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 : 000B34 ( Main/Exploration ); précédent : 000B33; suivant : 000B35Risk 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.
Url:
DOI: 10.1002/art.24632
PubMed: 19565495
PubMed Central: 2921546
Affiliations:
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Le document en format XML
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<author><name sortKey="Allanore, Yannick" sort="Allanore, Yannick" uniqKey="Allanore Y" first="Yannick" last="Allanore">Yannick Allanore</name>
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<author><name sortKey="Breban, Maxime" sort="Breban, Maxime" uniqKey="Breban M" first="Maxime" last="Bréban">Maxime Bréban</name>
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<author><name sortKey="Pallot Prades, Beatrice" sort="Pallot Prades, Beatrice" uniqKey="Pallot Prades B" first="Béatrice" last="Pallot-Prades">Béatrice Pallot-Prades</name>
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<author><name sortKey="Chichemanian, Rose Marie" sort="Chichemanian, Rose Marie" uniqKey="Chichemanian R" first="Rose Marie" last="Chichemanian">Rose Marie Chichemanian</name>
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<author><name sortKey="Bretagne, Stephane" sort="Bretagne, Stephane" uniqKey="Bretagne S" first="Stéphane" last="Bretagne">Stéphane Bretagne</name>
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<author><name sortKey="Emilie, Dominique" sort="Emilie, Dominique" uniqKey="Emilie D" first="Dominique" last="Emilie">Dominique Emilie</name>
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<author><name sortKey="Lorthololary, Olivier" sort="Lorthololary, Olivier" uniqKey="Lorthololary O" first="Olivier" last="Lorthololary">Olivier Lorthololary</name>
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<author><name sortKey="Tubach, Florence" sort="Tubach, Florence" uniqKey="Tubach F" first="Florence" last="Tubach">Florence Tubach</name>
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<author><name sortKey="Salmon, Dominique" sort="Salmon, Dominique" uniqKey="Salmon D" first="Dominique" last="Salmon">Dominique Salmon</name>
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<author><name sortKey="Ravaud, Philippe" sort="Ravaud, Philippe" uniqKey="Ravaud P" first="Philippe" last="Ravaud">Philippe Ravaud</name>
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<addr-line>46 rue Henri Huchard 75018 Paris,FR</addr-line>
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<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>
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<addr-line>27 rue du Faubourg Saint-Jacques 75679 Paris Cedex 14,FR</addr-line>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<affiliations><list></list>
<tree><noCountry><name sortKey="Allanore, Yannick" sort="Allanore, Yannick" uniqKey="Allanore Y" first="Yannick" last="Allanore">Yannick Allanore</name>
<name sortKey="Breban, Maxime" sort="Breban, Maxime" uniqKey="Breban M" first="Maxime" last="Bréban">Maxime Bréban</name>
<name sortKey="Bretagne, Stephane" sort="Bretagne, Stephane" uniqKey="Bretagne S" first="Stéphane" last="Bretagne">Stéphane Bretagne</name>
<name sortKey="Chichemanian, Rose Marie" sort="Chichemanian, Rose Marie" uniqKey="Chichemanian R" first="Rose Marie" last="Chichemanian">Rose Marie Chichemanian</name>
<name sortKey="Emilie, Dominique" sort="Emilie, Dominique" uniqKey="Emilie D" first="Dominique" last="Emilie">Dominique Emilie</name>
<name sortKey="Goupille, Philippe" sort="Goupille, Philippe" uniqKey="Goupille P" first="Philippe" last="Goupille">Philippe Goupille</name>
<name sortKey="Lemann, Marc" sort="Lemann, Marc" uniqKey="Lemann M" first="Marc" last="Lemann">Marc Lemann</name>
<name sortKey="Lorthololary, Olivier" sort="Lorthololary, Olivier" uniqKey="Lorthololary O" first="Olivier" last="Lorthololary">Olivier Lorthololary</name>
<name sortKey="Mariette, Xavier" sort="Mariette, Xavier" uniqKey="Mariette X" first="Xavier" last="Mariette">Xavier Mariette</name>
<name sortKey="Pallot Prades, Beatrice" sort="Pallot Prades, Beatrice" uniqKey="Pallot Prades B" first="Béatrice" last="Pallot-Prades">Béatrice Pallot-Prades</name>
<name sortKey="Pouplin, Sophie" sort="Pouplin, Sophie" uniqKey="Pouplin S" first="Sophie" last="Pouplin">Sophie Pouplin</name>
<name sortKey="Ravaud, Philippe" sort="Ravaud, Philippe" uniqKey="Ravaud P" first="Philippe" last="Ravaud">Philippe Ravaud</name>
<name sortKey="Sacchi, Antoinette" sort="Sacchi, Antoinette" uniqKey="Sacchi A" first="Antoinette" last="Sacchi">Antoinette Sacchi</name>
<name sortKey="Salmon, Dominique" sort="Salmon, Dominique" uniqKey="Salmon D" first="Dominique" last="Salmon">Dominique Salmon</name>
<name sortKey="Tubach, Florence" sort="Tubach, Florence" uniqKey="Tubach F" first="Florence" last="Tubach">Florence Tubach</name>
</noCountry>
</tree>
</affiliations>
</record>
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