Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three-year prospective French Research Axed on Tolerance of Biotherapies registry
Identifieur interne : 000199 ( Pmc/Curation ); précédent : 000198; suivant : 000200Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three-year prospective French Research Axed on Tolerance of Biotherapies registry
Auteurs : Florence Tubach ; Dominique Salmon ; Philippe Ravaud ; Yannick Allanore ; Philippe Goupille ; Maxime Bréban ; Béatrice Pallot-Prades ; Sophie Pouplin ; Antoinette Sacchi ; Rose Marie Chichemanian ; Stéphane Bretagne ; Dominique Emilie ; Marc Lemann ; Olivier Lorthololary ; Xavier MarietteSource :
- Arthritis and Rheumatism [ 0004-3591 ] ; 2009.
Abstract
Tuberculosis (TB) is associated with anti-tumour necrosis factor (TNF) therapy but whether it is drug-specific remains a concern. Our objective was to describe cases of tuberculosis associated with anti-TNF therapy, identify risk factors and estimate the incidence.
An incidence study with the French population as reference and a case-control analysis. We collected, for 3 years, cases of TB among French patients receiving anti-TNF therapy, whatever the indication, with two controls treated with anti-TNF agents per case.
We collected 69 cases of TB in patients treated for rheumatoid arthritis (n=40), spondylarthropathies (n=18), inflammatory colitis (n=9), psoriasis (n=1) and Behçet’s disease (n=1) treated with infliximab (n=36), adalimumab (n=28) and etanercept (n=5). None of the cases had received correct chemoprophylaxis treatment. The sex and age-adjusted incidence rate of TB was 116.7 per 100,000 patient-years. The SIR was 12.2 (95% confidence interval 9.7–15.5) and was higher for therapy with infliximab and adalimumab than for that with etanercept: 18.6 (13.4–25.8) and 29.3 (20.2–42.4) versus 1.8 (0.7–4.3), respectively. In the case-control analysis, the exposure to infliximab or adalimumab versus etanercept was an independent risk factor for TB: odds ratio=13.3 (2.6–69.0) and 17.1 (3.6–80.6), respectively. Other risk factors were age, the first year of anti-TNF treatment, and being born in an endemic area.
The risk of TB is higher for patients receiving monoclonal-antibody than soluble-receptor anti-TNF therapy. The increased risk with early anti-TNF treatment and the absence of correct chemoprophylaxis treatment favours the reactivation of latent TB.
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DOI: 10.1002/art.24632
PubMed: 19565495
PubMed Central: 2921546
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Florence Tubach<affiliation><nlm:aff id="A2">Département d'épidémiologie, biostatistique et recherche clinique<institution>AP-HP</institution><institution>Hôpital Bichat - Claude Bernard</institution><addr-line>46 rue Henri Huchard 75018 Paris,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A1">Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques<institution>INSERM : U738</institution><institution>Université Paris-Diderot - Paris VII</institution><addr-line>Faculté de médecine Paris 7 16, Rue Henri Huchard 75018 Paris,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A1">Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques<institution>INSERM : U738</institution><institution>Université Paris-Diderot - Paris VII</institution><addr-line>Faculté de médecine Paris 7 16, Rue Henri Huchard 75018 Paris,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A3">Service de médecine interne<institution>AP-HP</institution><institution>Hôpital Cochin</institution><institution>Université Paris Descartes</institution><addr-line>27 rue du Faubourg Saint Antoine, 75679 Paris Cedex 14, France,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A1">Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques<institution>INSERM : U738</institution><institution>Université Paris-Diderot - Paris VII</institution><addr-line>Faculté de médecine Paris 7 16, Rue Henri Huchard 75018 Paris,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A2">Département d'épidémiologie, biostatistique et recherche clinique<institution>AP-HP</institution><institution>Hôpital Bichat - Claude Bernard</institution><addr-line>46 rue Henri Huchard 75018 Paris,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A2">Département d'épidémiologie, biostatistique et recherche clinique<institution>AP-HP</institution><institution>Hôpital Bichat - Claude Bernard</institution><addr-line>46 rue Henri Huchard 75018 Paris,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A4">Service de rhumatologie<institution>AP-HP</institution><institution>Hôpital Cochin</institution><institution>Université Paris Descartes</institution><addr-line>27 rue du Faubourg Saint-Jacques 75679 Paris Cedex 14,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A5">Service de rhumatologie<institution>CHU Tours</institution><institution>Université François Rabelais - Tours</institution><addr-line>Tours,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A6">Service de Rhumatologie<institution>AP-HP</institution><institution>Hôpital Ambroise Paré</institution><addr-line>9 avenue Charles-de-Gaulle 92100 Boulogne,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A7">Service de rhumatologie<institution>Hôpital Bellevue</institution><addr-line>Saint-Etienne,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A8">Service de rhumatologie<institution>CHU Rouen</institution><addr-line>76000 Rouen,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A9">CH F. Quesnay, Service de médecine interne<institution>Centre hospitalier F. Quesnay</institution><addr-line>Mantes la Jolie,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A10">Centre régional de pharmacovigilance<institution>Centre régional de pharmacovigilance</institution><addr-line>Nice,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A11">Service de parasitologie<institution>AP-HP</institution><institution>Hôpital Henri Mondor</institution><institution>Université Paris-Est</institution><addr-line>Créteil,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A12">Service d'hépato-gastro-entérologie<institution>AP-HP</institution><institution>Hôpital Saint-Louis</institution><institution>Université Paris-Diderot - Paris VII</institution><addr-line>1 avenue Claude Vellefaux 75475 Paris,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A13">Cytokines, chimiokines et immunopathologie<institution>INSERM : U764</institution><institution>IFR13</institution><institution>Université Paris Sud - Paris XI</institution><addr-line>Centre de Recherche Inserm 32, Rue Des Carnets 92140 CLAMART,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A14">Service des maladies infectieuses et tropicales<institution>Université Paris Descartes</institution><institution>AP-HP</institution><institution>Hôpital Necker - Enfants Malades</institution><institution>Centre d'infectiologie Necker-Pasteur</institution><addr-line>Paris,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A15">Immunologie antivirale systémique et cérébrale<institution>INSERM : U802</institution><institution>IFR93</institution><institution>Université Paris Sud - Paris XI</institution><addr-line>Faculte de Medecine Paris Sud 63, Rue Gabriel Peri 94276 LE KREMLIN BICETRE CEDEX,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation>Le document en format XML
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Quesnay, Service de médecine interne<institution>Centre hospitalier F. Quesnay</institution><addr-line>Mantes la Jolie,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Chichemanian, Rose Marie" sort="Chichemanian, Rose Marie" uniqKey="Chichemanian R" first="Rose Marie" last="Chichemanian">Rose Marie Chichemanian</name><affiliation><nlm:aff id="A10">Centre régional de pharmacovigilance<institution>Centre régional de pharmacovigilance</institution><addr-line>Nice,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Bretagne, Stephane" sort="Bretagne, Stephane" uniqKey="Bretagne S" first="Stéphane" last="Bretagne">Stéphane Bretagne</name><affiliation><nlm:aff id="A11">Service de parasitologie<institution>AP-HP</institution><institution>Hôpital Henri Mondor</institution><institution>Université Paris-Est</institution><addr-line>Créteil,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Emilie, Dominique" sort="Emilie, Dominique" uniqKey="Emilie D" first="Dominique" last="Emilie">Dominique Emilie</name><affiliation><nlm:aff id="A12">Service d'hépato-gastro-entérologie<institution>AP-HP</institution><institution>Hôpital Saint-Louis</institution><institution>Université Paris-Diderot - Paris VII</institution><addr-line>1 avenue Claude Vellefaux 75475 Paris,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Lemann, Marc" sort="Lemann, Marc" uniqKey="Lemann M" first="Marc" last="Lemann">Marc Lemann</name><affiliation><nlm:aff id="A13">Cytokines, chimiokines et immunopathologie<institution>INSERM : U764</institution><institution>IFR13</institution><institution>Université Paris Sud - Paris XI</institution><addr-line>Centre de Recherche Inserm 32, Rue Des Carnets 92140 CLAMART,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Lorthololary, Olivier" sort="Lorthololary, Olivier" uniqKey="Lorthololary O" first="Olivier" last="Lorthololary">Olivier Lorthololary</name><affiliation><nlm:aff id="A14">Service des maladies infectieuses et tropicales<institution>Université Paris Descartes</institution><institution>AP-HP</institution><institution>Hôpital Necker - Enfants Malades</institution><institution>Centre d'infectiologie Necker-Pasteur</institution><addr-line>Paris,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Mariette, Xavier" sort="Mariette, Xavier" uniqKey="Mariette X" first="Xavier" last="Mariette">Xavier Mariette</name><affiliation><nlm:aff id="A15">Immunologie antivirale systémique et cérébrale<institution>INSERM : U802</institution><institution>IFR93</institution><institution>Université Paris Sud - Paris XI</institution><addr-line>Faculte de Medecine Paris Sud 63, Rue Gabriel Peri 94276 LE KREMLIN BICETRE CEDEX,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">19565495</idno><idno type="pmc">2921546</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2921546</idno><idno type="RBID">PMC:2921546</idno><idno type="doi">10.1002/art.24632</idno><date when="2009">2009</date><idno type="wicri:Area/Pmc/Corpus">000201</idno><idno type="wicri:Area/Pmc/Curation">000199</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three-year prospective French Research Axed on Tolerance of Biotherapies registry</title><author><name sortKey="Tubach, Florence" sort="Tubach, Florence" uniqKey="Tubach F" first="Florence" last="Tubach">Florence Tubach</name><affiliation><nlm:aff id="A2">Département d'épidémiologie, biostatistique et recherche clinique<institution>AP-HP</institution><institution>Hôpital Bichat - Claude Bernard</institution><addr-line>46 rue Henri Huchard 75018 Paris,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A1">Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques<institution>INSERM : U738</institution><institution>Université Paris-Diderot - Paris VII</institution><addr-line>Faculté de médecine Paris 7 16, Rue Henri Huchard 75018 Paris,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Salmon, Dominique" sort="Salmon, Dominique" uniqKey="Salmon D" first="Dominique" last="Salmon">Dominique Salmon</name><affiliation><nlm:aff id="A3">Service de médecine interne<institution>AP-HP</institution><institution>Hôpital Cochin</institution><institution>Université Paris Descartes</institution><addr-line>27 rue du Faubourg Saint Antoine, 75679 Paris Cedex 14, France,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Ravaud, Philippe" sort="Ravaud, Philippe" uniqKey="Ravaud P" first="Philippe" last="Ravaud">Philippe Ravaud</name><affiliation><nlm:aff id="A1">Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques<institution>INSERM : U738</institution><institution>Université Paris-Diderot - Paris VII</institution><addr-line>Faculté de médecine Paris 7 16, Rue Henri Huchard 75018 Paris,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation><affiliation><nlm:aff id="A2">Département d'épidémiologie, biostatistique et recherche clinique<institution>AP-HP</institution><institution>Hôpital Bichat - Claude Bernard</institution><addr-line>46 rue Henri Huchard 75018 Paris,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Allanore, Yannick" sort="Allanore, Yannick" uniqKey="Allanore Y" first="Yannick" last="Allanore">Yannick Allanore</name><affiliation><nlm:aff id="A4">Service de rhumatologie<institution>AP-HP</institution><institution>Hôpital Cochin</institution><institution>Université Paris Descartes</institution><addr-line>27 rue du Faubourg Saint-Jacques 75679 Paris Cedex 14,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Goupille, Philippe" sort="Goupille, Philippe" uniqKey="Goupille P" first="Philippe" last="Goupille">Philippe Goupille</name><affiliation><nlm:aff id="A5">Service de rhumatologie<institution>CHU Tours</institution><institution>Université François Rabelais - Tours</institution><addr-line>Tours,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Breban, Maxime" sort="Breban, Maxime" uniqKey="Breban M" first="Maxime" last="Bréban">Maxime Bréban</name><affiliation><nlm:aff id="A6">Service de Rhumatologie<institution>AP-HP</institution><institution>Hôpital Ambroise Paré</institution><addr-line>9 avenue Charles-de-Gaulle 92100 Boulogne,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Pallot Prades, Beatrice" sort="Pallot Prades, Beatrice" uniqKey="Pallot Prades B" first="Béatrice" last="Pallot-Prades">Béatrice Pallot-Prades</name><affiliation><nlm:aff id="A7">Service de rhumatologie<institution>Hôpital Bellevue</institution><addr-line>Saint-Etienne,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Pouplin, Sophie" sort="Pouplin, Sophie" uniqKey="Pouplin S" first="Sophie" last="Pouplin">Sophie Pouplin</name><affiliation><nlm:aff id="A8">Service de rhumatologie<institution>CHU Rouen</institution><addr-line>76000 Rouen,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Sacchi, Antoinette" sort="Sacchi, Antoinette" uniqKey="Sacchi A" first="Antoinette" last="Sacchi">Antoinette Sacchi</name><affiliation><nlm:aff id="A9">CH F. Quesnay, Service de médecine interne<institution>Centre hospitalier F. Quesnay</institution><addr-line>Mantes la Jolie,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Chichemanian, Rose Marie" sort="Chichemanian, Rose Marie" uniqKey="Chichemanian R" first="Rose Marie" last="Chichemanian">Rose Marie Chichemanian</name><affiliation><nlm:aff id="A10">Centre régional de pharmacovigilance<institution>Centre régional de pharmacovigilance</institution><addr-line>Nice,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Bretagne, Stephane" sort="Bretagne, Stephane" uniqKey="Bretagne S" first="Stéphane" last="Bretagne">Stéphane Bretagne</name><affiliation><nlm:aff id="A11">Service de parasitologie<institution>AP-HP</institution><institution>Hôpital Henri Mondor</institution><institution>Université Paris-Est</institution><addr-line>Créteil,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Emilie, Dominique" sort="Emilie, Dominique" uniqKey="Emilie D" first="Dominique" last="Emilie">Dominique Emilie</name><affiliation><nlm:aff id="A12">Service d'hépato-gastro-entérologie<institution>AP-HP</institution><institution>Hôpital Saint-Louis</institution><institution>Université Paris-Diderot - Paris VII</institution><addr-line>1 avenue Claude Vellefaux 75475 Paris,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Lemann, Marc" sort="Lemann, Marc" uniqKey="Lemann M" first="Marc" last="Lemann">Marc Lemann</name><affiliation><nlm:aff id="A13">Cytokines, chimiokines et immunopathologie<institution>INSERM : U764</institution><institution>IFR13</institution><institution>Université Paris Sud - Paris XI</institution><addr-line>Centre de Recherche Inserm 32, Rue Des Carnets 92140 CLAMART,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Lorthololary, Olivier" sort="Lorthololary, Olivier" uniqKey="Lorthololary O" first="Olivier" last="Lorthololary">Olivier Lorthololary</name><affiliation><nlm:aff id="A14">Service des maladies infectieuses et tropicales<institution>Université Paris Descartes</institution><institution>AP-HP</institution><institution>Hôpital Necker - Enfants Malades</institution><institution>Centre d'infectiologie Necker-Pasteur</institution><addr-line>Paris,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author><author><name sortKey="Mariette, Xavier" sort="Mariette, Xavier" uniqKey="Mariette X" first="Xavier" last="Mariette">Xavier Mariette</name><affiliation><nlm:aff id="A15">Immunologie antivirale systémique et cérébrale<institution>INSERM : U802</institution><institution>IFR93</institution><institution>Université Paris Sud - Paris XI</institution><addr-line>Faculte de Medecine Paris Sud 63, Rue Gabriel Peri 94276 LE KREMLIN BICETRE CEDEX,FR</addr-line></nlm:aff><wicri:noCountry code="subfield">R</wicri:noCountry></affiliation></author></analytic><series><title level="j">Arthritis and Rheumatism</title><idno type="ISSN">0004-3591</idno><idno type="eISSN">1529-0131</idno><imprint><date when="2009">2009</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title><p id="P1">Tuberculosis (TB) is associated with anti-tumour necrosis factor (TNF) therapy but whether it is drug-specific remains a concern. Our objective was to describe cases of tuberculosis associated with anti-TNF therapy, identify risk factors and estimate the incidence.</p></sec><sec id="S2"><title>Methods</title><p id="P2">An incidence study with the French population as reference and a case-control analysis. We collected, for 3 years, cases of TB among French patients receiving anti-TNF therapy, whatever the indication, with two controls treated with anti-TNF agents per case.</p></sec><sec id="S3"><title>Results</title><p id="P3">We collected 69 cases of TB in patients treated for rheumatoid arthritis (n=40), spondylarthropathies (n=18), inflammatory colitis (n=9), psoriasis (n=1) and Behçet’s disease (n=1) treated with infliximab (n=36), adalimumab (n=28) and etanercept (n=5). None of the cases had received correct chemoprophylaxis treatment. The sex and age-adjusted incidence rate of TB was 116.7 per 100,000 patient-years. The SIR was 12.2 (95% confidence interval 9.7–15.5) and was higher for therapy with infliximab and adalimumab than for that with etanercept: 18.6 (13.4–25.8) and 29.3 (20.2–42.4) versus 1.8 (0.7–4.3), respectively. In the case-control analysis, the exposure to infliximab or adalimumab versus etanercept was an independent risk factor for TB: odds ratio=13.3 (2.6–69.0) and 17.1 (3.6–80.6), respectively. Other risk factors were age, the first year of anti-TNF treatment, and being born in an endemic area.</p></sec><sec id="S4"><title>Conclusions</title><p id="P4">The risk of TB is higher for patients receiving monoclonal-antibody than soluble-receptor anti-TNF therapy. The increased risk with early anti-TNF treatment and the absence of correct chemoprophylaxis treatment favours the reactivation of latent TB.</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Arthritis Rheum</journal-id><journal-title-group><journal-title>Arthritis and Rheumatism</journal-title></journal-title-group><issn pub-type="ppub">0004-3591</issn><issn pub-type="epub">1529-0131</issn><publisher><publisher-name>Wiley-Liss, Inc</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">19565495</article-id><article-id pub-id-type="pmc">2921546</article-id><article-id pub-id-type="manuscript">HALMS400633</article-id><article-id pub-id-type="doi">10.1002/art.24632</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject><subj-group subj-group-type="subrepository"><subject>INSERM Subrepository</subject></subj-group></subj-group></article-categories><title-group><article-title>Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three-year prospective French Research Axed on Tolerance of Biotherapies registry</article-title><alt-title>Tuberculosis complicating anti-TNF therapy</alt-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Tubach</surname><given-names>Florence</given-names></name><xref ref-type="aff" rid="A2">2</xref><xref ref-type="aff" rid="A1">1</xref><xref ref-type="author-notes" rid="FN2">#</xref></contrib><contrib contrib-type="author"><name><surname>Salmon</surname><given-names>Dominique</given-names></name><xref ref-type="aff" rid="A3">3</xref><xref ref-type="author-notes" rid="FN2">#</xref></contrib><contrib contrib-type="author"><name><surname>Ravaud</surname><given-names>Philippe</given-names></name><xref ref-type="aff" rid="A1">1</xref><xref ref-type="aff" rid="A2">2</xref></contrib><contrib contrib-type="author"><name><surname>Allanore</surname><given-names>Yannick</given-names></name><xref ref-type="aff" rid="A4">4</xref></contrib><contrib contrib-type="author"><name><surname>Goupille</surname><given-names>Philippe</given-names></name><xref ref-type="aff" rid="A5">5</xref></contrib><contrib contrib-type="author"><name><surname>Bréban</surname><given-names>Maxime</given-names></name><xref ref-type="aff" rid="A6">6</xref></contrib><contrib contrib-type="author"><name><surname>Pallot-Prades</surname><given-names>Béatrice</given-names></name><xref ref-type="aff" rid="A7">7</xref></contrib><contrib contrib-type="author"><name><surname>Pouplin</surname><given-names>Sophie</given-names></name><xref ref-type="aff" rid="A8">8</xref></contrib><contrib contrib-type="author"><name><surname>Sacchi</surname><given-names>Antoinette</given-names></name><xref ref-type="aff" rid="A9">9</xref></contrib><contrib contrib-type="author"><name><surname>Chichemanian</surname><given-names>Rose Marie</given-names></name><xref ref-type="aff" rid="A10">10</xref></contrib><contrib contrib-type="author"><name><surname>Bretagne</surname><given-names>Stéphane</given-names></name><xref ref-type="aff" rid="A11">11</xref></contrib><contrib contrib-type="author"><name><surname>Emilie</surname><given-names>Dominique</given-names></name><xref ref-type="aff" rid="A12">12</xref></contrib><contrib contrib-type="author"><name><surname>Lemann</surname><given-names>Marc</given-names></name><xref ref-type="aff" rid="A13">13</xref></contrib><contrib contrib-type="author"><name><surname>Lorthololary</surname><given-names>Olivier</given-names></name><xref ref-type="aff" rid="A14">14</xref></contrib><contrib contrib-type="author"><name><surname>Mariette</surname><given-names>Xavier</given-names></name><xref ref-type="aff" rid="A15">15</xref><xref rid="FN1" ref-type="author-notes">*</xref></contrib><on-behalf-of>for the RATIO group</on-behalf-of></contrib-group><aff id="A1"><label>1</label>Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques<institution>INSERM : U738</institution><institution>Université Paris-Diderot - Paris VII</institution><addr-line>Faculté de médecine Paris 7 16, Rue Henri Huchard 75018 Paris,FR</addr-line></aff><aff id="A2"><label>2</label>Département d'épidémiologie, biostatistique et recherche clinique<institution>AP-HP</institution><institution>Hôpital Bichat - Claude Bernard</institution><addr-line>46 rue Henri Huchard 75018 Paris,FR</addr-line></aff><aff id="A3"><label>3</label>Service de médecine interne<institution>AP-HP</institution><institution>Hôpital Cochin</institution><institution>Université Paris Descartes</institution><addr-line>27 rue du Faubourg Saint Antoine, 75679 Paris Cedex 14, France,FR</addr-line></aff><aff id="A4"><label>4</label>Service de rhumatologie<institution>AP-HP</institution><institution>Hôpital Cochin</institution><institution>Université Paris Descartes</institution><addr-line>27 rue du Faubourg Saint-Jacques 75679 Paris Cedex 14,FR</addr-line></aff><aff id="A5"><label>5</label>Service de rhumatologie<institution>CHU Tours</institution><institution>Université François Rabelais - Tours</institution><addr-line>Tours,FR</addr-line></aff><aff id="A6"><label>6</label>Service de Rhumatologie<institution>AP-HP</institution><institution>Hôpital Ambroise Paré</institution><addr-line>9 avenue Charles-de-Gaulle 92100 Boulogne,FR</addr-line></aff><aff id="A7"><label>7</label>Service de rhumatologie<institution>Hôpital Bellevue</institution><addr-line>Saint-Etienne,FR</addr-line></aff><aff id="A8"><label>8</label>Service de rhumatologie<institution>CHU Rouen</institution><addr-line>76000 Rouen,FR</addr-line></aff><aff id="A9"><label>9</label>CH F. Quesnay, Service de médecine interne<institution>Centre hospitalier F. Quesnay</institution><addr-line>Mantes la Jolie,FR</addr-line></aff><aff id="A10"><label>10</label>Centre régional de pharmacovigilance<institution>Centre régional de pharmacovigilance</institution><addr-line>Nice,FR</addr-line></aff><aff id="A11"><label>11</label>Service de parasitologie<institution>AP-HP</institution><institution>Hôpital Henri Mondor</institution><institution>Université Paris-Est</institution><addr-line>Créteil,FR</addr-line></aff><aff id="A12"><label>12</label>Service d'hépato-gastro-entérologie<institution>AP-HP</institution><institution>Hôpital Saint-Louis</institution><institution>Université Paris-Diderot - Paris VII</institution><addr-line>1 avenue Claude Vellefaux 75475 Paris,FR</addr-line></aff><aff id="A13"><label>13</label>Cytokines, chimiokines et immunopathologie<institution>INSERM : U764</institution><institution>IFR13</institution><institution>Université Paris Sud - Paris XI</institution><addr-line>Centre de Recherche Inserm 32, Rue Des Carnets 92140 CLAMART,FR</addr-line></aff><aff id="A14"><label>14</label>Service des maladies infectieuses et tropicales<institution>Université Paris Descartes</institution><institution>AP-HP</institution><institution>Hôpital Necker - Enfants Malades</institution><institution>Centre d'infectiologie Necker-Pasteur</institution><addr-line>Paris,FR</addr-line></aff><aff id="A15"><label>15</label>Immunologie antivirale systémique et cérébrale<institution>INSERM : U802</institution><institution>IFR93</institution><institution>Université Paris Sud - Paris XI</institution><addr-line>Faculte de Medecine Paris Sud 63, Rue Gabriel Peri 94276 LE KREMLIN BICETRE CEDEX,FR</addr-line></aff><author-notes><corresp id="FN1">* Correspondence should be adressed to: Xavier Mariette <email>xavier.mariette@bct.aphp.fr</email></corresp><fn id="FN2" fn-type="equal"><label>#</label><p>the two authors contributed equally to the work</p></fn></author-notes><pub-date pub-type="ppub"><month>7</month><year>2009</year></pub-date><pub-date pub-type="pmc-release"><day>16</day><month>8</month><year>2010</year></pub-date><volume>60</volume><issue>7</issue><fpage>1884</fpage><lpage>1894</lpage><abstract><sec id="S1"><title>Background</title><p id="P1">Tuberculosis (TB) is associated with anti-tumour necrosis factor (TNF) therapy but whether it is drug-specific remains a concern. Our objective was to describe cases of tuberculosis associated with anti-TNF therapy, identify risk factors and estimate the incidence.</p></sec><sec id="S2"><title>Methods</title><p id="P2">An incidence study with the French population as reference and a case-control analysis. We collected, for 3 years, cases of TB among French patients receiving anti-TNF therapy, whatever the indication, with two controls treated with anti-TNF agents per case.</p></sec><sec id="S3"><title>Results</title><p id="P3">We collected 69 cases of TB in patients treated for rheumatoid arthritis (n=40), spondylarthropathies (n=18), inflammatory colitis (n=9), psoriasis (n=1) and Behçet’s disease (n=1) treated with infliximab (n=36), adalimumab (n=28) and etanercept (n=5). None of the cases had received correct chemoprophylaxis treatment. The sex and age-adjusted incidence rate of TB was 116.7 per 100,000 patient-years. The SIR was 12.2 (95% confidence interval 9.7–15.5) and was higher for therapy with infliximab and adalimumab than for that with etanercept: 18.6 (13.4–25.8) and 29.3 (20.2–42.4) versus 1.8 (0.7–4.3), respectively. In the case-control analysis, the exposure to infliximab or adalimumab versus etanercept was an independent risk factor for TB: odds ratio=13.3 (2.6–69.0) and 17.1 (3.6–80.6), respectively. Other risk factors were age, the first year of anti-TNF treatment, and being born in an endemic area.</p></sec><sec id="S4"><title>Conclusions</title><p id="P4">The risk of TB is higher for patients receiving monoclonal-antibody than soluble-receptor anti-TNF therapy. The increased risk with early anti-TNF treatment and the absence of correct chemoprophylaxis treatment favours the reactivation of latent TB.</p></sec></abstract><kwd-group kwd-group-type="MESH"><kwd>Adult</kwd><kwd>Aged</kwd><kwd>Antibodies, Monoclonal</kwd><kwd>adverse effects</kwd><kwd>therapeutic use</kwd><kwd>Arthritis, Rheumatoid</kwd><kwd>drug therapy</kwd><kwd>Behcet Syndrome</kwd><kwd>drug therapy</kwd><kwd>Case-Control Studies</kwd><kwd>Colitis</kwd><kwd>drug therapy</kwd><kwd>Female</kwd><kwd>France</kwd><kwd>Humans</kwd><kwd>Immunoglobulin G</kwd><kwd>adverse effects</kwd><kwd>therapeutic use</kwd><kwd>Male</kwd><kwd>Middle Aged</kwd><kwd>Prospective Studies</kwd><kwd>Receptors, Tumor Necrosis Factor</kwd><kwd>therapeutic use</kwd><kwd>Registries</kwd><kwd>Risk Factors</kwd><kwd>Spondylarthritis</kwd><kwd>drug therapy</kwd><kwd>Treatment Outcome</kwd><kwd>Tuberculosis</kwd><kwd>chemically induced</kwd><kwd>drug therapy</kwd><kwd>epidemiology</kwd><kwd>Tumor Necrosis Factor-alpha</kwd><kwd>immunology</kwd></kwd-group><kwd-group kwd-group-type="Author"><kwd>anti-TNF-alpha</kwd><kwd>tuberculosis</kwd><kwd>safety</kwd><kwd>rheumatoid arthritis</kwd><kwd>inflammatory chronic diseases</kwd></kwd-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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