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ESCMID Study Group for Infections in Compromised Hosts (ESGICH) Consensus Document on the safety of targeted and biological therapies: an infectious diseases perspective (Soluble immune effector molecules [I]: anti-tumor necrosis factor-α agents).

Identifieur interne : 000931 ( Main/Exploration ); précédent : 000930; suivant : 000932

ESCMID Study Group for Infections in Compromised Hosts (ESGICH) Consensus Document on the safety of targeted and biological therapies: an infectious diseases perspective (Soluble immune effector molecules [I]: anti-tumor necrosis factor-α agents).

Auteurs : J W Baddley [États-Unis] ; F. Cantini [Italie] ; D. Goletti [Italie] ; J J G Mez-Reino [Espagne] ; E. Mylonakis [États-Unis] ; R. San-Juan [Espagne] ; M. Fernández-Ruiz [Espagne] ; J. Torre-Cisneros [Espagne]

Source :

RBID : pubmed:29459143

Descripteurs français

English descriptors

Abstract

BACKGROUND

The present review is part of the ESCMID Study Group for Infections in Compromised Hosts (ESGICH) Consensus Document on the safety of targeted and biological therapies.

AIMS

To review, from an Infectious Diseases perspective, the safety profile of agents targeting tumour necrosis factor-α (TNF-α) and to suggest preventive recommendations.

SOURCES

Computer-based MEDLINE searches with MeSH terms pertaining to each agent or therapeutic family.

CONTENT

Preclinical and clinical evidence indicate that anti-TNF-α therapy (infliximab, adalimumab, golimumab, certolizumab pegol and etanercept) is associated with a two-to four-fold increase in the risk of active tuberculosis and other granulomatous conditions (mostly resulting from the reactivation of a latent infection). In addition, it may lead to the occurrence of other serious infections (bacterial, fungal, opportunistic and certain viral infections). These associated risks seem to be lower for etanercept than other agents. Screening for latent tuberculosis infection should be performed before starting anti-TNF-α therapy, followed by anti-tuberculosis therapy if appropriate. Screening for chronic hepatitis B virus (HBV) infection is also recommended, and antiviral prophylaxis may be warranted for hepatitis B surface antigen-positive individuals. No benefit is expected from the use of antibacterial, anti-Pneumocystis or antifungal prophylaxis. Pneumococcal and age-appropriate antiviral vaccinations (i.e. influenza) should be administered. Live-virus vaccines (i.e. varicella-zoster virus or measles-mumps-rubella) may be contraindicated in people receiving anti-TNF-α therapy, although additional data are needed before definitive recommendations can be made.

IMPLICATIONS

Prevention measures should be implemented to reduce the risk of latent tuberculosis or HBV reactivation among individuals receiving anti-TNF-α therapy.


DOI: 10.1016/j.cmi.2017.12.025
PubMed: 29459143


Affiliations:


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<term>Anti-Inflammatory Agents (adverse effects)</term>
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<p>
<b>BACKGROUND</b>
</p>
<p>The present review is part of the ESCMID Study Group for Infections in Compromised Hosts (ESGICH) Consensus Document on the safety of targeted and biological therapies.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>AIMS</b>
</p>
<p>To review, from an Infectious Diseases perspective, the safety profile of agents targeting tumour necrosis factor-α (TNF-α) and to suggest preventive recommendations.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>SOURCES</b>
</p>
<p>Computer-based MEDLINE searches with MeSH terms pertaining to each agent or therapeutic family.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>CONTENT</b>
</p>
<p>Preclinical and clinical evidence indicate that anti-TNF-α therapy (infliximab, adalimumab, golimumab, certolizumab pegol and etanercept) is associated with a two-to four-fold increase in the risk of active tuberculosis and other granulomatous conditions (mostly resulting from the reactivation of a latent infection). In addition, it may lead to the occurrence of other serious infections (bacterial, fungal, opportunistic and certain viral infections). These associated risks seem to be lower for etanercept than other agents. Screening for latent tuberculosis infection should be performed before starting anti-TNF-α therapy, followed by anti-tuberculosis therapy if appropriate. Screening for chronic hepatitis B virus (HBV) infection is also recommended, and antiviral prophylaxis may be warranted for hepatitis B surface antigen-positive individuals. No benefit is expected from the use of antibacterial, anti-Pneumocystis or antifungal prophylaxis. Pneumococcal and age-appropriate antiviral vaccinations (i.e. influenza) should be administered. Live-virus vaccines (i.e. varicella-zoster virus or measles-mumps-rubella) may be contraindicated in people receiving anti-TNF-α therapy, although additional data are needed before definitive recommendations can be made.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>IMPLICATIONS</b>
</p>
<p>Prevention measures should be implemented to reduce the risk of latent tuberculosis or HBV reactivation among individuals receiving anti-TNF-α therapy.</p>
</div>
</front>
</TEI>
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<DateCompleted>
<Year>2018</Year>
<Month>11</Month>
<Day>15</Day>
</DateCompleted>
<DateRevised>
<Year>2018</Year>
<Month>11</Month>
<Day>15</Day>
</DateRevised>
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<Journal>
<ISSN IssnType="Electronic">1469-0691</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>24 Suppl 2</Volume>
<PubDate>
<Year>2018</Year>
<Month>Jun</Month>
</PubDate>
</JournalIssue>
<Title>Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases</Title>
<ISOAbbreviation>Clin Microbiol Infect</ISOAbbreviation>
</Journal>
<ArticleTitle>ESCMID Study Group for Infections in Compromised Hosts (ESGICH) Consensus Document on the safety of targeted and biological therapies: an infectious diseases perspective (Soluble immune effector molecules [I]: anti-tumor necrosis factor-α agents).</ArticleTitle>
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<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.cmi.2017.12.025</ELocationID>
<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The present review is part of the ESCMID Study Group for Infections in Compromised Hosts (ESGICH) Consensus Document on the safety of targeted and biological therapies.</AbstractText>
<AbstractText Label="AIMS" NlmCategory="OBJECTIVE">To review, from an Infectious Diseases perspective, the safety profile of agents targeting tumour necrosis factor-α (TNF-α) and to suggest preventive recommendations.</AbstractText>
<AbstractText Label="SOURCES" NlmCategory="METHODS">Computer-based MEDLINE searches with MeSH terms pertaining to each agent or therapeutic family.</AbstractText>
<AbstractText Label="CONTENT" NlmCategory="BACKGROUND">Preclinical and clinical evidence indicate that anti-TNF-α therapy (infliximab, adalimumab, golimumab, certolizumab pegol and etanercept) is associated with a two-to four-fold increase in the risk of active tuberculosis and other granulomatous conditions (mostly resulting from the reactivation of a latent infection). In addition, it may lead to the occurrence of other serious infections (bacterial, fungal, opportunistic and certain viral infections). These associated risks seem to be lower for etanercept than other agents. Screening for latent tuberculosis infection should be performed before starting anti-TNF-α therapy, followed by anti-tuberculosis therapy if appropriate. Screening for chronic hepatitis B virus (HBV) infection is also recommended, and antiviral prophylaxis may be warranted for hepatitis B surface antigen-positive individuals. No benefit is expected from the use of antibacterial, anti-Pneumocystis or antifungal prophylaxis. Pneumococcal and age-appropriate antiviral vaccinations (i.e. influenza) should be administered. Live-virus vaccines (i.e. varicella-zoster virus or measles-mumps-rubella) may be contraindicated in people receiving anti-TNF-α therapy, although additional data are needed before definitive recommendations can be made.</AbstractText>
<AbstractText Label="IMPLICATIONS" NlmCategory="CONCLUSIONS">Prevention measures should be implemented to reduce the risk of latent tuberculosis or HBV reactivation among individuals receiving anti-TNF-α therapy.</AbstractText>
<CopyrightInformation>Copyright © 2018 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Baddley</LastName>
<ForeName>J W</ForeName>
<Initials>JW</Initials>
<AffiliationInfo>
<Affiliation>Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: jbaddley@uabmc.edu.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Cantini</LastName>
<ForeName>F</ForeName>
<Initials>F</Initials>
<AffiliationInfo>
<Affiliation>Division of Rheumatology, Hospital of Prato, Prato, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Goletti</LastName>
<ForeName>D</ForeName>
<Initials>D</Initials>
<AffiliationInfo>
<Affiliation>Department of Epidemiology and Preclinical Research, Translational Research Unit, National Institute for Infectious Diseases 'Lazzaro Spallanzani', Rome, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Gómez-Reino</LastName>
<ForeName>J J</ForeName>
<Initials>JJ</Initials>
<AffiliationInfo>
<Affiliation>Department of Rheumatology, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Mylonakis</LastName>
<ForeName>E</ForeName>
<Initials>E</Initials>
<AffiliationInfo>
<Affiliation>Division of Infectious Diseases, Warren Alpert Medical School of Brown University, Providence, RI, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>San-Juan</LastName>
<ForeName>R</ForeName>
<Initials>R</Initials>
<AffiliationInfo>
<Affiliation>Unit of Infectious Diseases, Hospital Universitario '12 de Octubre', Instituto de Investigación Hospital '12 de Octubre' (i+12), School of Medicine, Universidad Complutense, Madrid, Spain; Spanish Network for Research in Infectious Diseases (REIPI RD16/0016), Instituto de Salud Carlos III, Madrid, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Fernández-Ruiz</LastName>
<ForeName>M</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Unit of Infectious Diseases, Hospital Universitario '12 de Octubre', Instituto de Investigación Hospital '12 de Octubre' (i+12), School of Medicine, Universidad Complutense, Madrid, Spain; Spanish Network for Research in Infectious Diseases (REIPI RD16/0016), Instituto de Salud Carlos III, Madrid, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Torre-Cisneros</LastName>
<ForeName>J</ForeName>
<Initials>J</Initials>
<AffiliationInfo>
<Affiliation>Clinical Unit of Infectious Diseases, University Hospital 'Reina Sofía', Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), School of Medicine, University of Córdoba, Córdoba, Spain; Spanish Network for Research in Infectious Diseases (REIPI RD16/0016), Instituto de Salud Carlos III, Madrid, Spain.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList>
<PublicationType UI="D016446">Consensus Development Conference</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016454">Review</PublicationType>
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<ArticleDate DateType="Electronic">
<Year>2018</Year>
<Month>02</Month>
<Day>06</Day>
</ArticleDate>
</Article>
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<Country>England</Country>
<MedlineTA>Clin Microbiol Infect</MedlineTA>
<NlmUniqueID>9516420</NlmUniqueID>
<ISSNLinking>1198-743X</ISSNLinking>
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<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000893">Anti-Inflammatory Agents</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000911">Antibodies, Monoclonal</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D007155">Immunologic Factors</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="C439524">TNF protein, human</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D014409">Tumor Necrosis Factor-alpha</NameOfSubstance>
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<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D014765">Viral Vaccines</NameOfSubstance>
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<RegistryNumber>91X1KLU43E</RegistryNumber>
<NameOfSubstance UI="C529000">golimumab</NameOfSubstance>
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<RegistryNumber>B72HH48FLU</RegistryNumber>
<NameOfSubstance UI="D000069285">Infliximab</NameOfSubstance>
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<RegistryNumber>FYS6T7F842</RegistryNumber>
<NameOfSubstance UI="D000068879">Adalimumab</NameOfSubstance>
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<Chemical>
<RegistryNumber>OP401G7OJC</RegistryNumber>
<NameOfSubstance UI="D000068800">Etanercept</NameOfSubstance>
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<MeshHeading>
<DescriptorName UI="D000068879" MajorTopicYN="N">Adalimumab</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading>
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<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
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<MeshHeading>
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<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName>
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<MeshHeading>
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<QualifierName UI="Q000379" MajorTopicYN="N">methods</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D002986" MajorTopicYN="N">Clinical Trials as Topic</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D003140" MajorTopicYN="N">Communicable Disease Control</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D003141" MajorTopicYN="N">Communicable Diseases</DescriptorName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
<QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName>
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<MeshHeading>
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<MeshHeading>
<DescriptorName UI="D019694" MajorTopicYN="N">Hepatitis B, Chronic</DescriptorName>
<QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName>
<QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName>
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<MeshHeading>
<DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
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<MeshHeading>
<DescriptorName UI="D016867" MajorTopicYN="N">Immunocompromised Host</DescriptorName>
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<QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName>
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<MeshHeading>
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