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Safety of resuming biologic DMARDs in patients who develop tuberculosis after anti-TNF treatment.

Identifieur interne : 000B66 ( Main/Exploration ); précédent : 000B65; suivant : 000B67

Safety of resuming biologic DMARDs in patients who develop tuberculosis after anti-TNF treatment.

Auteurs : Soo-Kyung Cho [Corée du Sud] ; Dam Kim [Corée du Sud] ; Soyoung Won [Corée du Sud] ; Minkyung Han [Corée du Sud] ; Jiyoung Lee [Corée du Sud] ; Eun Jin Jang [Corée du Sud] ; Tae-Hyung Kim [Corée du Sud] ; Sang-Cheol Bae [Corée du Sud] ; Yoon-Kyoung Sung [Corée du Sud]

Source :

RBID : pubmed:28216194

Descripteurs français

English descriptors

Abstract

OBJECTIVES

To estimate the incidence of tuberculosis (TB) in rheumatoid arthritis (RA) patients treated with tumor necrotizing factor inhibitor (TNFI) and evaluate the safety of resuming biologic disease-modifying anti-rheumatic drugs (DMARDs) in patients who developed TB after anti-TNF treatment.

METHODS

We conducted an inception cohort study of RA patients in the Korean Healthcare Claims Database who started TNFI as the first biologic DMARD between January 2009 and December 2013. The incidence rate (IR) of TB was estimated among total TNFI starters and a nested case-control analysis was performed to compare the characteristics of patients who developed TB and those did not. Patients diagnosed with relapsed TB after resuming biologic DMARDs were identified and their features were described.

RESULTS

We included 4638 RA patients who started TNFI, contributing 8542 PYs of follow-up. The IR of TB in TNFI users was 1.10 (CI: 0.86-1.34) per 100 PYs. After the initial 6 months, the IR was highest at 1.56 (CI: 1.02-2.10) and decreased gradually over time. Among the 81 patients who developed TB, 30 patients (37.0%) resumed biologic DMARDs with a mean interval of 3.3 months after TB development. Two cases of TB were detected among 30 patients with an observational period of 45.7 PY.

CONCLUSIONS

The IR of TB in RA patients who started TNFI was 1.10 per 100 PYs. This rate was highest during the first 6 months. Resumption of biologic DMARDs requires careful monitoring for TB relapse.


DOI: 10.1016/j.semarthrit.2017.01.004
PubMed: 28216194


Affiliations:


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<term>Age Factors (MeSH)</term>
<term>Aged (MeSH)</term>
<term>Antibodies, Monoclonal (adverse effects)</term>
<term>Antirheumatic Agents (adverse effects)</term>
<term>Arthritis, Rheumatoid (drug therapy)</term>
<term>Biological Products (MeSH)</term>
<term>Case-Control Studies (MeSH)</term>
<term>Cohort Studies (MeSH)</term>
<term>Comorbidity (MeSH)</term>
<term>Etanercept (adverse effects)</term>
<term>Female (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Male (MeSH)</term>
<term>Middle Aged (MeSH)</term>
<term>Recurrence (MeSH)</term>
<term>Risk Factors (MeSH)</term>
<term>Sex Factors (MeSH)</term>
<term>Tuberculosis (chemically induced)</term>
<term>Tuberculosis (epidemiology)</term>
<term>Tumor Necrosis Factor-alpha (antagonists & inhibitors)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr">
<term>Adulte d'âge moyen (MeSH)</term>
<term>Anticorps monoclonaux (effets indésirables)</term>
<term>Antirhumatismaux (effets indésirables)</term>
<term>Comorbidité (MeSH)</term>
<term>Facteur de nécrose tumorale alpha (antagonistes et inhibiteurs)</term>
<term>Facteurs de risque (MeSH)</term>
<term>Facteurs sexuels (MeSH)</term>
<term>Facteurs âges (MeSH)</term>
<term>Femelle (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Mâle (MeSH)</term>
<term>Polyarthrite rhumatoïde (traitement médicamenteux)</term>
<term>Produits biologiques (MeSH)</term>
<term>Récidive (MeSH)</term>
<term>Sujet âgé (MeSH)</term>
<term>Tuberculose (induit chimiquement)</term>
<term>Tuberculose (épidémiologie)</term>
<term>Étanercept (effets indésirables)</term>
<term>Études cas-témoins (MeSH)</term>
<term>Études de cohortes (MeSH)</term>
</keywords>
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<term>Antibodies, Monoclonal</term>
<term>Antirheumatic Agents</term>
<term>Etanercept</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en">
<term>Tumor Necrosis Factor-alpha</term>
</keywords>
<keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr">
<term>Facteur de nécrose tumorale alpha</term>
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<term>Tuberculosis</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en">
<term>Arthritis, Rheumatoid</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr">
<term>Anticorps monoclonaux</term>
<term>Antirhumatismaux</term>
<term>Étanercept</term>
</keywords>
<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en">
<term>Tuberculosis</term>
</keywords>
<keywords scheme="MESH" qualifier="induit chimiquement" xml:lang="fr">
<term>Tuberculose</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr">
<term>Polyarthrite rhumatoïde</term>
</keywords>
<keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr">
<term>Tuberculose</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Age Factors</term>
<term>Aged</term>
<term>Biological Products</term>
<term>Case-Control Studies</term>
<term>Cohort Studies</term>
<term>Comorbidity</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Recurrence</term>
<term>Risk Factors</term>
<term>Sex Factors</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Adulte d'âge moyen</term>
<term>Comorbidité</term>
<term>Facteurs de risque</term>
<term>Facteurs sexuels</term>
<term>Facteurs âges</term>
<term>Femelle</term>
<term>Humains</term>
<term>Mâle</term>
<term>Produits biologiques</term>
<term>Récidive</term>
<term>Sujet âgé</term>
<term>Études cas-témoins</term>
<term>Études de cohortes</term>
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<front>
<div type="abstract" xml:lang="en">
<p>
<b>OBJECTIVES</b>
</p>
<p>To estimate the incidence of tuberculosis (TB) in rheumatoid arthritis (RA) patients treated with tumor necrotizing factor inhibitor (TNFI) and evaluate the safety of resuming biologic disease-modifying anti-rheumatic drugs (DMARDs) in patients who developed TB after anti-TNF treatment.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS</b>
</p>
<p>We conducted an inception cohort study of RA patients in the Korean Healthcare Claims Database who started TNFI as the first biologic DMARD between January 2009 and December 2013. The incidence rate (IR) of TB was estimated among total TNFI starters and a nested case-control analysis was performed to compare the characteristics of patients who developed TB and those did not. Patients diagnosed with relapsed TB after resuming biologic DMARDs were identified and their features were described.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>RESULTS</b>
</p>
<p>We included 4638 RA patients who started TNFI, contributing 8542 PYs of follow-up. The IR of TB in TNFI users was 1.10 (CI: 0.86-1.34) per 100 PYs. After the initial 6 months, the IR was highest at 1.56 (CI: 1.02-2.10) and decreased gradually over time. Among the 81 patients who developed TB, 30 patients (37.0%) resumed biologic DMARDs with a mean interval of 3.3 months after TB development. Two cases of TB were detected among 30 patients with an observational period of 45.7 PY.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>CONCLUSIONS</b>
</p>
<p>The IR of TB in RA patients who started TNFI was 1.10 per 100 PYs. This rate was highest during the first 6 months. Resumption of biologic DMARDs requires careful monitoring for TB relapse.</p>
</div>
</front>
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<PMID Version="1">28216194</PMID>
<DateCompleted>
<Year>2018</Year>
<Month>04</Month>
<Day>24</Day>
</DateCompleted>
<DateRevised>
<Year>2018</Year>
<Month>05</Month>
<Day>16</Day>
</DateRevised>
<Article PubModel="Print-Electronic">
<Journal>
<ISSN IssnType="Electronic">1532-866X</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>47</Volume>
<Issue>1</Issue>
<PubDate>
<Year>2017</Year>
<Month>08</Month>
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<Title>Seminars in arthritis and rheumatism</Title>
<ISOAbbreviation>Semin Arthritis Rheum</ISOAbbreviation>
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<ArticleTitle>Safety of resuming biologic DMARDs in patients who develop tuberculosis after anti-TNF treatment.</ArticleTitle>
<Pagination>
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<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.semarthrit.2017.01.004</ELocationID>
<Abstract>
<AbstractText Label="OBJECTIVES">To estimate the incidence of tuberculosis (TB) in rheumatoid arthritis (RA) patients treated with tumor necrotizing factor inhibitor (TNFI) and evaluate the safety of resuming biologic disease-modifying anti-rheumatic drugs (DMARDs) in patients who developed TB after anti-TNF treatment.</AbstractText>
<AbstractText Label="METHODS">We conducted an inception cohort study of RA patients in the Korean Healthcare Claims Database who started TNFI as the first biologic DMARD between January 2009 and December 2013. The incidence rate (IR) of TB was estimated among total TNFI starters and a nested case-control analysis was performed to compare the characteristics of patients who developed TB and those did not. Patients diagnosed with relapsed TB after resuming biologic DMARDs were identified and their features were described.</AbstractText>
<AbstractText Label="RESULTS">We included 4638 RA patients who started TNFI, contributing 8542 PYs of follow-up. The IR of TB in TNFI users was 1.10 (CI: 0.86-1.34) per 100 PYs. After the initial 6 months, the IR was highest at 1.56 (CI: 1.02-2.10) and decreased gradually over time. Among the 81 patients who developed TB, 30 patients (37.0%) resumed biologic DMARDs with a mean interval of 3.3 months after TB development. Two cases of TB were detected among 30 patients with an observational period of 45.7 PY.</AbstractText>
<AbstractText Label="CONCLUSIONS">The IR of TB in RA patients who started TNFI was 1.10 per 100 PYs. This rate was highest during the first 6 months. Resumption of biologic DMARDs requires careful monitoring for TB relapse.</AbstractText>
<CopyrightInformation>Copyright © 2017 Elsevier Inc. All rights reserved.</CopyrightInformation>
</Abstract>
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<Affiliation>Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea; Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea.</Affiliation>
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<Initials>D</Initials>
<AffiliationInfo>
<Affiliation>Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea; Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Won</LastName>
<ForeName>Soyoung</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Han</LastName>
<ForeName>Minkyung</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Lee</LastName>
<ForeName>Jiyoung</ForeName>
<Initials>J</Initials>
<AffiliationInfo>
<Affiliation>Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Jang</LastName>
<ForeName>Eun Jin</ForeName>
<Initials>EJ</Initials>
<AffiliationInfo>
<Affiliation>Department of Information Statistics, Andong National University, Andong-si, South Korea.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Kim</LastName>
<ForeName>Tae-Hyung</ForeName>
<Initials>TH</Initials>
<AffiliationInfo>
<Affiliation>Division of Pulmonary and Critical Care Medicine, Hanyang University Guri Hospital, Guri-si, South Korea.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Bae</LastName>
<ForeName>Sang-Cheol</ForeName>
<Initials>SC</Initials>
<AffiliationInfo>
<Affiliation>Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea; Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Sung</LastName>
<ForeName>Yoon-Kyoung</ForeName>
<Initials>YK</Initials>
<AffiliationInfo>
<Affiliation>Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea; Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea. Electronic address: sungyk@hanyang.ac.kr.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic">
<Year>2017</Year>
<Month>01</Month>
<Day>18</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo>
<Country>United States</Country>
<MedlineTA>Semin Arthritis Rheum</MedlineTA>
<NlmUniqueID>1306053</NlmUniqueID>
<ISSNLinking>0049-0172</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000911">Antibodies, Monoclonal</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D018501">Antirheumatic Agents</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D001688">Biological Products</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D014409">Tumor Necrosis Factor-alpha</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>OP401G7OJC</RegistryNumber>
<NameOfSubstance UI="D000068800">Etanercept</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList>
<MeshHeading>
<DescriptorName UI="D000367" MajorTopicYN="N">Age Factors</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D000911" MajorTopicYN="N">Antibodies, Monoclonal</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D018501" MajorTopicYN="N">Antirheumatic Agents</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D001172" MajorTopicYN="N">Arthritis, Rheumatoid</DescriptorName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D001688" MajorTopicYN="N">Biological Products</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D016022" MajorTopicYN="N">Case-Control Studies</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D015331" MajorTopicYN="N">Cohort Studies</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D015897" MajorTopicYN="N">Comorbidity</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D000068800" MajorTopicYN="N">Etanercept</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D005260" MajorTopicYN="N">Female</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="D012008" MajorTopicYN="N">Recurrence</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D012307" MajorTopicYN="N">Risk Factors</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D012737" MajorTopicYN="N">Sex Factors</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D014376" MajorTopicYN="N">Tuberculosis</DescriptorName>
<QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName>
<QualifierName UI="Q000453" MajorTopicYN="Y">epidemiology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D014409" MajorTopicYN="N">Tumor Necrosis Factor-alpha</DescriptorName>
<QualifierName UI="Q000037" MajorTopicYN="Y">antagonists & inhibitors</QualifierName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM">
<Keyword MajorTopicYN="Y">Biologic DMARDs</Keyword>
<Keyword MajorTopicYN="Y">Rheumatoid arthritis</Keyword>
<Keyword MajorTopicYN="Y">TNF inhibitor</Keyword>
<Keyword MajorTopicYN="Y">Tuberculosis</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData>
<History>
<PubMedPubDate PubStatus="received">
<Year>2016</Year>
<Month>11</Month>
<Day>01</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised">
<Year>2017</Year>
<Month>01</Month>
<Day>05</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted">
<Year>2017</Year>
<Month>01</Month>
<Day>16</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed">
<Year>2017</Year>
<Month>2</Month>
<Day>22</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline">
<Year>2018</Year>
<Month>4</Month>
<Day>25</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez">
<Year>2017</Year>
<Month>2</Month>
<Day>21</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList>
<ArticleId IdType="pubmed">28216194</ArticleId>
<ArticleId IdType="pii">S0049-0172(16)30408-5</ArticleId>
<ArticleId IdType="doi">10.1016/j.semarthrit.2017.01.004</ArticleId>
</ArticleIdList>
</PubmedData>
</pubmed>
<affiliations>
<list>
<country>
<li>Corée du Sud</li>
</country>
<region>
<li>Région capitale de Séoul</li>
</region>
<settlement>
<li>Séoul</li>
</settlement>
</list>
<tree>
<country name="Corée du Sud">
<region name="Région capitale de Séoul">
<name sortKey="Cho, Soo Kyung" sort="Cho, Soo Kyung" uniqKey="Cho S" first="Soo-Kyung" last="Cho">Soo-Kyung Cho</name>
</region>
<name sortKey="Bae, Sang Cheol" sort="Bae, Sang Cheol" uniqKey="Bae S" first="Sang-Cheol" last="Bae">Sang-Cheol Bae</name>
<name sortKey="Han, Minkyung" sort="Han, Minkyung" uniqKey="Han M" first="Minkyung" last="Han">Minkyung Han</name>
<name sortKey="Jang, Eun Jin" sort="Jang, Eun Jin" uniqKey="Jang E" first="Eun Jin" last="Jang">Eun Jin Jang</name>
<name sortKey="Kim, Dam" sort="Kim, Dam" uniqKey="Kim D" first="Dam" last="Kim">Dam Kim</name>
<name sortKey="Kim, Tae Hyung" sort="Kim, Tae Hyung" uniqKey="Kim T" first="Tae-Hyung" last="Kim">Tae-Hyung Kim</name>
<name sortKey="Lee, Jiyoung" sort="Lee, Jiyoung" uniqKey="Lee J" first="Jiyoung" last="Lee">Jiyoung Lee</name>
<name sortKey="Sung, Yoon Kyoung" sort="Sung, Yoon Kyoung" uniqKey="Sung Y" first="Yoon-Kyoung" last="Sung">Yoon-Kyoung Sung</name>
<name sortKey="Won, Soyoung" sort="Won, Soyoung" uniqKey="Won S" first="Soyoung" last="Won">Soyoung Won</name>
</country>
</tree>
</affiliations>
</record>

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