Lymphoma in patients treated with anti-TNF: results of the 3-year prospective French RATIO registry
Identifieur interne : 001784 ( Istex/Corpus ); précédent : 001783; suivant : 001785Lymphoma in patients treated with anti-TNF: results of the 3-year prospective French RATIO registry
Auteurs : X. Mariette ; F. Tubach ; H. Bagheri ; M. Bardet ; J M Berthelot ; P. Gaudin ; D. Heresbach ; A. Martin ; T. Schaeverbeke ; D. Salmon ; M. Lemann ; O. Hermine ; M. Raphael ; P. RavaudSource :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2010-02.
Abstract
Objective: To describe cases of lymphoma associated with anti-TNF therapy, identify risk factors, estimate the incidence and compare the risks for different anti-TNF agents. Methods: A national prospective registry was designed (Research Axed on Tolerance of bIOtherapies; RATIO) to collect all cases of lymphoma in French patients receiving anti-TNF therapy from 2004 to 2006, whatever the indication. A case–control analysis was conducted including two controls treated with anti-TNF per case and an incidence study of lymphoma with the French population was used as the reference. Results: 38 cases of lymphoma, 31 non-Hodgkin’s lymphoma (NHL) (26 B cell and five T cell), five Hodgkin’s lymphoma (HL) and two Hodgkin’s-like lymphoma were collected. Epstein–Barr virus was detected in both of two Hodgkin’s-like lymphoma, three of five HL and one NHL. Patients receiving adalimumab or infliximab had a higher risk than those treated with etanercept: standardised incidence ratio (SIR) 4.1 (2.3–7.1) and 3.6 (2.3–5.6) versus 0.9 (0.4–1.8). The exposure to adalimumab or infliximab versus etanercept was an independent risk factor for lymphoma in the case–control study: odds ratio 4.7 (1.3–17.7) and 4.1 (1.4–12.5), respectively. The sex and age-adjusted incidence rate of lymphoma was 42.1 per 100 000 patient-years. The SIR was 2.4 (95% CI 1.7 to 3.2). Conclusion: The two to threefold increased risk of lymphoma in patients receiving anti-TNF therapy is similar to that expected for such patients with severe inflammatory diseases. Some lymphomas associated with immunosuppression may occur, and the risk of lymphoma is higher with monoclonal-antibody therapy than with soluble-receptor therapy.
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DOI: 10.1136/ard.2009.117762
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Ravaud</name><affiliation><mods:affiliation>Université Paris 7 Denis Diderot, UFR de médecine; INSERM, U738; AP-HP, Hôpital Bichat, Département d’Epidémiologie, Biostatistique et Recherche Clinique, Paris, France</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:733F58FA17CA878BEB83478B8B10B3590B340E75</idno><date when="2010" year="2010">2010</date><idno type="doi">10.1136/ard.2009.117762</idno><idno type="url">https://api.istex.fr/document/733F58FA17CA878BEB83478B8B10B3590B340E75/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">001784</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a">Lymphoma in patients treated with anti-TNF: results of the 3-year prospective French RATIO registry</title><author><name sortKey="Mariette, X" sort="Mariette, X" uniqKey="Mariette X" first="X" last="Mariette">X. Mariette</name><affiliation><mods:affiliation>Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Bicêtre, Service de rhumatologie, Université Paris-Sud 11, INSERM U802, Le Kremlin-Bicêtre, France</mods:affiliation></affiliation></author><author><name sortKey="Tubach, F" sort="Tubach, F" uniqKey="Tubach F" first="F" last="Tubach">F. Tubach</name><affiliation><mods:affiliation>Université Paris 7 Denis Diderot, UFR de médecine; INSERM, U738; AP-HP, Hôpital Bichat, Département d’Epidémiologie, Biostatistique et Recherche Clinique, Paris, France</mods:affiliation></affiliation></author><author><name sortKey="Bagheri, H" sort="Bagheri, H" uniqKey="Bagheri H" first="H" last="Bagheri">H. Bagheri</name><affiliation><mods:affiliation>Service de Pharmacologie Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d’Informations sur le Médicament, Unité de Pharmacoépidémiologie, EA 3696, Université de Toulouse, Faculté de Médecine, Toulouse, France</mods:affiliation></affiliation></author><author><name sortKey="Bardet, M" sort="Bardet, M" uniqKey="Bardet M" first="M" last="Bardet">M. Bardet</name><affiliation><mods:affiliation>Hôpital de la Source, Service de médecine interne et rhumatologie, Orléans, France</mods:affiliation></affiliation></author><author><name sortKey="Berthelot, J M" sort="Berthelot, J M" uniqKey="Berthelot J" first="J M" last="Berthelot">J M Berthelot</name><affiliation><mods:affiliation>Hôtel Dieu, Service de rhumatologie, Nantes, France</mods:affiliation></affiliation></author><author><name sortKey="Gaudin, P" sort="Gaudin, P" uniqKey="Gaudin P" first="P" last="Gaudin">P. Gaudin</name><affiliation><mods:affiliation>Centre Hospitalo-Universitaire, Service de rhumatologie, Grenoble, France</mods:affiliation></affiliation></author><author><name sortKey="Heresbach, D" sort="Heresbach, D" uniqKey="Heresbach D" first="D" last="Heresbach">D. Heresbach</name><affiliation><mods:affiliation>Hôpital Pontchaillou, Service des maladies digestives, Rennes, France</mods:affiliation></affiliation></author><author><name sortKey="Martin, A" sort="Martin, A" uniqKey="Martin A" first="A" last="Martin">A. Martin</name><affiliation><mods:affiliation>Hôpital de Saint Brieuc, Service de rhumatologie, Saint Brieuc, France</mods:affiliation></affiliation></author><author><name sortKey="Schaeverbeke, T" sort="Schaeverbeke, T" uniqKey="Schaeverbeke T" first="T" last="Schaeverbeke">T. Schaeverbeke</name><affiliation><mods:affiliation>Hôpital Pellegrin, Service de rhumatologie, Université Bordeaux II, Bordeaux, France</mods:affiliation></affiliation></author><author><name sortKey="Salmon, D" sort="Salmon, D" uniqKey="Salmon D" first="D" last="Salmon">D. Salmon</name><affiliation><mods:affiliation>AP-HP, Hôpital Cochin, Service de médecine interne, Université Paris V, Paris, France</mods:affiliation></affiliation></author><author><name sortKey="Lemann, M" sort="Lemann, M" uniqKey="Lemann M" first="M" last="Lemann">M. Lemann</name><affiliation><mods:affiliation>AP-HP, Hôpital Saint Louis, Service de gastro-entérologie, Université Paris 7, Paris, France</mods:affiliation></affiliation></author><author><name sortKey="Hermine, O" sort="Hermine, O" uniqKey="Hermine O" first="O" last="Hermine">O. Hermine</name><affiliation><mods:affiliation>AP-HP, Hôpital Necker, Service d’hématologie, CNRS UMR 8143, Université Paris V, Paris, France</mods:affiliation></affiliation></author><author><name sortKey="Raphael, M" sort="Raphael, M" uniqKey="Raphael M" first="M" last="Raphael">M. Raphael</name><affiliation><mods:affiliation>AP-HP, Hôpital Bicêtre, Laboratoire d’hématologie, Université Paris-Sud 11, Le Kremlin-Bicêtre, France</mods:affiliation></affiliation></author><author><name sortKey="Ravaud, P" sort="Ravaud, P" uniqKey="Ravaud P" first="P" last="Ravaud">P. Ravaud</name><affiliation><mods:affiliation>Université Paris 7 Denis Diderot, UFR de médecine; INSERM, U738; AP-HP, Hôpital Bichat, Département d’Epidémiologie, Biostatistique et Recherche Clinique, Paris, France</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Annals of the Rheumatic Diseases</title><title level="j" type="abbrev">Ann Rheum Dis</title><idno type="ISSN">0003-4967</idno><idno type="eISSN">1468-2060</idno><imprint><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><date type="published" when="2010-02">2010-02</date><biblScope unit="volume">69</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="400">400</biblScope></imprint><idno type="ISSN">0003-4967</idno></series><idno type="istex">733F58FA17CA878BEB83478B8B10B3590B340E75</idno><idno type="DOI">10.1136/ard.2009.117762</idno><idno type="href">annrheumdis-69-400.pdf</idno><idno type="ArticleID">ar117762</idno><idno type="PMID">19828563</idno><idno type="local">annrheumdis;69/2/400</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0003-4967</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Objective: To describe cases of lymphoma associated with anti-TNF therapy, identify risk factors, estimate the incidence and compare the risks for different anti-TNF agents. Methods: A national prospective registry was designed (Research Axed on Tolerance of bIOtherapies; RATIO) to collect all cases of lymphoma in French patients receiving anti-TNF therapy from 2004 to 2006, whatever the indication. A case–control analysis was conducted including two controls treated with anti-TNF per case and an incidence study of lymphoma with the French population was used as the reference. Results: 38 cases of lymphoma, 31 non-Hodgkin’s lymphoma (NHL) (26 B cell and five T cell), five Hodgkin’s lymphoma (HL) and two Hodgkin’s-like lymphoma were collected. Epstein–Barr virus was detected in both of two Hodgkin’s-like lymphoma, three of five HL and one NHL. Patients receiving adalimumab or infliximab had a higher risk than those treated with etanercept: standardised incidence ratio (SIR) 4.1 (2.3–7.1) and 3.6 (2.3–5.6) versus 0.9 (0.4–1.8). The exposure to adalimumab or infliximab versus etanercept was an independent risk factor for lymphoma in the case–control study: odds ratio 4.7 (1.3–17.7) and 4.1 (1.4–12.5), respectively. The sex and age-adjusted incidence rate of lymphoma was 42.1 per 100 000 patient-years. The SIR was 2.4 (95% CI 1.7 to 3.2). Conclusion: The two to threefold increased risk of lymphoma in patients receiving anti-TNF therapy is similar to that expected for such patients with severe inflammatory diseases. Some lymphomas associated with immunosuppression may occur, and the risk of lymphoma is higher with monoclonal-antibody therapy than with soluble-receptor therapy.</div></front></TEI><istex><corpusName>bmj</corpusName><author><json:item><name>X Mariette</name><affiliations><json:string>Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Bicêtre, Service de rhumatologie, Université Paris-Sud 11, INSERM U802, Le Kremlin-Bicêtre, France</json:string></affiliations></json:item><json:item><name>F Tubach</name><affiliations><json:string>Université Paris 7 Denis Diderot, UFR de médecine; INSERM, U738; AP-HP, Hôpital Bichat, Département d’Epidémiologie, Biostatistique et Recherche Clinique, Paris, France</json:string></affiliations></json:item><json:item><name>H Bagheri</name><affiliations><json:string>Service de Pharmacologie Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d’Informations sur le Médicament, Unité de Pharmacoépidémiologie, EA 3696, Université de Toulouse, Faculté de Médecine, Toulouse, France</json:string></affiliations></json:item><json:item><name>M Bardet</name><affiliations><json:string>Hôpital de la Source, Service de médecine interne et rhumatologie, Orléans, France</json:string></affiliations></json:item><json:item><name>J M Berthelot</name><affiliations><json:string>Hôtel Dieu, Service de rhumatologie, Nantes, France</json:string></affiliations></json:item><json:item><name>P Gaudin</name><affiliations><json:string>Centre Hospitalo-Universitaire, Service de rhumatologie, Grenoble, France</json:string></affiliations></json:item><json:item><name>D Heresbach</name><affiliations><json:string>Hôpital Pontchaillou, Service des maladies digestives, Rennes, France</json:string></affiliations></json:item><json:item><name>A Martin</name><affiliations><json:string>Hôpital de Saint Brieuc, Service de rhumatologie, Saint Brieuc, France</json:string></affiliations></json:item><json:item><name>T Schaeverbeke</name><affiliations><json:string>Hôpital Pellegrin, Service de rhumatologie, Université Bordeaux II, Bordeaux, France</json:string></affiliations></json:item><json:item><name>D Salmon</name><affiliations><json:string>AP-HP, Hôpital Cochin, Service de médecine interne, Université Paris V, Paris, France</json:string></affiliations></json:item><json:item><name>M Lemann</name><affiliations><json:string>AP-HP, Hôpital Saint Louis, Service de gastro-entérologie, Université Paris 7, Paris, France</json:string></affiliations></json:item><json:item><name>O Hermine</name><affiliations><json:string>AP-HP, Hôpital Necker, Service d’hématologie, CNRS UMR 8143, Université Paris V, Paris, France</json:string></affiliations></json:item><json:item><name>M Raphael</name><affiliations><json:string>AP-HP, Hôpital Bicêtre, Laboratoire d’hématologie, Université Paris-Sud 11, Le Kremlin-Bicêtre, France</json:string></affiliations></json:item><json:item><name>P Ravaud</name><affiliations><json:string>Université Paris 7 Denis Diderot, UFR de médecine; INSERM, U738; AP-HP, Hôpital Bichat, Département d’Epidémiologie, Biostatistique et Recherche Clinique, Paris, France</json:string></affiliations></json:item></author><articleId><json:string>ar117762</json:string></articleId><language><json:string>eng</json:string></language><originalGenre><json:string>research-article</json:string></originalGenre><abstract>Objective: To describe cases of lymphoma associated with anti-TNF therapy, identify risk factors, estimate the incidence and compare the risks for different anti-TNF agents. Methods: A national prospective registry was designed (Research Axed on Tolerance of bIOtherapies; RATIO) to collect all cases of lymphoma in French patients receiving anti-TNF therapy from 2004 to 2006, whatever the indication. A case–control analysis was conducted including two controls treated with anti-TNF per case and an incidence study of lymphoma with the French population was used as the reference. Results: 38 cases of lymphoma, 31 non-Hodgkin’s lymphoma (NHL) (26 B cell and five T cell), five Hodgkin’s lymphoma (HL) and two Hodgkin’s-like lymphoma were collected. Epstein–Barr virus was detected in both of two Hodgkin’s-like lymphoma, three of five HL and one NHL. Patients receiving adalimumab or infliximab had a higher risk than those treated with etanercept: standardised incidence ratio (SIR) 4.1 (2.3–7.1) and 3.6 (2.3–5.6) versus 0.9 (0.4–1.8). The exposure to adalimumab or infliximab versus etanercept was an independent risk factor for lymphoma in the case–control study: odds ratio 4.7 (1.3–17.7) and 4.1 (1.4–12.5), respectively. The sex and age-adjusted incidence rate of lymphoma was 42.1 per 100 000 patient-years. The SIR was 2.4 (95% CI 1.7 to 3.2). Conclusion: The two to threefold increased risk of lymphoma in patients receiving anti-TNF therapy is similar to that expected for such patients with severe inflammatory diseases. Some lymphomas associated with immunosuppression may occur, and the risk of lymphoma is higher with monoclonal-antibody therapy than with soluble-receptor therapy.</abstract><qualityIndicators><score>8</score><pdfVersion>1.2</pdfVersion><pdfPageSize>595.276 x 793.701 pts</pdfPageSize><refBibsNative>false</refBibsNative><keywordCount>0</keywordCount><abstractCharCount>1700</abstractCharCount><pdfWordCount>5124</pdfWordCount><pdfCharCount>35106</pdfCharCount><pdfPageCount>9</pdfPageCount><abstractWordCount>251</abstractWordCount></qualityIndicators><title>Lymphoma in patients treated with anti-TNF: results of the 3-year prospective French RATIO registry</title><pmid><json:string>19828563</json:string></pmid><genre><json:string>research-article</json:string></genre><host><volume>69</volume><publisherId><json:string>ard</json:string></publisherId><pages><first>400</first></pages><issn><json:string>0003-4967</json:string></issn><issue>2</issue><genre><json:string>journal</json:string></genre><language><json:string>unknown</json:string></language><eissn><json:string>1468-2060</json:string></eissn><title>Annals of the Rheumatic Diseases</title></host><publicationDate>2010</publicationDate><copyrightDate>2010</copyrightDate><doi><json:string>10.1136/ard.2009.117762</json:string></doi><id>733F58FA17CA878BEB83478B8B10B3590B340E75</id><score>0.10615927</score><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/733F58FA17CA878BEB83478B8B10B3590B340E75/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/733F58FA17CA878BEB83478B8B10B3590B340E75/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/733F58FA17CA878BEB83478B8B10B3590B340E75/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a">Lymphoma in patients treated with anti-TNF: results of the 3-year prospective French RATIO registry</title><respStmt><resp>Références bibliographiques récupérées via GROBID</resp><name resp="ISTEX-API">ISTEX-API (INIST-CNRS)</name></respStmt></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><availability><p>BMJ Publishing Group Ltd and European League Against Rheumatism. All rights reserved.</p></availability><date>2009-10-14</date></publicationStmt><notesStmt><note>▸ Additional supplementary files and supplementary fig 1 are published online only at http://ard.bmj.com/content/vol69/issue2</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a">Lymphoma in patients treated with anti-TNF: results of the 3-year prospective French RATIO registry</title><author xml:id="author-1"><persName><forename type="first">X</forename><surname>Mariette</surname></persName><affiliation>Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Bicêtre, Service de rhumatologie, Université Paris-Sud 11, INSERM U802, Le Kremlin-Bicêtre, France</affiliation></author><author xml:id="author-2"><persName><forename type="first">F</forename><surname>Tubach</surname></persName><affiliation>Université Paris 7 Denis Diderot, UFR de médecine; INSERM, U738; AP-HP, Hôpital Bichat, Département d’Epidémiologie, Biostatistique et Recherche Clinique, Paris, France</affiliation></author><author xml:id="author-3"><persName><forename type="first">H</forename><surname>Bagheri</surname></persName><affiliation>Service de Pharmacologie Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d’Informations sur le Médicament, Unité de Pharmacoépidémiologie, EA 3696, Université de Toulouse, Faculté de Médecine, Toulouse, France</affiliation></author><author xml:id="author-4"><persName><forename type="first">M</forename><surname>Bardet</surname></persName><affiliation>Hôpital de la Source, Service de médecine interne et rhumatologie, Orléans, France</affiliation></author><author xml:id="author-5"><persName><forename type="first">J M</forename><surname>Berthelot</surname></persName><affiliation>Hôtel Dieu, Service de rhumatologie, Nantes, France</affiliation></author><author xml:id="author-6"><persName><forename type="first">P</forename><surname>Gaudin</surname></persName><affiliation>Centre Hospitalo-Universitaire, Service de rhumatologie, Grenoble, France</affiliation></author><author xml:id="author-7"><persName><forename type="first">D</forename><surname>Heresbach</surname></persName><affiliation>Hôpital Pontchaillou, Service des maladies digestives, Rennes, France</affiliation></author><author xml:id="author-8"><persName><forename type="first">A</forename><surname>Martin</surname></persName><affiliation>Hôpital de Saint Brieuc, Service de rhumatologie, Saint Brieuc, France</affiliation></author><author xml:id="author-9"><persName><forename type="first">T</forename><surname>Schaeverbeke</surname></persName><affiliation>Hôpital Pellegrin, Service de rhumatologie, Université Bordeaux II, Bordeaux, France</affiliation></author><author xml:id="author-10"><persName><forename type="first">D</forename><surname>Salmon</surname></persName><affiliation>AP-HP, Hôpital Cochin, Service de médecine interne, Université Paris V, Paris, France</affiliation></author><author xml:id="author-11"><persName><forename type="first">M</forename><surname>Lemann</surname></persName><affiliation>AP-HP, Hôpital Saint Louis, Service de gastro-entérologie, Université Paris 7, Paris, France</affiliation></author><author xml:id="author-12"><persName><forename type="first">O</forename><surname>Hermine</surname></persName><affiliation>AP-HP, Hôpital Necker, Service d’hématologie, CNRS UMR 8143, Université Paris V, Paris, France</affiliation></author><author xml:id="author-13"><persName><forename type="first">M</forename><surname>Raphael</surname></persName><affiliation>AP-HP, Hôpital Bicêtre, Laboratoire d’hématologie, Université Paris-Sud 11, Le Kremlin-Bicêtre, France</affiliation></author><author xml:id="author-14"><persName><forename type="first">P</forename><surname>Ravaud</surname></persName><affiliation>Université Paris 7 Denis Diderot, UFR de médecine; INSERM, U738; AP-HP, Hôpital Bichat, Département d’Epidémiologie, Biostatistique et Recherche Clinique, Paris, France</affiliation></author></analytic><monogr><title level="j">Annals of the Rheumatic Diseases</title><title level="j" type="abbrev">Ann Rheum Dis</title><idno type="pISSN">0003-4967</idno><idno type="eISSN">1468-2060</idno><imprint><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><date type="published" when="2010-02"></date><biblScope unit="volume">69</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="400">400</biblScope></imprint></monogr><idno type="istex">733F58FA17CA878BEB83478B8B10B3590B340E75</idno><idno type="DOI">10.1136/ard.2009.117762</idno><idno type="href">annrheumdis-69-400.pdf</idno><idno type="ArticleID">ar117762</idno><idno type="PMID">19828563</idno><idno type="local">annrheumdis;69/2/400</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2009-10-14</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>Objective: To describe cases of lymphoma associated with anti-TNF therapy, identify risk factors, estimate the incidence and compare the risks for different anti-TNF agents. Methods: A national prospective registry was designed (Research Axed on Tolerance of bIOtherapies; RATIO) to collect all cases of lymphoma in French patients receiving anti-TNF therapy from 2004 to 2006, whatever the indication. A case–control analysis was conducted including two controls treated with anti-TNF per case and an incidence study of lymphoma with the French population was used as the reference. Results: 38 cases of lymphoma, 31 non-Hodgkin’s lymphoma (NHL) (26 B cell and five T cell), five Hodgkin’s lymphoma (HL) and two Hodgkin’s-like lymphoma were collected. Epstein–Barr virus was detected in both of two Hodgkin’s-like lymphoma, three of five HL and one NHL. Patients receiving adalimumab or infliximab had a higher risk than those treated with etanercept: standardised incidence ratio (SIR) 4.1 (2.3–7.1) and 3.6 (2.3–5.6) versus 0.9 (0.4–1.8). The exposure to adalimumab or infliximab versus etanercept was an independent risk factor for lymphoma in the case–control study: odds ratio 4.7 (1.3–17.7) and 4.1 (1.4–12.5), respectively. The sex and age-adjusted incidence rate of lymphoma was 42.1 per 100 000 patient-years. The SIR was 2.4 (95% CI 1.7 to 3.2). Conclusion: The two to threefold increased risk of lymphoma in patients receiving anti-TNF therapy is similar to that expected for such patients with severe inflammatory diseases. Some lymphomas associated with immunosuppression may occur, and the risk of lymphoma is higher with monoclonal-antibody therapy than with soluble-receptor therapy.</p></abstract></profileDesc><revisionDesc><change when="2009-10-14">Created</change><change when="2010-02">Published</change><change xml:id="refBibs-istex" who="#ISTEX-API" when="2016-10-4">References added</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/733F58FA17CA878BEB83478B8B10B3590B340E75/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus bmj" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="no"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Archiving and Interchange DTD v2.3 20070202//EN" URI="archivearticle.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="research-article"><front><journal-meta><journal-id journal-id-type="hwp">annrheumdis</journal-id><journal-id journal-id-type="nlm-ta">Ann Rheum Dis</journal-id><journal-id journal-id-type="publisher-id">ard</journal-id><journal-title>Annals of the Rheumatic Diseases</journal-title><abbrev-journal-title abbrev-type="publisher">Ann Rheum Dis</abbrev-journal-title><abbrev-journal-title>Ann Rheum Dis</abbrev-journal-title><issn pub-type="ppub">0003-4967</issn><issn pub-type="epub">1468-2060</issn><publisher><publisher-name>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">ar117762</article-id><article-id pub-id-type="doi">10.1136/ard.2009.117762</article-id><article-id pub-id-type="other">annrheumdis;69/2/400</article-id><article-id pub-id-type="other">annrheumdis;ard.2009.117762</article-id><article-id pub-id-type="pmid">19828563</article-id><article-id pub-id-type="other">400</article-id><article-id pub-id-type="other">ard.2009.117762</article-id><article-categories><subj-group subj-group-type="heading"><subject>Clinical and epidemiological research</subject></subj-group><series-title>Extended report</series-title></article-categories><title-group><article-title>Lymphoma in patients treated with anti-TNF: results of the 3-year prospective French RATIO registry</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Mariette</surname><given-names>X</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Tubach</surname><given-names>F</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Bagheri</surname><given-names>H</given-names></name><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Bardet</surname><given-names>M</given-names></name><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Berthelot</surname><given-names>J M</given-names></name><xref ref-type="aff" rid="aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Gaudin</surname><given-names>P</given-names></name><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Heresbach</surname><given-names>D</given-names></name><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Martin</surname><given-names>A</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Schaeverbeke</surname><given-names>T</given-names></name><xref ref-type="aff" rid="aff9">9</xref></contrib><contrib contrib-type="author"><name><surname>Salmon</surname><given-names>D</given-names></name><xref ref-type="aff" rid="aff10">10</xref></contrib><contrib contrib-type="author"><name><surname>Lemann</surname><given-names>M</given-names></name><xref ref-type="aff" rid="aff11">11</xref></contrib><contrib contrib-type="author"><name><surname>Hermine</surname><given-names>O</given-names></name><xref ref-type="aff" rid="aff12">12</xref></contrib><contrib contrib-type="author"><name><surname>Raphael</surname><given-names>M</given-names></name><xref ref-type="aff" rid="aff13">13</xref></contrib><contrib contrib-type="author"><name><surname>Ravaud</surname><given-names>P</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib></contrib-group><aff id="aff1"><label>1</label><addr-line>Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Bicêtre, Service de rhumatologie, Université Paris-Sud 11, INSERM U802, Le Kremlin-Bicêtre, France</addr-line></aff><aff id="aff2"><label>2</label><addr-line>Université Paris 7 Denis Diderot, UFR de médecine; INSERM, U738; AP-HP, Hôpital Bichat, Département d’Epidémiologie, Biostatistique et Recherche Clinique, Paris, France</addr-line></aff><aff id="aff3"><label>3</label><addr-line>Service de Pharmacologie Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d’Informations sur le Médicament, Unité de Pharmacoépidémiologie, EA 3696, Université de Toulouse, Faculté de Médecine, Toulouse, France</addr-line></aff><aff id="aff4"><label>4</label><addr-line>Hôpital de la Source, Service de médecine interne et rhumatologie, Orléans, France</addr-line></aff><aff id="aff5"><label>5</label><addr-line>Hôtel Dieu, Service de rhumatologie, Nantes, France</addr-line></aff><aff id="aff6"><label>6</label><addr-line>Centre Hospitalo-Universitaire, Service de rhumatologie, Grenoble, France</addr-line></aff><aff id="aff7"><label>7</label><addr-line>Hôpital Pontchaillou, Service des maladies digestives, Rennes, France</addr-line></aff><aff id="aff8"><label>8</label><addr-line>Hôpital de Saint Brieuc, Service de rhumatologie, Saint Brieuc, France</addr-line></aff><aff id="aff9"><label>9</label><addr-line>Hôpital Pellegrin, Service de rhumatologie, Université Bordeaux II, Bordeaux, France</addr-line></aff><aff id="aff10"><label>10</label><addr-line>AP-HP, Hôpital Cochin, Service de médecine interne, Université Paris V, Paris, France</addr-line></aff><aff id="aff11"><label>11</label><addr-line>AP-HP, Hôpital Saint Louis, Service de gastro-entérologie, Université Paris 7, Paris, France</addr-line></aff><aff id="aff12"><label>12</label><addr-line>AP-HP, Hôpital Necker, Service d’hématologie, CNRS UMR 8143, Université Paris V, Paris, France</addr-line></aff><aff id="aff13"><label>13</label><addr-line>AP-HP, Hôpital Bicêtre, Laboratoire d’hématologie, Université Paris-Sud 11, Le Kremlin-Bicêtre, France</addr-line></aff><author-notes><fn fn-type="other"><p>▸ Additional supplementary files and supplementary fig 1 are published online only at <ext-link ext-link-type="uri" xlink:href="http://ard.bmj.com/content/vol69/issue2">http://ard.bmj.com/content/vol69/issue2</ext-link></p></fn><corresp><label>Correspondence to</label> Pr Xavier Mariette, Service de Rhumatologie, Hôpital de Bicêtre, 78 rue du Général Leclerc, 94275 Le Kremlin Bicêtre, France; <email xlink:type="simple">xavier.mariette@bct.ap-hop-paris.fr</email></corresp><fn fn-type="other"><p>For numbered affiliations see end of article</p></fn></author-notes><pub-date pub-type="ppub"><month>2</month><year>2010</year></pub-date><pub-date pub-type="epub-original"><day>14</day><month>10</month><year>2008</year></pub-date><pub-date pub-type="epub"><day>14</day><month>10</month><year>2009</year></pub-date><volume>69</volume><volume-id pub-id-type="other">69</volume-id><volume-id pub-id-type="other">69</volume-id><issue>2</issue><issue-id pub-id-type="other">annrheumdis;69/2</issue-id><issue-id pub-id-type="other">2</issue-id><issue-id pub-id-type="other">69/2</issue-id><fpage>400</fpage><history><date date-type="accepted"><day>17</day><month>9</month><year>2009</year></date></history><permissions><copyright-statement>BMJ Publishing Group Ltd and European League Against Rheumatism. All rights reserved.</copyright-statement><copyright-year>2010</copyright-year></permissions><self-uri content-type="pdf" xlink:role="full-text" xlink:href="annrheumdis-69-400.pdf"></self-uri><abstract><sec><title>Objective:</title><p>To describe cases of lymphoma associated with anti-TNF therapy, identify risk factors, estimate the incidence and compare the risks for different anti-TNF agents.</p></sec><sec><title>Methods:</title><p>A national prospective registry was designed (Research Axed on Tolerance of bIOtherapies; RATIO) to collect all cases of lymphoma in French patients receiving anti-TNF therapy from 2004 to 2006, whatever the indication. A case–control analysis was conducted including two controls treated with anti-TNF per case and an incidence study of lymphoma with the French population was used as the reference.</p></sec><sec><title>Results:</title><p>38 cases of lymphoma, 31 non-Hodgkin’s lymphoma (NHL) (26 B cell and five T cell), five Hodgkin’s lymphoma (HL) and two Hodgkin’s-like lymphoma were collected. Epstein–Barr virus was detected in both of two Hodgkin’s-like lymphoma, three of five HL and one NHL. Patients receiving adalimumab or infliximab had a higher risk than those treated with etanercept: standardised incidence ratio (SIR) 4.1 (2.3–7.1) and 3.6 (2.3–5.6) versus 0.9 (0.4–1.8). The exposure to adalimumab or infliximab versus etanercept was an independent risk factor for lymphoma in the case–control study: odds ratio 4.7 (1.3–17.7) and 4.1 (1.4–12.5), respectively. The sex and age-adjusted incidence rate of lymphoma was 42.1 per 100 000 patient-years. The SIR was 2.4 (95% CI 1.7 to 3.2).</p></sec><sec><title>Conclusion:</title><p>The two to threefold increased risk of lymphoma in patients receiving anti-TNF therapy is similar to that expected for such patients with severe inflammatory diseases. Some lymphomas associated with immunosuppression may occur, and the risk of lymphoma is higher with monoclonal-antibody therapy than with soluble-receptor therapy.</p></sec></abstract></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo><title>Lymphoma in patients treated with anti-TNF: results of the 3-year prospective French RATIO registry</title><partName>Extended report</partName></titleInfo><titleInfo type="alternative" contentType="CDATA"><title>Lymphoma in patients treated with anti-TNF: results of the 3-year prospective French RATIO registry</title><partName>Extended report</partName></titleInfo><name type="personal"><namePart type="given">X</namePart><namePart type="family">Mariette</namePart><affiliation>Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Bicêtre, Service de rhumatologie, Université Paris-Sud 11, INSERM U802, Le Kremlin-Bicêtre, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">F</namePart><namePart type="family">Tubach</namePart><affiliation>Université Paris 7 Denis Diderot, UFR de médecine; INSERM, U738; AP-HP, Hôpital Bichat, Département d’Epidémiologie, Biostatistique et Recherche Clinique, Paris, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H</namePart><namePart type="family">Bagheri</namePart><affiliation>Service de Pharmacologie Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d’Informations sur le Médicament, Unité de Pharmacoépidémiologie, EA 3696, Université de Toulouse, Faculté de Médecine, Toulouse, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M</namePart><namePart type="family">Bardet</namePart><affiliation>Hôpital de la Source, Service de médecine interne et rhumatologie, Orléans, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J M</namePart><namePart type="family">Berthelot</namePart><affiliation>Hôtel Dieu, Service de rhumatologie, Nantes, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P</namePart><namePart type="family">Gaudin</namePart><affiliation>Centre Hospitalo-Universitaire, Service de rhumatologie, Grenoble, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D</namePart><namePart type="family">Heresbach</namePart><affiliation>Hôpital Pontchaillou, Service des maladies digestives, Rennes, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A</namePart><namePart type="family">Martin</namePart><affiliation>Hôpital de Saint Brieuc, Service de rhumatologie, Saint Brieuc, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">T</namePart><namePart type="family">Schaeverbeke</namePart><affiliation>Hôpital Pellegrin, Service de rhumatologie, Université Bordeaux II, Bordeaux, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D</namePart><namePart type="family">Salmon</namePart><affiliation>AP-HP, Hôpital Cochin, Service de médecine interne, Université Paris V, Paris, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M</namePart><namePart type="family">Lemann</namePart><affiliation>AP-HP, Hôpital Saint Louis, Service de gastro-entérologie, Université Paris 7, Paris, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">O</namePart><namePart type="family">Hermine</namePart><affiliation>AP-HP, Hôpital Necker, Service d’hématologie, CNRS UMR 8143, Université Paris V, Paris, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M</namePart><namePart type="family">Raphael</namePart><affiliation>AP-HP, Hôpital Bicêtre, Laboratoire d’hématologie, Université Paris-Sud 11, Le Kremlin-Bicêtre, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P</namePart><namePart type="family">Ravaud</namePart><affiliation>Université Paris 7 Denis Diderot, UFR de médecine; INSERM, U738; AP-HP, Hôpital Bichat, Département d’Epidémiologie, Biostatistique et Recherche Clinique, Paris, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="research-article"></genre><originInfo><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><dateIssued encoding="w3cdtf">2010-02</dateIssued><dateCreated encoding="w3cdtf">2009-10-14</dateCreated><copyrightDate encoding="w3cdtf">2010</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract>Objective: To describe cases of lymphoma associated with anti-TNF therapy, identify risk factors, estimate the incidence and compare the risks for different anti-TNF agents. Methods: A national prospective registry was designed (Research Axed on Tolerance of bIOtherapies; RATIO) to collect all cases of lymphoma in French patients receiving anti-TNF therapy from 2004 to 2006, whatever the indication. A case–control analysis was conducted including two controls treated with anti-TNF per case and an incidence study of lymphoma with the French population was used as the reference. Results: 38 cases of lymphoma, 31 non-Hodgkin’s lymphoma (NHL) (26 B cell and five T cell), five Hodgkin’s lymphoma (HL) and two Hodgkin’s-like lymphoma were collected. Epstein–Barr virus was detected in both of two Hodgkin’s-like lymphoma, three of five HL and one NHL. Patients receiving adalimumab or infliximab had a higher risk than those treated with etanercept: standardised incidence ratio (SIR) 4.1 (2.3–7.1) and 3.6 (2.3–5.6) versus 0.9 (0.4–1.8). The exposure to adalimumab or infliximab versus etanercept was an independent risk factor for lymphoma in the case–control study: odds ratio 4.7 (1.3–17.7) and 4.1 (1.4–12.5), respectively. The sex and age-adjusted incidence rate of lymphoma was 42.1 per 100 000 patient-years. The SIR was 2.4 (95% CI 1.7 to 3.2). Conclusion: The two to threefold increased risk of lymphoma in patients receiving anti-TNF therapy is similar to that expected for such patients with severe inflammatory diseases. Some lymphomas associated with immunosuppression may occur, and the risk of lymphoma is higher with monoclonal-antibody therapy than with soluble-receptor therapy.</abstract><note type="footnotes">▸ Additional supplementary files and supplementary fig 1 are published online only at http://ard.bmj.com/content/vol69/issue2</note><relatedItem type="host"><titleInfo><title>Annals of the Rheumatic Diseases</title></titleInfo><titleInfo type="abbreviated"><title>Ann Rheum Dis</title></titleInfo><genre type="journal">journal</genre><identifier type="ISSN">0003-4967</identifier><identifier type="eISSN">1468-2060</identifier><identifier type="PublisherID">ard</identifier><identifier type="PublisherID-hwp">annrheumdis</identifier><identifier type="PublisherID-nlm-ta">Ann Rheum Dis</identifier><part><date>2010</date><detail type="volume"><caption>vol.</caption><number>69</number></detail><detail type="issue"><caption>no.</caption><number>2</number></detail><extent unit="pages"><start>400</start></extent></part></relatedItem><identifier type="istex">733F58FA17CA878BEB83478B8B10B3590B340E75</identifier><identifier type="DOI">10.1136/ard.2009.117762</identifier><identifier type="href">annrheumdis-69-400.pdf</identifier><identifier type="ArticleID">ar117762</identifier><identifier type="PMID">19828563</identifier><identifier type="local">annrheumdis;69/2/400</identifier><accessCondition type="use and reproduction" contentType="copyright">BMJ Publishing Group Ltd and European League Against Rheumatism. 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