Ruxolitinib versus dexamethasone in hospitalized adults with COVID-19: multicenter matched cohort study.
Autor: | Stanevich OV; Pavlov University, Saint-Petersburg, Russian Federation. oksana.stanevich@gmail.com., Fomina DS; State City Hospital №52, Moscow, Russian Federation.; First Sechenov Moscow State Medical University of the Ministry of Healthcare of the Russian Federation, Moscow, Russia., Bakulin IG; North-Western State Medical University Named After I.I. Mechnikov, Saint-Petersburg, Russian Federation., Galeev SI; State City Hospital №20, Saint-Petersburg, Russian Federation., Bakin EA; Pavlov University, Saint-Petersburg, Russian Federation., Belash VA; Pavlov University, Saint-Petersburg, Russian Federation., Kulikov AN; Pavlov University, Saint-Petersburg, Russian Federation., Lebedeva AA; Pavlov University, Saint-Petersburg, Russian Federation., Lioznov DA; Pavlov University, Saint-Petersburg, Russian Federation., Polushin YS; Pavlov University, Saint-Petersburg, Russian Federation., Shlyk IV; Pavlov University, Saint-Petersburg, Russian Federation., Vorobyev EA; Pavlov University, Saint-Petersburg, Russian Federation., Vorobyeva SV; Pavlov University, Saint-Petersburg, Russian Federation., Surovceva TV; State City Hospital №20, Saint-Petersburg, Russian Federation., Bakulina NV; North-Western State Medical University Named After I.I. Mechnikov, Saint-Petersburg, Russian Federation., Lysenko MA; State City Hospital №52, Moscow, Russian Federation.; Pirogov Russian National Research Medical University (RNRMU) of the Ministry of Healthcare of the Russian Federation, Moscow, Russia., Moiseev IS; Pavlov University, Saint-Petersburg, Russian Federation. |
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Jazyk: | angličtina |
Zdroj: | BMC infectious diseases [BMC Infect Dis] 2021 Dec 22; Vol. 21 (1), pp. 1277. Date of Electronic Publication: 2021 Dec 22. |
DOI: | 10.1186/s12879-021-06982-z |
Abstrakt: | 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. (© 2021. The Author(s).) |
Databáze: | MEDLINE |
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