uzmj0w6

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?:abstract	Background Immunomodulants have been proposed to mitigate SARS-Cov-2-induced cytokine storm, which drives acute respiratory distress syndrome in COVID-19. Objective To determine efficacy and safety of the association of IL-1 receptor antagonist anakinra plus methylprednisolone in severe COVID-19 pneumonia with hyperinflammation. Methods Secondary analysis of prospective observational cohort studies at an Italian tertiary health-care facility. COVID-19 patients consecutively hospitalized (02/25/2020 to 03/30/2020), with hyperinflammation (ferritin ≥1000ng/mL and/or C-reactive protein >10mg/dL) and respiratory failure (oxygen therapy from 0.4 FiO2 Venturi mask to invasive mechanical ventilation) were evaluated to investigate the effect of high-dose anakinra plus methylprednisolone on survival. Patients were followed from study inclusion to day 28 or death. Crude and adjusted (sex, age, baseline PaO2:FiO2 ratio, Charlson Index, baseline mechanical ventilation, hospitalization to inclusion lapse) risks were calculated (Cox proportional regression model). Results 120 COVID-19 patients with hyperinflammation (median age 62 years, 80.0% males, median PaO2:FiO2 ratio 151, 32.5% on mechanical ventilation) were evaluated. Of these, 65 were treated with anakinra and methylprednisolone and 55 were untreated historical controls. At 28 days, mortality was 13.9% in treated patients and 35.6% in controls (Kaplan-Meier plots, p=0.005). Unadjusted and adjusted risk of death was significantly lower for treated patients compared to controls (HR 0.33 (95%CI 0.15-0.74), p=0.007 and HR 0.18 (95%CI 0.07-0.50), p=0.001, respectively). No significant differences in bloodstream infections or laboratory alterations were registered. Conclusions Treatment with anakinra plus methylprednisolone may be a valid therapeutic option in COVID-19 patients with hyperinflammation and respiratory failure, also on mechanical ventilation. Randomized, controlled trials including use of either agent alone are needed to confirm these results.
is ?:annotates of	<https://research.tib.eu/covid-19/entity/7uzmj0w6_hasAnnotation_C0027627> <https://research.tib.eu/covid-19/entity/7uzmj0w6_hasAnnotation_C5203676>
?:creator	<https://research.tib.eu/covid-19/entity/Bozzi%2C_Giorgio%3B_Mangioni%2C_Davide%3B_Minoia%2C_Francesca%3B_Aliberti%2C_Stefano%3B_Grasselli%2C_Giacomo%3B_Barbetta%2C_Laura%3B_Castelli%2C_Valeria%3B_Palomba%2C_Emanuele%3B_Alagna%2C_Laura%3B_Lombardi%2C_Andrea%3B_Ungaro%2C_Riccardo%3B_Agostoni%2C_Carlo%3B_Baldini%2C_Marina%3B_Blasi%2C_Francesco%3B_Cesari%2C_Matteo%3B_Costantino%2C_Giorgio%3B_Fracanzani%2C_Anna_Ludovica%3B_Montano%2C_Nicola%3B_Monzani%2C_Valter%3B_Pesenti%2C_Antonio%3B_Peyvandi%2C_Flora%3B_Sottocorno%2C_Marcello%3B_Muscatello%2C_Antonio%3B_Filocamo%2C_Giovanni%3B_Gori%2C_Andrea%3B_Bandera%2C_Alessandra>
?:doi	<https://research.tib.eu/covid-19/entity/10.1016/j.jaci.2020.11.006>
?:doi	10.1016/j.jaci.2020.11.006
?:journal	J_Allergy_Clin_Immunol
?:license	els-covid
?:pdf_json_files	document_parses/pdf_json/b687299999c5e81438d447845ff306f1d09731ff.json
?:pmcid	<https://research.tib.eu/covid-19/entity/PMC7674131>
?:pmid	<https://research.tib.eu/covid-19/entity/33220354.0>
?:pmid	33220354.0
?:publication_isRelatedTo_Disease	<https://research.tib.eu/covid-19/entity/COVID-19>
is ?:relation_isRelatedTo_publication of	<https://research.tib.eu/covid-19/entity/7uzmj0w6_HAS_C0035222_COEXISTS_WITH_C5203670> <https://research.tib.eu/covid-19/entity/7uzmj0w6_HAS_C0245109_TREATS_C1145670> <https://research.tib.eu/covid-19/entity/7uzmj0w6_HAS_C5203676_CAUSES_C0919747>
?:sha_id	<https://research.tib.eu/covid-19/entity/b687299999c5e81438d447845ff306f1d09731ff>
?:source	Elsevier; Medline; PMC
?:title	Anakinra combined with methylprednisolone in patients with severe COVID-19 pneumonia and hyperinflammation: an observational cohort study
?:type	<https://research.tib.eu/covid-19/vocab/Publication>
?:year	2020-11-19

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Value

?:abstract

Background Immunomodulants have been proposed to mitigate SARS-Cov-2-induced cytokine storm, which drives acute respiratory distress syndrome in COVID-19. Objective To determine efficacy and safety of the association of IL-1 receptor antagonist anakinra plus methylprednisolone in severe COVID-19 pneumonia with hyperinflammation. Methods Secondary analysis of prospective observational cohort studies at an Italian tertiary health-care facility. COVID-19 patients consecutively hospitalized (02/25/2020 to 03/30/2020), with hyperinflammation (ferritin ≥1000ng/mL and/or C-reactive protein >10mg/dL) and respiratory failure (oxygen therapy from 0.4 FiO2 Venturi mask to invasive mechanical ventilation) were evaluated to investigate the effect of high-dose anakinra plus methylprednisolone on survival. Patients were followed from study inclusion to day 28 or death. Crude and adjusted (sex, age, baseline PaO2:FiO2 ratio, Charlson Index, baseline mechanical ventilation, hospitalization to inclusion lapse) risks were calculated (Cox proportional regression model). Results 120 COVID-19 patients with hyperinflammation (median age 62 years, 80.0% males, median PaO2:FiO2 ratio 151, 32.5% on mechanical ventilation) were evaluated. Of these, 65 were treated with anakinra and methylprednisolone and 55 were untreated historical controls. At 28 days, mortality was 13.9% in treated patients and 35.6% in controls (Kaplan-Meier plots, p=0.005). Unadjusted and adjusted risk of death was significantly lower for treated patients compared to controls (HR 0.33 (95%CI 0.15-0.74), p=0.007 and HR 0.18 (95%CI 0.07-0.50), p=0.001, respectively). No significant differences in bloodstream infections or laboratory alterations were registered. Conclusions Treatment with anakinra plus methylprednisolone may be a valid therapeutic option in COVID-19 patients with hyperinflammation and respiratory failure, also on mechanical ventilation. Randomized, controlled trials including use of either agent alone are needed to confirm these results.

is ?:annotates of