The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial
Identifieur interne : 002941 ( Istex/Corpus ); précédent : 002940; suivant : 002942The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial
Auteurs : M. Schiff ; C. Pritchard ; J E Huffstutter ; V. Rodriguez-Valverde ; P. Durez ; X. Zhou ; T. Li ; K. Bahrt ; S. Kelly ; M. Le Bars ; M C GenoveseSource :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2009-11.
English descriptors
- Teeft :
- Abatacept, Abatacept treatment, Acceptable safety, Adverse events, American college, Antitnf, Antitnf therapy, Arthritis, Autoimmune, Autoimmune disorders, Available data, Background dmard, Baseline, Baseline demographics, Clinical practice, Consulting fees, Directswitch patients, Discontinuation, Disease activity, Disease activity score, Disease activity state, Disease characteristics, Dmard, Early termination visit, Editorial assistance, Error bars, European union, Health assessment questionnaire disability index, Higher frequency, Inadequate response, Infusional reactions, Latent tuberculosis, Ldas, Meaningful improvement, Meaningful improvements, Mental component summary, Monotherapy, Necrosis factor, Necrosis factor therapy, Negative chest, Opportunistic infections, Overall population, Physical component summary, Physical function, Previous agent, Previous findings, Previous therapies, Previous therapy, Remission, Report table, Research grants, Review boards, Rheum, Rheumatoid, Rheumatoid arthritis, Serious infections, Squibb, Study design, Study entry, Study medication, Test result, Tolerability, Tolerability reasons, Tract infection, Visit days, Washout, Washout group, Washout patients, Washout period.
Abstract
Objective: To assess the safety, tolerability and efficacy of abatacept in patients with rheumatoid arthritis (RA) who had failed anti-tumour necrosis factor (TNF) therapy and were switched to abatacept directly or after completing washout. Methods: In this international, 6-month, open-label trial, patients had active RA, an inadequate response to anti-TNF therapy for 3 months or longer and a disease activity score in 28 joints (DAS28 (C-reactive protein; CRP) of 5.1 or greater. “Washout” patients discontinued anti-TNF therapy 2 months or longer pre-screening; “direct-switch” patients began abatacept (∼10 mg/kg) at their next scheduled anti-TNF therapy dose. Results: 1046 patients were treated (449 washout, 597 direct-switch; baseline characteristics were similar between groups). At 6 months, adverse events (AE; 78.0% vs 79.2%), serious AE (11.1% vs 9.9%) and discontinuations due to AE (3.8% vs 4.0%) and serious AE (2.0% vs 1.3%) were comparable in washout versus direct-switch patients. There were no opportunistic infections. At 6 months, in washout versus direct-switch patients, similar clinically meaningful improvements were seen in DAS28 (CRP) (⩾1.2 unit improvement, 59.5% vs 53.6%, respectively; low disease activity state, 22.5% vs 22.3%; DAS28-defined remission, 12.0% vs 13.7%), physical function (health assessment questionnaire disability index ⩾0.22 improvement; 46.3% vs 47.1%) and health-related quality of life (mean change in short-form 36 scores: physical component summary, 5.5 vs 6.1; mental component summary, 4.8 vs 5.4). Conclusion: Abatacept demonstrated acceptable safety and tolerability and clinically meaningful efficacy over 6 months in patients with inadequate response to anti-TNF therapy. Results were comparable with or without a washout, supporting direct switching from anti-TNF therapy to abatacept as an option in clinical practice. Trial registration number: NCT00124982.
Url:
DOI: 10.1136/ard.2008.099218
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Pritchard</name><affiliation><mods:affiliation>Rheumatology Specialty Center, Willow Grove, Pennsylvania, USA</mods:affiliation></affiliation></author><author><name sortKey="Huffstutter, J E" sort="Huffstutter, J E" uniqKey="Huffstutter J" first="J E" last="Huffstutter">J E Huffstutter</name><affiliation><mods:affiliation>Arthritis Associates, Hixson, Tennessee, USA</mods:affiliation></affiliation></author><author><name sortKey="Rodriguez Valverde, V" sort="Rodriguez Valverde, V" uniqKey="Rodriguez Valverde V" first="V" last="Rodriguez-Valverde">V. Rodriguez-Valverde</name><affiliation><mods:affiliation>Hospital Universitario Marques De Valdecilla, Universidad de Cantabria, Santander, Spain</mods:affiliation></affiliation></author><author><name sortKey="Durez, P" sort="Durez, P" uniqKey="Durez P" first="P" last="Durez">P. Durez</name><affiliation><mods:affiliation>Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium</mods:affiliation></affiliation></author><author><name sortKey="Zhou, X" sort="Zhou, X" uniqKey="Zhou X" first="X" last="Zhou">X. Zhou</name><affiliation><mods:affiliation>Bristol-Myers Squibb, Princeton, New Jersey, USA</mods:affiliation></affiliation></author><author><name sortKey="Li, T" sort="Li, T" uniqKey="Li T" first="T" last="Li">T. Li</name><affiliation><mods:affiliation>Bristol-Myers Squibb, Princeton, New Jersey, USA</mods:affiliation></affiliation></author><author><name sortKey="Bahrt, K" sort="Bahrt, K" uniqKey="Bahrt K" first="K" last="Bahrt">K. Bahrt</name><affiliation><mods:affiliation>Bristol-Myers Squibb, Princeton, New Jersey, USA</mods:affiliation></affiliation></author><author><name sortKey="Kelly, S" sort="Kelly, S" uniqKey="Kelly S" first="S" last="Kelly">S. 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Schiff</name><affiliation><mods:affiliation>University of Colorado, Denver, Colorado, USA</mods:affiliation></affiliation></author><author><name sortKey="Pritchard, C" sort="Pritchard, C" uniqKey="Pritchard C" first="C" last="Pritchard">C. Pritchard</name><affiliation><mods:affiliation>Rheumatology Specialty Center, Willow Grove, Pennsylvania, USA</mods:affiliation></affiliation></author><author><name sortKey="Huffstutter, J E" sort="Huffstutter, J E" uniqKey="Huffstutter J" first="J E" last="Huffstutter">J E Huffstutter</name><affiliation><mods:affiliation>Arthritis Associates, Hixson, Tennessee, USA</mods:affiliation></affiliation></author><author><name sortKey="Rodriguez Valverde, V" sort="Rodriguez Valverde, V" uniqKey="Rodriguez Valverde V" first="V" last="Rodriguez-Valverde">V. Rodriguez-Valverde</name><affiliation><mods:affiliation>Hospital Universitario Marques De Valdecilla, Universidad de Cantabria, Santander, Spain</mods:affiliation></affiliation></author><author><name sortKey="Durez, P" sort="Durez, P" uniqKey="Durez P" first="P" last="Durez">P. Durez</name><affiliation><mods:affiliation>Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium</mods:affiliation></affiliation></author><author><name sortKey="Zhou, X" sort="Zhou, X" uniqKey="Zhou X" first="X" last="Zhou">X. Zhou</name><affiliation><mods:affiliation>Bristol-Myers Squibb, Princeton, New Jersey, USA</mods:affiliation></affiliation></author><author><name sortKey="Li, T" sort="Li, T" uniqKey="Li T" first="T" last="Li">T. Li</name><affiliation><mods:affiliation>Bristol-Myers Squibb, Princeton, New Jersey, USA</mods:affiliation></affiliation></author><author><name sortKey="Bahrt, K" sort="Bahrt, K" uniqKey="Bahrt K" first="K" last="Bahrt">K. Bahrt</name><affiliation><mods:affiliation>Bristol-Myers Squibb, Princeton, New Jersey, USA</mods:affiliation></affiliation></author><author><name sortKey="Kelly, S" sort="Kelly, S" uniqKey="Kelly S" first="S" last="Kelly">S. Kelly</name><affiliation><mods:affiliation>Bristol-Myers Squibb, Princeton, New Jersey, USA</mods:affiliation></affiliation></author><author><name sortKey="Le Bars, M" sort="Le Bars, M" uniqKey="Le Bars M" first="M" last="Le Bars">M. Le Bars</name><affiliation><mods:affiliation>Bristol-Myers Squibb, Rueil-Malmaison, France</mods:affiliation></affiliation></author><author><name sortKey="Genovese, M C" sort="Genovese, M C" uniqKey="Genovese M" first="M C" last="Genovese">M C Genovese</name><affiliation><mods:affiliation>Stanford University, Palo Alto, California, USA</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="2009-11">2009-11</date><biblScope unit="volume">68</biblScope><biblScope unit="issue">11</biblScope><biblScope unit="page" from="1708">1708</biblScope></imprint><idno type="ISSN">0003-4967</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0003-4967</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="Teeft" xml:lang="en"><term>Abatacept</term><term>Abatacept treatment</term><term>Acceptable safety</term><term>Adverse events</term><term>American college</term><term>Antitnf</term><term>Antitnf therapy</term><term>Arthritis</term><term>Autoimmune</term><term>Autoimmune disorders</term><term>Available data</term><term>Background dmard</term><term>Baseline</term><term>Baseline demographics</term><term>Clinical practice</term><term>Consulting fees</term><term>Directswitch patients</term><term>Discontinuation</term><term>Disease activity</term><term>Disease activity score</term><term>Disease activity state</term><term>Disease characteristics</term><term>Dmard</term><term>Early termination visit</term><term>Editorial assistance</term><term>Error bars</term><term>European union</term><term>Health assessment questionnaire disability index</term><term>Higher frequency</term><term>Inadequate response</term><term>Infusional reactions</term><term>Latent tuberculosis</term><term>Ldas</term><term>Meaningful improvement</term><term>Meaningful improvements</term><term>Mental component summary</term><term>Monotherapy</term><term>Necrosis factor</term><term>Necrosis factor therapy</term><term>Negative chest</term><term>Opportunistic infections</term><term>Overall population</term><term>Physical component summary</term><term>Physical function</term><term>Previous agent</term><term>Previous findings</term><term>Previous therapies</term><term>Previous therapy</term><term>Remission</term><term>Report table</term><term>Research grants</term><term>Review boards</term><term>Rheum</term><term>Rheumatoid</term><term>Rheumatoid arthritis</term><term>Serious infections</term><term>Squibb</term><term>Study design</term><term>Study entry</term><term>Study medication</term><term>Test result</term><term>Tolerability</term><term>Tolerability reasons</term><term>Tract infection</term><term>Visit days</term><term>Washout</term><term>Washout group</term><term>Washout patients</term><term>Washout period</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Objective: To assess the safety, tolerability and efficacy of abatacept in patients with rheumatoid arthritis (RA) who had failed anti-tumour necrosis factor (TNF) therapy and were switched to abatacept directly or after completing washout. Methods: In this international, 6-month, open-label trial, patients had active RA, an inadequate response to anti-TNF therapy for 3 months or longer and a disease activity score in 28 joints (DAS28 (C-reactive protein; CRP) of 5.1 or greater. “Washout” patients discontinued anti-TNF therapy 2 months or longer pre-screening; “direct-switch” patients began abatacept (∼10 mg/kg) at their next scheduled anti-TNF therapy dose. Results: 1046 patients were treated (449 washout, 597 direct-switch; baseline characteristics were similar between groups). At 6 months, adverse events (AE; 78.0% vs 79.2%), serious AE (11.1% vs 9.9%) and discontinuations due to AE (3.8% vs 4.0%) and serious AE (2.0% vs 1.3%) were comparable in washout versus direct-switch patients. There were no opportunistic infections. At 6 months, in washout versus direct-switch patients, similar clinically meaningful improvements were seen in DAS28 (CRP) (⩾1.2 unit improvement, 59.5% vs 53.6%, respectively; low disease activity state, 22.5% vs 22.3%; DAS28-defined remission, 12.0% vs 13.7%), physical function (health assessment questionnaire disability index ⩾0.22 improvement; 46.3% vs 47.1%) and health-related quality of life (mean change in short-form 36 scores: physical component summary, 5.5 vs 6.1; mental component summary, 4.8 vs 5.4). Conclusion: Abatacept demonstrated acceptable safety and tolerability and clinically meaningful efficacy over 6 months in patients with inadequate response to anti-TNF therapy. Results were comparable with or without a washout, supporting direct switching from anti-TNF therapy to abatacept as an option in clinical practice. 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assistance</json:string><json:string>research grants</json:string><json:string>health assessment questionnaire disability index</json:string></teeft></keywords><author><json:item><name>M Schiff</name><affiliations><json:string>University of Colorado, Denver, Colorado, USA</json:string></affiliations></json:item><json:item><name>C Pritchard</name><affiliations><json:string>Rheumatology Specialty Center, Willow Grove, Pennsylvania, USA</json:string></affiliations></json:item><json:item><name>J E Huffstutter</name><affiliations><json:string>Arthritis Associates, Hixson, Tennessee, USA</json:string></affiliations></json:item><json:item><name>V Rodriguez-Valverde</name><affiliations><json:string>Hospital Universitario Marques De Valdecilla, Universidad de Cantabria, Santander, Spain</json:string></affiliations></json:item><json:item><name>P Durez</name><affiliations><json:string>Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium</json:string></affiliations></json:item><json:item><name>X Zhou</name><affiliations><json:string>Bristol-Myers Squibb, Princeton, New Jersey, USA</json:string></affiliations></json:item><json:item><name>T Li</name><affiliations><json:string>Bristol-Myers Squibb, Princeton, New Jersey, USA</json:string></affiliations></json:item><json:item><name>K Bahrt</name><affiliations><json:string>Bristol-Myers Squibb, Princeton, New Jersey, USA</json:string></affiliations></json:item><json:item><name>S Kelly</name><affiliations><json:string>Bristol-Myers Squibb, Princeton, New Jersey, USA</json:string></affiliations></json:item><json:item><name>M Le Bars</name><affiliations><json:string>Bristol-Myers Squibb, Rueil-Malmaison, France</json:string></affiliations></json:item><json:item><name>M C Genovese</name><affiliations><json:string>Stanford University, Palo Alto, California, USA</json:string></affiliations></json:item></author><articleId><json:string>ar99218</json:string></articleId><arkIstex>ark:/67375/NVC-6FTS3Q53-9</arkIstex><language><json:string>eng</json:string></language><originalGenre><json:string>research-article</json:string></originalGenre><abstract>Objective: To assess the safety, tolerability and efficacy of abatacept in patients with rheumatoid arthritis (RA) who had failed anti-tumour necrosis factor (TNF) therapy and were switched to abatacept directly or after completing washout. Methods: In this international, 6-month, open-label trial, patients had active RA, an inadequate response to anti-TNF therapy for 3 months or longer and a disease activity score in 28 joints (DAS28 (C-reactive protein; CRP) of 5.1 or greater. “Washout” patients discontinued anti-TNF therapy 2 months or longer pre-screening; “direct-switch” patients began abatacept (∼10 mg/kg) at their next scheduled anti-TNF therapy dose. Results: 1046 patients were treated (449 washout, 597 direct-switch; baseline characteristics were similar between groups). At 6 months, adverse events (AE; 78.0% vs 79.2%), serious AE (11.1% vs 9.9%) and discontinuations due to AE (3.8% vs 4.0%) and serious AE (2.0% vs 1.3%) were comparable in washout versus direct-switch patients. There were no opportunistic infections. At 6 months, in washout versus direct-switch patients, similar clinically meaningful improvements were seen in DAS28 (CRP) (⩾1.2 unit improvement, 59.5% vs 53.6%, respectively; low disease activity state, 22.5% vs 22.3%; DAS28-defined remission, 12.0% vs 13.7%), physical function (health assessment questionnaire disability index ⩾0.22 improvement; 46.3% vs 47.1%) and health-related quality of life (mean change in short-form 36 scores: physical component summary, 5.5 vs 6.1; mental component summary, 4.8 vs 5.4). Conclusion: Abatacept demonstrated acceptable safety and tolerability and clinically meaningful efficacy over 6 months in patients with inadequate response to anti-TNF therapy. Results were comparable with or without a washout, supporting direct switching from anti-TNF therapy to abatacept as an option in clinical practice. Trial registration number: NCT00124982.</abstract><qualityIndicators><score>9.456</score><pdfWordCount>4456</pdfWordCount><pdfCharCount>30790</pdfCharCount><pdfVersion>1.2</pdfVersion><pdfPageCount>7</pdfPageCount><pdfPageSize>595.276 x 793.701 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractWordCount>269</abstractWordCount><abstractCharCount>1925</abstractCharCount><keywordCount>0</keywordCount></qualityIndicators><title>The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial</title><pmid><json:string>19074911</json:string></pmid><genre><json:string>research-article</json:string></genre><host><title>Annals of the Rheumatic 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osteoarticulaire</json:string></inist></categories><publicationDate>2009</publicationDate><copyrightDate>2009</copyrightDate><doi><json:string>10.1136/ard.2008.099218</json:string></doi><id>34A8D8E3E01D8717D40C9166094E5283D7E99939</id><score>1</score><fulltext><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/ark:/67375/NVC-6FTS3Q53-9/fulltext.pdf</uri></json:item><json:item><extension>zip</extension><original>false</original><mimetype>application/zip</mimetype><uri>https://api.istex.fr/ark:/67375/NVC-6FTS3Q53-9/bundle.zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/ark:/67375/NVC-6FTS3Q53-9/fulltext.tei"><teiHeader><fileDesc><titleStmt><title level="a">The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher scheme="https://publisher-list.data.istex.fr">BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><availability status="free"><p>Open Access</p></availability><date>2008-12-15</date></publicationStmt><notesStmt><note type="research-article" scheme="https://content-type.data.istex.fr/ark:/67375/XTP-1JC4F85T-7">research-article</note><note type="journal" scheme="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a">The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial</title><author xml:id="author-0000"><persName><forename type="first">M</forename><surname>Schiff</surname></persName><affiliation>University of Colorado, Denver, Colorado, USA</affiliation></author><author xml:id="author-0001"><persName><forename type="first">C</forename><surname>Pritchard</surname></persName><affiliation>Rheumatology Specialty Center, Willow Grove, Pennsylvania, USA</affiliation></author><author xml:id="author-0002"><persName><forename type="first">J E</forename><surname>Huffstutter</surname></persName><affiliation>Arthritis Associates, Hixson, Tennessee, USA</affiliation></author><author xml:id="author-0003"><persName><forename type="first">V</forename><surname>Rodriguez-Valverde</surname></persName><affiliation>Hospital Universitario Marques De Valdecilla, Universidad de Cantabria, Santander, Spain</affiliation></author><author xml:id="author-0004"><persName><forename type="first">P</forename><surname>Durez</surname></persName><affiliation>Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium</affiliation></author><author xml:id="author-0005"><persName><forename type="first">X</forename><surname>Zhou</surname></persName><affiliation>Bristol-Myers Squibb, Princeton, New Jersey, USA</affiliation></author><author xml:id="author-0006"><persName><forename type="first">T</forename><surname>Li</surname></persName><affiliation>Bristol-Myers Squibb, Princeton, New Jersey, USA</affiliation></author><author xml:id="author-0007"><persName><forename type="first">K</forename><surname>Bahrt</surname></persName><affiliation>Bristol-Myers Squibb, Princeton, New Jersey, USA</affiliation></author><author xml:id="author-0008"><persName><forename type="first">S</forename><surname>Kelly</surname></persName><affiliation>Bristol-Myers Squibb, Princeton, New Jersey, USA</affiliation></author><author xml:id="author-0009"><persName><forename type="first">M</forename><surname>Le Bars</surname></persName><affiliation>Bristol-Myers Squibb, Rueil-Malmaison, France</affiliation></author><author xml:id="author-0010"><persName><forename type="first">M C</forename><surname>Genovese</surname></persName><affiliation>Stanford University, Palo Alto, California, USA</affiliation></author><idno type="istex">34A8D8E3E01D8717D40C9166094E5283D7E99939</idno><idno type="ark">ark:/67375/NVC-6FTS3Q53-9</idno><idno type="DOI">10.1136/ard.2008.099218</idno><idno type="href">annrheumdis-68-1708.pdf</idno><idno type="article-id">ar99218</idno><idno type="PMID">19074911</idno><idno type="local">annrheumdis;68/11/1708</idno></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><idno type="publisher-id">ard</idno><idno type="PublisherID-hwp">annrheumdis</idno><idno type="PublisherID-nlm-ta">Ann Rheum Dis</idno><imprint><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><date type="published" when="2009-11"></date><biblScope unit="volume">68</biblScope><biblScope unit="issue">11</biblScope><biblScope unit="page" from="1708">1708</biblScope></imprint></monogr></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2008-12-15</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>Objective: To assess the safety, tolerability and efficacy of abatacept in patients with rheumatoid arthritis (RA) who had failed anti-tumour necrosis factor (TNF) therapy and were switched to abatacept directly or after completing washout. Methods: In this international, 6-month, open-label trial, patients had active RA, an inadequate response to anti-TNF therapy for 3 months or longer and a disease activity score in 28 joints (DAS28 (C-reactive protein; CRP) of 5.1 or greater. “Washout” patients discontinued anti-TNF therapy 2 months or longer pre-screening; “direct-switch” patients began abatacept (∼10 mg/kg) at their next scheduled anti-TNF therapy dose. Results: 1046 patients were treated (449 washout, 597 direct-switch; baseline characteristics were similar between groups). At 6 months, adverse events (AE; 78.0% vs 79.2%), serious AE (11.1% vs 9.9%) and discontinuations due to AE (3.8% vs 4.0%) and serious AE (2.0% vs 1.3%) were comparable in washout versus direct-switch patients. There were no opportunistic infections. At 6 months, in washout versus direct-switch patients, similar clinically meaningful improvements were seen in DAS28 (CRP) (⩾1.2 unit improvement, 59.5% vs 53.6%, respectively; low disease activity state, 22.5% vs 22.3%; DAS28-defined remission, 12.0% vs 13.7%), physical function (health assessment questionnaire disability index ⩾0.22 improvement; 46.3% vs 47.1%) and health-related quality of life (mean change in short-form 36 scores: physical component summary, 5.5 vs 6.1; mental component summary, 4.8 vs 5.4). Conclusion: Abatacept demonstrated acceptable safety and tolerability and clinically meaningful efficacy over 6 months in patients with inadequate response to anti-TNF therapy. Results were comparable with or without a washout, supporting direct switching from anti-TNF therapy to abatacept as an option in clinical practice. Trial registration number: NCT00124982.</p></abstract><textClass><keywords scheme="Journal Subject"><list><head>hwp-journal-coll</head><item><term>Unlocked</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>hwp-journal-coll</head><item><term>Immunology (including allergy)</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>hwp-journal-coll</head><item><term>Connective tissue disease</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>hwp-journal-coll</head><item><term>Degenerative joint disease</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>hwp-journal-coll</head><item><term>Musculoskeletal syndromes</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>hwp-journal-coll</head><item><term>Rheumatoid arthritis</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2008-12-15">Created</change><change when="2009-11">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/ark:/67375/NVC-6FTS3Q53-9/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">ar99218</article-id><article-id pub-id-type="doi">10.1136/ard.2008.099218</article-id><article-id pub-id-type="other">annrheumdis;68/11/1708</article-id><article-id pub-id-type="other">annrheumdis;ard.2008.099218</article-id><article-id pub-id-type="pmid">19074911</article-id><article-id pub-id-type="other">1708</article-id><article-id pub-id-type="other">ard.2008.099218</article-id><article-categories><subj-group subj-group-type="heading"><subject>Clinical and epidemiological research</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Unlocked</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Immunology (including allergy)</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Connective tissue disease</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Degenerative joint disease</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Musculoskeletal syndromes</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Rheumatoid arthritis</subject></subj-group><series-title>Extended report</series-title></article-categories><title-group><article-title>The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Schiff</surname><given-names>M</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Pritchard</surname><given-names>C</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Huffstutter</surname><given-names>J E</given-names></name><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Rodriguez-Valverde</surname><given-names>V</given-names></name><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Durez</surname><given-names>P</given-names></name><xref ref-type="aff" rid="aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Zhou</surname><given-names>X</given-names></name><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Li</surname><given-names>T</given-names></name><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Bahrt</surname><given-names>K</given-names></name><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Kelly</surname><given-names>S</given-names></name><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Le Bars</surname><given-names>M</given-names></name><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Genovese</surname><given-names>M C</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib></contrib-group><aff id="aff1"><label>1</label><addr-line>University of Colorado, Denver, Colorado, USA</addr-line></aff><aff id="aff2"><label>2</label><addr-line>Rheumatology Specialty Center, Willow Grove, Pennsylvania, USA</addr-line></aff><aff id="aff3"><label>3</label><addr-line>Arthritis Associates, Hixson, Tennessee, USA</addr-line></aff><aff id="aff4"><label>4</label><addr-line>Hospital Universitario Marques De Valdecilla, Universidad de Cantabria, Santander, Spain</addr-line></aff><aff id="aff5"><label>5</label><addr-line>Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium</addr-line></aff><aff id="aff6"><label>6</label><addr-line>Bristol-Myers Squibb, Princeton, New Jersey, USA</addr-line></aff><aff id="aff7"><label>7</label><addr-line>Bristol-Myers Squibb, Rueil-Malmaison, France</addr-line></aff><aff id="aff8"><label>8</label><addr-line>Stanford University, Palo Alto, California, USA</addr-line></aff><author-notes><corresp><label>Correspondence to</label> Dr M Schiff, University of Colorado, 5400 South Monaco Street, Greenwood Village, CO 80111, USA; <email xlink:type="simple">Lmschiff@aol.com</email></corresp></author-notes><pub-date pub-type="collection"><year>2009</year></pub-date><pub-date pub-type="ppub"><month>11</month><year>2009</year></pub-date><pub-date pub-type="epub-original"><day>14</day><month>12</month><year>2008</year></pub-date><pub-date pub-type="epub"><day>15</day><month>12</month><year>2008</year></pub-date><volume>68</volume><volume-id pub-id-type="other">68</volume-id><volume-id pub-id-type="other">68</volume-id><issue>11</issue><issue-id pub-id-type="other">annrheumdis;68/11</issue-id><issue-id pub-id-type="other">11</issue-id><issue-id pub-id-type="other">68/11</issue-id><fpage>1708</fpage><history><date date-type="accepted"><day>18</day><month>11</month><year>2008</year></date></history><permissions><copyright-statement>© Schiff et al 2009</copyright-statement><copyright-year>2009</copyright-year><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/2.0/"><p>This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</p></license></permissions><self-uri content-type="pdf" xlink:role="full-text" xlink:href="annrheumdis-68-1708.pdf"></self-uri><abstract><sec><title>Objective:</title><p>To assess the safety, tolerability and efficacy of abatacept in patients with rheumatoid arthritis (RA) who had failed anti-tumour necrosis factor (TNF) therapy and were switched to abatacept directly or after completing washout.</p></sec><sec><title>Methods:</title><p>In this international, 6-month, open-label trial, patients had active RA, an inadequate response to anti-TNF therapy for 3 months or longer and a disease activity score in 28 joints (DAS28 (C-reactive protein; CRP) of 5.1 or greater. “Washout” patients discontinued anti-TNF therapy 2 months or longer pre-screening; “direct-switch” patients began abatacept (∼10 mg/kg) at their next scheduled anti-TNF therapy dose.</p></sec><sec><title>Results:</title><p>1046 patients were treated (449 washout, 597 direct-switch; baseline characteristics were similar between groups). At 6 months, adverse events (AE; 78.0% vs 79.2%), serious AE (11.1% vs 9.9%) and discontinuations due to AE (3.8% vs 4.0%) and serious AE (2.0% vs 1.3%) were comparable in washout versus direct-switch patients. There were no opportunistic infections. At 6 months, in washout versus direct-switch patients, similar clinically meaningful improvements were seen in DAS28 (CRP) (⩾1.2 unit improvement, 59.5% vs 53.6%, respectively; low disease activity state, 22.5% vs 22.3%; DAS28-defined remission, 12.0% vs 13.7%), physical function (health assessment questionnaire disability index ⩾0.22 improvement; 46.3% vs 47.1%) and health-related quality of life (mean change in short-form 36 scores: physical component summary, 5.5 vs 6.1; mental component summary, 4.8 vs 5.4).</p></sec><sec><title>Conclusion:</title><p>Abatacept demonstrated acceptable safety and tolerability and clinically meaningful efficacy over 6 months in patients with inadequate response to anti-TNF therapy. Results were comparable with or without a washout, supporting direct switching from anti-TNF therapy to abatacept as an option in clinical practice.</p></sec><sec><title>Trial registration number:</title><p>NCT00124982.</p></sec></abstract></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo><title>The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial</title><partName>Extended report</partName></titleInfo><titleInfo type="alternative" contentType="CDATA"><title>The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial</title><partName>Extended report</partName></titleInfo><name type="personal"><namePart type="given">M</namePart><namePart type="family">Schiff</namePart><affiliation>University of Colorado, Denver, Colorado, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C</namePart><namePart type="family">Pritchard</namePart><affiliation>Rheumatology Specialty Center, Willow Grove, Pennsylvania, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J E</namePart><namePart type="family">Huffstutter</namePart><affiliation>Arthritis Associates, Hixson, Tennessee, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">V</namePart><namePart type="family">Rodriguez-Valverde</namePart><affiliation>Hospital Universitario Marques De Valdecilla, Universidad de Cantabria, Santander, Spain</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P</namePart><namePart type="family">Durez</namePart><affiliation>Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">X</namePart><namePart type="family">Zhou</namePart><affiliation>Bristol-Myers Squibb, Princeton, New Jersey, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">T</namePart><namePart type="family">Li</namePart><affiliation>Bristol-Myers Squibb, Princeton, New Jersey, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">K</namePart><namePart type="family">Bahrt</namePart><affiliation>Bristol-Myers Squibb, Princeton, New Jersey, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S</namePart><namePart type="family">Kelly</namePart><affiliation>Bristol-Myers Squibb, Princeton, New Jersey, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M</namePart><namePart type="family">Le Bars</namePart><affiliation>Bristol-Myers Squibb, Rueil-Malmaison, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M C</namePart><namePart type="family">Genovese</namePart><affiliation>Stanford University, Palo Alto, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="research-article" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-1JC4F85T-7">research-article</genre><originInfo><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><dateIssued encoding="w3cdtf">2009-11</dateIssued><dateCreated encoding="w3cdtf">2008-12-15</dateCreated><copyrightDate encoding="w3cdtf">2009</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><abstract>Objective: To assess the safety, tolerability and efficacy of abatacept in patients with rheumatoid arthritis (RA) who had failed anti-tumour necrosis factor (TNF) therapy and were switched to abatacept directly or after completing washout. Methods: In this international, 6-month, open-label trial, patients had active RA, an inadequate response to anti-TNF therapy for 3 months or longer and a disease activity score in 28 joints (DAS28 (C-reactive protein; CRP) of 5.1 or greater. “Washout” patients discontinued anti-TNF therapy 2 months or longer pre-screening; “direct-switch” patients began abatacept (∼10 mg/kg) at their next scheduled anti-TNF therapy dose. Results: 1046 patients were treated (449 washout, 597 direct-switch; baseline characteristics were similar between groups). At 6 months, adverse events (AE; 78.0% vs 79.2%), serious AE (11.1% vs 9.9%) and discontinuations due to AE (3.8% vs 4.0%) and serious AE (2.0% vs 1.3%) were comparable in washout versus direct-switch patients. There were no opportunistic infections. At 6 months, in washout versus direct-switch patients, similar clinically meaningful improvements were seen in DAS28 (CRP) (⩾1.2 unit improvement, 59.5% vs 53.6%, respectively; low disease activity state, 22.5% vs 22.3%; DAS28-defined remission, 12.0% vs 13.7%), physical function (health assessment questionnaire disability index ⩾0.22 improvement; 46.3% vs 47.1%) and health-related quality of life (mean change in short-form 36 scores: physical component summary, 5.5 vs 6.1; mental component summary, 4.8 vs 5.4). Conclusion: Abatacept demonstrated acceptable safety and tolerability and clinically meaningful efficacy over 6 months in patients with inadequate response to anti-TNF therapy. Results were comparable with or without a washout, supporting direct switching from anti-TNF therapy to abatacept as an option in clinical practice. Trial registration number: NCT00124982.</abstract><relatedItem type="host"><titleInfo><title>Annals of the Rheumatic Diseases</title></titleInfo><titleInfo type="abbreviated"><title>Ann Rheum Dis</title></titleInfo><genre type="journal" authority="ISTEX" authorityURI="https://publication-type.data.istex.fr" valueURI="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</genre><subject><genre>hwp-journal-coll</genre><topic>Unlocked</topic></subject><subject><genre>hwp-journal-coll</genre><topic>Immunology (including allergy)</topic></subject><subject><genre>hwp-journal-coll</genre><topic>Connective tissue disease</topic></subject><subject><genre>hwp-journal-coll</genre><topic>Degenerative joint disease</topic></subject><subject><genre>hwp-journal-coll</genre><topic>Musculoskeletal syndromes</topic></subject><subject><genre>hwp-journal-coll</genre><topic>Rheumatoid arthritis</topic></subject><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>2009</date><detail type="volume"><caption>vol.</caption><number>68</number></detail><detail type="issue"><caption>no.</caption><number>11</number></detail><extent unit="pages"><start>1708</start></extent></part></relatedItem><identifier type="istex">34A8D8E3E01D8717D40C9166094E5283D7E99939</identifier><identifier type="ark">ark:/67375/NVC-6FTS3Q53-9</identifier><identifier type="DOI">10.1136/ard.2008.099218</identifier><identifier type="href">annrheumdis-68-1708.pdf</identifier><identifier type="ArticleID">ar99218</identifier><identifier type="PMID">19074911</identifier><identifier type="local">annrheumdis;68/11/1708</identifier><accessCondition type="use and reproduction" contentType="open-access">This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</accessCondition><recordInfo><recordContentSource authority="ISTEX" authorityURI="https://loaded-corpus.data.istex.fr" valueURI="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-7M42M2QJ-2">bmj</recordContentSource><recordOrigin>© Schiff et al 2009</recordOrigin></recordInfo></mods><json:item><extension>json</extension><original>false</original><mimetype>application/json</mimetype><uri>https://api.istex.fr/ark:/67375/NVC-6FTS3Q53-9/record.json</uri></json:item></metadata><annexes><json:item><extension>jpeg</extension><original>true</original><mimetype>image/jpeg</mimetype><uri>https://api.istex.fr/ark:/67375/NVC-6FTS3Q53-9/annexes.jpeg</uri></json:item></annexes><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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