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 : 000273 ( France/Analysis ); précédent : 000272; suivant : 000274The 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 [États-Unis] ; C. Pritchard [États-Unis] ; J E Huffstutter [États-Unis] ; V. Rodriguez-Valverde [Espagne] ; P. Durez [Belgique] ; X. Zhou [États-Unis] ; T. Li [États-Unis] ; K. Bahrt [États-Unis] ; S. Kelly [États-Unis] ; M. Le Bars [France] ; M C Genovese [États-Unis]Source :
- 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
Affiliations:
- Belgique, Espagne, France, États-Unis
- Californie, Colorado, New Jersey, Pennsylvanie, Région de Bruxelles-Capitale, Tennessee
- Bruxelles
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Durez</name></author><author><name sortKey="Zhou, X" sort="Zhou, X" uniqKey="Zhou X" first="X" last="Zhou">X. Zhou</name></author><author><name sortKey="Li, T" sort="Li, T" uniqKey="Li T" first="T" last="Li">T. Li</name></author><author><name sortKey="Bahrt, K" sort="Bahrt, K" uniqKey="Bahrt K" first="K" last="Bahrt">K. Bahrt</name></author><author><name sortKey="Kelly, S" sort="Kelly, S" uniqKey="Kelly S" first="S" last="Kelly">S. Kelly</name></author><author><name sortKey="Le Bars, M" sort="Le Bars, M" uniqKey="Le Bars M" first="M" last="Le Bars">M. 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Schiff</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Colorado, Denver, Colorado</wicri:regionArea><placeName><region type="state">Colorado</region></placeName></affiliation></author><author><name sortKey="Pritchard, C" sort="Pritchard, C" uniqKey="Pritchard C" first="C" last="Pritchard">C. Pritchard</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Rheumatology Specialty Center, Willow Grove, Pennsylvania</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></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 wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Arthritis Associates, Hixson, Tennessee</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></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 wicri:level="1"><country xml:lang="fr">Espagne</country><wicri:regionArea>Hospital Universitario Marques De Valdecilla, Universidad de Cantabria, Santander</wicri:regionArea><wicri:noRegion>Santander</wicri:noRegion></affiliation></author><author><name sortKey="Durez, P" sort="Durez, P" uniqKey="Durez P" first="P" last="Durez">P. Durez</name><affiliation wicri:level="3"><country xml:lang="fr">Belgique</country><wicri:regionArea>Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName></affiliation></author><author><name sortKey="Zhou, X" sort="Zhou, X" uniqKey="Zhou X" first="X" last="Zhou">X. Zhou</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Bristol-Myers Squibb, Princeton, New Jersey</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Li, T" sort="Li, T" uniqKey="Li T" first="T" last="Li">T. Li</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Bristol-Myers Squibb, Princeton, New Jersey</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Bahrt, K" sort="Bahrt, K" uniqKey="Bahrt K" first="K" last="Bahrt">K. Bahrt</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Bristol-Myers Squibb, Princeton, New Jersey</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Kelly, S" sort="Kelly, S" uniqKey="Kelly S" first="S" last="Kelly">S. Kelly</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Bristol-Myers Squibb, Princeton, New Jersey</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></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 wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Bristol-Myers Squibb, Rueil-Malmaison</wicri:regionArea><wicri:noRegion>Rueil-Malmaison</wicri:noRegion><wicri:noRegion>Rueil-Malmaison</wicri:noRegion></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 wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Stanford University, Palo Alto, California</wicri:regionArea><placeName><region type="state">Californie</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="2009-11">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. Trial registration number: NCT00124982.</div></front></TEI><affiliations><list><country><li>Belgique</li><li>Espagne</li><li>France</li><li>États-Unis</li></country><region><li>Californie</li><li>Colorado</li><li>New Jersey</li><li>Pennsylvanie</li><li>Région de Bruxelles-Capitale</li><li>Tennessee</li></region><settlement><li>Bruxelles</li></settlement></list><tree><country name="États-Unis"><region name="Colorado"><name sortKey="Schiff, M" sort="Schiff, M" uniqKey="Schiff M" first="M" last="Schiff">M. Schiff</name></region><name sortKey="Bahrt, K" sort="Bahrt, K" uniqKey="Bahrt K" first="K" last="Bahrt">K. Bahrt</name><name sortKey="Genovese, M C" sort="Genovese, M C" uniqKey="Genovese M" first="M C" last="Genovese">M C Genovese</name><name sortKey="Huffstutter, J E" sort="Huffstutter, J E" uniqKey="Huffstutter J" first="J E" last="Huffstutter">J E Huffstutter</name><name sortKey="Kelly, S" sort="Kelly, S" uniqKey="Kelly S" first="S" last="Kelly">S. Kelly</name><name sortKey="Li, T" sort="Li, T" uniqKey="Li T" first="T" last="Li">T. Li</name><name sortKey="Pritchard, C" sort="Pritchard, C" uniqKey="Pritchard C" first="C" last="Pritchard">C. Pritchard</name><name sortKey="Zhou, X" sort="Zhou, X" uniqKey="Zhou X" first="X" last="Zhou">X. Zhou</name></country><country name="Espagne"><noRegion><name sortKey="Rodriguez Valverde, V" sort="Rodriguez Valverde, V" uniqKey="Rodriguez Valverde V" first="V" last="Rodriguez-Valverde">V. Rodriguez-Valverde</name></noRegion></country><country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Durez, P" sort="Durez, P" uniqKey="Durez P" first="P" last="Durez">P. Durez</name></region></country><country name="France"><noRegion><name sortKey="Le Bars, M" sort="Le Bars, M" uniqKey="Le Bars M" first="M" last="Le Bars">M. Le Bars</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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