis
. 2021 Nov 22;9(1)
fab588.
doi: 10.1093/ofid/ofab588. eCollection 2022 Jan.
Real-Life Effectiveness and Safety of Baricitinib as Adjunctive to Standard-of-Care Treatment in Hospitalized Patients With Severe Coronavirus Disease 2019
Nikolaos Tziolos[SUP] 1 [/SUP], Emmanouil Karofylakis[SUP] 1 [/SUP], Ioannis Grigoropoulos[SUP] 2 [/SUP], Pinelopi Kazakou[SUP] 1 [/SUP], Emmanouil Koullias[SUP] 2 [/SUP], Athina Savva[SUP] 1 [/SUP], Hariklia Kranidioti[SUP] 2 [/SUP], Aimilia Pelekanou[SUP] 1 [/SUP], Anna Boulouta[SUP] 1 [/SUP], Maria Pirounaki[SUP] 2 [/SUP], Sotirios Tsiodras[SUP] 1 [/SUP], Georgios Georgiopoulos[SUP] 2 [/SUP], Dimitrios T Boumpas[SUP] 1 [/SUP], Dimitra Kavatha[SUP] 1 [/SUP], Konstantinos Thomas[SUP] 1 [/SUP], Dimitrios Vassilopoulos[SUP] 2 [/SUP], Anastasia Antoniadou[SUP] 1 [/SUP]
Affiliations
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.
Keywords: COVID-19; ICU admission; baricitinib; dexamethasone; respiratory failure.
. 2021 Nov 22;9(1)
fab588.doi: 10.1093/ofid/ofab588. eCollection 2022 Jan.
Real-Life Effectiveness and Safety of Baricitinib as Adjunctive to Standard-of-Care Treatment in Hospitalized Patients With Severe Coronavirus Disease 2019
Nikolaos Tziolos[SUP] 1 [/SUP], Emmanouil Karofylakis[SUP] 1 [/SUP], Ioannis Grigoropoulos[SUP] 2 [/SUP], Pinelopi Kazakou[SUP] 1 [/SUP], Emmanouil Koullias[SUP] 2 [/SUP], Athina Savva[SUP] 1 [/SUP], Hariklia Kranidioti[SUP] 2 [/SUP], Aimilia Pelekanou[SUP] 1 [/SUP], Anna Boulouta[SUP] 1 [/SUP], Maria Pirounaki[SUP] 2 [/SUP], Sotirios Tsiodras[SUP] 1 [/SUP], Georgios Georgiopoulos[SUP] 2 [/SUP], Dimitrios T Boumpas[SUP] 1 [/SUP], Dimitra Kavatha[SUP] 1 [/SUP], Konstantinos Thomas[SUP] 1 [/SUP], Dimitrios Vassilopoulos[SUP] 2 [/SUP], Anastasia Antoniadou[SUP] 1 [/SUP]
Affiliations
- PMID: 34988257
- PMCID: PMC8711791
- DOI: 10.1093/ofid/ofab588
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.
Keywords: COVID-19; ICU admission; baricitinib; dexamethasone; respiratory failure.