Interleukin-6 blockade with sarilumab in severe COVID-19 pneumonia with systemic hyperinflammation: an open-label cohort study.
Identifieur interne : 001239 ( Main/Corpus ); précédent : 001238; suivant : 001240Interleukin-6 blockade with sarilumab in severe COVID-19 pneumonia with systemic hyperinflammation: an open-label cohort study.
Auteurs : Emanuel Della-Torre ; Corrado Campochiaro ; Giulio Cavalli ; Giacomo De Luca ; Angela Napolitano ; Salvatore La Marca ; Nicola Boffini ; Valentina Da Prat ; Gaetano Di Terlizzi ; Marco Lanzillotta ; Patrizia Rovere Querini ; Annalisa Ruggeri ; Giovanni Landoni ; Moreno Tresoldi ; Fabio Ciceri ; Alberto Zangrillo ; Francesco De Cobelli ; Lorenzo DagnaSource :
- Annals of the rheumatic diseases [ 1468-2060 ] ; 2020.
English descriptors
- KwdEn :
- Administration, Intravenous (MeSH), Anti-Bacterial Agents (therapeutic use), Antibodies, Monoclonal, Humanized (therapeutic use), Antiviral Agents (therapeutic use), Azithromycin (therapeutic use), Bacteremia (epidemiology), Betacoronavirus (MeSH), C-Reactive Protein (immunology), COVID-19 (MeSH), Cohort Studies (MeSH), Coinfection (epidemiology), Coronavirus Infections (diagnostic imaging), Coronavirus Infections (drug therapy), Coronavirus Infections (immunology), Coronavirus Infections (mortality), Drug Combinations (MeSH), Enzyme Inhibitors (therapeutic use), Female (MeSH), Humans (MeSH), Hydroxychloroquine (therapeutic use), Inflammation (immunology), Interleukin-6 (immunology), Italy (MeSH), Lopinavir (therapeutic use), Lung (diagnostic imaging), Male (MeSH), Middle Aged (MeSH), Noninvasive Ventilation (MeSH), Oxygen Inhalation Therapy (MeSH), Pandemics (MeSH), Pneumonia, Viral (diagnostic imaging), Pneumonia, Viral (drug therapy), Pneumonia, Viral (immunology), Pneumonia, Viral (mortality), Proportional Hazards Models (MeSH), Receptors, Interleukin-6 (antagonists & inhibitors), Ritonavir (therapeutic use), SARS-CoV-2 (MeSH), Severity of Illness Index (MeSH), Time Factors (MeSH), Tomography, X-Ray Computed (MeSH), Treatment Outcome (MeSH).
- MESH :
- chemical , antagonists & inhibitors : Receptors, Interleukin-6.
- chemical , immunology : C-Reactive Protein, Interleukin-6.
- chemical , therapeutic use : Anti-Bacterial Agents, Antibodies, Monoclonal, Humanized, Antiviral Agents, Azithromycin, Enzyme Inhibitors, Hydroxychloroquine, Lopinavir, Ritonavir.
- geographic : Italy.
- diagnostic imaging : Coronavirus Infections, Lung, Pneumonia, Viral.
- drug therapy : Coronavirus Infections, Pneumonia, Viral.
- epidemiology : Bacteremia, Coinfection.
- immunology : Coronavirus Infections, Inflammation, Pneumonia, Viral.
- mortality : Coronavirus Infections, Pneumonia, Viral.
- Administration, Intravenous, Betacoronavirus, COVID-19, Cohort Studies, Drug Combinations, Female, Humans, Male, Middle Aged, Noninvasive Ventilation, Oxygen Inhalation Therapy, Pandemics, Proportional Hazards Models, SARS-CoV-2, Severity of Illness Index, Time Factors, Tomography, X-Ray Computed, Treatment Outcome.
Abstract
OBJECTIVES
To assess the safety and efficacy of interleukin (IL)-6 blockade with sarilumab in patients with severe COVID-19 pneumonia and systemic hyperinflammation.
METHODS
We conducted an open-label study of sarilumab in severe COVID-19 pneumonia (PaO
RESULTS
Twenty-eight patients were treated with sarilumab and 28 contemporary patients receiving standard of care alone were used as controls. At day 28 of follow-up, 61% of patients treated with sarilumab experienced clinical improvement and 7% died. These findings were not significantly different from the comparison group (clinical improvement 64%, mortality 18%; p=NS). Baseline PaO
CONCLUSIONS
At day 28, overall clinical improvement and mortality in patients with severe COVID-19 were not significantly different between sarilumab and standard of care. Sarilumab was associated with faster recovery in a subset of patients showing minor lung consolidation at baseline.
DOI: 10.1136/annrheumdis-2020-218122
PubMed: 32620597
PubMed Central: PMC7509526
Links to Exploration step
pubmed:32620597Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Interleukin-6 blockade with sarilumab in severe COVID-19 pneumonia with systemic hyperinflammation: an open-label cohort study.</title><author><name sortKey="Della Torre, Emanuel" sort="Della Torre, Emanuel" uniqKey="Della Torre E" first="Emanuel" last="Della-Torre">Emanuel Della-Torre</name><affiliation><nlm:affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy dellatorre.emanuel@hsr.it dagna.lorenzo@unisr.it.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Campochiaro, Corrado" sort="Campochiaro, Corrado" uniqKey="Campochiaro C" first="Corrado" last="Campochiaro">Corrado Campochiaro</name><affiliation><nlm:affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Cavalli, Giulio" sort="Cavalli, Giulio" uniqKey="Cavalli G" first="Giulio" last="Cavalli">Giulio Cavalli</name><affiliation><nlm:affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="De Luca, Giacomo" sort="De Luca, Giacomo" uniqKey="De Luca G" first="Giacomo" last="De Luca">Giacomo De Luca</name><affiliation><nlm:affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Napolitano, Angela" sort="Napolitano, Angela" uniqKey="Napolitano A" first="Angela" last="Napolitano">Angela Napolitano</name><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Clinical and Experimental Radiology Unit, Experimental Imaging Center, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="La Marca, Salvatore" sort="La Marca, Salvatore" uniqKey="La Marca S" first="Salvatore" last="La Marca">Salvatore La Marca</name><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Clinical and Experimental Radiology Unit, Experimental Imaging Center, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Boffini, Nicola" sort="Boffini, Nicola" uniqKey="Boffini N" first="Nicola" last="Boffini">Nicola Boffini</name><affiliation><nlm:affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Da Prat, Valentina" sort="Da Prat, Valentina" uniqKey="Da Prat V" first="Valentina" last="Da Prat">Valentina Da Prat</name><affiliation><nlm:affiliation>General Medicine and Advanced Care Unit, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Di Terlizzi, Gaetano" sort="Di Terlizzi, Gaetano" uniqKey="Di Terlizzi G" first="Gaetano" last="Di Terlizzi">Gaetano Di Terlizzi</name><affiliation><nlm:affiliation>General Medicine and Advanced Care Unit, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Lanzillotta, Marco" sort="Lanzillotta, Marco" uniqKey="Lanzillotta M" first="Marco" last="Lanzillotta">Marco Lanzillotta</name><affiliation><nlm:affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Rovere Querini, Patrizia" sort="Rovere Querini, Patrizia" uniqKey="Rovere Querini P" first="Patrizia" last="Rovere Querini">Patrizia Rovere Querini</name><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Internal Medicine, Diabetes & Endocrinology Unit, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Ruggeri, Annalisa" sort="Ruggeri, Annalisa" uniqKey="Ruggeri A" first="Annalisa" last="Ruggeri">Annalisa Ruggeri</name><affiliation><nlm:affiliation>Hematology and Bone Marrow Transplant Unit, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Landoni, Giovanni" sort="Landoni, Giovanni" uniqKey="Landoni G" first="Giovanni" last="Landoni">Giovanni Landoni</name><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Anesthesia and Intensive Care, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Tresoldi, Moreno" sort="Tresoldi, Moreno" uniqKey="Tresoldi M" first="Moreno" last="Tresoldi">Moreno Tresoldi</name><affiliation><nlm:affiliation>General Medicine and Advanced Care Unit, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Ciceri, Fabio" sort="Ciceri, Fabio" uniqKey="Ciceri F" first="Fabio" last="Ciceri">Fabio Ciceri</name><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Hematology and Bone Marrow Transplant Unit, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Zangrillo, Alberto" sort="Zangrillo, Alberto" uniqKey="Zangrillo A" first="Alberto" last="Zangrillo">Alberto Zangrillo</name><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Anesthesia and Intensive Care, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="De Cobelli, Francesco" sort="De Cobelli, Francesco" uniqKey="De Cobelli F" first="Francesco" last="De Cobelli">Francesco De Cobelli</name><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Clinical and Experimental Radiology Unit, Experimental Imaging Center, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Dagna, Lorenzo" sort="Dagna, Lorenzo" uniqKey="Dagna L" first="Lorenzo" last="Dagna">Lorenzo Dagna</name><affiliation><nlm:affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy dellatorre.emanuel@hsr.it dagna.lorenzo@unisr.it.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:32620597</idno><idno type="pmid">32620597</idno><idno type="doi">10.1136/annrheumdis-2020-218122</idno><idno type="pmc">PMC7509526</idno><idno type="wicri:Area/Main/Corpus">001239</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">001239</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Interleukin-6 blockade with sarilumab in severe COVID-19 pneumonia with systemic hyperinflammation: an open-label cohort study.</title><author><name sortKey="Della Torre, Emanuel" sort="Della Torre, Emanuel" uniqKey="Della Torre E" first="Emanuel" last="Della-Torre">Emanuel Della-Torre</name><affiliation><nlm:affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy dellatorre.emanuel@hsr.it dagna.lorenzo@unisr.it.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Campochiaro, Corrado" sort="Campochiaro, Corrado" uniqKey="Campochiaro C" first="Corrado" last="Campochiaro">Corrado Campochiaro</name><affiliation><nlm:affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Cavalli, Giulio" sort="Cavalli, Giulio" uniqKey="Cavalli G" first="Giulio" last="Cavalli">Giulio Cavalli</name><affiliation><nlm:affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="De Luca, Giacomo" sort="De Luca, Giacomo" uniqKey="De Luca G" first="Giacomo" last="De Luca">Giacomo De Luca</name><affiliation><nlm:affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Napolitano, Angela" sort="Napolitano, Angela" uniqKey="Napolitano A" first="Angela" last="Napolitano">Angela Napolitano</name><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Clinical and Experimental Radiology Unit, Experimental Imaging Center, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="La Marca, Salvatore" sort="La Marca, Salvatore" uniqKey="La Marca S" first="Salvatore" last="La Marca">Salvatore La Marca</name><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Clinical and Experimental Radiology Unit, Experimental Imaging Center, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Boffini, Nicola" sort="Boffini, Nicola" uniqKey="Boffini N" first="Nicola" last="Boffini">Nicola Boffini</name><affiliation><nlm:affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Da Prat, Valentina" sort="Da Prat, Valentina" uniqKey="Da Prat V" first="Valentina" last="Da Prat">Valentina Da Prat</name><affiliation><nlm:affiliation>General Medicine and Advanced Care Unit, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Di Terlizzi, Gaetano" sort="Di Terlizzi, Gaetano" uniqKey="Di Terlizzi G" first="Gaetano" last="Di Terlizzi">Gaetano Di Terlizzi</name><affiliation><nlm:affiliation>General Medicine and Advanced Care Unit, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Lanzillotta, Marco" sort="Lanzillotta, Marco" uniqKey="Lanzillotta M" first="Marco" last="Lanzillotta">Marco Lanzillotta</name><affiliation><nlm:affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Rovere Querini, Patrizia" sort="Rovere Querini, Patrizia" uniqKey="Rovere Querini P" first="Patrizia" last="Rovere Querini">Patrizia Rovere Querini</name><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Internal Medicine, Diabetes & Endocrinology Unit, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Ruggeri, Annalisa" sort="Ruggeri, Annalisa" uniqKey="Ruggeri A" first="Annalisa" last="Ruggeri">Annalisa Ruggeri</name><affiliation><nlm:affiliation>Hematology and Bone Marrow Transplant Unit, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Landoni, Giovanni" sort="Landoni, Giovanni" uniqKey="Landoni G" first="Giovanni" last="Landoni">Giovanni Landoni</name><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Anesthesia and Intensive Care, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Tresoldi, Moreno" sort="Tresoldi, Moreno" uniqKey="Tresoldi M" first="Moreno" last="Tresoldi">Moreno Tresoldi</name><affiliation><nlm:affiliation>General Medicine and Advanced Care Unit, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Ciceri, Fabio" sort="Ciceri, Fabio" uniqKey="Ciceri F" first="Fabio" last="Ciceri">Fabio Ciceri</name><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Hematology and Bone Marrow Transplant Unit, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Zangrillo, Alberto" sort="Zangrillo, Alberto" uniqKey="Zangrillo A" first="Alberto" last="Zangrillo">Alberto Zangrillo</name><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Anesthesia and Intensive Care, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="De Cobelli, Francesco" sort="De Cobelli, Francesco" uniqKey="De Cobelli F" first="Francesco" last="De Cobelli">Francesco De Cobelli</name><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Clinical and Experimental Radiology Unit, Experimental Imaging Center, San Raffaele Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Dagna, Lorenzo" sort="Dagna, Lorenzo" uniqKey="Dagna L" first="Lorenzo" last="Dagna">Lorenzo Dagna</name><affiliation><nlm:affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy dellatorre.emanuel@hsr.it dagna.lorenzo@unisr.it.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Annals of the rheumatic diseases</title><idno type="eISSN">1468-2060</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Intravenous (MeSH)</term><term>Anti-Bacterial Agents (therapeutic use)</term><term>Antibodies, Monoclonal, Humanized (therapeutic use)</term><term>Antiviral Agents (therapeutic use)</term><term>Azithromycin (therapeutic use)</term><term>Bacteremia (epidemiology)</term><term>Betacoronavirus (MeSH)</term><term>C-Reactive Protein (immunology)</term><term>COVID-19 (MeSH)</term><term>Cohort Studies (MeSH)</term><term>Coinfection (epidemiology)</term><term>Coronavirus Infections (diagnostic imaging)</term><term>Coronavirus Infections (drug therapy)</term><term>Coronavirus Infections (immunology)</term><term>Coronavirus Infections (mortality)</term><term>Drug Combinations (MeSH)</term><term>Enzyme Inhibitors (therapeutic use)</term><term>Female (MeSH)</term><term>Humans (MeSH)</term><term>Hydroxychloroquine (therapeutic use)</term><term>Inflammation (immunology)</term><term>Interleukin-6 (immunology)</term><term>Italy (MeSH)</term><term>Lopinavir (therapeutic use)</term><term>Lung (diagnostic imaging)</term><term>Male (MeSH)</term><term>Middle Aged (MeSH)</term><term>Noninvasive Ventilation (MeSH)</term><term>Oxygen Inhalation Therapy (MeSH)</term><term>Pandemics (MeSH)</term><term>Pneumonia, Viral (diagnostic imaging)</term><term>Pneumonia, Viral (drug therapy)</term><term>Pneumonia, Viral (immunology)</term><term>Pneumonia, Viral (mortality)</term><term>Proportional Hazards Models (MeSH)</term><term>Receptors, Interleukin-6 (antagonists & inhibitors)</term><term>Ritonavir (therapeutic use)</term><term>SARS-CoV-2 (MeSH)</term><term>Severity of Illness Index (MeSH)</term><term>Time Factors (MeSH)</term><term>Tomography, X-Ray Computed (MeSH)</term><term>Treatment Outcome (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Receptors, Interleukin-6</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>C-Reactive Protein</term><term>Interleukin-6</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Anti-Bacterial Agents</term><term>Antibodies, Monoclonal, Humanized</term><term>Antiviral Agents</term><term>Azithromycin</term><term>Enzyme Inhibitors</term><term>Hydroxychloroquine</term><term>Lopinavir</term><term>Ritonavir</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Italy</term></keywords><keywords scheme="MESH" qualifier="diagnostic imaging" xml:lang="en"><term>Coronavirus Infections</term><term>Lung</term><term>Pneumonia, Viral</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Coronavirus Infections</term><term>Pneumonia, Viral</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Bacteremia</term><term>Coinfection</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Coronavirus Infections</term><term>Inflammation</term><term>Pneumonia, Viral</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Coronavirus Infections</term><term>Pneumonia, Viral</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Intravenous</term><term>Betacoronavirus</term><term>COVID-19</term><term>Cohort Studies</term><term>Drug Combinations</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Noninvasive Ventilation</term><term>Oxygen Inhalation Therapy</term><term>Pandemics</term><term>Proportional Hazards Models</term><term>SARS-CoV-2</term><term>Severity of Illness Index</term><term>Time Factors</term><term>Tomography, X-Ray Computed</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>OBJECTIVES</b></p><p>To assess the safety and efficacy of interleukin (IL)-6 blockade with sarilumab in patients with severe COVID-19 pneumonia and systemic hyperinflammation.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>We conducted an open-label study of sarilumab in severe COVID-19 pneumonia (PaO</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>Twenty-eight patients were treated with sarilumab and 28 contemporary patients receiving standard of care alone were used as controls. At day 28 of follow-up, 61% of patients treated with sarilumab experienced clinical improvement and 7% died. These findings were not significantly different from the comparison group (clinical improvement 64%, mortality 18%; p=NS). Baseline PaO</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>At day 28, overall clinical improvement and mortality in patients with severe COVID-19 were not significantly different between sarilumab and standard of care. Sarilumab was associated with faster recovery in a subset of patients showing minor lung consolidation at baseline.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32620597</PMID><DateCompleted><Year>2020</Year><Month>09</Month><Day>24</Day></DateCompleted><DateRevised><Year>2020</Year><Month>12</Month><Day>10</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1468-2060</ISSN><JournalIssue CitedMedium="Internet"><Volume>79</Volume><Issue>10</Issue><PubDate><Year>2020</Year><Month>10</Month></PubDate></JournalIssue><Title>Annals of the rheumatic diseases</Title><ISOAbbreviation>Ann Rheum Dis</ISOAbbreviation></Journal><ArticleTitle>Interleukin-6 blockade with sarilumab in severe COVID-19 pneumonia with systemic hyperinflammation: an open-label cohort study.</ArticleTitle><Pagination><MedlinePgn>1277-1285</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1136/annrheumdis-2020-218122</ELocationID><Abstract><AbstractText Label="OBJECTIVES">To assess the safety and efficacy of interleukin (IL)-6 blockade with sarilumab in patients with severe COVID-19 pneumonia and systemic hyperinflammation.</AbstractText><AbstractText Label="METHODS">We conducted an open-label study of sarilumab in severe COVID-19 pneumonia (PaO<sub>2</sub>/FiO<sub>2</sub> <300 mm Hg) with hyperinflammation (elevated inflammatory markers and serum IL-6 levels). Sarilumab 400 mg was administered intravenously in addition to standard of care and results were compared with contemporary matched patients treated with standard of care alone. Clinical improvement, mortality, safety and predictors of response were assessed at 28 days.</AbstractText><AbstractText Label="RESULTS">Twenty-eight patients were treated with sarilumab and 28 contemporary patients receiving standard of care alone were used as controls. At day 28 of follow-up, 61% of patients treated with sarilumab experienced clinical improvement and 7% died. These findings were not significantly different from the comparison group (clinical improvement 64%, mortality 18%; p=NS). Baseline PaO<sub>2</sub>/FiO<sub>2</sub> ratio >100 mm Hg and lung consolidation <17% at CT scan predicted clinical improvement in patients treated with sarilumab. Median time to clinical improvement in patients with lung consolidation <17% was shorter after sarilumab (10 days) than after standard treatment (24 days; p=0.01). The rate of infection and pulmonary thrombosis was similar between the two groups.</AbstractText><AbstractText Label="CONCLUSIONS">At day 28, overall clinical improvement and mortality in patients with severe COVID-19 were not significantly different between sarilumab and standard of care. Sarilumab was associated with faster recovery in a subset of patients showing minor lung consolidation at baseline.</AbstractText><CopyrightInformation>© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Della-Torre</LastName><ForeName>Emanuel</ForeName><Initials>E</Initials><Identifier Source="ORCID">0000-0002-9192-4270</Identifier><AffiliationInfo><Affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy dellatorre.emanuel@hsr.it dagna.lorenzo@unisr.it.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Campochiaro</LastName><ForeName>Corrado</ForeName><Initials>C</Initials><Identifier Source="ORCID">0000-0001-6806-3794</Identifier><AffiliationInfo><Affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cavalli</LastName><ForeName>Giulio</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>De Luca</LastName><ForeName>Giacomo</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Napolitano</LastName><ForeName>Angela</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Clinical and Experimental Radiology Unit, Experimental Imaging Center, San Raffaele Hospital, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>La Marca</LastName><ForeName>Salvatore</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Clinical and Experimental Radiology Unit, Experimental Imaging Center, San Raffaele Hospital, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Boffini</LastName><ForeName>Nicola</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Da Prat</LastName><ForeName>Valentina</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>General Medicine and Advanced Care Unit, San Raffaele Hospital, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Di Terlizzi</LastName><ForeName>Gaetano</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>General Medicine and Advanced Care Unit, San Raffaele Hospital, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lanzillotta</LastName><ForeName>Marco</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rovere Querini</LastName><ForeName>Patrizia</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Internal Medicine, Diabetes & Endocrinology Unit, San Raffaele Hospital, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ruggeri</LastName><ForeName>Annalisa</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Hematology and Bone Marrow Transplant Unit, San Raffaele Hospital, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Landoni</LastName><ForeName>Giovanni</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Anesthesia and Intensive Care, San Raffaele Hospital, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tresoldi</LastName><ForeName>Moreno</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>General Medicine and Advanced Care Unit, San Raffaele Hospital, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ciceri</LastName><ForeName>Fabio</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Hematology and Bone Marrow Transplant Unit, San Raffaele Hospital, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zangrillo</LastName><ForeName>ALberto</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Anesthesia and Intensive Care, San Raffaele Hospital, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>De Cobelli</LastName><ForeName>Francesco</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Clinical and Experimental Radiology Unit, Experimental Imaging Center, San Raffaele Hospital, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dagna</LastName><ForeName>Lorenzo</ForeName><Initials>L</Initials><Identifier Source="ORCID">0000-0002-7428-315X</Identifier><AffiliationInfo><Affiliation>Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, San Raffaele Hospital, Milano, Lombardia, Italy dellatorre.emanuel@hsr.it dagna.lorenzo@unisr.it.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Università Vita-Salute San Raffaele, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>SARI-RAF Study Group</CollectiveName></Author><Author ValidYN="Y"><CollectiveName>SARI-RAF Study Group members</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D064888">Observational Study</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>07</Month><Day>03</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Ann Rheum Dis</MedlineTA><NlmUniqueID>0372355</NlmUniqueID><ISSNLinking>0003-4967</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000900">Anti-Bacterial Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D061067">Antibodies, Monoclonal, Humanized</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000998">Antiviral Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D004338">Drug 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MajorTopicYN="N">Severity of Illness Index</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014057" MajorTopicYN="N">Tomography, X-Ray Computed</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">anti-inflammatory agents, non-steroidal</Keyword><Keyword MajorTopicYN="Y">inflammation</Keyword><Keyword MajorTopicYN="Y">therapeutics</Keyword></KeywordList><CoiStatement>Competing interests: None declared.</CoiStatement><InvestigatorList><Investigator ValidYN="Y"><LastName>Angelillo</LastName><ForeName>Piera</ForeName><Initials>P</Initials></Investigator><Investigator ValidYN="Y"><LastName>Assanelli</LastName><ForeName>Andrea</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Baldissera</LastName><ForeName>Elena</ForeName><Initials>E</Initials></Investigator><Investigator ValidYN="Y"><LastName>Boffini</LastName><ForeName>Nicola</ForeName><Initials>N</Initials></Investigator><Investigator ValidYN="Y"><LastName>Bozzolo</LastName><ForeName>Enrica Paola</ForeName><Initials>EP</Initials></Investigator><Investigator ValidYN="Y"><LastName>Calvisi</LastName><ForeName>Stefania</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Campochiaro</LastName><ForeName>Corrado</ForeName><Initials>C</Initials></Investigator><Investigator ValidYN="Y"><LastName>Prat</LastName><ForeName>Valentina Da</ForeName><Initials>VD</Initials></Investigator><Investigator ValidYN="Y"><LastName>Canetti</LastName><ForeName>Diana</ForeName><Initials>D</Initials></Investigator><Investigator ValidYN="Y"><LastName>Cariddi</LastName><ForeName>Adriana</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Castagna</LastName><ForeName>Antonella</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Cavalli</LastName><ForeName>Giulio</ForeName><Initials>G</Initials></Investigator><Investigator ValidYN="Y"><LastName>Cicalese</LastName><ForeName>Maria Pia</ForeName><Initials>MP</Initials></Investigator><Investigator ValidYN="Y"><LastName>Ciceri</LastName><ForeName>Fabio</ForeName><Initials>F</Initials></Investigator><Investigator ValidYN="Y"><LastName>Dagna</LastName><ForeName>Lorenzo</ForeName><Initials>L</Initials></Investigator><Investigator ValidYN="Y"><LastName>Cobelli</LastName><ForeName>Francesco De</ForeName><Initials>F</Initials></Investigator><Investigator ValidYN="Y"><LastName>Luca</LastName><ForeName>Giacomo De</ForeName><Initials>G</Initials></Investigator><Investigator ValidYN="Y"><LastName>Della-Torre</LastName><ForeName>Emanuel</ForeName><Initials>E</Initials></Investigator><Investigator ValidYN="Y"><LastName>Lucca</LastName><ForeName>Giuseppe Di</ForeName><Initials>GD</Initials></Investigator><Investigator ValidYN="Y"><LastName>Terlizzi</LastName><ForeName>Gaetano di</ForeName><Initials>GD</Initials></Investigator><Investigator ValidYN="Y"><LastName>Farina</LastName><ForeName>Nicola</ForeName><Initials>N</Initials></Investigator><Investigator ValidYN="Y"><LastName>Fazio</LastName><ForeName>Maria</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Marca</LastName><ForeName>Salvatore La</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Landoni</LastName><ForeName>Giovanni</ForeName><Initials>G</Initials></Investigator><Investigator ValidYN="Y"><LastName>Lanzillotta</LastName><ForeName>Marco</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Mancuso</LastName><ForeName>Gaia</ForeName><Initials>G</Initials></Investigator><Investigator 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ValidYN="Y"><LastName>Sartorelli</LastName><ForeName>Silvia</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Scarpellini</LastName><ForeName>Paolo</ForeName><Initials>P</Initials></Investigator><Investigator ValidYN="Y"><LastName>Spessot</LastName><ForeName>Marzia</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Tomelleri</LastName><ForeName>Alessandro</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Tresoldi</LastName><ForeName>Moreno</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Zangrillo</LastName><ForeName>Alberto</ForeName><Initials>A</Initials></Investigator></InvestigatorList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>05</Month><Day>28</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2020</Year><Month>06</Month><Day>14</Day></PubMedPubDate><PubMedPubDate 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