Impact of intravenous abatacept on synovitis, osteitis and structural damage in patients with rheumatoid arthritis and an inadequate response to methotrexate: the ASSET randomised controlled trial
Identifieur interne : 000053 ( France/Analysis ); précédent : 000052; suivant : 000054Impact of intravenous abatacept on synovitis, osteitis and structural damage in patients with rheumatoid arthritis and an inadequate response to methotrexate: the ASSET randomised controlled trial
Auteurs : Philip G. Conaghan [Royaume-Uni] ; Patrick Durez [Belgique] ; Rieke E. Alten [Allemagne] ; Gerd-Rüdiger Burmester [Allemagne] ; Paul P. Tak [Pays-Bas, Royaume-Uni] ; Lars Klareskog [Suède] ; Anca Irinel Catrina [Suède] ; Julie Dicarlo [États-Unis] ; Corine Gaillez [France] ; Manuela Le Bars [France] ; Xianhuang Zhou [États-Unis] ; Charles Peterfy [États-Unis]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2013-08.
Abstract
Objectives This randomised, double-blind, placebo-controlled phase IIIb study evaluated the impact of abatacept on MRI pathology as a primary outcome in methotrexate (MTX)-refractory patients with rheumatoid arthritis. Methods Patients received intravenous abatacept (∼10 mg/kg) or placebo, on background MTX, for 4 months, followed by an 8-month open-label extension (OLE; all patients received abatacept plus MTX). Patients had 1.5T MRI with intravenous contrast at baseline, Months 4 and 12; wrist synovitis (three locations assessed), and wrist and hand (15 and eight locations assessed, respectively) osteitis and erosion were scored using OMERACT-RAMRIS. Results 26/27 abatacept- and 23/23 placebo-randomised patients completed Month 4 and entered the OLE; 26 and 21 completed Month 12. The primary endpoint was not achieved; mean change (SD) from baseline in synovitis was −0.44 (1.47) for abatacept versus 0.52 (1.38) for placebo (p=0.103) at Month 4. For mean change in synovitis adjusted for baseline score (sensitivity analysis), the difference between groups was −0.69, p=0.078. Adjusted mean changes (SE) in osteitis and erosion were −1.94 (0.86) and 0.45 (0.43) for abatacept, and 1.54 (0.90) and 0.95 (0.45) for placebo. Further MRI improvements were observed up to Month 12 for abatacept and from Months 4 to 12 for placebo-treated patients switched to abatacept at Month 4. Clinical efficacy was shown with abatacept and sustained to Month 12. Conclusions Despite small patient numbers, MRI detected structural and synovial benefit, sustained to Month 12 in abatacept+MTX-treated patients, and improvements in structural and inflammatory outcomes for placebo+MTX-treated patients following addition of abatacept. Clinical trial registration Clinicaltrials.gov NCT00420199.
Url:
- https://api.istex.fr/document/336BCF75DB41E385CD04946756C08C259D9A4808/fulltext/pdf
- http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3711370
DOI: 10.1136/annrheumdis-2012-201611
Affiliations:
- Allemagne, Belgique, France, Pays-Bas, Royaume-Uni, Suède, États-Unis
- Berlin, Californie, Hollande-Septentrionale, New Jersey, Région de Bruxelles-Capitale, Svealand
- Amsterdam, Berlin, Bruxelles, Stockholm
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ISTEX:336BCF75DB41E385CD04946756C08C259D9A4808Le document en format XML
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Conaghan</name><affiliation wicri:level="1"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Section of Musculoskeletal Disease, University of Leeds & NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds</wicri:regionArea><wicri:noRegion>Leeds</wicri:noRegion></affiliation></author><author><name sortKey="Durez, Patrick" sort="Durez, Patrick" uniqKey="Durez P" first="Patrick" last="Durez">Patrick 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="Alten, Rieke E" sort="Alten, Rieke E" uniqKey="Alten R" first="Rieke E" last="Alten">Rieke E. Alten</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Schlosspark-Klinik, University Medicine, Berlin</wicri:regionArea><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Burmester, Gerd Rudiger" sort="Burmester, Gerd Rudiger" uniqKey="Burmester G" first="Gerd-Rüdiger" last="Burmester">Gerd-Rüdiger Burmester</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Rheumatology and Clinical Immunology, Charité-Universitatsmedizin, Berlin</wicri:regionArea><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Tak, Paul P" sort="Tak, Paul P" uniqKey="Tak P" first="Paul P" last="Tak">Paul P. Tak</name><affiliation wicri:level="3"><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Clinical Immunology and Rheumatology, F4-105, Academic Medical Center/University of Amsterdam, Amsterdam</wicri:regionArea><placeName><settlement type="city">Amsterdam</settlement><region nuts="2" type="province">Hollande-Septentrionale</region></placeName></affiliation><affiliation wicri:level="1"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>GlaxoSmithKine, Stevenage</wicri:regionArea><wicri:noRegion>Stevenage</wicri:noRegion></affiliation></author><author><name sortKey="Klareskog, Lars" sort="Klareskog, Lars" uniqKey="Klareskog L" first="Lars" last="Klareskog">Lars Klareskog</name><affiliation wicri:level="3"><country xml:lang="fr">Suède</country><wicri:regionArea>Rheumatology Unit, Department of Medicine, Karolinska Institute and Karolinska University Hospital, Stockholm</wicri:regionArea><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation></author><author><name sortKey="Catrina, Anca Irinel" sort="Catrina, Anca Irinel" uniqKey="Catrina A" first="Anca Irinel" last="Catrina">Anca Irinel Catrina</name><affiliation wicri:level="3"><country xml:lang="fr">Suède</country><wicri:regionArea>Rheumatology Unit, Department of Medicine, Karolinska Institute and Karolinska University Hospital, Stockholm</wicri:regionArea><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation></author><author><name sortKey="Dicarlo, Julie" sort="Dicarlo, Julie" uniqKey="Dicarlo J" first="Julie" last="Dicarlo">Julie Dicarlo</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Spire Sciences LCC, San Francisco, California</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Gaillez, Corine" sort="Gaillez, Corine" uniqKey="Gaillez C" first="Corine" last="Gaillez">Corine Gaillez</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="Le Bars, Manuela" sort="Le Bars, Manuela" uniqKey="Le Bars M" first="Manuela" last="Le Bars">Manuela 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="Zhou, Xianhuang" sort="Zhou, Xianhuang" uniqKey="Zhou X" first="Xianhuang" last="Zhou">Xianhuang 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="Peterfy, Charles" sort="Peterfy, Charles" uniqKey="Peterfy C" first="Charles" last="Peterfy">Charles Peterfy</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Spire Sciences LCC, San Francisco, 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="2013-08">2013-08</date><biblScope unit="volume">72</biblScope><biblScope unit="issue">8</biblScope><biblScope unit="page" from="1287">1287</biblScope></imprint><idno type="ISSN">0003-4967</idno></series><idno type="istex">336BCF75DB41E385CD04946756C08C259D9A4808</idno><idno type="DOI">10.1136/annrheumdis-2012-201611</idno><idno type="href">annrheumdis-72-1287.pdf</idno><idno type="ArticleID">annrheumdis-2012-201611</idno><idno type="PMID">22915624</idno><idno type="local">annrheumdis;72/8/1287</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0003-4967</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Objectives This randomised, double-blind, placebo-controlled phase IIIb study evaluated the impact of abatacept on MRI pathology as a primary outcome in methotrexate (MTX)-refractory patients with rheumatoid arthritis. Methods Patients received intravenous abatacept (∼10 mg/kg) or placebo, on background MTX, for 4 months, followed by an 8-month open-label extension (OLE; all patients received abatacept plus MTX). Patients had 1.5T MRI with intravenous contrast at baseline, Months 4 and 12; wrist synovitis (three locations assessed), and wrist and hand (15 and eight locations assessed, respectively) osteitis and erosion were scored using OMERACT-RAMRIS. Results 26/27 abatacept- and 23/23 placebo-randomised patients completed Month 4 and entered the OLE; 26 and 21 completed Month 12. The primary endpoint was not achieved; mean change (SD) from baseline in synovitis was −0.44 (1.47) for abatacept versus 0.52 (1.38) for placebo (p=0.103) at Month 4. For mean change in synovitis adjusted for baseline score (sensitivity analysis), the difference between groups was −0.69, p=0.078. Adjusted mean changes (SE) in osteitis and erosion were −1.94 (0.86) and 0.45 (0.43) for abatacept, and 1.54 (0.90) and 0.95 (0.45) for placebo. Further MRI improvements were observed up to Month 12 for abatacept and from Months 4 to 12 for placebo-treated patients switched to abatacept at Month 4. Clinical efficacy was shown with abatacept and sustained to Month 12. Conclusions Despite small patient numbers, MRI detected structural and synovial benefit, sustained to Month 12 in abatacept+MTX-treated patients, and improvements in structural and inflammatory outcomes for placebo+MTX-treated patients following addition of abatacept. Clinical trial registration Clinicaltrials.gov NCT00420199.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Belgique</li><li>France</li><li>Pays-Bas</li><li>Royaume-Uni</li><li>Suède</li><li>États-Unis</li></country><region><li>Berlin</li><li>Californie</li><li>Hollande-Septentrionale</li><li>New Jersey</li><li>Région de Bruxelles-Capitale</li><li>Svealand</li></region><settlement><li>Amsterdam</li><li>Berlin</li><li>Bruxelles</li><li>Stockholm</li></settlement></list><tree><country name="Royaume-Uni"><noRegion><name sortKey="Conaghan, Philip G" sort="Conaghan, Philip G" uniqKey="Conaghan P" first="Philip G" last="Conaghan">Philip G. Conaghan</name></noRegion><name sortKey="Tak, Paul P" sort="Tak, Paul P" uniqKey="Tak P" first="Paul P" last="Tak">Paul P. Tak</name></country><country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Durez, Patrick" sort="Durez, Patrick" uniqKey="Durez P" first="Patrick" last="Durez">Patrick Durez</name></region></country><country name="Allemagne"><region name="Berlin"><name sortKey="Alten, Rieke E" sort="Alten, Rieke E" uniqKey="Alten R" first="Rieke E" last="Alten">Rieke E. Alten</name></region><name sortKey="Burmester, Gerd Rudiger" sort="Burmester, Gerd Rudiger" uniqKey="Burmester G" first="Gerd-Rüdiger" last="Burmester">Gerd-Rüdiger Burmester</name></country><country name="Pays-Bas"><region name="Hollande-Septentrionale"><name sortKey="Tak, Paul P" sort="Tak, Paul P" uniqKey="Tak P" first="Paul P" last="Tak">Paul P. Tak</name></region></country><country name="Suède"><region name="Svealand"><name sortKey="Klareskog, Lars" sort="Klareskog, Lars" uniqKey="Klareskog L" first="Lars" last="Klareskog">Lars Klareskog</name></region><name sortKey="Catrina, Anca Irinel" sort="Catrina, Anca Irinel" uniqKey="Catrina A" first="Anca Irinel" last="Catrina">Anca Irinel Catrina</name></country><country name="États-Unis"><region name="Californie"><name sortKey="Dicarlo, Julie" sort="Dicarlo, Julie" uniqKey="Dicarlo J" first="Julie" last="Dicarlo">Julie Dicarlo</name></region><name sortKey="Peterfy, Charles" sort="Peterfy, Charles" uniqKey="Peterfy C" first="Charles" last="Peterfy">Charles Peterfy</name><name sortKey="Zhou, Xianhuang" sort="Zhou, Xianhuang" uniqKey="Zhou X" first="Xianhuang" last="Zhou">Xianhuang Zhou</name></country><country name="France"><noRegion><name sortKey="Gaillez, Corine" sort="Gaillez, Corine" uniqKey="Gaillez C" first="Corine" last="Gaillez">Corine Gaillez</name></noRegion><name sortKey="Le Bars, Manuela" sort="Le Bars, Manuela" uniqKey="Le Bars M" first="Manuela" last="Le Bars">Manuela Le Bars</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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