Observational study on off-label use of tocilizumab in patients with severe COVID-19.
Identifieur interne : 000A34 ( Main/Exploration ); précédent : 000A33; suivant : 000A35Observational study on off-label use of tocilizumab in patients with severe COVID-19.
Auteurs : Laetitia Albertini [Oman] ; Mickael Soletchnik [France] ; Anais Razurel [France] ; Johana Cohen [France] ; Frédéric Bidegain [France] ; Francis Fauvelle [France] ; Geoffroy Safrano [France] ; Jacques Piquet [France] ; Cyril Maurer [France] ; Dany Goldgran-Toledano [France]Source :
- European journal of hospital pharmacy : science and practice [ 2047-9956 ] ; 2020.
Abstract
BACKGROUND
In December 2019 a novel coronavirus designated SARS-CoV-2 was identified, and the disease COVID-19 has caused many deaths. SARS-CoV-2 infection has been associated with the development of cytokine storm (including interleukin 6 (IL-6)), which can cause lung damage and lack of oxygen. Tocilizumab (TCZ) inhibits ligand binding to the IL-6 receptor and may be a potential treatment for the hyperinflammation symptoms of COVID-19. However, data regarding the efficacy of TCZ in COVID-19 are lacking. The rapid spread of the pandemic in France, especially in the Paris region, constrained us to the off-label use of TCZ in patients with severe clinical conditions.
METHODS
A single-centre observational cohort study of 44 patients infected with COVID-19 was carried out between 6 April and 21 April 2020 in Groupe Hospitalier Intercommunal Le Raincy-Montfermeil (GHILRM). Twenty-two patients diagnosed with COVID-19 were treated with TCZ and were compared with 22 patients not treated with TCZ matched for age, gender and length of hospital stay for COVID-19. Respiratory rate and oxygen supplementation as well as laboratory parameters (such as C-reactive protein (CRP), aspartate aminotransferase and alanine aminotransferase) were collected at baseline and during 14 days of follow-up. Our primary objective was to assess the efficacy of TCZ on respiratory clinical conditions.
FINDINGS
The average respiratory rate was lower in the TCZ group than in the control group (21.5 vs 25.5 breaths/min at day 14, 95% CI -7
INTERPRETATION
There was a significant difference in the respiratory rate on day 14 of follow-up, with a greater decrease observed in the treated group. Fewer patients required mechanical ventilation in the TCZ group, especially among patients with more extensive CT lung damage, than in the control group. The same number of patients were weaned off oxygen on day 14 in the two groups, while the patients in the TCZ group had more severe impairment at inclusion. We consider that TCZ showed significant control of the biological inflammatory syndrome, suggesting that it may limit the effect of the cytokine storm. Our study seems to indicate the efficacy of TCZ, particularly in patients with severe initial pulmonary impairment. Selecting the best candidates and the best timing for TCZ therapy needs to be determined in randomised clinical trials.
DOI: 10.1136/ejhpharm-2020-002414
PubMed: 32912961
Affiliations:
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last="Albertini">Laetitia Albertini</name><affiliation wicri:level="1"><nlm:affiliation>Pharmacist, Montfermeil, France albertini.laetitia@gmail.com.</nlm:affiliation><country wicri:rule="url">Oman</country><wicri:regionArea>Pharmacist, Montfermeil</wicri:regionArea><wicri:noRegion>Montfermeil</wicri:noRegion></affiliation></author><author><name sortKey="Soletchnik, Mickael" sort="Soletchnik, Mickael" uniqKey="Soletchnik M" first="Mickael" last="Soletchnik">Mickael Soletchnik</name><affiliation wicri:level="1"><nlm:affiliation>Emergency, Montfermeil, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Emergency, Montfermeil</wicri:regionArea><wicri:noRegion>Montfermeil</wicri:noRegion><wicri:noRegion>Montfermeil</wicri:noRegion></affiliation></author><author><name sortKey="Razurel, Anais" sort="Razurel, Anais" uniqKey="Razurel A" first="Anais" last="Razurel">Anais Razurel</name><affiliation wicri:level="1"><nlm:affiliation>Pharmacist, CH Saint Denis, Saint Denis, Île-de-France, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pharmacist, CH Saint Denis, Saint Denis, Île-de-France</wicri:regionArea><wicri:noRegion>Île-de-France</wicri:noRegion><wicri:noRegion>Île-de-France</wicri:noRegion></affiliation></author><author><name sortKey="Cohen, Johana" sort="Cohen, Johana" uniqKey="Cohen J" first="Johana" last="Cohen">Johana Cohen</name><affiliation wicri:level="1"><nlm:affiliation>Intensive care, Montfermeil, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Intensive care, Montfermeil</wicri:regionArea><wicri:noRegion>Montfermeil</wicri:noRegion><wicri:noRegion>Montfermeil</wicri:noRegion></affiliation></author><author><name sortKey="Bidegain, Frederic" sort="Bidegain, Frederic" uniqKey="Bidegain F" first="Frédéric" last="Bidegain">Frédéric Bidegain</name><affiliation wicri:level="1"><nlm:affiliation>Infectious diseases, Montfermeil, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Infectious diseases, Montfermeil</wicri:regionArea><wicri:noRegion>Montfermeil</wicri:noRegion><wicri:noRegion>Montfermeil</wicri:noRegion></affiliation></author><author><name sortKey="Fauvelle, Francis" sort="Fauvelle, Francis" uniqKey="Fauvelle F" first="Francis" last="Fauvelle">Francis Fauvelle</name><affiliation wicri:level="1"><nlm:affiliation>Pharmacy, Montfermeil, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pharmacy, Montfermeil</wicri:regionArea><wicri:noRegion>Montfermeil</wicri:noRegion><wicri:noRegion>Montfermeil</wicri:noRegion></affiliation></author><author><name sortKey="Safrano, Geoffroy" sort="Safrano, Geoffroy" uniqKey="Safrano G" first="Geoffroy" last="Safrano">Geoffroy Safrano</name><affiliation wicri:level="1"><nlm:affiliation>Emergency, Montfermeil, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Emergency, Montfermeil</wicri:regionArea><wicri:noRegion>Montfermeil</wicri:noRegion><wicri:noRegion>Montfermeil</wicri:noRegion></affiliation></author><author><name sortKey="Piquet, Jacques" sort="Piquet, Jacques" uniqKey="Piquet J" first="Jacques" last="Piquet">Jacques Piquet</name><affiliation wicri:level="1"><nlm:affiliation>Pneumology, Montfermeil, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pneumology, Montfermeil</wicri:regionArea><wicri:noRegion>Montfermeil</wicri:noRegion><wicri:noRegion>Montfermeil</wicri:noRegion></affiliation></author><author><name sortKey="Maurer, Cyril" sort="Maurer, Cyril" uniqKey="Maurer C" first="Cyril" last="Maurer">Cyril Maurer</name><affiliation wicri:level="1"><nlm:affiliation>Pneumology, Montfermeil, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pneumology, Montfermeil</wicri:regionArea><wicri:noRegion>Montfermeil</wicri:noRegion><wicri:noRegion>Montfermeil</wicri:noRegion></affiliation></author><author><name sortKey="Goldgran Toledano, Dany" sort="Goldgran Toledano, Dany" uniqKey="Goldgran Toledano D" first="Dany" last="Goldgran-Toledano">Dany Goldgran-Toledano</name><affiliation wicri:level="1"><nlm:affiliation>Intensive care, Montfermeil, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Intensive care, Montfermeil</wicri:regionArea><wicri:noRegion>Montfermeil</wicri:noRegion><wicri:noRegion>Montfermeil</wicri:noRegion></affiliation></author></analytic><series><title level="j">European journal of hospital pharmacy : science and practice</title><idno type="ISSN">2047-9956</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>In December 2019 a novel coronavirus designated SARS-CoV-2 was identified, and the disease COVID-19 has caused many deaths. SARS-CoV-2 infection has been associated with the development of cytokine storm (including interleukin 6 (IL-6)), which can cause lung damage and lack of oxygen. Tocilizumab (TCZ) inhibits ligand binding to the IL-6 receptor and may be a potential treatment for the hyperinflammation symptoms of COVID-19. However, data regarding the efficacy of TCZ in COVID-19 are lacking. The rapid spread of the pandemic in France, especially in the Paris region, constrained us to the off-label use of TCZ in patients with severe clinical conditions.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>A single-centre observational cohort study of 44 patients infected with COVID-19 was carried out between 6 April and 21 April 2020 in Groupe Hospitalier Intercommunal Le Raincy-Montfermeil (GHILRM). Twenty-two patients diagnosed with COVID-19 were treated with TCZ and were compared with 22 patients not treated with TCZ matched for age, gender and length of hospital stay for COVID-19. Respiratory rate and oxygen supplementation as well as laboratory parameters (such as C-reactive protein (CRP), aspartate aminotransferase and alanine aminotransferase) were collected at baseline and during 14 days of follow-up. Our primary objective was to assess the efficacy of TCZ on respiratory clinical conditions.</p></div><div type="abstract" xml:lang="en"><p><b>FINDINGS</b></p><p>The average respiratory rate was lower in the TCZ group than in the control group (21.5 vs 25.5 breaths/min at day 14, 95% CI -7</p></div><div type="abstract" xml:lang="en"><p><b>INTERPRETATION</b></p><p>There was a significant difference in the respiratory rate on day 14 of follow-up, with a greater decrease observed in the treated group. Fewer patients required mechanical ventilation in the TCZ group, especially among patients with more extensive CT lung damage, than in the control group. The same number of patients were weaned off oxygen on day 14 in the two groups, while the patients in the TCZ group had more severe impairment at inclusion. We consider that TCZ showed significant control of the biological inflammatory syndrome, suggesting that it may limit the effect of the cytokine storm. Our study seems to indicate the efficacy of TCZ, particularly in patients with severe initial pulmonary impairment. Selecting the best candidates and the best timing for TCZ therapy needs to be determined in randomised clinical trials.</p></div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">32912961</PMID><DateRevised><Year>2020</Year><Month>09</Month><Day>11</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Print">2047-9956</ISSN><JournalIssue CitedMedium="Print"><PubDate><Year>2020</Year><Month>Sep</Month><Day>10</Day></PubDate></JournalIssue><Title>European journal of hospital pharmacy : science and practice</Title><ISOAbbreviation>Eur J Hosp Pharm</ISOAbbreviation></Journal><ArticleTitle>Observational study on off-label use of tocilizumab in patients with severe COVID-19.</ArticleTitle><ELocationID EIdType="pii" ValidYN="Y">ejhpharm-2020-002414</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1136/ejhpharm-2020-002414</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">In December 2019 a novel coronavirus designated SARS-CoV-2 was identified, and the disease COVID-19 has caused many deaths. SARS-CoV-2 infection has been associated with the development of cytokine storm (including interleukin 6 (IL-6)), which can cause lung damage and lack of oxygen. Tocilizumab (TCZ) inhibits ligand binding to the IL-6 receptor and may be a potential treatment for the hyperinflammation symptoms of COVID-19. However, data regarding the efficacy of TCZ in COVID-19 are lacking. The rapid spread of the pandemic in France, especially in the Paris region, constrained us to the off-label use of TCZ in patients with severe clinical conditions.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">A single-centre observational cohort study of 44 patients infected with COVID-19 was carried out between 6 April and 21 April 2020 in Groupe Hospitalier Intercommunal Le Raincy-Montfermeil (GHILRM). Twenty-two patients diagnosed with COVID-19 were treated with TCZ and were compared with 22 patients not treated with TCZ matched for age, gender and length of hospital stay for COVID-19. Respiratory rate and oxygen supplementation as well as laboratory parameters (such as C-reactive protein (CRP), aspartate aminotransferase and alanine aminotransferase) were collected at baseline and during 14 days of follow-up. Our primary objective was to assess the efficacy of TCZ on respiratory clinical conditions.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">The average respiratory rate was lower in the TCZ group than in the control group (21.5 vs 25.5 breaths/min at day 14, 95% CI -7<i>.</i>5 to -0<i>.</i>4; p=0.03). Treated patients tended to be intubated less during the course of the disease (2/22 vs 6/22, 95% CI -0<i>.</i>4 to 0<i>.</i>1; p=0.12). In each group, 10 patients no longer required oxygen therapy. We found a significant decrease in CRP in treated patients on day 7 (p=0.04). TCZ caused cytolysis in more than half (14/22) of the patients but without clinical impact.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">There was a significant difference in the respiratory rate on day 14 of follow-up, with a greater decrease observed in the treated group. Fewer patients required mechanical ventilation in the TCZ group, especially among patients with more extensive CT lung damage, than in the control group. The same number of patients were weaned off oxygen on day 14 in the two groups, while the patients in the TCZ group had more severe impairment at inclusion. We consider that TCZ showed significant control of the biological inflammatory syndrome, suggesting that it may limit the effect of the cytokine storm. Our study seems to indicate the efficacy of TCZ, particularly in patients with severe initial pulmonary impairment. Selecting the best candidates and the best timing for TCZ therapy needs to be determined in randomised clinical trials.</AbstractText><CopyrightInformation>© European Association of Hospital Pharmacists 2020. No commercial re-use. See rights and permissions. Published by BMJ.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Albertini</LastName><ForeName>Laetitia</ForeName><Initials>L</Initials><Identifier Source="ORCID">http://orcid.org/0000-0001-7184-4639</Identifier><AffiliationInfo><Affiliation>Pharmacist, Montfermeil, France albertini.laetitia@gmail.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Soletchnik</LastName><ForeName>Mickael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Emergency, Montfermeil, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Razurel</LastName><ForeName>Anais</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Pharmacist, CH Saint Denis, Saint Denis, Île-de-France, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cohen</LastName><ForeName>Johana</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Intensive care, Montfermeil, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bidegain</LastName><ForeName>Frédéric</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Infectious diseases, Montfermeil, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fauvelle</LastName><ForeName>Francis</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Pharmacy, Montfermeil, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Safrano</LastName><ForeName>Geoffroy</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Emergency, Montfermeil, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Piquet</LastName><ForeName>Jacques</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Pneumology, Montfermeil, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Maurer</LastName><ForeName>Cyril</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Pneumology, Montfermeil, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Goldgran-Toledano</LastName><ForeName>Dany</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Intensive care, Montfermeil, France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>09</Month><Day>10</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Eur J Hosp Pharm</MedlineTA><NlmUniqueID>101578294</NlmUniqueID><ISSNLinking>2047-9956</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">clinical medicine</Keyword><Keyword MajorTopicYN="N">critical care</Keyword><Keyword MajorTopicYN="N">pharmaceutical preparations</Keyword><Keyword MajorTopicYN="N">pulmonary medicine</Keyword><Keyword MajorTopicYN="N">virology</Keyword></KeywordList><CoiStatement>Competing interests: None declared.</CoiStatement></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>06</Month><Day>15</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2020</Year><Month>08</Month><Day>17</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>08</Month><Day>18</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>9</Month><Day>11</Day><Hour>5</Hour><Minute>39</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>9</Month><Day>12</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>9</Month><Day>12</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>aheadofprint</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">32912961</ArticleId><ArticleId 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Fauvelle</name><name sortKey="Goldgran Toledano, Dany" sort="Goldgran Toledano, Dany" uniqKey="Goldgran Toledano D" first="Dany" last="Goldgran-Toledano">Dany Goldgran-Toledano</name><name sortKey="Maurer, Cyril" sort="Maurer, Cyril" uniqKey="Maurer C" first="Cyril" last="Maurer">Cyril Maurer</name><name sortKey="Piquet, Jacques" sort="Piquet, Jacques" uniqKey="Piquet J" first="Jacques" last="Piquet">Jacques Piquet</name><name sortKey="Razurel, Anais" sort="Razurel, Anais" uniqKey="Razurel A" first="Anais" last="Razurel">Anais Razurel</name><name sortKey="Safrano, Geoffroy" sort="Safrano, Geoffroy" uniqKey="Safrano G" first="Geoffroy" last="Safrano">Geoffroy Safrano</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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