Efficacy, safety and patient-reported outcomes of combination etanercept and sulfasalazine versus etanercept alone in patients with rheumatoid arthritis: a double-blind randomised 2-year study
Identifieur interne : 002111 ( Pmc/Curation ); précédent : 002110; suivant : 002112Efficacy, safety and patient-reported outcomes of combination etanercept and sulfasalazine versus etanercept alone in patients with rheumatoid arthritis: a double-blind randomised 2-year study
Auteurs : B. Combe [France] ; C. Codreanu [Roumanie] ; U. Fiocco [Italie] ; M. Gaubitz [Allemagne] ; P P Geusens [Belgique, Pays-Bas] ; T K Kvien [Norvège] ; K. Pavelka [République tchèque] ; P N Sambrook [Australie] ; J S Smolen [Autriche] ; R. Khandker [États-Unis] ; A. Singh [États-Unis] ; J. Wajdula [États-Unis] ; S. Fatenejad [États-Unis]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2008.
Abstract
To determine the efficacy and safety of etanercept and etanercept plus sulfasalazine versus sulfasalazine in patients with rheumatoid arthritis (RA) despite sulfasalazine therapy.
Patients were randomly assigned to etanercept (25 mg twice weekly; sulfasalazine was discontinued at baseline), etanercept plus sulfasalazine (unchanged regimen of 2–3 g/day) or sulfasalazine in a double-blind, randomised, 2-year study in adult patients with active RA despite sulfasalazine therapy. Efficacy was assessed using the American College of Rheumatology criteria, disease activity scores (DAS) and patient-reported outcomes (PRO).
Demographic variables and baseline disease characteristics were comparable among treatment groups; mean DAS 5.1, 5.2 and 5.1 for etanercept (n = 103), etanercept plus sulfasalazine (n = 101) and sulfasalazine (n = 50), respectively. Withdrawal due to lack of efficacy was highest with sulfasalazine (26 (52%) vs 6 (6%) for either etanercept group, p<0.001). Patients receiving etanercept or etanercept plus sulfasalazine had a more rapid initial response, which was sustained at 2 years, than those receiving sulfasalazine: mean DAS 2.8, 2.5 versus 4.5, respectively (p<0.05); ACR 20 response was achieved by 67%, 77% versus 34% of patients, respectively (p<0.01) Overall, PRO followed a similar pattern; a clinically significant improvement in health assessment questionnaire was achieved by 76%, 78% versus 40% of patients, respectively (p<0.01). Commonly reported adverse events occurring in the etanercept groups were injection site reactions and pharyngitis/laryngitis (p<0.01).
Etanercept and etanercept plus sulfasalazine are efficacious for the long-term management of patients with RA. The addition of etanercept or substitution with etanercept should be considered as treatment options for patients not adequately responding to sulfasalazine.
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DOI: 10.1136/ard.2007.087106
PubMed: 18794178
PubMed Central: 2689524
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Codreanu</name><affiliation wicri:level="1"><nlm:aff id="aff2"><addr-line>Centrul Metodologic de Reumatologie, Bucuresti, Romania</addr-line></nlm:aff><country xml:lang="fr">Roumanie</country><wicri:regionArea>Centrul Metodologic de Reumatologie, Bucuresti</wicri:regionArea></affiliation></author><author><name sortKey="Fiocco, U" sort="Fiocco, U" uniqKey="Fiocco U" first="U" last="Fiocco">U. Fiocco</name><affiliation wicri:level="1"><nlm:aff id="aff3"><addr-line>Cattedra e Divisione di Reumatologia, Policlinico Universitario, Padova, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Cattedra e Divisione di Reumatologia, Policlinico Universitario, Padova</wicri:regionArea></affiliation></author><author><name sortKey="Gaubitz, M" sort="Gaubitz, M" uniqKey="Gaubitz M" first="M" last="Gaubitz">M. 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Pavelka</name><affiliation wicri:level="1"><nlm:aff id="aff8"><addr-line>Institute of Rheumatology, Praha, Czech Republic</addr-line></nlm:aff><country xml:lang="fr">République tchèque</country><wicri:regionArea>Institute of Rheumatology, Praha</wicri:regionArea></affiliation></author><author><name sortKey="Sambrook, P N" sort="Sambrook, P N" uniqKey="Sambrook P" first="P N" last="Sambrook">P N Sambrook</name><affiliation wicri:level="1"><nlm:aff id="aff9"><addr-line>Kolling Institute, University of Sydney, Sydney, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Kolling Institute, University of Sydney, Sydney</wicri:regionArea></affiliation></author><author><name sortKey="Smolen, J S" sort="Smolen, J S" uniqKey="Smolen J" first="J S" last="Smolen">J S Smolen</name><affiliation wicri:level="1"><nlm:aff id="aff10"><addr-line>2nd Department of Medicine, Krankenhaus Lainz and Department of Rheumatology, Internal Medicine III, Medical University of Vienna, Vienna, Austria</addr-line></nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea>2nd Department of Medicine, Krankenhaus Lainz and Department of Rheumatology, Internal Medicine III, Medical University of Vienna, Vienna</wicri:regionArea></affiliation></author><author><name sortKey="Khandker, R" sort="Khandker, R" uniqKey="Khandker R" first="R" last="Khandker">R. Khandker</name><affiliation wicri:level="1"><nlm:aff id="aff11"><addr-line>Wyeth Research, Collegeville, Pennsylvania, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wyeth Research, Collegeville, Pennsylvania</wicri:regionArea></affiliation></author><author><name sortKey="Singh, A" sort="Singh, A" uniqKey="Singh A" first="A" last="Singh">A. Singh</name><affiliation wicri:level="1"><nlm:aff id="aff11"><addr-line>Wyeth Research, Collegeville, Pennsylvania, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wyeth Research, Collegeville, Pennsylvania</wicri:regionArea></affiliation></author><author><name sortKey="Wajdula, J" sort="Wajdula, J" uniqKey="Wajdula J" first="J" last="Wajdula">J. Wajdula</name><affiliation wicri:level="1"><nlm:aff id="aff11"><addr-line>Wyeth Research, Collegeville, Pennsylvania, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wyeth Research, Collegeville, Pennsylvania</wicri:regionArea></affiliation></author><author><name sortKey="Fatenejad, S" sort="Fatenejad, S" uniqKey="Fatenejad S" first="S" last="Fatenejad">S. Fatenejad</name><affiliation wicri:level="1"><nlm:aff id="aff11"><addr-line>Wyeth Research, Collegeville, Pennsylvania, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wyeth Research, Collegeville, Pennsylvania</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">18794178</idno><idno type="pmc">2689524</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2689524</idno><idno type="RBID">PMC:2689524</idno><idno type="doi">10.1136/ard.2007.087106</idno><date when="2008">2008</date><idno type="wicri:Area/Pmc/Corpus">002261</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">002261</idno><idno type="wicri:Area/Pmc/Curation">002111</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">002111</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Efficacy, safety and patient-reported outcomes of combination etanercept and sulfasalazine versus etanercept alone in patients with rheumatoid arthritis: a double-blind randomised 2-year study</title><author><name sortKey="Combe, B" sort="Combe, B" uniqKey="Combe B" first="B" last="Combe">B. Combe</name><affiliation wicri:level="1"><nlm:aff id="aff1"><addr-line>Service d'Immuno-Rhumatologie, Hopital Lapeyronie, Montpellier, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Service d'Immuno-Rhumatologie, Hopital Lapeyronie, Montpellier</wicri:regionArea></affiliation></author><author><name sortKey="Codreanu, C" sort="Codreanu, C" uniqKey="Codreanu C" first="C" last="Codreanu">C. Codreanu</name><affiliation wicri:level="1"><nlm:aff id="aff2"><addr-line>Centrul Metodologic de Reumatologie, Bucuresti, Romania</addr-line></nlm:aff><country xml:lang="fr">Roumanie</country><wicri:regionArea>Centrul Metodologic de Reumatologie, Bucuresti</wicri:regionArea></affiliation></author><author><name sortKey="Fiocco, U" sort="Fiocco, U" uniqKey="Fiocco U" first="U" last="Fiocco">U. Fiocco</name><affiliation wicri:level="1"><nlm:aff id="aff3"><addr-line>Cattedra e Divisione di Reumatologia, Policlinico Universitario, Padova, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Cattedra e Divisione di Reumatologia, Policlinico Universitario, Padova</wicri:regionArea></affiliation></author><author><name sortKey="Gaubitz, M" sort="Gaubitz, M" uniqKey="Gaubitz M" first="M" last="Gaubitz">M. Gaubitz</name><affiliation wicri:level="1"><nlm:aff id="aff4"><addr-line>Medical Clinic B Westfalian-Wilhelms-Univ, Munster, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Medical Clinic B Westfalian-Wilhelms-Univ, Munster</wicri:regionArea></affiliation></author><author><name sortKey="Geusens, P P" sort="Geusens, P P" uniqKey="Geusens P" first="P P" last="Geusens">P P Geusens</name><affiliation wicri:level="1"><nlm:aff id="aff5"><addr-line>Biomedical Research Center, University Hasselt, Hasselt, Belgium</addr-line></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea>Biomedical Research Center, University Hasselt, Hasselt</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff6"><addr-line>Department of Internal Medicine/Rheumatology, University Maastricht, Maastricht, The Netherlands</addr-line></nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Internal Medicine/Rheumatology, University Maastricht, Maastricht</wicri:regionArea></affiliation></author><author><name sortKey="Kvien, T K" sort="Kvien, T K" uniqKey="Kvien T" first="T K" last="Kvien">T K Kvien</name><affiliation wicri:level="1"><nlm:aff id="aff7"><addr-line>Department of Rheumatology, Diakonhjemmets Hospital, Oslo, Norway</addr-line></nlm:aff><country xml:lang="fr">Norvège</country><wicri:regionArea>Department of Rheumatology, Diakonhjemmets Hospital, Oslo</wicri:regionArea></affiliation></author><author><name sortKey="Pavelka, K" sort="Pavelka, K" uniqKey="Pavelka K" first="K" last="Pavelka">K. Pavelka</name><affiliation wicri:level="1"><nlm:aff id="aff8"><addr-line>Institute of Rheumatology, Praha, Czech Republic</addr-line></nlm:aff><country xml:lang="fr">République tchèque</country><wicri:regionArea>Institute of Rheumatology, Praha</wicri:regionArea></affiliation></author><author><name sortKey="Sambrook, P N" sort="Sambrook, P N" uniqKey="Sambrook P" first="P N" last="Sambrook">P N Sambrook</name><affiliation wicri:level="1"><nlm:aff id="aff9"><addr-line>Kolling Institute, University of Sydney, Sydney, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Kolling Institute, University of Sydney, Sydney</wicri:regionArea></affiliation></author><author><name sortKey="Smolen, J S" sort="Smolen, J S" uniqKey="Smolen J" first="J S" last="Smolen">J S Smolen</name><affiliation wicri:level="1"><nlm:aff id="aff10"><addr-line>2nd Department of Medicine, Krankenhaus Lainz and Department of Rheumatology, Internal Medicine III, Medical University of Vienna, Vienna, Austria</addr-line></nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea>2nd Department of Medicine, Krankenhaus Lainz and Department of Rheumatology, Internal Medicine III, Medical University of Vienna, Vienna</wicri:regionArea></affiliation></author><author><name sortKey="Khandker, R" sort="Khandker, R" uniqKey="Khandker R" first="R" last="Khandker">R. Khandker</name><affiliation wicri:level="1"><nlm:aff id="aff11"><addr-line>Wyeth Research, Collegeville, Pennsylvania, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wyeth Research, Collegeville, Pennsylvania</wicri:regionArea></affiliation></author><author><name sortKey="Singh, A" sort="Singh, A" uniqKey="Singh A" first="A" last="Singh">A. Singh</name><affiliation wicri:level="1"><nlm:aff id="aff11"><addr-line>Wyeth Research, Collegeville, Pennsylvania, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wyeth Research, Collegeville, Pennsylvania</wicri:regionArea></affiliation></author><author><name sortKey="Wajdula, J" sort="Wajdula, J" uniqKey="Wajdula J" first="J" last="Wajdula">J. Wajdula</name><affiliation wicri:level="1"><nlm:aff id="aff11"><addr-line>Wyeth Research, Collegeville, Pennsylvania, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wyeth Research, Collegeville, Pennsylvania</wicri:regionArea></affiliation></author><author><name sortKey="Fatenejad, S" sort="Fatenejad, S" uniqKey="Fatenejad S" first="S" last="Fatenejad">S. Fatenejad</name><affiliation wicri:level="1"><nlm:aff id="aff11"><addr-line>Wyeth Research, Collegeville, Pennsylvania, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wyeth Research, Collegeville, Pennsylvania</wicri:regionArea></affiliation></author></analytic><series><title level="j">Annals of the Rheumatic Diseases</title><idno type="ISSN">0003-4967</idno><idno type="eISSN">1468-2060</idno><imprint><date when="2008">2008</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Objective:</title><p>To determine the efficacy and safety of etanercept and etanercept plus sulfasalazine versus sulfasalazine in patients with rheumatoid arthritis (RA) despite sulfasalazine therapy.</p></sec><sec><title>Methods:</title><p>Patients were randomly assigned to etanercept (25 mg twice weekly; sulfasalazine was discontinued at baseline), etanercept plus sulfasalazine (unchanged regimen of 2–3 g/day) or sulfasalazine in a double-blind, randomised, 2-year study in adult patients with active RA despite sulfasalazine therapy. Efficacy was assessed using the American College of Rheumatology criteria, disease activity scores (DAS) and patient-reported outcomes (PRO).</p></sec><sec><title>Results:</title><p>Demographic variables and baseline disease characteristics were comparable among treatment groups; mean DAS 5.1, 5.2 and 5.1 for etanercept (n = 103), etanercept plus sulfasalazine (n = 101) and sulfasalazine (n = 50), respectively. Withdrawal due to lack of efficacy was highest with sulfasalazine (26 (52%) vs 6 (6%) for either etanercept group, p<0.001). Patients receiving etanercept or etanercept plus sulfasalazine had a more rapid initial response, which was sustained at 2 years, than those receiving sulfasalazine: mean DAS 2.8, 2.5 versus 4.5, respectively (p<0.05); ACR 20 response was achieved by 67%, 77% versus 34% of patients, respectively (p<0.01) Overall, PRO followed a similar pattern; a clinically significant improvement in health assessment questionnaire was achieved by 76%, 78% versus 40% of patients, respectively (p<0.01). Commonly reported adverse events occurring in the etanercept groups were injection site reactions and pharyngitis/laryngitis (p<0.01).</p></sec><sec><title>Conclusion:</title><p>Etanercept and etanercept plus sulfasalazine are efficacious for the long-term management of patients with RA. The addition of etanercept or substitution with etanercept should be considered as treatment options for patients not adequately responding to sulfasalazine.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="O Ell, Jr" uniqKey="O Ell J">JR O’Dell</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Furst, De" uniqKey="Furst D">DE Furst</name></author><author><name sortKey="Breedveld, Fc" uniqKey="Breedveld F">FC Breedveld</name></author><author><name sortKey="Kalden, Jr" uniqKey="Kalden J">JR Kalden</name></author><author><name sortKey="Smolen, Js" uniqKey="Smolen J">JS Smolen</name></author><author><name sortKey="Burmester, Gr" uniqKey="Burmester G">GR Burmester</name></author><author><name sortKey="Emery, P" uniqKey="Emery P">P Emery</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Weinblatt, Me" uniqKey="Weinblatt M">ME Weinblatt</name></author><author><name 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Ann Rheum Dis</journal-id><journal-id journal-id-type="publisher-id">ard</journal-id><journal-title-group><journal-title>Annals of the Rheumatic Diseases</journal-title></journal-title-group><issn pub-type="ppub">0003-4967</issn><issn pub-type="epub">1468-2060</issn><publisher><publisher-name>BMJ Publishing Group</publisher-name><publisher-loc>BMA House, Tavistock Square, London, WC1H 9JR</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">18794178</article-id><article-id pub-id-type="pmc">2689524</article-id><article-id pub-id-type="publisher-id">ar87106</article-id><article-id pub-id-type="doi">10.1136/ard.2007.087106</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>1506</subject></subj-group><series-title>Extended report</series-title></article-categories><title-group><article-title>Efficacy, safety and patient-reported outcomes of combination etanercept and sulfasalazine versus etanercept alone in patients with rheumatoid arthritis: a double-blind randomised 2-year study</article-title><alt-title alt-title-type="running-head">Extended report</alt-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Combe</surname><given-names>B</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Codreanu</surname><given-names>C</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Fiocco</surname><given-names>U</given-names></name><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Gaubitz</surname><given-names>M</given-names></name><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Geusens</surname><given-names>P P</given-names></name><xref ref-type="aff" rid="aff5">5</xref><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Kvien</surname><given-names>T K</given-names></name><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Pavelka</surname><given-names>K</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Sambrook</surname><given-names>P N</given-names></name><xref ref-type="aff" rid="aff9">9</xref></contrib><contrib contrib-type="author"><name><surname>Smolen</surname><given-names>J S</given-names></name><xref ref-type="aff" rid="aff10">10</xref></contrib><contrib contrib-type="author"><name><surname>Khandker</surname><given-names>R</given-names></name><xref ref-type="aff" rid="aff11">11</xref></contrib><contrib contrib-type="author"><name><surname>Singh</surname><given-names>A</given-names></name><xref ref-type="aff" rid="aff11">11</xref></contrib><contrib contrib-type="author"><name><surname>Wajdula</surname><given-names>J</given-names></name><xref ref-type="aff" rid="aff11">11</xref></contrib><contrib contrib-type="author"><name><surname>Fatenejad</surname><given-names>S</given-names></name><xref ref-type="aff" rid="aff11">11</xref></contrib><contrib contrib-type="author"><collab>for the Etanercept European Investigators Network<sup>*</sup></collab></contrib></contrib-group><aff id="aff1"><label>1</label><addr-line>Service d'Immuno-Rhumatologie, Hopital Lapeyronie, Montpellier, France</addr-line></aff><aff id="aff2"><label>2</label><addr-line>Centrul Metodologic de Reumatologie, Bucuresti, Romania</addr-line></aff><aff id="aff3"><label>3</label><addr-line>Cattedra e Divisione di Reumatologia, Policlinico Universitario, Padova, Italy</addr-line></aff><aff id="aff4"><label>4</label><addr-line>Medical Clinic B Westfalian-Wilhelms-Univ, Munster, Germany</addr-line></aff><aff id="aff5"><label>5</label><addr-line>Biomedical Research Center, University Hasselt, Hasselt, Belgium</addr-line></aff><aff id="aff6"><label>6</label><addr-line>Department of Internal Medicine/Rheumatology, University Maastricht, Maastricht, The Netherlands</addr-line></aff><aff id="aff7"><label>7</label><addr-line>Department of Rheumatology, Diakonhjemmets Hospital, Oslo, Norway</addr-line></aff><aff id="aff8"><label>8</label><addr-line>Institute of Rheumatology, Praha, Czech Republic</addr-line></aff><aff id="aff9"><label>9</label><addr-line>Kolling Institute, University of Sydney, Sydney, Australia</addr-line></aff><aff id="aff10"><label>10</label><addr-line>2nd Department of Medicine, Krankenhaus Lainz and Department of Rheumatology, Internal Medicine III, Medical University of Vienna, Vienna, Austria</addr-line></aff><aff id="aff11"><label>11</label><addr-line>Wyeth Research, Collegeville, Pennsylvania, USA</addr-line></aff><author-notes><corresp>Correspondence to: Dr J Wajdula, Clinical Research and Development, Wyeth Research, 500 Arcola Road, Collegeville, PA 19426, USA; <email>wajdulj@wyeth.com</email></corresp><fn fn-type="other"><p>*Etanercept Study 309 investigators are listed at the end of the paper</p></fn></author-notes><pub-date pub-type="collection"><month>7</month><year>2009</year></pub-date><pub-date pub-type="epub"><day>11</day><month>9</month><year>2008</year></pub-date><volume>68</volume><issue>7</issue><fpage>1146</fpage><lpage>1152</lpage><history><date date-type="accepted"><day>17</day><month>8</month><year>2008</year></date></history><permissions><copyright-statement>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</copyright-statement><copyright-year>2009</copyright-year><license license-type="open-access"><license-p>This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/2.0/">http://creativecommons.org/licenses/by-nc/2.0/</ext-link> and <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/2.0/legalcode">http://creativecommons.org/licenses/by-nc/2.0/legalcode</ext-link>.</license-p></license></permissions><self-uri xlink:title="pdf" xlink:type="simple" xlink:href="ard-68-07-1146.pdf"></self-uri><abstract><sec><title>Objective:</title><p>To determine the efficacy and safety of etanercept and etanercept plus sulfasalazine versus sulfasalazine in patients with rheumatoid arthritis (RA) despite sulfasalazine therapy.</p></sec><sec><title>Methods:</title><p>Patients were randomly assigned to etanercept (25 mg twice weekly; sulfasalazine was discontinued at baseline), etanercept plus sulfasalazine (unchanged regimen of 2–3 g/day) or sulfasalazine in a double-blind, randomised, 2-year study in adult patients with active RA despite sulfasalazine therapy. Efficacy was assessed using the American College of Rheumatology criteria, disease activity scores (DAS) and patient-reported outcomes (PRO).</p></sec><sec><title>Results:</title><p>Demographic variables and baseline disease characteristics were comparable among treatment groups; mean DAS 5.1, 5.2 and 5.1 for etanercept (n = 103), etanercept plus sulfasalazine (n = 101) and sulfasalazine (n = 50), respectively. Withdrawal due to lack of efficacy was highest with sulfasalazine (26 (52%) vs 6 (6%) for either etanercept group, p<0.001). Patients receiving etanercept or etanercept plus sulfasalazine had a more rapid initial response, which was sustained at 2 years, than those receiving sulfasalazine: mean DAS 2.8, 2.5 versus 4.5, respectively (p<0.05); ACR 20 response was achieved by 67%, 77% versus 34% of patients, respectively (p<0.01) Overall, PRO followed a similar pattern; a clinically significant improvement in health assessment questionnaire was achieved by 76%, 78% versus 40% of patients, respectively (p<0.01). Commonly reported adverse events occurring in the etanercept groups were injection site reactions and pharyngitis/laryngitis (p<0.01).</p></sec><sec><title>Conclusion:</title><p>Etanercept and etanercept plus sulfasalazine are efficacious for the long-term management of patients with RA. The addition of etanercept or substitution with etanercept should be considered as treatment options for patients not adequately responding to sulfasalazine.</p></sec></abstract><custom-meta-group><custom-meta><meta-name>special-feature</meta-name><meta-value>unlocked</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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