tetano
Editor, Senior Moderator
BMC Infect Dis
. 2021 Dec 22;21(1):1277.
doi: 10.1186/s12879-021-06982-z.
Ruxolitinib versus dexamethasone in hospitalized adults with COVID-19: multicenter matched cohort study
O V Stanevich[SUP] 1 [/SUP], D S Fomina[SUP] 2 3 [/SUP], I G Bakulin[SUP] 4 [/SUP], S I Galeev[SUP] 5 [/SUP], E A Bakin[SUP] 6 [/SUP], V A Belash[SUP] 6 [/SUP], A N Kulikov[SUP] 6 [/SUP], A A Lebedeva[SUP] 6 [/SUP], D A Lioznov[SUP] 6 [/SUP], Yu S Polushin[SUP] 6 [/SUP], I V Shlyk[SUP] 6 [/SUP], E A Vorobyev[SUP] 6 [/SUP], S V Vorobyeva[SUP] 6 [/SUP], T V Surovceva[SUP] 5 [/SUP], N V Bakulina[SUP] 4 [/SUP], M A Lysenko[SUP] 2 7 [/SUP], I S Moiseev[SUP] 6 [/SUP]
Affiliations
Abstract
Background: Several anti-cytokine therapies were tested in the randomized trials in hospitalized patients with severe acute respiratory syndrome coronavirus 2 infection (COVID-19). Previously, dexamethasone demonstrated a reduction of case-fatality rate in hospitalized patients with respiratory failure. In this matched control study we compared dexamethasone to a Janus kinase inhibitor, ruxolitinib.
Methods: The matched cohort study included 146 hospitalized patients with COVID-19 and oxygen support requirement. The control group was selected 1:1 from 1355 dexamethasone-treated patients and was matched by main clinical and laboratory parameters predicting survival. Recruitment period was April 7, 2020 through September 9, 2020.
Results: Ruxolitinib treatment in the general cohort of patients was associated with case-fatality rate similar to dexamethasone treatment: 9.6% (95% CI [4.6-14.6%]) vs 13.0% (95% CI [7.5-18.5%]) respectively (p = 0.35, OR = 0.71, 95% CI [0.31-1.57]). Median time to discharge without oxygen support requirement was also not different between these groups: 13 vs. 11 days (p = 0.13). Subgroup analysis without adjustment for multiple comparisons demonstrated a reduced case-fatality rate in ruxolitnib-treated patients with a high fever (≥ 38.5 °C) (OR 0.33, 95% CI [0.11-1.00]). Except higher incidence of grade 1 thrombocytopenia (37% vs 23%, p = 0.042), ruxolitinib therapy was associated with a better safety profile due to a reduced rate of severe cardiovascular adverse events (6.8% vs 15%, p = 0.025). For 32 patients from ruxolitinib group (21.9%) with ongoing progression of respiratory failure after 72 h of treatment, additional anti-cytokine therapy was prescribed (8-16 mg dexamethasone).
Conclusions: Ruxolitinib may be an alternative initial anti-cytokine therapy with comparable effectiveness in patients with potential risks of steroid administration. Patients with a high fever (≥ 38.5 °C) at admission may potentially benefit from ruxolitinib administration. Trial registration The Ruxolitinib Managed Access Program (MAP) for Patients Diagnosed With Severe/Very Severe COVID-19 Illness NCT04337359, CINC424A2001M, registered April, 7, 2020. First participant was recruited after registration date.
Keywords: Anti-cytokine therapy; COVID-19; Dexamethasone; Ruxolitinib; SARS-CoV-2.
. 2021 Dec 22;21(1):1277.
doi: 10.1186/s12879-021-06982-z.
Ruxolitinib versus dexamethasone in hospitalized adults with COVID-19: multicenter matched cohort study
O V Stanevich[SUP] 1 [/SUP], D S Fomina[SUP] 2 3 [/SUP], I G Bakulin[SUP] 4 [/SUP], S I Galeev[SUP] 5 [/SUP], E A Bakin[SUP] 6 [/SUP], V A Belash[SUP] 6 [/SUP], A N Kulikov[SUP] 6 [/SUP], A A Lebedeva[SUP] 6 [/SUP], D A Lioznov[SUP] 6 [/SUP], Yu S Polushin[SUP] 6 [/SUP], I V Shlyk[SUP] 6 [/SUP], E A Vorobyev[SUP] 6 [/SUP], S V Vorobyeva[SUP] 6 [/SUP], T V Surovceva[SUP] 5 [/SUP], N V Bakulina[SUP] 4 [/SUP], M A Lysenko[SUP] 2 7 [/SUP], I S Moiseev[SUP] 6 [/SUP]
Affiliations
- PMID: 34937556
- DOI: 10.1186/s12879-021-06982-z
Abstract
Background: Several anti-cytokine therapies were tested in the randomized trials in hospitalized patients with severe acute respiratory syndrome coronavirus 2 infection (COVID-19). Previously, dexamethasone demonstrated a reduction of case-fatality rate in hospitalized patients with respiratory failure. In this matched control study we compared dexamethasone to a Janus kinase inhibitor, ruxolitinib.
Methods: The matched cohort study included 146 hospitalized patients with COVID-19 and oxygen support requirement. The control group was selected 1:1 from 1355 dexamethasone-treated patients and was matched by main clinical and laboratory parameters predicting survival. Recruitment period was April 7, 2020 through September 9, 2020.
Results: Ruxolitinib treatment in the general cohort of patients was associated with case-fatality rate similar to dexamethasone treatment: 9.6% (95% CI [4.6-14.6%]) vs 13.0% (95% CI [7.5-18.5%]) respectively (p = 0.35, OR = 0.71, 95% CI [0.31-1.57]). Median time to discharge without oxygen support requirement was also not different between these groups: 13 vs. 11 days (p = 0.13). Subgroup analysis without adjustment for multiple comparisons demonstrated a reduced case-fatality rate in ruxolitnib-treated patients with a high fever (≥ 38.5 °C) (OR 0.33, 95% CI [0.11-1.00]). Except higher incidence of grade 1 thrombocytopenia (37% vs 23%, p = 0.042), ruxolitinib therapy was associated with a better safety profile due to a reduced rate of severe cardiovascular adverse events (6.8% vs 15%, p = 0.025). For 32 patients from ruxolitinib group (21.9%) with ongoing progression of respiratory failure after 72 h of treatment, additional anti-cytokine therapy was prescribed (8-16 mg dexamethasone).
Conclusions: Ruxolitinib may be an alternative initial anti-cytokine therapy with comparable effectiveness in patients with potential risks of steroid administration. Patients with a high fever (≥ 38.5 °C) at admission may potentially benefit from ruxolitinib administration. Trial registration The Ruxolitinib Managed Access Program (MAP) for Patients Diagnosed With Severe/Very Severe COVID-19 Illness NCT04337359, CINC424A2001M, registered April, 7, 2020. First participant was recruited after registration date.
Keywords: Anti-cytokine therapy; COVID-19; Dexamethasone; Ruxolitinib; SARS-CoV-2.