Historically controlled comparison of glucocorticoids with or without tocilizumab versus supportive care only in patients with COVID-19-associated cytokine storm syndrome: results of the CHIC study.
Identifieur interne : 000538 ( Main/Exploration ); précédent : 000537; suivant : 000539Historically controlled comparison of glucocorticoids with or without tocilizumab versus supportive care only in patients with COVID-19-associated cytokine storm syndrome: results of the CHIC study.
Auteurs : Sofia Ramiro [Oman, Pays-Bas] ; Rémy L M. Mostard [Pays-Bas] ; César Magro-Checa [Pays-Bas] ; Christel M P. Van Dongen [Pays-Bas] ; Tom Dormans [Pays-Bas] ; Jacqueline Buijs [Pays-Bas] ; Michiel Gronenschild [Pays-Bas] ; Martijn D. De Kruif [Pays-Bas] ; Eric H J. Van Haren [Pays-Bas] ; Tom Van Kraaij [Pays-Bas] ; Mathie P G. Leers [Pays-Bas] ; Ralph Peeters [Pays-Bas] ; Dennis R. Wong [Pays-Bas] ; Robert B M. Landewé [Pays-Bas]Source :
- Annals of the rheumatic diseases [ 1468-2060 ] ; 2020.
Descripteurs français
- KwdFr :
- Adulte d'âge moyen (MeSH), Anticorps monoclonaux humanisés (administration et posologie), Association de médicaments (MeSH), Betacoronavirus (MeSH), Cytokines (sang), Femelle (MeSH), Ferritines (sang), Glucocorticoïdes (administration et posologie), Humains (MeSH), Infections à coronavirus (complications), Infections à coronavirus (sang), Infections à coronavirus (traitement médicamenteux), Infections à coronavirus (virologie), Mâle (MeSH), Norme de soins (MeSH), Pandémies (MeSH), Pneumopathie virale (complications), Pneumopathie virale (sang), Pneumopathie virale (traitement médicamenteux), Pneumopathie virale (virologie), Produits de dégradation de la fibrine et du fibrinogène (analyse), Protéine C-réactive (analyse), Résultat thérapeutique (MeSH), Sujet âgé (MeSH), Étude contrôle historique (MeSH), Études prospectives (MeSH).
- MESH :
- administration et posologie : Anticorps monoclonaux humanisés, Glucocorticoïdes.
- analyse : Produits de dégradation de la fibrine et du fibrinogène, Protéine C-réactive.
- sang : Cytokines, Ferritines, Infections à coronavirus, Pneumopathie virale.
- traitement médicamenteux : Infections à coronavirus, Pneumopathie virale.
- virologie : Infections à coronavirus, Pneumopathie virale.
- Adulte d'âge moyen, Association de médicaments, Betacoronavirus, Femelle, Humains, Mâle, Norme de soins, Pandémies, Résultat thérapeutique, Sujet âgé, Étude contrôle historique, Études prospectives.
English descriptors
- KwdEn :
- Aged (MeSH), Antibodies, Monoclonal, Humanized (administration & dosage), Betacoronavirus (MeSH), C-Reactive Protein (analysis), Coronavirus Infections (blood), Coronavirus Infections (complications), Coronavirus Infections (drug therapy), Coronavirus Infections (virology), Cytokine Release Syndrome (blood), Cytokine Release Syndrome (drug therapy), Cytokine Release Syndrome (virology), Cytokines (blood), Drug Therapy, Combination (MeSH), Female (MeSH), Ferritins (blood), Fibrin Fibrinogen Degradation Products (analysis), Glucocorticoids (administration & dosage), Historically Controlled Study (MeSH), Humans (MeSH), Male (MeSH), Middle Aged (MeSH), Pandemics (MeSH), Pneumonia, Viral (blood), Pneumonia, Viral (complications), Pneumonia, Viral (drug therapy), Pneumonia, Viral (virology), Prospective Studies (MeSH), Standard of Care (MeSH), Treatment Outcome (MeSH).
- MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Humanized, Glucocorticoids.
- chemical , analysis : C-Reactive Protein, Fibrin Fibrinogen Degradation Products.
- blood : Coronavirus Infections, Cytokine Release Syndrome, Cytokines, Ferritins, Pneumonia, Viral.
- complications : Coronavirus Infections, Pneumonia, Viral.
- drug therapy : Coronavirus Infections, Cytokine Release Syndrome, Pneumonia, Viral.
- virology : Coronavirus Infections, Cytokine Release Syndrome, Pneumonia, Viral.
- Aged, Betacoronavirus, Drug Therapy, Combination, Female, Historically Controlled Study, Humans, Male, Middle Aged, Pandemics, Prospective Studies, Standard of Care, Treatment Outcome.
Abstract
OBJECTIVES
To prospectively investigate in patients with severe COVID-19-associated cytokine storm syndrome (CSS) whether an intensive course of glucocorticoids with or without tocilizumab accelerates clinical improvement, reduces mortality and prevents invasive mechanical ventilation, in comparison with a historic control group of patients who received supportive care only.
METHODS
From 1 April 2020, patients with COVID-19-associated CSS, defined as rapid respiratory deterioration plus at least two out of three biomarkers with important elevations (C-reactive protein >100 mg/L; ferritin >900 µg/L; D-dimer >1500 µg/L), received high-dose intravenous methylprednisolone for 5 consecutive days (250 mg on day 1 followed by 80 mg on days 2-5). If the respiratory condition had not improved sufficiently (in 43%), the interleukin-6 receptor blocker tocilizumab (8 mg/kg body weight, single infusion) was added on or after day 2. Control patients with COVID-19-associated CSS (same definition) were retrospectively sampled from the pool of patients (n=350) admitted between 7 March and 31 March, and matched one to one to treated patients on sex and age. The primary outcome was ≥2 stages of improvement on a 7-item WHO-endorsed scale for trials in patients with severe influenza pneumonia, or discharge from the hospital. Secondary outcomes were hospital mortality and mechanical ventilation.
RESULTS
At baseline all patients with COVID-19 in the treatment group (n=86) and control group (n=86) had symptoms of CSS and faced acute respiratory failure. Treated patients had 79% higher likelihood on reaching the primary outcome (HR: 1.8; 95% CI 1.2 to 2.7) (7 days earlier), 65% less mortality (HR: 0.35; 95% CI 0.19 to 0.65) and 71% less invasive mechanical ventilation (HR: 0.29; 95% CI 0.14 to 0.65). Treatment effects remained constant in confounding and sensitivity analyses.
CONCLUSIONS
A strategy involving a course of high-dose methylprednisolone, followed by tocilizumab if needed, may accelerate respiratory recovery, lower hospital mortality and reduce the likelihood of invasive mechanical ventilation in COVID-19-associated CSS.
DOI: 10.1136/annrheumdis-2020-218479
PubMed: 32719045
PubMed Central: PMC7456552
Affiliations:
Links toward previous steps (curation, corpus...)
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De Kruif</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg</wicri:regionArea><wicri:noRegion>Limburg</wicri:noRegion></affiliation></author><author><name sortKey="Van Haren, Eric H J" sort="Van Haren, Eric H J" uniqKey="Van Haren E" first="Eric H J" last="Van Haren">Eric H J. 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Wong</name><affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Pharmacy, Pharmacology and Toxicology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Clinical Pharmacy, Pharmacology and Toxicology, Zuyderland Medical Center, Heerlen, Limburg</wicri:regionArea><wicri:noRegion>Limburg</wicri:noRegion></affiliation></author><author><name sortKey="Landewe, Robert B M" sort="Landewe, Robert B M" uniqKey="Landewe R" first="Robert B M" last="Landewé">Robert B M. 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Mostard</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg</wicri:regionArea><wicri:noRegion>Limburg</wicri:noRegion></affiliation></author><author><name sortKey="Magro Checa, Cesar" sort="Magro Checa, Cesar" uniqKey="Magro Checa C" first="César" last="Magro-Checa">César Magro-Checa</name><affiliation wicri:level="1"><nlm:affiliation>Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Rheumatology, Zuyderland Medical Center, Heerlen, Limburg</wicri:regionArea><wicri:noRegion>Limburg</wicri:noRegion></affiliation></author><author><name sortKey="Van Dongen, Christel M P" sort="Van Dongen, Christel M P" uniqKey="Van Dongen C" first="Christel M P" last="Van Dongen">Christel M P. Van Dongen</name><affiliation wicri:level="1"><nlm:affiliation>Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Rheumatology, Zuyderland Medical Center, Heerlen, Limburg</wicri:regionArea><wicri:noRegion>Limburg</wicri:noRegion></affiliation></author><author><name sortKey="Dormans, Tom" sort="Dormans, Tom" uniqKey="Dormans T" first="Tom" last="Dormans">Tom Dormans</name><affiliation wicri:level="1"><nlm:affiliation>Department of Intensive Care, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Intensive Care, Zuyderland Medical Center, Heerlen, Limburg</wicri:regionArea><wicri:noRegion>Limburg</wicri:noRegion></affiliation></author><author><name sortKey="Buijs, Jacqueline" sort="Buijs, Jacqueline" uniqKey="Buijs J" first="Jacqueline" last="Buijs">Jacqueline Buijs</name><affiliation wicri:level="1"><nlm:affiliation>Department of Internal Medicine, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Internal Medicine, Zuyderland Medical Center, Heerlen, Limburg</wicri:regionArea><wicri:noRegion>Limburg</wicri:noRegion></affiliation></author><author><name sortKey="Gronenschild, Michiel" sort="Gronenschild, Michiel" uniqKey="Gronenschild M" first="Michiel" last="Gronenschild">Michiel Gronenschild</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg</wicri:regionArea><wicri:noRegion>Limburg</wicri:noRegion></affiliation></author><author><name sortKey="De Kruif, Martijn D" sort="De Kruif, Martijn D" uniqKey="De Kruif M" first="Martijn D" last="De Kruif">Martijn D. De Kruif</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg</wicri:regionArea><wicri:noRegion>Limburg</wicri:noRegion></affiliation></author><author><name sortKey="Van Haren, Eric H J" sort="Van Haren, Eric H J" uniqKey="Van Haren E" first="Eric H J" last="Van Haren">Eric H J. Van Haren</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg</wicri:regionArea><wicri:noRegion>Limburg</wicri:noRegion></affiliation></author><author><name sortKey="Van Kraaij, Tom" sort="Van Kraaij, Tom" uniqKey="Van Kraaij T" first="Tom" last="Van Kraaij">Tom Van Kraaij</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg</wicri:regionArea><wicri:noRegion>Limburg</wicri:noRegion></affiliation></author><author><name sortKey="Leers, Mathie P G" sort="Leers, Mathie P G" uniqKey="Leers M" first="Mathie P G" last="Leers">Mathie P G. Leers</name><affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Chemistry and Hematology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Clinical Chemistry and Hematology, Zuyderland Medical Center, Heerlen, Limburg</wicri:regionArea><wicri:noRegion>Limburg</wicri:noRegion></affiliation></author><author><name sortKey="Peeters, Ralph" sort="Peeters, Ralph" uniqKey="Peeters R" first="Ralph" last="Peeters">Ralph Peeters</name><affiliation wicri:level="1"><nlm:affiliation>Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Rheumatology, Zuyderland Medical Center, Heerlen, Limburg</wicri:regionArea><wicri:noRegion>Limburg</wicri:noRegion></affiliation></author><author><name sortKey="Wong, Dennis R" sort="Wong, Dennis R" uniqKey="Wong D" first="Dennis R" last="Wong">Dennis R. Wong</name><affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Pharmacy, Pharmacology and Toxicology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Clinical Pharmacy, Pharmacology and Toxicology, Zuyderland Medical Center, Heerlen, Limburg</wicri:regionArea><wicri:noRegion>Limburg</wicri:noRegion></affiliation></author><author><name sortKey="Landewe, Robert B M" sort="Landewe, Robert B M" uniqKey="Landewe R" first="Robert B M" last="Landewé">Robert B M. Landewé</name><affiliation wicri:level="1"><nlm:affiliation>Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Rheumatology, Zuyderland Medical Center, Heerlen, Limburg</wicri:regionArea><wicri:noRegion>Limburg</wicri:noRegion></affiliation><affiliation wicri:level="3"><nlm:affiliation>Amsterdam Rheumatology Center, AMC, Amsterdam, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Amsterdam Rheumatology Center, AMC, Amsterdam</wicri:regionArea><placeName><settlement type="city">Amsterdam</settlement><region nuts="2" type="province">Hollande-Septentrionale</region></placeName></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>Aged (MeSH)</term><term>Antibodies, Monoclonal, Humanized (administration & dosage)</term><term>Betacoronavirus (MeSH)</term><term>C-Reactive Protein (analysis)</term><term>Coronavirus Infections (blood)</term><term>Coronavirus Infections (complications)</term><term>Coronavirus Infections (drug therapy)</term><term>Coronavirus Infections (virology)</term><term>Cytokine Release Syndrome (blood)</term><term>Cytokine Release Syndrome (drug therapy)</term><term>Cytokine Release Syndrome (virology)</term><term>Cytokines (blood)</term><term>Drug Therapy, Combination (MeSH)</term><term>Female (MeSH)</term><term>Ferritins (blood)</term><term>Fibrin Fibrinogen Degradation Products (analysis)</term><term>Glucocorticoids (administration & dosage)</term><term>Historically Controlled Study (MeSH)</term><term>Humans (MeSH)</term><term>Male (MeSH)</term><term>Middle Aged (MeSH)</term><term>Pandemics (MeSH)</term><term>Pneumonia, Viral (blood)</term><term>Pneumonia, Viral (complications)</term><term>Pneumonia, Viral (drug therapy)</term><term>Pneumonia, Viral (virology)</term><term>Prospective Studies (MeSH)</term><term>Standard of Care (MeSH)</term><term>Treatment Outcome (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte d'âge moyen (MeSH)</term><term>Anticorps monoclonaux humanisés (administration et posologie)</term><term>Association de médicaments (MeSH)</term><term>Betacoronavirus (MeSH)</term><term>Cytokines (sang)</term><term>Femelle (MeSH)</term><term>Ferritines (sang)</term><term>Glucocorticoïdes (administration et posologie)</term><term>Humains (MeSH)</term><term>Infections à coronavirus (complications)</term><term>Infections à coronavirus (sang)</term><term>Infections à coronavirus (traitement médicamenteux)</term><term>Infections à coronavirus (virologie)</term><term>Mâle (MeSH)</term><term>Norme de soins (MeSH)</term><term>Pandémies (MeSH)</term><term>Pneumopathie virale (complications)</term><term>Pneumopathie virale (sang)</term><term>Pneumopathie virale (traitement médicamenteux)</term><term>Pneumopathie virale (virologie)</term><term>Produits de dégradation de la fibrine et du fibrinogène (analyse)</term><term>Protéine C-réactive (analyse)</term><term>Résultat thérapeutique (MeSH)</term><term>Sujet âgé (MeSH)</term><term>Étude contrôle historique (MeSH)</term><term>Études prospectives (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term><term>Glucocorticoids</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analysis" xml:lang="en"><term>C-Reactive Protein</term><term>Fibrin Fibrinogen Degradation Products</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Anticorps monoclonaux humanisés</term><term>Glucocorticoïdes</term></keywords><keywords scheme="MESH" qualifier="analyse" xml:lang="fr"><term>Produits de dégradation de la fibrine et du fibrinogène</term><term>Protéine C-réactive</term></keywords><keywords scheme="MESH" qualifier="blood" xml:lang="en"><term>Coronavirus Infections</term><term>Cytokine Release Syndrome</term><term>Cytokines</term><term>Ferritins</term><term>Pneumonia, Viral</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Coronavirus Infections</term><term>Pneumonia, Viral</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Coronavirus Infections</term><term>Cytokine Release Syndrome</term><term>Pneumonia, Viral</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Cytokines</term><term>Ferritines</term><term>Infections à coronavirus</term><term>Pneumopathie virale</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Infections à coronavirus</term><term>Pneumopathie virale</term></keywords><keywords scheme="MESH" qualifier="virologie" xml:lang="fr"><term>Infections à coronavirus</term><term>Pneumopathie virale</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>Coronavirus Infections</term><term>Cytokine Release Syndrome</term><term>Pneumonia, Viral</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Betacoronavirus</term><term>Drug Therapy, Combination</term><term>Female</term><term>Historically Controlled Study</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Pandemics</term><term>Prospective Studies</term><term>Standard of Care</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Association de médicaments</term><term>Betacoronavirus</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Norme de soins</term><term>Pandémies</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Étude contrôle historique</term><term>Études prospectives</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>OBJECTIVES</b></p><p>To prospectively investigate in patients with severe COVID-19-associated cytokine storm syndrome (CSS) whether an intensive course of glucocorticoids with or without tocilizumab accelerates clinical improvement, reduces mortality and prevents invasive mechanical ventilation, in comparison with a historic control group of patients who received supportive care only.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>From 1 April 2020, patients with COVID-19-associated CSS, defined as rapid respiratory deterioration plus at least two out of three biomarkers with important elevations (C-reactive protein >100 mg/L; ferritin >900 µg/L; D-dimer >1500 µg/L), received high-dose intravenous methylprednisolone for 5 consecutive days (250 mg on day 1 followed by 80 mg on days 2-5). If the respiratory condition had not improved sufficiently (in 43%), the interleukin-6 receptor blocker tocilizumab (8 mg/kg body weight, single infusion) was added on or after day 2. Control patients with COVID-19-associated CSS (same definition) were retrospectively sampled from the pool of patients (n=350) admitted between 7 March and 31 March, and matched one to one to treated patients on sex and age. The primary outcome was ≥2 stages of improvement on a 7-item WHO-endorsed scale for trials in patients with severe influenza pneumonia, or discharge from the hospital. Secondary outcomes were hospital mortality and mechanical ventilation.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>At baseline all patients with COVID-19 in the treatment group (n=86) and control group (n=86) had symptoms of CSS and faced acute respiratory failure. Treated patients had 79% higher likelihood on reaching the primary outcome (HR: 1.8; 95% CI 1.2 to 2.7) (7 days earlier), 65% less mortality (HR: 0.35; 95% CI 0.19 to 0.65) and 71% less invasive mechanical ventilation (HR: 0.29; 95% CI 0.14 to 0.65). Treatment effects remained constant in confounding and sensitivity analyses.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>A strategy involving a course of high-dose methylprednisolone, followed by tocilizumab if needed, may accelerate respiratory recovery, lower hospital mortality and reduce the likelihood of invasive mechanical ventilation in COVID-19-associated CSS.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32719045</PMID><DateCompleted><Year>2020</Year><Month>09</Month><Day>08</Day></DateCompleted><DateRevised><Year>2020</Year><Month>10</Month><Day>13</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1468-2060</ISSN><JournalIssue CitedMedium="Internet"><Volume>79</Volume><Issue>9</Issue><PubDate><Year>2020</Year><Month>09</Month></PubDate></JournalIssue><Title>Annals of the rheumatic diseases</Title><ISOAbbreviation>Ann Rheum Dis</ISOAbbreviation></Journal><ArticleTitle>Historically controlled comparison of glucocorticoids with or without tocilizumab versus supportive care only in patients with COVID-19-associated cytokine storm syndrome: results of the CHIC study.</ArticleTitle><Pagination><MedlinePgn>1143-1151</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1136/annrheumdis-2020-218479</ELocationID><Abstract><AbstractText Label="OBJECTIVES">To prospectively investigate in patients with severe COVID-19-associated cytokine storm syndrome (CSS) whether an intensive course of glucocorticoids with or without tocilizumab accelerates clinical improvement, reduces mortality and prevents invasive mechanical ventilation, in comparison with a historic control group of patients who received supportive care only.</AbstractText><AbstractText Label="METHODS">From 1 April 2020, patients with COVID-19-associated CSS, defined as rapid respiratory deterioration plus at least two out of three biomarkers with important elevations (C-reactive protein >100 mg/L; ferritin >900 µg/L; D-dimer >1500 µg/L), received high-dose intravenous methylprednisolone for 5 consecutive days (250 mg on day 1 followed by 80 mg on days 2-5). If the respiratory condition had not improved sufficiently (in 43%), the interleukin-6 receptor blocker tocilizumab (8 mg/kg body weight, single infusion) was added on or after day 2. Control patients with COVID-19-associated CSS (same definition) were retrospectively sampled from the pool of patients (n=350) admitted between 7 March and 31 March, and matched one to one to treated patients on sex and age. The primary outcome was ≥2 stages of improvement on a 7-item WHO-endorsed scale for trials in patients with severe influenza pneumonia, or discharge from the hospital. Secondary outcomes were hospital mortality and mechanical ventilation.</AbstractText><AbstractText Label="RESULTS">At baseline all patients with COVID-19 in the treatment group (n=86) and control group (n=86) had symptoms of CSS and faced acute respiratory failure. Treated patients had 79% higher likelihood on reaching the primary outcome (HR: 1.8; 95% CI 1.2 to 2.7) (7 days earlier), 65% less mortality (HR: 0.35; 95% CI 0.19 to 0.65) and 71% less invasive mechanical ventilation (HR: 0.29; 95% CI 0.14 to 0.65). Treatment effects remained constant in confounding and sensitivity analyses.</AbstractText><AbstractText Label="CONCLUSIONS">A strategy involving a course of high-dose methylprednisolone, followed by tocilizumab if needed, may accelerate respiratory recovery, lower hospital mortality and reduce the likelihood of invasive mechanical ventilation in COVID-19-associated CSS.</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>Ramiro</LastName><ForeName>Sofia</ForeName><Initials>S</Initials><Identifier Source="ORCID">0000-0002-8899-9087</Identifier><AffiliationInfo><Affiliation>Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands sofiaramiro@gmail.com.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Rheumatology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mostard</LastName><ForeName>Rémy L M</ForeName><Initials>RLM</Initials><AffiliationInfo><Affiliation>Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Magro-Checa</LastName><ForeName>César</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>van Dongen</LastName><ForeName>Christel M P</ForeName><Initials>CMP</Initials><AffiliationInfo><Affiliation>Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dormans</LastName><ForeName>Tom</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Department of Intensive Care, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Buijs</LastName><ForeName>Jacqueline</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gronenschild</LastName><ForeName>Michiel</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>de Kruif</LastName><ForeName>Martijn D</ForeName><Initials>MD</Initials><AffiliationInfo><Affiliation>Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>van Haren</LastName><ForeName>Eric H J</ForeName><Initials>EHJ</Initials><AffiliationInfo><Affiliation>Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>van Kraaij</LastName><ForeName>Tom</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Leers</LastName><ForeName>Mathie P G</ForeName><Initials>MPG</Initials><AffiliationInfo><Affiliation>Department of Clinical Chemistry and Hematology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Peeters</LastName><ForeName>Ralph</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wong</LastName><ForeName>Dennis R</ForeName><Initials>DR</Initials><AffiliationInfo><Affiliation>Department of Clinical Pharmacy, Pharmacology and Toxicology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Landewé</LastName><ForeName>Robert B M</ForeName><Initials>RBM</Initials><Identifier Source="ORCID">0000-0002-0577-6620</Identifier><AffiliationInfo><Affiliation>Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Amsterdam Rheumatology Center, AMC, Amsterdam, The Netherlands.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>07</Month><Day>20</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="D061067">Antibodies, Monoclonal, Humanized</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D016207">Cytokines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D005338">Fibrin Fibrinogen Degradation Products</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D005938">Glucocorticoids</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C036309">fibrin fragment D</NameOfSubstance></Chemical><Chemical><RegistryNumber>9007-41-4</RegistryNumber><NameOfSubstance UI="D002097">C-Reactive Protein</NameOfSubstance></Chemical><Chemical><RegistryNumber>9007-73-2</RegistryNumber><NameOfSubstance UI="D005293">Ferritins</NameOfSubstance></Chemical><Chemical><RegistryNumber>I031V2H011</RegistryNumber><NameOfSubstance UI="C502936">tocilizumab</NameOfSubstance></Chemical></ChemicalList><SupplMeshList><SupplMeshName Type="Disease" UI="C000657245">COVID-19</SupplMeshName><SupplMeshName Type="Protocol" UI="C000705127">COVID-19 drug treatment</SupplMeshName><SupplMeshName Type="Organism" UI="C000656484">severe acute respiratory syndrome coronavirus 2</SupplMeshName></SupplMeshList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>Ann Rheum Dis. 2020 Sep;79(9):1129-1131</RefSource><PMID Version="1">32753413</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D061067" MajorTopicYN="N">Antibodies, Monoclonal, Humanized</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000073640" MajorTopicYN="Y">Betacoronavirus</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002097" MajorTopicYN="N">C-Reactive Protein</DescriptorName><QualifierName UI="Q000032" MajorTopicYN="N">analysis</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018352" MajorTopicYN="N">Coronavirus Infections</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName><QualifierName UI="Q000150" MajorTopicYN="N">complications</QualifierName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000821" MajorTopicYN="N">virology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000080424" MajorTopicYN="N">Cytokine Release Syndrome</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000821" MajorTopicYN="N">virology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016207" MajorTopicYN="N">Cytokines</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005293" MajorTopicYN="N">Ferritins</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005338" MajorTopicYN="N">Fibrin Fibrinogen Degradation Products</DescriptorName><QualifierName UI="Q000032" MajorTopicYN="N">analysis</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005938" MajorTopicYN="N">Glucocorticoids</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D065386" MajorTopicYN="N">Historically Controlled Study</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D058873" MajorTopicYN="N">Pandemics</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011024" MajorTopicYN="N">Pneumonia, Viral</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName><QualifierName UI="Q000150" MajorTopicYN="N">complications</QualifierName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000821" MajorTopicYN="N">virology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011446" MajorTopicYN="N">Prospective Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D059039" MajorTopicYN="N">Standard of Care</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">biological therapy</Keyword><Keyword MajorTopicYN="Y">cytokines</Keyword><Keyword MajorTopicYN="Y">epidemiology</Keyword><Keyword MajorTopicYN="Y">glucocorticoids</Keyword></KeywordList><CoiStatement>Competing interests: SR reports personal fees from AbbVie, personal fees from Eli Lilly, grants and personal fees from MSD, personal fees from Novartis, personal fees from UCB, personal fees from Sanofi, outside the submitted work. RLMM reports personal fees from Boehringer Ingelheim, personal fees from Roche, personal fees from Galapagos, outside the submitted work. CMC is a clinical trial investigator for a study sponsored by Lilly and was a subinvestigator for a study sponsored by GSK. CvD reports personal fees from Novartis, personal fees from Roche, outside the submitted work. TD reports grants from Adrenomed, grants from Inotrem, grants from Roche, grants from Shionogi and Co, other from CASTOR, outside the submitted work. MG reports personal fees from Roche, personal fees from MSD, outside the submitted work. MdK reports personal fees from ALK, personal fees from AstraZeneca, personal fees from Boehringer Ingelheim, personal fees from Sanofi Genzyme, outside the submitted work. ML reports grants from AstraZeneca, grants from Pfizer, personal fees from Roche, outside the submitted work. RP reports grants and personal fees from Pfizer, grants and personal fees from AbbVie, outside the submitted work. RL reports personal fees from AbbVie, personal fees from BMS, personal fees from Galapagos, personal fees from Gilead, personal fees from Jansen, personal fees from Novartis, personal fees from Pfizer, personal fees from Roche, personal fees from UCB, outside the submitted work; and owner and director of Rheumatology Consultancy, a company that provides consultancy and read services for clinical trials.</CoiStatement></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>07</Month><Day>01</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2020</Year><Month>07</Month><Day>11</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>07</Month><Day>13</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>7</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>9</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>7</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">32719045</ArticleId><ArticleId IdType="pii">annrheumdis-2020-218479</ArticleId><ArticleId IdType="doi">10.1136/annrheumdis-2020-218479</ArticleId><ArticleId IdType="pmc">PMC7456552</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>N Engl J Med. 2020 May 7;382(19):1787-1799</Citation><ArticleIdList><ArticleId IdType="pubmed">32187464</ArticleId></ArticleIdList></Reference><Reference><Citation>Arthritis Rheumatol. 2020 Jul;72(7):1059-1063</Citation><ArticleIdList><ArticleId IdType="pubmed">32293098</ArticleId></ArticleIdList></Reference><Reference><Citation>Lancet. 2020 Mar 28;395(10229):1054-1062</Citation><ArticleIdList><ArticleId IdType="pubmed">32171076</ArticleId></ArticleIdList></Reference><Reference><Citation>Lancet. 2020 May 2;395(10234):1407-1409</Citation><ArticleIdList><ArticleId IdType="pubmed">32278362</ArticleId></ArticleIdList></Reference><Reference><Citation>Science. 2020 May 1;368(6490):473-474</Citation><ArticleIdList><ArticleId IdType="pubmed">32303591</ArticleId></ArticleIdList></Reference><Reference><Citation>Ann Rheum Dis. 2020 Jul;79(7):851-858</Citation><ArticleIdList><ArticleId IdType="pubmed">32503854</ArticleId></ArticleIdList></Reference><Reference><Citation>Radiology. 2020 Aug;296(2):E97-E104</Citation><ArticleIdList><ArticleId IdType="pubmed">32339082</ArticleId></ArticleIdList></Reference><Reference><Citation>Lancet Rheumatol. 2020 Jul;2(7):e393-e400</Citation><ArticleIdList><ArticleId IdType="pubmed">32835245</ArticleId></ArticleIdList></Reference><Reference><Citation>Annu Rev Med. 2012;63:233-46</Citation><ArticleIdList><ArticleId IdType="pubmed">22248322</ArticleId></ArticleIdList></Reference><Reference><Citation>JAMA Intern Med. 2020 Jul 1;180(7):934-943</Citation><ArticleIdList><ArticleId IdType="pubmed">32167524</ArticleId></ArticleIdList></Reference><Reference><Citation>Lancet. 2020 Mar 28;395(10229):1033-1034</Citation><ArticleIdList><ArticleId IdType="pubmed">32192578</ArticleId></ArticleIdList></Reference><Reference><Citation>Annu Rev Public Health. 1991;12:425-57</Citation><ArticleIdList><ArticleId IdType="pubmed">2049144</ArticleId></ArticleIdList></Reference><Reference><Citation>Lancet. 2020 May 16;395(10236):1569-1578</Citation><ArticleIdList><ArticleId IdType="pubmed">32423584</ArticleId></ArticleIdList></Reference><Reference><Citation>Lancet Rheumatol. 2020 Jun;2(6):e325-e331</Citation><ArticleIdList><ArticleId IdType="pubmed">32501454</ArticleId></ArticleIdList></Reference><Reference><Citation>Leukemia. 2020 Jun;34(6):1503-1511</Citation><ArticleIdList><ArticleId IdType="pubmed">32372026</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>Oman</li><li>Pays-Bas</li></country><region><li>Hollande-Septentrionale</li></region><settlement><li>Amsterdam</li></settlement></list><tree><country name="Oman"><noRegion><name sortKey="Ramiro, Sofia" sort="Ramiro, Sofia" uniqKey="Ramiro S" first="Sofia" last="Ramiro">Sofia Ramiro</name></noRegion></country><country name="Pays-Bas"><noRegion><name sortKey="Ramiro, Sofia" sort="Ramiro, Sofia" uniqKey="Ramiro S" first="Sofia" last="Ramiro">Sofia Ramiro</name></noRegion><name sortKey="Buijs, Jacqueline" sort="Buijs, Jacqueline" uniqKey="Buijs J" first="Jacqueline" last="Buijs">Jacqueline Buijs</name><name sortKey="De Kruif, Martijn D" sort="De Kruif, Martijn D" uniqKey="De Kruif M" first="Martijn D" last="De Kruif">Martijn D. De Kruif</name><name sortKey="Dormans, Tom" sort="Dormans, Tom" uniqKey="Dormans T" first="Tom" last="Dormans">Tom Dormans</name><name sortKey="Gronenschild, Michiel" sort="Gronenschild, Michiel" uniqKey="Gronenschild M" first="Michiel" last="Gronenschild">Michiel Gronenschild</name><name sortKey="Landewe, Robert B M" sort="Landewe, Robert B M" uniqKey="Landewe R" first="Robert B M" last="Landewé">Robert B M. Landewé</name><name sortKey="Landewe, Robert B M" sort="Landewe, Robert B M" uniqKey="Landewe R" first="Robert B M" last="Landewé">Robert B M. Landewé</name><name sortKey="Leers, Mathie P G" sort="Leers, Mathie P G" uniqKey="Leers M" first="Mathie P G" last="Leers">Mathie P G. Leers</name><name sortKey="Magro Checa, Cesar" sort="Magro Checa, Cesar" uniqKey="Magro Checa C" first="César" last="Magro-Checa">César Magro-Checa</name><name sortKey="Mostard, Remy L M" sort="Mostard, Remy L M" uniqKey="Mostard R" first="Rémy L M" last="Mostard">Rémy L M. Mostard</name><name sortKey="Peeters, Ralph" sort="Peeters, Ralph" uniqKey="Peeters R" first="Ralph" last="Peeters">Ralph Peeters</name><name sortKey="Van Dongen, Christel M P" sort="Van Dongen, Christel M P" uniqKey="Van Dongen C" first="Christel M P" last="Van Dongen">Christel M P. Van Dongen</name><name sortKey="Van Haren, Eric H J" sort="Van Haren, Eric H J" uniqKey="Van Haren E" first="Eric H J" last="Van Haren">Eric H J. Van Haren</name><name sortKey="Van Kraaij, Tom" sort="Van Kraaij, Tom" uniqKey="Van Kraaij T" first="Tom" last="Van Kraaij">Tom Van Kraaij</name><name sortKey="Wong, Dennis R" sort="Wong, Dennis R" uniqKey="Wong D" first="Dennis R" last="Wong">Dennis R. Wong</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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