Safety of tocilizumab in COVID-19 pregnant women and their newborn: A retrospective study.
Identifieur interne : 000152 ( Main/Exploration ); précédent : 000151; suivant : 000153Safety of tocilizumab in COVID-19 pregnant women and their newborn: A retrospective study.
Auteurs : Inés Jiménez-Lozano [Espagne] ; José Manuel Caro-Teller [Espagne] ; Nuria Fernández-Hidalgo [Espagne] ; Marta Miarons [Espagne] ; Marie Antoinette Frick [Espagne] ; Emma Batllori Badia [Espagne] ; Berta Serrano [Espagne] ; Carlos Javier Parramon-Teixid [Espagne] ; Fátima Camba-Longueira [Espagne] ; Maria Teresa Moral-Pumarega [Espagne] ; Rafael San Juan-Garrido [Espagne] ; Maria Josep Caba As Poy [Espagne] ; Anna Suy [Espagne] ; Maria Queralt Gorgas Torner [Espagne]Source :
- Journal of clinical pharmacy and therapeutics [ 1365-2710 ] ; 2021.
Abstract
WHAT IS KNOWN AND OBJECTIVE
Tocilizumab is an IL-6 receptor inhibitor agent which has been proposed as a candidate to stop the inflammatory phase of infection by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). However, safety data of tocilizumab in pregnant women and their newborn are scarce. We aimed to describe maternal and neonatal safety outcomes associated with tocilizumab treatment in pregnant women with severe COVID-19.
METHODS
This is a retrospective study of severe COVID-19 pregnant women, treated with tocilizumab in two Spanish hospitals between 1 March and 31 April 2020. Demographics, medical history, clinical and radiologic findings, treatment information and laboratory data of mothers and their newborns were collected from electronic medical records.
RESULTS AND DISCUSSION
A total of 12 pregnant women were identified to have received tocilizumab during pregnancy in the two hospitals. Median gestational age at admission was 27.7 weeks (interquartile range, 18.0-36.4). Most of them received lopinavir/ritonavir, azithromycin and hydroxychloroquine, two patients received corticosteroids and one received interferon beta 1B. All 12 pregnancies resulted in live births. Somatometric values were normal for all newborns, and evolution at 14 and 28 days was favourable for all of them. Hepatotoxicity was observed in 2 patients, which improved or resolved at discharge. Cytomegalovirus reactivation was detected in another patient who had also received corticosteroids for 15 days, causing a congenital infection in her newborn. Both hepatotoxicity and viral reactivation adverse events were classified as possibly related to tocilizumab administration according to Naranjo's causality algorithm.
WHAT IS NEW AND CONCLUSIONS
It does not appear that tocilizumab has detrimental effects for the mother and newborn. Close monitoring of infections should be considered, especially if other immunosuppressive agents are used.
DOI: 10.1111/jcpt.13394
PubMed: 33638257
PubMed Central: PMC8014796
Affiliations:
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Hospital, Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Pharmacy Department. Hospital, Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid</wicri:regionArea><placeName><settlement type="city">Madrid</settlement><region nuts="2" type="region">Communauté de Madrid</region></placeName></affiliation></author><author><name sortKey="Fernandez Hidalgo, Nuria" sort="Fernandez Hidalgo, Nuria" uniqKey="Fernandez Hidalgo N" first="Nuria" last="Fernández-Hidalgo">Nuria Fernández-Hidalgo</name><affiliation wicri:level="3"><nlm:affiliation>Pediatric Infectious Diseases and Primary Immunodeficiencies Unit, Pediatrics Department, Vall d´hebron Hospital, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Pediatric Infectious Diseases and Primary Immunodeficiencies Unit, Pediatrics Department, Vall d´hebron Hospital, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name 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type="city">Madrid</settlement><region nuts="2" type="region">Communauté de Madrid</region></placeName></affiliation></author><author><name sortKey="Serrano, Berta" sort="Serrano, Berta" uniqKey="Serrano B" first="Berta" last="Serrano">Berta Serrano</name><affiliation wicri:level="3"><nlm:affiliation>Department of Obstetrics and Gynecology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Department of Obstetrics and Gynecology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Parramon Teixid, Carlos Javier" sort="Parramon Teixid, Carlos Javier" uniqKey="Parramon Teixid C" first="Carlos Javier" last="Parramon-Teixid">Carlos Javier 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Madrid</region></placeName></affiliation></author><author><name sortKey="San Juan Garrido, Rafael" sort="San Juan Garrido, Rafael" uniqKey="San Juan Garrido R" first="Rafael" last="San Juan-Garrido">Rafael San Juan-Garrido</name><affiliation wicri:level="3"><nlm:affiliation>Unit of Infectious Diseases, Hospital Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Unit of Infectious Diseases, Hospital Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid</wicri:regionArea><placeName><settlement type="city">Madrid</settlement><region nuts="2" type="region">Communauté de Madrid</region></placeName></affiliation></author><author><name sortKey="Caba As Poy, Maria Josep" sort="Caba As Poy, Maria Josep" uniqKey="Caba As Poy M" first="Maria Josep" last="Caba As Poy">Maria Josep Caba As Poy</name><affiliation wicri:level="3"><nlm:affiliation>Pharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Pharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Suy, Anna" sort="Suy, Anna" uniqKey="Suy A" first="Anna" last="Suy">Anna Suy</name><affiliation wicri:level="3"><nlm:affiliation>Department of Obstetrics and Gynecology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Department of Obstetrics and Gynecology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Gorgas Torner, Maria Queralt" sort="Gorgas Torner, Maria Queralt" uniqKey="Gorgas Torner M" first="Maria Queralt" last="Gorgas Torner">Maria Queralt Gorgas Torner</name><affiliation wicri:level="3"><nlm:affiliation>Pharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Pharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2021">2021</date><idno type="RBID">pubmed:33638257</idno><idno type="pmid">33638257</idno><idno type="doi">10.1111/jcpt.13394</idno><idno type="pmc">PMC8014796</idno><idno type="wicri:Area/Main/Corpus">000303</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000303</idno><idno type="wicri:Area/Main/Curation">000303</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000303</idno><idno type="wicri:Area/Main/Exploration">000303</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Safety of tocilizumab in COVID-19 pregnant women and their newborn: A retrospective study.</title><author><name sortKey="Jimenez Lozano, Ines" sort="Jimenez Lozano, Ines" uniqKey="Jimenez Lozano I" first="Inés" last="Jiménez-Lozano">Inés Jiménez-Lozano</name><affiliation wicri:level="3"><nlm:affiliation>Pharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Pharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Caro Teller, Jose Manuel" sort="Caro Teller, Jose Manuel" uniqKey="Caro Teller J" first="José Manuel" last="Caro-Teller">José Manuel Caro-Teller</name><affiliation wicri:level="3"><nlm:affiliation>Pharmacy Department. Hospital, Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Pharmacy Department. Hospital, Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid</wicri:regionArea><placeName><settlement type="city">Madrid</settlement><region nuts="2" type="region">Communauté de Madrid</region></placeName></affiliation></author><author><name sortKey="Fernandez Hidalgo, Nuria" sort="Fernandez Hidalgo, Nuria" uniqKey="Fernandez Hidalgo N" first="Nuria" last="Fernández-Hidalgo">Nuria Fernández-Hidalgo</name><affiliation wicri:level="3"><nlm:affiliation>Pediatric Infectious Diseases and Primary Immunodeficiencies Unit, Pediatrics Department, Vall d´hebron Hospital, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Pediatric Infectious Diseases and Primary Immunodeficiencies Unit, Pediatrics Department, Vall d´hebron Hospital, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Miarons, Marta" sort="Miarons, Marta" uniqKey="Miarons M" first="Marta" last="Miarons">Marta Miarons</name><affiliation wicri:level="3"><nlm:affiliation>Pharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Pharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Frick, Marie Antoinette" sort="Frick, Marie Antoinette" uniqKey="Frick M" first="Marie Antoinette" last="Frick">Marie Antoinette Frick</name><affiliation wicri:level="3"><nlm:affiliation>Pediatric Infectious Diseases and Primary Immunodeficiencies Unit, Pediatrics Department, Vall d´hebron Hospital, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Pediatric Infectious Diseases and Primary Immunodeficiencies Unit, Pediatrics Department, Vall d´hebron Hospital, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Batllori Badia, Emma" sort="Batllori Badia, Emma" uniqKey="Batllori Badia E" first="Emma" last="Batllori Badia">Emma Batllori Badia</name><affiliation wicri:level="3"><nlm:affiliation>Unit of perinatal medicine, Obstetric and Gynaecology Department, Hospital Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Unit of perinatal medicine, Obstetric and Gynaecology Department, Hospital Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid</wicri:regionArea><placeName><settlement type="city">Madrid</settlement><region nuts="2" type="region">Communauté de Madrid</region></placeName></affiliation></author><author><name sortKey="Serrano, Berta" sort="Serrano, Berta" uniqKey="Serrano B" first="Berta" last="Serrano">Berta Serrano</name><affiliation wicri:level="3"><nlm:affiliation>Department of Obstetrics and Gynecology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Department of Obstetrics and Gynecology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Parramon Teixid, Carlos Javier" sort="Parramon Teixid, Carlos Javier" uniqKey="Parramon Teixid C" first="Carlos Javier" last="Parramon-Teixid">Carlos Javier Parramon-Teixid</name><affiliation wicri:level="3"><nlm:affiliation>Pharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Pharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Camba Longueira, Fatima" sort="Camba Longueira, Fatima" uniqKey="Camba Longueira F" first="Fátima" last="Camba-Longueira">Fátima Camba-Longueira</name><affiliation wicri:level="3"><nlm:affiliation>Department of Neonatology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Department of Neonatology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Moral Pumarega, Maria Teresa" sort="Moral Pumarega, Maria Teresa" uniqKey="Moral Pumarega M" first="Maria Teresa" last="Moral-Pumarega">Maria Teresa Moral-Pumarega</name><affiliation wicri:level="3"><nlm:affiliation>Unit of perinatal medicine, Obstetric and Gynaecology Department, Hospital Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Unit of perinatal medicine, Obstetric and Gynaecology Department, Hospital Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid</wicri:regionArea><placeName><settlement type="city">Madrid</settlement><region nuts="2" type="region">Communauté de Madrid</region></placeName></affiliation></author><author><name sortKey="San Juan Garrido, Rafael" sort="San Juan Garrido, Rafael" uniqKey="San Juan Garrido R" first="Rafael" last="San Juan-Garrido">Rafael San Juan-Garrido</name><affiliation wicri:level="3"><nlm:affiliation>Unit of Infectious Diseases, Hospital Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Unit of Infectious Diseases, Hospital Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid</wicri:regionArea><placeName><settlement type="city">Madrid</settlement><region nuts="2" type="region">Communauté de Madrid</region></placeName></affiliation></author><author><name sortKey="Caba As Poy, Maria Josep" sort="Caba As Poy, Maria Josep" uniqKey="Caba As Poy M" first="Maria Josep" last="Caba As Poy">Maria Josep Caba As Poy</name><affiliation wicri:level="3"><nlm:affiliation>Pharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Pharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Suy, Anna" sort="Suy, Anna" uniqKey="Suy A" first="Anna" last="Suy">Anna Suy</name><affiliation wicri:level="3"><nlm:affiliation>Department of Obstetrics and Gynecology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Department of Obstetrics and Gynecology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Gorgas Torner, Maria Queralt" sort="Gorgas Torner, Maria Queralt" uniqKey="Gorgas Torner M" first="Maria Queralt" last="Gorgas Torner">Maria Queralt Gorgas Torner</name><affiliation wicri:level="3"><nlm:affiliation>Pharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Pharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author></analytic><series><title level="j">Journal of clinical pharmacy and therapeutics</title><idno type="eISSN">1365-2710</idno><imprint><date when="2021" type="published">2021</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>WHAT IS KNOWN AND OBJECTIVE</b></p><p>Tocilizumab is an IL-6 receptor inhibitor agent which has been proposed as a candidate to stop the inflammatory phase of infection by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). However, safety data of tocilizumab in pregnant women and their newborn are scarce. We aimed to describe maternal and neonatal safety outcomes associated with tocilizumab treatment in pregnant women with severe COVID-19.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>This is a retrospective study of severe COVID-19 pregnant women, treated with tocilizumab in two Spanish hospitals between 1 March and 31 April 2020. Demographics, medical history, clinical and radiologic findings, treatment information and laboratory data of mothers and their newborns were collected from electronic medical records.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS AND DISCUSSION</b></p><p>A total of 12 pregnant women were identified to have received tocilizumab during pregnancy in the two hospitals. Median gestational age at admission was 27.7 weeks (interquartile range, 18.0-36.4). Most of them received lopinavir/ritonavir, azithromycin and hydroxychloroquine, two patients received corticosteroids and one received interferon beta 1B. All 12 pregnancies resulted in live births. Somatometric values were normal for all newborns, and evolution at 14 and 28 days was favourable for all of them. Hepatotoxicity was observed in 2 patients, which improved or resolved at discharge. Cytomegalovirus reactivation was detected in another patient who had also received corticosteroids for 15 days, causing a congenital infection in her newborn. Both hepatotoxicity and viral reactivation adverse events were classified as possibly related to tocilizumab administration according to Naranjo's causality algorithm.</p></div><div type="abstract" xml:lang="en"><p><b>WHAT IS NEW AND CONCLUSIONS</b></p><p>It does not appear that tocilizumab has detrimental effects for the mother and newborn. Close monitoring of infections should be considered, especially if other immunosuppressive agents are used.</p></div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">33638257</PMID><DateRevised><Year>2021</Year><Month>04</Month><Day>02</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1365-2710</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2021</Year><Month>Feb</Month><Day>26</Day></PubDate></JournalIssue><Title>Journal of clinical pharmacy and therapeutics</Title><ISOAbbreviation>J Clin Pharm Ther</ISOAbbreviation></Journal><ArticleTitle>Safety of tocilizumab in COVID-19 pregnant women and their newborn: A retrospective study.</ArticleTitle><ELocationID EIdType="doi" ValidYN="Y">10.1111/jcpt.13394</ELocationID><Abstract><AbstractText Label="WHAT IS KNOWN AND OBJECTIVE" NlmCategory="OBJECTIVE">Tocilizumab is an IL-6 receptor inhibitor agent which has been proposed as a candidate to stop the inflammatory phase of infection by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). However, safety data of tocilizumab in pregnant women and their newborn are scarce. We aimed to describe maternal and neonatal safety outcomes associated with tocilizumab treatment in pregnant women with severe COVID-19.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">This is a retrospective study of severe COVID-19 pregnant women, treated with tocilizumab in two Spanish hospitals between 1 March and 31 April 2020. Demographics, medical history, clinical and radiologic findings, treatment information and laboratory data of mothers and their newborns were collected from electronic medical records.</AbstractText><AbstractText Label="RESULTS AND DISCUSSION" NlmCategory="CONCLUSIONS">A total of 12 pregnant women were identified to have received tocilizumab during pregnancy in the two hospitals. Median gestational age at admission was 27.7 weeks (interquartile range, 18.0-36.4). Most of them received lopinavir/ritonavir, azithromycin and hydroxychloroquine, two patients received corticosteroids and one received interferon beta 1B. All 12 pregnancies resulted in live births. Somatometric values were normal for all newborns, and evolution at 14 and 28 days was favourable for all of them. Hepatotoxicity was observed in 2 patients, which improved or resolved at discharge. Cytomegalovirus reactivation was detected in another patient who had also received corticosteroids for 15 days, causing a congenital infection in her newborn. Both hepatotoxicity and viral reactivation adverse events were classified as possibly related to tocilizumab administration according to Naranjo's causality algorithm.</AbstractText><AbstractText Label="WHAT IS NEW AND CONCLUSIONS" NlmCategory="CONCLUSIONS">It does not appear that tocilizumab has detrimental effects for the mother and newborn. Close monitoring of infections should be considered, especially if other immunosuppressive agents are used.</AbstractText><CopyrightInformation>© 2021 John Wiley & Sons Ltd.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Jiménez-Lozano</LastName><ForeName>Inés</ForeName><Initials>I</Initials><Identifier Source="ORCID">https://orcid.org/0000-0003-4473-6768</Identifier><AffiliationInfo><Affiliation>Pharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Caro-Teller</LastName><ForeName>José Manuel</ForeName><Initials>JM</Initials><AffiliationInfo><Affiliation>Pharmacy Department. Hospital, Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fernández-Hidalgo</LastName><ForeName>Nuria</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Pediatric Infectious Diseases and Primary Immunodeficiencies Unit, Pediatrics Department, Vall d´hebron Hospital, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Miarons</LastName><ForeName>Marta</ForeName><Initials>M</Initials><Identifier Source="ORCID">https://orcid.org/0000-0001-7847-1580</Identifier><AffiliationInfo><Affiliation>Pharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Frick</LastName><ForeName>Marie Antoinette</ForeName><Initials>MA</Initials><AffiliationInfo><Affiliation>Pediatric Infectious Diseases and Primary Immunodeficiencies Unit, Pediatrics Department, Vall d´hebron Hospital, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Batllori Badia</LastName><ForeName>Emma</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Unit of perinatal medicine, Obstetric and Gynaecology Department, Hospital Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Serrano</LastName><ForeName>Berta</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Department of Obstetrics and Gynecology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Parramon-Teixidó</LastName><ForeName>Carlos Javier</ForeName><Initials>CJ</Initials><Identifier Source="ORCID">https://orcid.org/0000-0001-8023-3979</Identifier><AffiliationInfo><Affiliation>Pharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Camba-Longueira</LastName><ForeName>Fátima</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Department of Neonatology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Moral-Pumarega</LastName><ForeName>Maria Teresa</ForeName><Initials>MT</Initials><AffiliationInfo><Affiliation>Unit of perinatal medicine, Obstetric and Gynaecology Department, Hospital Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>San Juan-Garrido</LastName><ForeName>Rafael</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Unit of Infectious Diseases, Hospital Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cabañas Poy</LastName><ForeName>Maria Josep</ForeName><Initials>MJ</Initials><AffiliationInfo><Affiliation>Pharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Suy</LastName><ForeName>Anna</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Obstetrics and Gynecology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gorgas Torner</LastName><ForeName>Maria Queralt</ForeName><Initials>MQ</Initials><AffiliationInfo><Affiliation>Pharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2021</Year><Month>02</Month><Day>26</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>J Clin Pharm Ther</MedlineTA><NlmUniqueID>8704308</NlmUniqueID><ISSNLinking>0269-4727</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">COVID-19</Keyword><Keyword MajorTopicYN="N">adverse events</Keyword><Keyword MajorTopicYN="N">maternal safety</Keyword><Keyword MajorTopicYN="N">newborn safety</Keyword><Keyword MajorTopicYN="N">tocilizumab</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="revised"><Year>2021</Year><Month>02</Month><Day>09</Day></PubMedPubDate><PubMedPubDate 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