Ruxolitinib versus dexamethasone in hospitalized adults with COVID-19: multicenter matched cohort study

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 failu...

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Veröffentlicht in:	BMC infectious diseases Jg. 21; H. 1; S. 1277 - 9
Hauptverfasser:	Stanevich, O. V., Fomina, D. S., Bakulin, I. G., Galeev, S. I., Bakin, E. A., Belash, V. A., Kulikov, A. N., Lebedeva, A. A., Lioznov, D. A., Polushin, Yu. S., Shlyk, I. V., Vorobyev, E. A., Vorobyeva, S. V., Surovceva, T. V., Bakulina, N. V., Lysenko, M. A., Moiseev, I. S.
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	London BioMed Central 22.12.2021 BioMed Central Ltd Springer Nature B.V BMC
Schlagworte:	Adult Analysis Anti-cytokine therapy Cardiovascular disease Care and treatment Clinical trials Cohort analysis Cohort Studies Coronaviruses COVID-19 COVID-19 diagnostic tests COVID-19 Drug Treatment Cytokines Dexamethasone Dexamethasone - therapeutic use Dosage and administration Drug dosages Enzyme inhibitors Fatalities Fever Health services Hospital patients Hospitalization Humans Illnesses Infections Infectious Diseases Inhibitor drugs Internal Medicine Janus kinase Kinases Laboratories Medical Microbiology Medicine Medicine & Public Health Mortality Nitriles Oxygen Parasitology Patients Pyrazoles Pyrimidines Research Article Respiratory diseases Respiratory failure Ruxolitinib SARS-CoV-2 Severe acute respiratory syndrome Severe acute respiratory syndrome coronavirus 2 Steroids Subgroups Therapy Thrombocytopenia Treatment Outcome Tropical Medicine Viral diseases Russia COVID-19 Ruxolitinib SARS-CoV-2 Dexamethasone Anti-cytokine therapy
ISSN:	1471-2334, 1471-2334
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Zusammenfassung:	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
Bibliographie:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23
ISSN:	1471-2334 1471-2334
DOI:	10.1186/s12879-021-06982-z