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 : 007E81 ( Main/Exploration ); précédent : 007E80; suivant : 007E82Efficacy, 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 ] ; 2009-07.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
- Adalimumab, Adverse events, American college, Antiinflammatory agent, Antirheumatic drugs, Arthritis, Baseline, Chronic, Clinical studies, Combination group, Combination groups, Combination therapy, Comparative study, Czech republic, Disability index, Disease activity, Disease activity score, Dmard, Double blind study, Etanercept, Etanercept group, Etanercept groups, Ghvas, Health assessment questionnaire, Health status measures, Higher proportion, Human, Immunomodulator, Inadequate response, Leucopenia, Methotrexate, Monotherapy, Pgad, Physical function, Prognosis, Response rates, Rheum, Rheumatoid, Rheumatoid arthritis, Rheumatology, Significant differences, Significant improvement, Sulfasalazine, Sulfasalazine combination, Sulfasalazine group, Sulfasalazine therapy, Teae, Toxicity, Treatment groups, Wyeth, Wyeth research.
- Teeft :
- Adalimumab, Adverse events, American college, Antirheumatic drugs, Arthritis, Baseline, Clinical studies, Combination group, Combination groups, Combination therapy, Czech republic, Disability index, Disease activity, Disease activity score, Dmard, Etanercept, Etanercept group, Etanercept groups, Ghvas, Health assessment questionnaire, Health status measures, Higher proportion, Inadequate response, Leucopenia, Methotrexate, Monotherapy, Pgad, Physical function, Response rates, Rheum, Rheumatoid, Rheumatoid arthritis, Rheumatology, Significant differences, Significant improvement, Sulfasalazine, Sulfasalazine combination, Sulfasalazine group, Sulfasalazine therapy, Teae, Treatment groups, Wyeth, Wyeth research.
Abstract
Objective: To determine the efficacy and safety of etanercept and etanercept plus sulfasalazine versus sulfasalazine in patients with rheumatoid arthritis (RA) despite sulfasalazine therapy. Methods: 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). Results: 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). Conclusion: 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.
Url:
- https://api.istex.fr/document/2C7FE373662F88963FEA23D20DD755C7310C79F9/fulltext/pdf
- http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2689524
DOI: 10.1136/ard.2007.087106
Affiliations:
- Allemagne, Australie, Autriche, Belgique, France, Italie, Norvège, Pays-Bas, Roumanie, République tchèque, États-Unis
- Bohême centrale, Languedoc-Roussillon, Nouvelle-Galles du Sud, Occitanie (région administrative), Pennsylvanie, Vienne (Autriche), Østlandet
- Montpellier, Oslo, Prague, Sydney, Vienne (Autriche)
- Université de Sydney
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Combe</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Service d’Immuno-Rhumatologie, Hopital Lapeyronie, Montpellier</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author><author><name sortKey="Codreanu, C" sort="Codreanu, C" uniqKey="Codreanu C" first="C" last="Codreanu">C. Codreanu</name><affiliation wicri:level="1"><country xml:lang="fr">Roumanie</country><wicri:regionArea>Centrul Metodologic de Reumatologie, Bucuresti</wicri:regionArea><wicri:noRegion>Bucuresti</wicri:noRegion></affiliation></author><author><name sortKey="Fiocco, U" sort="Fiocco, U" uniqKey="Fiocco U" first="U" last="Fiocco">U. Fiocco</name><affiliation wicri:level="1"><country xml:lang="fr">Italie</country><wicri:regionArea>Cattedra e Divisione di Reumatologia, Policlinico Universitario, Padova</wicri:regionArea><wicri:noRegion>Padova</wicri:noRegion></affiliation></author><author><name sortKey="Gaubitz, M" sort="Gaubitz, M" uniqKey="Gaubitz M" first="M" last="Gaubitz">M. Gaubitz</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Medical Clinic B Westfalian-Wilhelms-Univ, Munster</wicri:regionArea><wicri:noRegion>Munster</wicri:noRegion><wicri:noRegion>Munster</wicri:noRegion></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"><country xml:lang="fr">Belgique</country><wicri:regionArea>Biomedical Research Center, University Hasselt, Hasselt</wicri:regionArea><wicri:noRegion>Hasselt</wicri:noRegion></affiliation><affiliation wicri:level="1"><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Internal Medicine/Rheumatology, University Maastricht, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></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="3"><country xml:lang="fr">Norvège</country><wicri:regionArea>Department of Rheumatology, Diakonhjemmets Hospital, Oslo</wicri:regionArea><placeName><settlement type="city">Oslo</settlement><region nuts="2">Østlandet</region></placeName></affiliation></author><author><name sortKey="Pavelka, K" sort="Pavelka, K" uniqKey="Pavelka K" first="K" last="Pavelka">K. Pavelka</name><affiliation wicri:level="3"><country xml:lang="fr">République tchèque</country><wicri:regionArea>Institute of Rheumatology, Praha</wicri:regionArea><placeName><settlement type="city">Prague</settlement><region type="région" nuts="2">Bohême centrale</region></placeName></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="4"><country xml:lang="fr">Australie</country><wicri:regionArea>Kolling Institute, University of Sydney, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region><settlement type="city">Sydney</settlement></placeName><orgName type="university">Université de Sydney</orgName></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="3"><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><placeName><settlement type="city">Vienne (Autriche)</settlement><region nuts="2" type="province">Vienne (Autriche)</region></placeName></affiliation></author><author><name sortKey="Khandker, R" sort="Khandker, R" uniqKey="Khandker R" first="R" last="Khandker">R. Khandker</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wyeth Research, Collegeville, Pennsylvania</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Singh, A" sort="Singh, A" uniqKey="Singh A" first="A" last="Singh">A. Singh</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wyeth Research, Collegeville, Pennsylvania</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Wajdula, J" sort="Wajdula, J" uniqKey="Wajdula J" first="J" last="Wajdula">J. Wajdula</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wyeth Research, Collegeville, Pennsylvania</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Fatenejad, S" sort="Fatenejad, S" uniqKey="Fatenejad S" first="S" last="Fatenejad">S. Fatenejad</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Wyeth Research, Collegeville, Pennsylvania</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></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="2009-07">2009-07</date><biblScope unit="volume">68</biblScope><biblScope unit="issue">7</biblScope><biblScope unit="page" from="1146">1146</biblScope></imprint><idno type="ISSN">0003-4967</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0003-4967</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adalimumab</term><term>Adverse events</term><term>American college</term><term>Antiinflammatory agent</term><term>Antirheumatic drugs</term><term>Arthritis</term><term>Baseline</term><term>Chronic</term><term>Clinical studies</term><term>Combination group</term><term>Combination groups</term><term>Combination therapy</term><term>Comparative study</term><term>Czech republic</term><term>Disability index</term><term>Disease activity</term><term>Disease activity score</term><term>Dmard</term><term>Double blind study</term><term>Etanercept</term><term>Etanercept group</term><term>Etanercept groups</term><term>Ghvas</term><term>Health assessment questionnaire</term><term>Health status measures</term><term>Higher proportion</term><term>Human</term><term>Immunomodulator</term><term>Inadequate response</term><term>Leucopenia</term><term>Methotrexate</term><term>Monotherapy</term><term>Pgad</term><term>Physical function</term><term>Prognosis</term><term>Response rates</term><term>Rheum</term><term>Rheumatoid</term><term>Rheumatoid arthritis</term><term>Rheumatology</term><term>Significant differences</term><term>Significant improvement</term><term>Sulfasalazine</term><term>Sulfasalazine combination</term><term>Sulfasalazine group</term><term>Sulfasalazine therapy</term><term>Teae</term><term>Toxicity</term><term>Treatment groups</term><term>Wyeth</term><term>Wyeth research</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Antiinflammatoire</term><term>Chronique</term><term>Etanercept</term><term>Etude comparative</term><term>Etude double insu</term><term>Homme</term><term>Immunomodulateur</term><term>Polyarthrite rhumatoïde</term><term>Pronostic</term><term>Rhumatologie</term><term>Sulfasalazine</term><term>Toxicité</term></keywords><keywords scheme="Teeft" xml:lang="en"><term>Adalimumab</term><term>Adverse events</term><term>American college</term><term>Antirheumatic drugs</term><term>Arthritis</term><term>Baseline</term><term>Clinical studies</term><term>Combination group</term><term>Combination groups</term><term>Combination therapy</term><term>Czech republic</term><term>Disability index</term><term>Disease activity</term><term>Disease activity score</term><term>Dmard</term><term>Etanercept</term><term>Etanercept group</term><term>Etanercept groups</term><term>Ghvas</term><term>Health assessment questionnaire</term><term>Health status measures</term><term>Higher proportion</term><term>Inadequate response</term><term>Leucopenia</term><term>Methotrexate</term><term>Monotherapy</term><term>Pgad</term><term>Physical function</term><term>Response rates</term><term>Rheum</term><term>Rheumatoid</term><term>Rheumatoid arthritis</term><term>Rheumatology</term><term>Significant differences</term><term>Significant improvement</term><term>Sulfasalazine</term><term>Sulfasalazine combination</term><term>Sulfasalazine group</term><term>Sulfasalazine therapy</term><term>Teae</term><term>Treatment groups</term><term>Wyeth</term><term>Wyeth research</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Objective: To determine the efficacy and safety of etanercept and etanercept plus sulfasalazine versus sulfasalazine in patients with rheumatoid arthritis (RA) despite sulfasalazine therapy. Methods: 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). Results: 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). Conclusion: 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.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Autriche</li><li>Belgique</li><li>France</li><li>Italie</li><li>Norvège</li><li>Pays-Bas</li><li>Roumanie</li><li>République tchèque</li><li>États-Unis</li></country><region><li>Bohême centrale</li><li>Languedoc-Roussillon</li><li>Nouvelle-Galles du Sud</li><li>Occitanie (région administrative)</li><li>Pennsylvanie</li><li>Vienne (Autriche)</li><li>Østlandet</li></region><settlement><li>Montpellier</li><li>Oslo</li><li>Prague</li><li>Sydney</li><li>Vienne (Autriche)</li></settlement><orgName><li>Université de Sydney</li></orgName></list><tree><country name="France"><region name="Occitanie (région administrative)"><name sortKey="Combe, B" sort="Combe, B" uniqKey="Combe B" first="B" last="Combe">B. Combe</name></region></country><country name="Roumanie"><noRegion><name sortKey="Codreanu, C" sort="Codreanu, C" uniqKey="Codreanu C" first="C" last="Codreanu">C. Codreanu</name></noRegion></country><country name="Italie"><noRegion><name sortKey="Fiocco, U" sort="Fiocco, U" uniqKey="Fiocco U" first="U" last="Fiocco">U. Fiocco</name></noRegion></country><country name="Allemagne"><noRegion><name sortKey="Gaubitz, M" sort="Gaubitz, M" uniqKey="Gaubitz M" first="M" last="Gaubitz">M. Gaubitz</name></noRegion></country><country name="Belgique"><noRegion><name sortKey="Geusens, P P" sort="Geusens, P P" uniqKey="Geusens P" first="P P" last="Geusens">P P Geusens</name></noRegion></country><country name="Pays-Bas"><noRegion><name sortKey="Geusens, P P" sort="Geusens, P P" uniqKey="Geusens P" first="P P" last="Geusens">P P Geusens</name></noRegion></country><country name="Norvège"><region name="Østlandet"><name sortKey="Kvien, T K" sort="Kvien, T K" uniqKey="Kvien T" first="T K" last="Kvien">T K Kvien</name></region></country><country name="République tchèque"><region name="Bohême centrale"><name sortKey="Pavelka, K" sort="Pavelka, K" uniqKey="Pavelka K" first="K" last="Pavelka">K. Pavelka</name></region></country><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Sambrook, P N" sort="Sambrook, P N" uniqKey="Sambrook P" first="P N" last="Sambrook">P N Sambrook</name></region></country><country name="Autriche"><region name="Vienne (Autriche)"><name sortKey="Smolen, J S" sort="Smolen, J S" uniqKey="Smolen J" first="J S" last="Smolen">J S Smolen</name></region></country><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Khandker, R" sort="Khandker, R" uniqKey="Khandker R" first="R" last="Khandker">R. Khandker</name></region><name sortKey="Fatenejad, S" sort="Fatenejad, S" uniqKey="Fatenejad S" first="S" last="Fatenejad">S. Fatenejad</name><name sortKey="Singh, A" sort="Singh, A" uniqKey="Singh A" first="A" last="Singh">A. Singh</name><name sortKey="Wajdula, J" sort="Wajdula, J" uniqKey="Wajdula J" first="J" last="Wajdula">J. Wajdula</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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